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From the 1/14/2022 release of VAERS data:

Found 1,031,637 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 537 out of 10,317

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VAERS ID: 1904624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Chills, Fatigue, Lymphadenopathy, Pyrexia, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema (Viral induced angioedema, last episode 4 years ago); Clinical trial participant; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSA2021SA390361

Write-up: fever; lymphadenopathy; fatigue; Shivers; Tongue started swelling; had viral induced angioedema; Initial information received on 23-Nov-2021 regarding an unsolicited valid serious case from consumer/non health care professional via Regulatory Authority (under reference GB-MHRA-WEBCOVID-202111201217452070-J8MQ4). This case involves a 55 years old female patient (height: 175 cm and weight: 75 kg) who had fever (pyrexia), lymphadenopathy, fatigue, shivers (chills), tongue started swelling (swollen tongue) and viral induced angioedema (angioedema) after receiving INFLUENZA VACCINE and COVID-19 VACCINE MRNA. The patient''s medical history included angioedema with Viral induced angioedema, last episode 4 years ago and was Clinical trial participant. The patient''s past medical treatment included EVOREL CONTI on 06-Jun-2019. The patient''s past vaccination(s) included COVID-19 VACCINE MRNA on 21-Apr-2021 (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. The patient''s past family history was not provided. Patient had not symptoms associated with coronavirus disease 2019 (COVID-19) and not had a COVID-19 test. Patient is not pregnant and not currently breastfeeding. On 18-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site and a dose of suspect COVID-19 VACCINE MRNA not produced by Sanofi Pasteur (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. On an unknown date the patient developed a serious fever (pyrexia) and lymphadenopathy (unknown latency) following the administration of vaccines. On 19-Nov-2021 the patient developed a serious fatigue, shivers (chills), tongue started swelling (swollen tongue) and viral induced angioedema (angioedema), one day following the administration of vaccines. This events were assessed as medically significant. No laboratory data reported. It was reported that patient had Fever, lymphadenopathy worse than previous doses. Spent 19/11 in bed with fatigue and shivers. Tongue started swelling during the night of 19/11/21. No respiratory obstruction. Settling with ice cubes. Of note patient had viral induced angioedema after previous bad colds, so not an anaphylactic reaction. Patient has not tested positive for COVID-19 since having the vaccine. The patient was treated with PREDNISOLONE (gargle) for Swollen tongue. The possible inflammation of the heart (myocarditis or pericarditis) was not related to patients report. No other relevant investigations or tests conducted. At time of reporting, the outcome was unknown for the event swollen tongue. The patient was recovering for rest of all the events. There would be no information on the batch number for this case.; Sender''s Comments: This case concerns a 55-year-old female patient who had pyrexia, lymphadenopathy, fatigue, chills, swollen tongue and angioedema after vaccination with INFLUENZA VACCINE and COVID-19 VACCINE MRNA. The time to onset is compatible. The patient''s medical history included angioedema with Viral induced angioedema, last episode 4 years ago and was Clinical trial participant. The patient''s past medical treatment included EVOREL CONTI on 06-Jun-2019. The patient''s past vaccination(s) included COVID-19 VACCINE MRNA on 21-Apr-2021. However, patient''s medical condition at the time of vaccination and relevant laboratory data were not reported. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 1904933 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Piloerection, Pyrexia, SARS-CoV-2 test, Yawning
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MODERNA
Current Illness: Osteoarthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: goosebumps; headache; yawning; Rigours; High temperature; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231272) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PILOERECTION (goosebumps), HEADACHE (headache), YAWNING (yawning), CHILLS (Rigours) and PYREXIA (High temperature) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)), ZUMENON (Patient take HRT Zumenon) and DIHYDROCODEINE (Patient take dyhydrocodeine for painful osteoarthritis.). Past adverse reactions to the above products included No adverse event with DIHYDROCODEINE, Steroid therapy and ZUMENON. Concurrent medical conditions included Osteoarthritis. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced CHILLS (Rigours) (seriousness criterion disability) and PYREXIA (High temperature) (seriousness criterion disability). On an unknown date, the patient experienced PILOERECTION (goosebumps) (seriousness criterion disability), HEADACHE (headache) (seriousness criterion disability) and YAWNING (yawning) (seriousness criterion disability). On 20-Nov-2021, CHILLS (Rigours) and PYREXIA (High temperature) was resolving. At the time of the report, PILOERECTION (goosebumps), HEADACHE (headache) and YAWNING (yawning) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient started to shake really bad, constant yawning, goosebumps, body hot to touch. Headache. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Took temperature which was 40A. No treatment information was provided. This a regulatory authority case concerning a 49-year-old, female patient with medical history of steriod therapy, zumenon and dihydrocodeine, who experienced the unexpected serious events of Piloerection, Headache, Yawning, Chills, Pyrexia .The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The use of concomitant medication remains a confounder The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine in not affected by this report.; Sender''s Comments: This a regulatory authority case concerning a 49-year-old, female patient with medical history of steriod therapy, zumenon and dihydrocodeine, who experienced the unexpected serious events of Piloerection, Headache, Yawning, Chills, Pyrexia .The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The use of concomitant medication remains a confounder The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine in not affected by this report.


VAERS ID: 1904984 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pruritus, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: itchy; high temperature; Rash; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 26231683) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itchy), PYREXIA (high temperature) and RASH (Rash) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itchy) (seriousness criterion medically significant) and PYREXIA (high temperature) (seriousness criterion medically significant). On 20-Nov-2021, RASH (Rash) was resolving. At the time of the report, PRURITUS (itchy) and PYREXIA (high temperature) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided Treatment information was not provided Reported text for relevant medical history : underwent thyroid surgery in March 2021. Not on any meds. Reported that the next day after the second dose Patient woke up with high temperature (38.5), body aching and a lump on the vaccination site. A bit later noticed an extended rash covering neck, torso (front and back) except arms. The area appears swollen, warm at touch and itchy around the neck. Reported that report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 44-year-old female patient with no relevant medical history, who experienced the unexpected events of Rash, Pruritus, and Pyrexia. The event occurred 1 day after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old female patient with no relevant medical history, who experienced the unexpected events of Rash, Pruritus, and Pyrexia. The event occurred 1 day after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1904987 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Fever; Chills; Muscle ache; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231939) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Clinical trial participant. On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Reported that Clinical trial participant Study details: Valneva COVID-19 vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This is a regulatory authority case concerning a 24-year-old, female patient with medical history of clinical trial participant (Valneva Covid-19 vaccine), who experienced the unexpected serious events of pyrexia, headache, chills, myalgia and nausea. The events pyrexia, headache, chills and myalgia occurred 1 day after the first dose of mRNA-1273 vaccine administration while the event nausea occurred 2 days after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 24-year-old, female patient with medical history of clinical trial participant (Valneva Covid-19 vaccine), who experienced the unexpected serious events of pyrexia, headache, chills, myalgia and nausea. The events pyrexia, headache, chills and myalgia occurred 1 day after the first dose of mRNA-1273 vaccine administration while the event nausea occurred 2 days after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1904988 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Illness, Influenza, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data: Test Date: 20201119; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBSA2021SA390357

Write-up: shivering; fever; headache; sickness; Flu; Initial information was received on 23-Nov-2021 regarding an unsolicited valid serious case received from consumer/non health care professional via Health Authority (under reference number GB-MHRA-WEBCOVID-202111210307057400-FVQVZ). This case involves a 63-year-old female patient (Height: 167 cm and Weight: 83 kg) who experienced flu (influenza), shivering (chills), fever (pyrexia), headache and sickness (illness), after receiving INFLUENZA VACCINE and ELASOMERAN [COVID-19 VACCINE MODERNA]. The patient''s medical history included Suspected COVID-19 on 19-NOV-2020 [unsure when symptoms stopped]. Covid-19 virus test on 19-Nov-2020 was positive. The patient''s past vaccinations included two doses of SARS-COV-2 VIRUS for prophylactic vaccination. The patient''s past medical treatments, concomitant medications and family history were not provided. On 19-Nov-2021, the patient received a dose of suspect COVID-19 VACCINE MODERNA not produced by Sanofi Pasteur [lot 3004675 and expiry date was not reported] via unknown route at unknown administration site for prophylactic vaccination. On 19-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date were not reported] via unknown route at unknown administration site for prophylactic vaccination. On 19-Nov-2021, the patient developed serious flu (influenza) on the same day following the administration of INFLUENZA VACCINE and COVID-19 VACCINE MODERNA. On an unknown date, the patient developed serious shivering (chills), fever (pyrexia), headache and sickness (illness) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE MODERNA. All the events were assessed as medically significant. Patient was not enrolled in clinical trial. Patient''s report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No related laboratory data was reported. It was not reported if the patient received any corrective treatment. At time of reporting, the patient was recovering from Flu and not recovered from rest reported events. There will be no information on the lot number for INFLUENZA VACCINE in this case.; Sender''s Comments: This case involves 63-year-old female patient who experienced influenza, chills, pyrexia, headache and illness, after vaccination with INFLUENZA VACCINE [unknown manufacturer] and ELASOMERAN [COVID-19 VACCINE MODERNA] [not produced by Sanofi pasteur]. The time to onset was compatible for influenza. The patient''s medical history included Suspected COVID-19. The patient''s past vaccinations included two doses of SARS-COV-2 VIRUS vaccine. Further information regarding medical history, concurrent condition during vaccination and tolerance, allergic history, laboratory investigations, concomitant medications excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of an individual suspect vaccine cannot be assessed.


VAERS ID: 1906892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Sensitive skin
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Hypersensitive skin; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231860) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Hypersensitive skin) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SENSITIVE SKIN (Hypersensitive skin) (seriousness criterion medically significant). At the time of the report, SENSITIVE SKIN (Hypersensitive skin) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. Company Comment: This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of sensitive skin. The event occurred the same day after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a female patient of unknown age, with no relevant medical history reported, who experienced the unexpected event of sensitive skin. The event occurred the same day after an unknown number of doses of mRNA-1273. The rechallenge was unknown since no information regarding the number of the doses was disclosed. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907281 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Head pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26228593) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Head pain) in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Head pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medication list was not provided. Treatment information was not provided. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant, Patient is not currently breastfeeding. It was reported that sharp head pain on left side. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 54-year-old female patient, with no relevant medical history, who experienced the unexpected serious event of HEADACHE. The event occurred on the following day of after the administration of the third dose (unknown dosage) of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 54-year-old female patient, with no relevant medical history, who experienced the unexpected serious event of HEADACHE. The event occurred on the following day of after the administration of the third dose (unknown dosage) of mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1907294 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26230656) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 67-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Flu vaccination. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient had sore arm, and was not able to lift it, and also had backache, shoulder ache, neck ache and headache. No treatment information was provided. The patient was not tested positive for COVID-19 since having the vaccine, neither had associated symptoms and also had not undergone COVID-19 test. The patient was not enrolled in any clinical trial. Company comment: This regulatory authority case concerns a 67-year-old female patient with no relevant medical history who experienced serious unexpected event of myalgia. The event occurred approximately one day after the third dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 67-year-old female patient with no relevant medical history who experienced serious unexpected event of myalgia. The event occurred approximately one day after the third dose of the Moderna COVID-19 vaccine . Rechallenge was not applicable since the event occurred after the third dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1907302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, SARS-CoV-2 test, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MRNA (BNT162B2)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Nausea; Vertigo; This case was received(Reference number: ADR 26231179) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and VERTIGO (Vertigo) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE MRNA (BNT162B2) from 29-Apr-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 20-Nov-2021, VERTIGO (Vertigo) had resolved. At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not had symptoms associated with COVID-19 . In the evening, approximately 10 hours after having the booster jab, the patient experienced a sensation of vertigo & disequilibrium, as if the room was spinning, even when lying down. This had resolved by morning but she was left with a headache and nausea. Treatment medication were not reported. Company Comment: This regulatory case concerns a female patient of unknown age, with unknown medical history, who experienced the serious unexpected events of VERTIGO, HEADACHE and NAUSEA. The event of vertigo occurred on the same day after receiving a booster dose of mRNA-1273. No date of occurrence was reported for headache and nausea. Patient previous vaccination schedule included COVID 19 mRNA Vaccine BIONTECH. The rechallenge was captured unknown as per the regulatory authority assessment. Patient states she experienced vertigo 10 hours after vaccination and that it solved by the next morning. She had headache and nausea after the event of vertigo resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness and terms captured as per regulatory authority assessment.; Sender''s Comments: This regulatory case concerns a female patient of unknown age, with unknown medical history, who experienced the serious unexpected events of VERTIGO, HEADACHE and NAUSEA. The event of vertigo occurred on the same day after receiving a booster dose of mRNA-1273. No date of occurrence was reported for headache and nausea. Patient previous vaccination schedule included COVID 19 mRNA Vaccine BIONTECH. The rechallenge was captured unknown as per the regulatory authority assessment. Patient states she experienced vertigo 10 hours after vaccination and that it solved by the next morning. She had headache and nausea after the event of vertigo resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness and terms captured as per regulatory authority assessment.


VAERS ID: 1907304 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dyspnoea, Fatigue, Insomnia, Lethargy, Pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPRO; BISOPROLOL; COVID-19 VACCINE ASTRAZENECA; GLYCERYL TRINITRATE; HYDROXOCOBALAMIN; OMEPRAZOLE; RAMIPRIL; SPIROLACTONE; VITAMIN B12 NOS
Current Illness: Scoliosis (Had scoliosis all my life, but it got much worse when being kicked into menopause with chemo. Had spine straightened with rods and pins in 2008 at Hospital); Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Chemotherapy; Mastectomy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Aching joints; Swollen arm; Tired out; Lethargic; Short of breath; Generalised aching; Difficulty sleeping; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26231259) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Aching joints), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Tired out), LETHARGY (Lethargic), DYSPNOEA (Short of breath), PAIN (Generalised aching) and INSOMNIA (Difficulty sleeping) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Breast cancer, Mastectomy in June 2005 and Chemotherapy in June 2005. Concurrent medical conditions included Scoliosis (Had scoliosis all my life, but it got much worse when being kicked into menopause with chemo. Had spine straightened with rods and pins in 2008 at Hospital.) and Suspected COVID-19 since 30-Oct-2021. Concomitant products included OMEPRAZOLE from May 2018 to an unknown date for Barrett''s esophagus, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 20-Feb-2021 to an unknown date for COVID-19 vaccination, ACETYLSALICYLIC ACID, ASPIRIN (ASPRO) from October 2017 to an unknown date, BISOPROLOL from October 2017 to an unknown date, GLYCERYL TRINITRATE from October 2017 to an unknown date and SPIROLACTONE from November 2017 to an unknown date for Heart failure, RAMIPRIL from October 2017 to an unknown date for Hypertension, HYDROXOCOBALAMIN from May 2010 to an unknown date for Vitamin B12 deficiency, VITAMIN B12 NOS for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), FATIGUE (Tired out) (seriousness criterion medically significant), LETHARGY (Lethargic) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Aching joints), PERIPHERAL SWELLING (Swollen arm), FATIGUE (Tired out), LETHARGY (Lethargic), DYSPNOEA (Short of breath), PAIN (Generalised aching) and INSOMNIA (Difficulty sleeping) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient had scoliosis all my life, but it got much worse when being kicked into menopause with chemotherapy. She had spine straightened with rods and pins in 2008. It was reported that due to have B12 injection (last one was 26th August) but cannot get nurses appointment at surgery until Tuesday 7th December, so perhaps naturally flagging because of this. The patient had no idea on state of her heart, once discharged from the hospital in 2018, there was no follow up on condition of heart. It was reported that all the tests with heart carried out 2017/2018. No treatment information was reported. Company Comment: This is a regulatory case concerning a 63-year-old female patient with medical history of breast cancer, mastectomy and chemotherapy on 2005/06 and scoliosis (surgery in 2008) who experienced the serious (medically significant) events arthralgia, swollen arm, fatigue, lethargy, dispnoea, generalised aching and insomnia. The events occurred approximately one-two days after the third dose of COVID-19 vaccination (first dose of mRNA-1273, previous CHADOX1 NCOV-19 - ASTRAZENECA). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 63-year-old female patient with medical history of breast cancer, mastectomy and chemotherapy on 2005/06 and scoliosis (surgery in 2008) who experienced the serious (medically significant) events arthralgia, swollen arm, fatigue, lethargy, dispnoea, generalised aching and insomnia. The events occurred approximately one-two days after the third dose of COVID-19 vaccination (first dose of mRNA-1273, previous CHADOX1 NCOV-19 - ASTRAZENECA). The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1907305 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness postural, Hyperhidrosis, Nausea, Pruritus, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BACLOFEN; CHLORPHENAMINE MALEATE; CONTIFLO; GABAPENTIN; LANSOPRAZOLE; MEBEVERINE; SOLIFENACIN
Current Illness: Multiple sclerosis (Taking medicines for multiple sclerosis)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No-Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Red rash; Sweating; Dizzy on standing; Itchy legs; Itchy scalp; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26231268) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), RASH ERYTHEMATOUS (Red rash), HYPERHIDROSIS (Sweating), DIZZINESS POSTURAL (Dizzy on standing), PRURITUS (Itchy legs) and PRURITUS (Itchy scalp) in a 64-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Multiple sclerosis (Taking medicines for multiple sclerosis). Concomitant products included CHLORPHENAMINE MALEATE for Allergy, BACLOFEN, TAMSULOSIN HYDROCHLORIDE (CONTIFLO), GABAPENTIN, LANSOPRAZOLE, MEBEVERINE and SOLIFENACIN for Secondary progressive multiple sclerosis. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), PRURITUS (Itchy legs) (seriousness criterion medically significant) and PRURITUS (Itchy scalp) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), RASH ERYTHEMATOUS (Red rash), HYPERHIDROSIS (Sweating), DIZZINESS POSTURAL (Dizzy on standing), PRURITUS (Itchy legs) and PRURITUS (Itchy scalp) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no-negative covid-19 test (Negative) No-Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Chlorphenamine maleate allergy tablets were prescribed by pharmacist. Cyclazine-anti nausea was prescribed by doctor. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 64-year-old male patient, with medical history of multiple sclerosis who experienced serious unexpected events of rash erythematous, nausea, hyperhidrosis, pruritus (itchy legs and itchy scalp) and dizziness postural after third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is unknown since no information regarding dose 1 and 2 was disclosed. Patient concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 64-year-old male patient, with medical history of multiple sclerosis who experienced serious unexpected events of rash erythematous, nausea, hyperhidrosis, pruritus (itchy legs and itchy scalp) and dizziness postural after third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is unknown since no information regarding dose 1 and 2 was disclosed. Patient concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1907309 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lethargy, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Muscle pains; Lethargic; Fever; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26231343) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pains), LETHARGY (Lethargic) and PYREXIA (Fever) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 30-Jan-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pains) (seriousness criterion medically significant) and LETHARGY (Lethargic) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), MYALGIA (Muscle pains) and LETHARGY (Lethargic) had not resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that the patient had Fever. Headache. Muscle pains. Freezing. Lethargic.Patient has not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Company Comment: This case concerns a 42-year-old patient (gender not provided) with past medical history of Covid-19, who experienced the unexpected events of Headache, Myalgia, Lethargy, and Pyrexia. The event of Pyrexia occurred approximately 1 day after a dose of mRNA-1273 (Moderna covid-19 vaccine); while Headache, Myalgia, and Lethargy occurred after an unspecified interval. Though reported as third dose, patient seems to have had two previous doses of other vaccine (AstraZeneca)The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old patient (gender not provided) with past medical history of Covid-19, who experienced the unexpected events of Headache, Myalgia, Lethargy, and Pyrexia. The event of Pyrexia occurred approximately 1 day after a dose of mRNA-1273 (Moderna covid-19 vaccine); while Headache, Myalgia, and Lethargy occurred after an unspecified interval. Though reported as third dose, patient seems to have had two previous doses of other vaccine (AstraZeneca)The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 1907313 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Heart rate, Hypopnoea, Nausea, Pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: about 18 hours after receiving vaccine; Heart rate; Shallow breathing; Nausea; Pain; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231445) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (about 18 hours after receiving vaccine), HEART RATE (Heart rate), HYPOPNOEA (Shallow breathing), NAUSEA (Nausea), PAIN (Pain) and FATIGUE (Tiredness) in a 71-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion medically significant), HYPOPNOEA (Shallow breathing) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (about 18 hours after receiving vaccine) (seriousness criterion medically significant). On 20-Nov-2021, NAUSEA (Nausea) and PAIN (Pain) had resolved. At the time of the report, SYNCOPE (about 18 hours after receiving vaccine) had not resolved and HEART RATE (Heart rate), HYPOPNOEA (Shallow breathing) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. About 18 hours after receiving vaccine, felt heart rate increase though this happened with Astra Zenica also. Patient breathing became shallow and was hot and very thirsty even though patient had drunk extra as advised. Patient became achy and tired, also had a feeling in midriff as if someone had punched there and it was tender and then felt like a tight band around my middle. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment: This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Syncope, Heart rate Increased, Hypopnea, Nausea, Pain, and Fatigue. About 18 hours after receiving mRNA-1273 (Moderna covid-19 vaccine), patient felt heart rate increased though this happened with Astra Zeneca also. Her breathing became shallow and was hot and very thirsty. Patient also became achy, tired, and experienced a pain in her midriff that felt like a punch. The rechallenge was not applicable. Though reported as third dose of mRNA-1273 (Moderna covid-19 vaccine) by regulatory authority; it appears patient had previous dose/doses of AstraZeneca. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old, female patient with no relevant medical history, who experienced the unexpected events of Syncope, Heart rate Increased, Hypopnea, Nausea, Pain, and Fatigue. About 18 hours after receiving mRNA-1273 (Moderna covid-19 vaccine), patient felt heart rate increased though this happened with Astra Zeneca also. Her breathing became shallow and was hot and very thirsty. Patient also became achy, tired, and experienced a pain in her midriff that felt like a punch. The rechallenge was not applicable. Though reported as third dose of mRNA-1273 (Moderna covid-19 vaccine) by regulatory authority; it appears patient had previous dose/doses of AstraZeneca. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 1907317 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Muscle spasms, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Cramp of limb; Light-headed; Diarrhoea; High temperature; Head pain; Nausea; Fatigue; This case was received via regulatory authority (Reference number: -MHRA-ADR 26231524) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramp of limb), DIZZINESS (Light-headed), DIARRHOEA (Diarrhoea), PYREXIA (High temperature), HEADACHE (Head pain), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 20-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MUSCLE SPASMS (Cramp of limb) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 20-Nov-2021, DIARRHOEA (Diarrhoea) had resolved. At the time of the report, MUSCLE SPASMS (Cramp of limb), DIZZINESS (Light-headed), PYREXIA (High temperature), HEADACHE (Head pain), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. For mRNA-1273, the reporter did not provide any causality assessments. Company comment: This case concerns a 57-year-old female patient with no medical history provided, who experienced the following serious unexpected events: Headache, Nausea, Fatigue, Muscle spasms, Pyrexia, Dizziness and Diarrhoea. The events Headache, Nausea and Fatigue occurred during the same day when the patient received the third dose of the mRNA-1273 vaccine, while the remaining events occurred one day after vaccination. At the time of this report, Diarrhoea was the only event which had resolved, while the remaining events were still ongoing. No information regarding the clinical course of the events was provided. The action taken with the suspect product and re-challenge were retained in line with Regulatory Authority (as unknown), even though the event occurred following the third dose and no additional doses are expected to be given at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 57-year-old female patient with no medical history provided, who experienced the following serious unexpected events: Headache, Nausea, Fatigue, Muscle spasms, Pyrexia, Dizziness and Diarrhoea. The events Headache, Nausea and Fatigue occurred during the same day when the patient received the third dose of the mRNA-1273 vaccine, while the remaining events occurred one day after vaccination. At the time of this report, Diarrhoea was the only event which had resolved, while the remaining events were still ongoing. No information regarding the clinical course of the events was provided. The action taken with the suspect product and re-challenge were retained in line with Regulatory Authority (as unknown), even though the event occurred following the third dose and no additional doses are expected to be given at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1907318 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Nerve pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Redness; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26231530) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Previously administered products included for Nerve pain: PREGABALIN. Past adverse reactions to the above products included No adverse event with PREGABALIN. Concurrent medical conditions included Nerve pain. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). At the time of the report, ERYTHEMA (Redness) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medications were reported. Company comment: This case concerns a 50-year-old female, with no relevant medical history reported in the case, who experience the serious unexpected event of Erythema. The event occurred two days after of the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the event was Not Recovered/Not Resolved. The rechallenge is not applicable since the event occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The non-serious event of "Interchange of vaccine products" was reported by the RA in the source document, however it was not captured by the RA as an event. Based on medical judgment this event is relevant to the case.; Sender''s Comments: This case concerns a 50-year-old female, with no relevant medical history reported in the case, who experience the serious unexpected event of Erythema. The event occurred two days after of the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the event was Not Recovered/Not Resolved. The rechallenge is not applicable since the event occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The non-serious event of "Interchange of vaccine products" was reported by the RA in the source document, however it was not captured by the RA as an event. Based on medical judgment this event is relevant to the case.


VAERS ID: 1907319 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry mouth, Feeling cold, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shaking; Dry mouth; Feeling cold; Fever; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26231565) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (Shaking), DRY MOUTH (Dry mouth), FEELING COLD (Feeling cold) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), DRY MOUTH (Dry mouth) (seriousness criterion medically significant) and FEELING COLD (Feeling cold) (seriousness criterion medically significant). At the time of the report, TREMOR (Shaking), DRY MOUTH (Dry mouth) and FEELING COLD (Feeling cold) had not resolved and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was provided as paracetamol. The patient had the vaccine at 8.15am, at 7pm started feeling cold & couldn''t stop shaking. Patient had a very dry mouth and ear very thirsty. Patient had temperature of 39.3�and took paracetamol at 10pm when it was 40�. Patient was very hot but not sweaty. By the morning the temperature was 37.5� Patient had this reaction with the 1st Covid vaccine (Astrazeneca) symptoms were lasted for 24hours. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 47 years old, female patient with no clinical history who experienced the unexpected events of TREMOR, DRY MOUTH, FEELING COLD and PYREXIA The events occurred one day after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 47 years old, female patient with no clinical history who experienced the unexpected events of TREMOR, DRY MOUTH, FEELING COLD and PYREXIA The events occurred one day after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907320 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Nausea, Retching
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; LEVOTHYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: stomach ache; shivering; retching; Nausea; This case was received via regulatory authority (Reference number: -MHRA-ADR 26231635) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), CHILLS (shivering), RETCHING (retching) and NAUSEA (Nausea) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for Hypothyroidism, COVID-19 VACCINE (COVID-19 VACCINE ) for Thyroxine. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (stomach ache) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant) and RETCHING (retching) (seriousness criterion medically significant). On 20-Nov-2021, NAUSEA (Nausea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), CHILLS (shivering) and RETCHING (retching) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medication was reported The patient had uncontrollable shivering and mild stomach ache but after a few hours, this suddenly worsened along with nausea and retching. After that nausea has resolved but the patient was not feeling to eat for 24 hours. Company Comment: This is a regulatory case concerning a 72 years old, female patient with no clinical history who experienced the unexpected events of ABDOMINAL PAIN UPPER, CHILLS, RETCHING and NAUSEA The events occurred one day after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 72 years old, female patient with no clinical history who experienced the unexpected events of ABDOMINAL PAIN UPPER, CHILLS, RETCHING and NAUSEA The events occurred one day after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907323 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASTRAZENECA COVID-19 VACCINE; ASTRAZENECA COVID-19 VACCINE; CITALOPRAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211003; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Back pain; High temperature; Stomach pain; Fever; Swelling arm; Back ache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231708) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), PERIPHERAL SWELLING (Swelling arm), BACK PAIN (Back ache), PYREXIA (Fever), BACK PAIN (Back pain) and PYREXIA (High temperature) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 02-Oct-2021. Concomitant products included PARACETAMOL from 04-Oct-2021 to 08-Oct-2021 for COVID-19, CITALOPRAM from 01-Aug-2011 to an unknown date for Depression, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) from 15-May-2021 to an unknown date for Revaccination, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) from 08-Mar-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and BACK PAIN (Back ache) (seriousness criterion medically significant). On 20-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (Back pain) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), PERIPHERAL SWELLING (Swelling arm), BACK PAIN (Back ache) and PYREXIA (Fever) had not resolved and BACK PAIN (Back pain) and PYREXIA (High temperature) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Oct-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was not pregnant, Patient was not breastfeeding at the time of reporting. Concomitant medication was not provided. Treatment information was not reported. Since having Moderna vaccine patient''s arm started to be painful to touch and move almost immediately, gradually worsening. Significant back pain started within two hours making it difficult to stand/walk. Twenty four hours after the vaccine patient started experiencing sharp stomach pain and high temperature. She had a positive PCR test on 3 October 2021 before she had the Moderna booster. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Reaction: It was reported that this report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 46-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of abdominal pain upper, peripheral swelling, back pain and pyrexia. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 46-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of abdominal pain upper, peripheral swelling, back pain and pyrexia. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907324 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint pain; Headache; shivers; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231725) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), HEADACHE (Headache), CHILLS (shivers) and PAIN IN EXTREMITY (Painful arm) in a 63-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (shivers) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint pain), HEADACHE (Headache) and CHILLS (shivers) outcome was unknown and PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Company Comment: This case concerns a 63-year-old patient of unknown gender, with no relevant medical history reported, who experienced the unexpected events of arthralgia, headache, chills and pain in extremity. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 63-year-old patient of unknown gender, with no relevant medical history reported, who experienced the unexpected events of arthralgia, headache, chills and pain in extremity. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907327 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Breast oedema, Injection site swelling, Lymphadenopathy, Musculoskeletal pain, Pain, Pain in extremity, Peripheral swelling, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE PHOSPHATE; COLECALCIFEROL; FLEXITOL HEEL BALM CREAM; FLUOXETINE; INFLUENZA VIRUS; PARACETAMOL; PROPRANOLOL; SUKKARTO; TRAMADOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231835) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes), PAIN (Pain burning), PAIN IN EXTREMITY (Pain in limb), BREAST OEDEMA (Breast edema), AXILLARY PAIN (Armpit pain), MUSCULOSKELETAL PAIN (Scapula pain), INJECTION SITE SWELLING (Swelling of injection site) and SOMNOLENCE (Sleepy) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included PROPRANOLOL for Chronic anxiety, FLUOXETINE for Depression, INFLUENZA VACCINE (INFLUENZA VIRUS) from 28-Sep-2021 to an unknown date for Diabetes, METFORMIN HYDROCHLORIDE (SUKKARTO) for Diabetes mellitus, UREA, WHITE SOFT PARAFFIN, WOOL FAT (FLEXITOL HEEL BALM CREAM) for Lymphedema, CODEINE PHOSPHATE, PARACETAMOL and TRAMADOL for Pain relief, COLECALCIFEROL for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant), PAIN (Pain burning) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in limb) (seriousness criterion medically significant), BREAST OEDEMA (Breast edema) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), MUSCULOSKELETAL PAIN (Scapula pain) (seriousness criterion medically significant), INJECTION SITE SWELLING (Swelling of injection site) (seriousness criterion medically significant) and SOMNOLENCE (Sleepy) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), LYMPHADENOPATHY (Swollen lymph nodes), PAIN (Pain burning), PAIN IN EXTREMITY (Pain in limb), BREAST OEDEMA (Breast edema) and AXILLARY PAIN (Armpit pain) had not resolved, MUSCULOSKELETAL PAIN (Scapula pain) and INJECTION SITE SWELLING (Swelling of injection site) was resolving and SOMNOLENCE (Sleepy) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial No treatment information was reported. Company Comment: This regulatory case concerns a female patient with medical history of pain, lymphoedema, depression, anxiety and diabetes, who experienced the unexpected, serious events of peripheral swelling, lymphadenopathy, pain, somnolence, injection site swelling and breast oedema, among others. The events occurred 1 day after third dose of mRNA-1273 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. Somnolence is listed for concomitant codeine, tramadol and fluoxetine. The medical history of pain, lymphoedema, depression, anxiety, diabetes and concomitant Influenza vaccine remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a female patient with medical history of pain, lymphoedema, depression, anxiety and diabetes, who experienced the unexpected, serious events of peripheral swelling, lymphadenopathy, pain, somnolence, injection site swelling and breast oedema, among others. The events occurred 1 day after third dose of mRNA-1273 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. Somnolence is listed for concomitant codeine, tramadol and fluoxetine. The medical history of pain, lymphoedema, depression, anxiety, diabetes and concomitant Influenza vaccine remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907328 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis, Hypoaesthesia, Hypoaesthesia oral, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tiredness; Tachycardia; Palpitations; Aching joints; Shivering; Sweating; Headache; Numbness of tongue; Numbness in hand; This case was received via regulatory (Reference number: GB-MHRA-ADR 26231873) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numbness of tongue), HYPOAESTHESIA (Numbness in hand), FATIGUE (Tiredness), TACHYCARDIA (Tachycardia), PALPITATIONS (Palpitations), ARTHRALGIA (Aching joints), CHILLS (Shivering), HYPERHIDROSIS (Sweating) and HEADACHE (Headache) in a 57-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HYPOAESTHESIA ORAL (Numbness of tongue) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in hand) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA ORAL (Numbness of tongue) and HYPOAESTHESIA (Numbness in hand) had not resolved, FATIGUE (Tiredness) outcome was unknown and TACHYCARDIA (Tachycardia), PALPITATIONS (Palpitations), ARTHRALGIA (Aching joints), CHILLS (Shivering), HYPERHIDROSIS (Sweating) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient took cardioplen 2.5mg daily. No treatment information was provided. Company Comment: This regulatory authority case concerns a 57-year-old patient of unknown gender with no details on relevant medical history, who experienced the unexpected serious events of Tachycardia, Hypoaesthesia oral, Hypoaesthesia, Palpitations, Arthralgia, Chills, Hyperhidrosis and Headache after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received two doses of COVID-19 CHADOX-1 AstraZeneca Vaccine as the initial schedule of vaccination on an unknown date. The events occurred approximately 1 day after the dose of mRNA- 1273 vaccine. Very limited information was provided. Arthralgia, Chills and Headache are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only one dose of mRNA- 1273 Moderna vaccine was administered. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 57-year-old patient of unknown gender with no details on relevant medical history, who experienced the unexpected serious events of Tachycardia, Hypoaesthesia oral, Hypoaesthesia, Palpitations, Arthralgia, Chills, Hyperhidrosis and Headache after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient had received two doses of COVID-19 CHADOX-1 AstraZeneca Vaccine as the initial schedule of vaccination on an unknown date. The events occurred approximately 1 day after the dose of mRNA- 1273 vaccine. Very limited information was provided. Arthralgia, Chills and Headache are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only one dose of mRNA- 1273 Moderna vaccine was administered. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1907332 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Fatigue, Hallucination, Headache, Insomnia, Myalgia, Nausea, Pain in extremity, Pyrexia, Restless legs syndrome
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Hallucinations; Shivers; Fever; Chills; Insomnia; Nausea; Restless legs; Headache; Myalgia; Stomach ache; Fatigue; Painful arm; This case was received via regulatory authority MHRA (Reference number: GB-MHRA-ADR 26231890) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Myalgia), PAIN IN EXTREMITY (Painful arm), ABDOMINAL PAIN UPPER (Stomach ache), FATIGUE (Fatigue), HALLUCINATION (Hallucinations), CHILLS (Shivers), PYREXIA (Fever), CHILLS (Chills), INSOMNIA (Insomnia), NAUSEA (Nausea) and RESTLESS LEGS SYNDROME (Restless legs) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 04-Mar-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Myalgia) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), INSOMNIA (Insomnia) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and RESTLESS LEGS SYNDROME (Restless legs) (seriousness criterion medically significant). On an unknown date, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). On 20-Nov-2021, PYREXIA (Fever), CHILLS (Chills), INSOMNIA (Insomnia), NAUSEA (Nausea) and RESTLESS LEGS SYNDROME (Restless legs) had resolved. At the time of the report, HEADACHE (Headache), MYALGIA (Myalgia), PAIN IN EXTREMITY (Painful arm), ABDOMINAL PAIN UPPER (Stomach ache) and FATIGUE (Fatigue) had not resolved and HALLUCINATION (Hallucinations) and CHILLS (Shivers) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Reported that arm pain started within 5 hours of vaccination and unable to move arm or lift. Shivers, fever, chills, restless legs, fatigue, nausea, headache, insomnia, and hallucinations started at 1am, 12 hours after vaccination. Reported that Paracetamol and ibuprofen taken Reported that report does not relate to possible inflammation of the heart (myocarditis or pericarditis). This case concerns a 51-year-old female patient with no relevant medical history, who experienced the unexpected events of Pain in Extremity, Headache, Myalgia, Abdominal Pain, Fatigue, Pyrexia, Chills, Insomnia, Nausea, Restless Legs Syndrome, and Hallucinations. The event occurred 1-2 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old female patient with no relevant medical history, who experienced the unexpected events of Pain in Extremity, Headache, Myalgia, Abdominal Pain, Fatigue, Pyrexia, Chills, Insomnia, Nausea, Restless Legs Syndrome, and Hallucinations. The event occurred 1-2 days after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1907334 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Nausea, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; Frontal headache; Sweating; Nausea; Vomiting; Shaking; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26231932) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frontal headache), HYPERHIDROSIS (Sweating), NAUSEA (Nausea), HEADACHE (headache), TREMOR (Shaking) and VOMITING (Vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 15-Mar-2020. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant). On 19-Nov-2021, TREMOR (Shaking) had resolved. On 20-Nov-2021, VOMITING (Vomiting) had resolved. At the time of the report, HEADACHE (Frontal headache), HYPERHIDROSIS (Sweating) and NAUSEA (Nausea) was resolving and HEADACHE (headache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Severe shaking last night. Today, severe headache most of the day, then nausea and vomiting. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment : This is a regulatory authority case concerning a female patient of unknown age, with no relevant medical history, who experienced the unexpected serious events of Headache, Tremor, Headache, Vomiting, Hyperhidrosis, Nausea. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a female patient of unknown age, with no relevant medical history, who experienced the unexpected serious events of Headache, Tremor, Headache, Vomiting, Hyperhidrosis, Nausea. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1907335 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness: Chronic fatigue syndrome (Was diagnosed with chronic fatigue syndrome/ME circa 15 years ago.)
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Swelling; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26231943) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and SWELLING (Swelling) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Anaphylaxis. Concurrent medical conditions included Chronic fatigue syndrome (Was diagnosed with chronic fatigue syndrome/ME circa 15 years ago.). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 29-Oct-2021 to an unknown date for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and SWELLING (Swelling) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had swelling under arm and on top of arm was the arm opposite to the injection site. Swelling has spread up glands in neck, opposite to the injection side. Severe headache which was being managed with migraleve and stiffness of neck present. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No treatment information was provided. company comment: This case concerns a 37-year-old, female patient with relevant medical history of chronic fatigue syndrome and anaphylaxis, who experienced the unexpected events of headache and swelling. The events occurred between 4 days and an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The medical history of chronic fatigue syndrome and anaphylaxis remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 37-year-old, female patient with relevant medical history of chronic fatigue syndrome and anaphylaxis, who experienced the unexpected events of headache and swelling. The events occurred between 4 days and an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The medical history of chronic fatigue syndrome and anaphylaxis remains a confounder. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1907340 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chills, Cold sweat, Facial pain, Headache, Lymphadenopathy, Migraine, Muscle spasms, Musculoskeletal stiffness, Nausea, Pain, Pain in jaw, Palpitations, Paraesthesia, Pyrexia, SARS-CoV-2 test, Tender joint count, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; INFLUENZA VIRUS; BUSCOPAN; CANDESARTAN; CO-CODAMOL; IBUPROFEN; MEBEVERINE; OMEPRAZOL [OMEPRAZOLE]; ONDANSETRON; RIZATRIPTAN; SERTRALINE
Current Illness: Anxiety; Asthma; Depression; Obesity; Polycystic ovarian syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: trembling; shaking; spasms; pain; fever; My shoulders; headache; Tingling sensation; Jaw pain; Nausea; Swollen glands; Muscle spasms; Cold sweat; Tender joint count; Migraine; Muscle stiffness; Facial pain; Palpitations; Chronic back pain; Shivering; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26232075) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TENDER JOINT COUNT (Tender joint count), MIGRAINE (Migraine), MUSCULOSKELETAL STIFFNESS (Muscle stiffness), FACIAL PAIN (Facial pain), PALPITATIONS (Palpitations), BACK PAIN (Chronic back pain), PAIN IN JAW (Jaw pain), COLD SWEAT (Cold sweat), NAUSEA (Nausea), LYMPHADENOPATHY (Swollen glands), MUSCLE SPASMS (Muscle spasms), TREMOR (trembling), TREMOR (shaking), MUSCLE SPASMS (spasms), PARAESTHESIA (Tingling sensation), PAIN (pain), PYREXIA (fever), ARTHRALGIA (My shoulders), HEADACHE (headache) and CHILLS (Shivering) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Anaemia and Suspected COVID-19 from 23-Dec-2020 to 31-Dec-2020. Concurrent medical conditions included Depression, Obesity, Anxiety, Asthma and Polycystic ovarian syndrome. Concomitant products included CANDESARTAN from 04-Jul-2021 to an unknown date for Chronic migraine, SERTRALINE from 01-Jan-2017 to an unknown date for Depression, OMEPRAZOL [OMEPRAZOLE] from 01-May-2021 to an unknown date for Gastritis, HYOSCINE BUTYLBROMIDE (BUSCOPAN) from 01-Jan-2019 to an unknown date and MEBEVERINE from 01-May-2020 to an unknown date for Irritable bowel syndrome, RIZATRIPTAN from 19-Nov-2021 to an unknown date for Migraine, IBUPROFEN from 19-Nov-2021 to an unknown date for Muscle ache, ONDANSETRON from 02-Aug-2021 to an unknown date for Nausea, CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) from 01-Jan-2021 to an unknown date for Pain, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and INFLUENZA VACCINE (INFLUENZA VIRUS) from 11-Oct-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced TENDER JOINT COUNT (Tender joint count) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Muscle stiffness) (seriousness criterion medically significant), FACIAL PAIN (Facial pain) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant), BACK PAIN (Chronic back pain) (seriousness criterion medically significant), COLD SWEAT (Cold sweat) (seriousness criterion medically significant), MUSCLE SPASMS (Muscle spasms) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 20-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PAIN IN JAW (Jaw pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and PARAESTHESIA (Tingling sensation) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (trembling) (seriousness criterion medically significant), TREMOR (shaking) (seriousness criterion medically significant), MUSCLE SPASMS (spasms) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant), ARTHRALGIA (My shoulders) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). At the time of the report, TENDER JOINT COUNT (Tender joint count), MIGRAINE (Migraine), MUSCULOSKELETAL STIFFNESS (Muscle stiffness), FACIAL PAIN (Facial pain), PALPITATIONS (Palpitations), BACK PAIN (Chronic back pain), PAIN IN JAW (Jaw pain), COLD SWEAT (Cold sweat), NAUSEA (Nausea), LYMPHADENOPATHY (Swollen glands) and MUSCLE SPASMS (Muscle spasms) had not resolved and TREMOR (trembling), TREMOR (shaking), MUSCLE SPASMS (spasms), PARAESTHESIA (Tingling sensation), PAIN (pain), PYREXIA (fever), ARTHRALGIA (My shoulders), HEADACHE (headache) and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Reported relevant medical history IBS ,chronic migraines and hay fever . Reported that since patient received the booster and started to get a mild headache and a bit of achiness, patient took ibuprofen a couple of hours after getting the jab. Then around 10 hours later started to get a fever, cold sweats during the night. She couldn''t sleep properly as kept waking up shaking, trembling, and with hot and cold sweats. A migraine appeared during the night with a sudden aura with nausea and a sick feeling. her temperature was at 37.8�C. Had to take Co-Codamol 30mg and ibuprofen to bring it down. All day 20th had to keep taking these medications to relieve some of the pain. Her entire body feels like it is on fire as every muscle in her body was hurting and incredibly tender. Just tapping shoulder lightly hurts. Her joints are clicking and very stiff. She can barely move out of bed. The right side of her face hurts. It feels tingly and keep feeling spasms in her right cheek. The left side feels fine. Her shoulders, neck and upper arms are so stiff it hurts to move. Moving around to quickly makes her feel nauseous, light-headed and dizzy. She have been needing her asthma pumps more regularly as well as feel a bit breathless. Company comment: This case concerns a 32-year-old female patient with medical history of anxiety, depression, obesity, asthma, irritable bowel syndrome, chronic migraine and polypharmacy who experienced the unexpected and serious events of muscle spasms, headache, tremor (reported as trembling and shaking), pain, pyrexia, arthralgia, tender joint count, migraine, muscle stiffness, facial pain, palpitations, muscle spasms, back pain, pain in jaw, lymphadenopathy, cold sweat, chills, nausea and paraesthesia. The events tremor (reported as trembling and shaking), muscle spasm, pain, pyrexia, arthralgia and headache occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered, the events tender joint count, migraine, musculoskeletal stiffness, facial pain, palpitations, back pain, cold sweat, muscle spasm and chills occurred the same day and the events pain in jaw, nausea, lymphadenopathy and paraeshesia after vaccine was given. The rechallenge was not applicable since the events happened after the third dose and only information of one dose is disclosed and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 32-year-old female patient with medical history of anxiety, depression, obesity, asthma, irritable bowel syndrome, chronic migraine and polypharmacy who experienced the unexpected and serious events of muscle spasms, headache, tremor (reported as trembling and shaking), pain, pyrexia, arthralgia, tender joint count, migraine, muscle stiffness, facial pain, palpitations, muscle spasms, back pain, pain in jaw, lymphadenopathy, cold sweat, chills, nausea and paraesthesia. The events tremor (reported as trembling and shaking), muscle spasm, pain, pyrexia, arthralgia and headache occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered, the events tender joint count, migraine, musculoskeletal stiffness, facial pain, palpitations, back pain, cold sweat, muscle spasm and chills occurred the same day and the events pain in jaw, nausea, lymphadenopathy and paraeshesia after vaccine was given. The rechallenge was not applicable since the events happened after the third dose and only information of one dose is disclosed and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907552 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-01
Onset:2021-11-19
   Days after vaccination:353
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein increased, Haematochezia, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Colitis ulcerative
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: CRP slightly increased; Haemorrhage; Bloody stool; This case was received via the regulatory authority (Reference number: 2021TJP121717) on 19-Nov-2021 and was forwarded to Moderna on 26-Nov-2021. This case was reported by a physician. Since the proprietary name of COVID-19 vaccine was not specified, the drug is handled as a RA product in this case report. Bloody stool and Haemorrhage were assessed as serious by the RA. On 01-DEC-2020, the patient started to receive vedolizumab. On an unknown date, the patient received COVID-19 vaccine (proprietary name: unknown). In 2021 (date unknown), shortly after the above administration, the patient presented with bloody stool and haemorrhage. On 12-NOV-2021, vedolizumab was administered. On 19-NOV-2021, the patient visited the outpatient dept and stated that her condition had improved compared with that on 12-NOV-2021. A slight increase was noted in the CRP, but the WBC count was normal. On an unknown date, the bloody stool and haemorrhage remained unresolved. The outcome of the event "CRP slightly increased" was unknown. Vedolizumab therapy is ongoing. Follow-up investigation will be made. Company Comment:


VAERS ID: 1908710 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No, Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle ache; Headaches; Chills; Fever; This case was received (Reference number: GB-MHRA-ADR 26232650) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache), HEADACHE (Headaches), CHILLS (Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headaches) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever) was resolving. At the time of the report, MYALGIA (Muscle ache), HEADACHE (Headaches) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) No, Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was in excellent health condition and had no symptoms associated with COVID-19. Concomitant medication and Treatment medication were not reported. Patient had experienced Headaches, muscle aches, joint aches, tired, chills and fever. Company comment: This case concerns a 59-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Myalgia, Headache, Chills and Pyrexia. The event of pyrexia occurred the day after the dose of COVID-19 Vaccine Moderna (mRNA-1273) and the other events onset date remain unknown. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.; Sender''s Comments: This case concerns a 59-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Myalgia, Headache, Chills and Pyrexia. The event of pyrexia occurred the day after the dose of COVID-19 Vaccine Moderna (mRNA-1273) and the other events onset date remain unknown. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.


VAERS ID: 1908718 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Contusion, Heart rate increased, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: fever; Pulse rapid; Bruising of arm; Body temperature increased; This case was received via RA (Reference number: GB-MHRA-ADR 26232023) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEART RATE INCREASED (Pulse rapid), CONTUSION (Bruising of arm) and BODY TEMPERATURE INCREASED (Body temperature increased) in a 19-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEART RATE INCREASED (Pulse rapid) (seriousness criterion medically significant), CONTUSION (Bruising of arm) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (Body temperature increased) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant). On 20-Nov-2021, HEART RATE INCREASED (Pulse rapid) and BODY TEMPERATURE INCREASED (Body temperature increased) had resolved. At the time of the report, PYREXIA (fever) was resolving and CONTUSION (Bruising of arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not provided. It was reported that around 6/7 hours after the injection, patient began to have rapid heart rate of about 120 Bpm whilst relaxing at home, this went on for hours. Patient thinks she had a fever of 39.2 degrees. When she woke up the next day the injection site was inflamed and bright red, it is still the same size (the size of roughly a 1p coin) but looks very bruised and still tender to the touch 3 days post injection. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No Treatment information was provided. Company comment: This case concerns a 19-year-old female patient with no relevant medical history, who experienced the serious unexpected events of pyrexia, heart rate increased. The events heart rate increased, contusion, body temperature increased occurred on the same day after the third dose of mRNA-1273. The event pyrexia occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 19-year-old female patient with no relevant medical history, who experienced the serious unexpected events of pyrexia, heart rate increased. The events heart rate increased, contusion, body temperature increased occurred on the same day after the third dose of mRNA-1273. The event pyrexia occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Chills, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Tested negative for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: muscle pain; chills; High temperature; Muscle ache; Weakness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232189) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), CHILLS (chills), PYREXIA (High temperature), MYALGIA (Muscle ache) and ASTHENIA (Weakness) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 21-Oct-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and ASTHENIA (Weakness) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (muscle pain) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). At the time of the report, MYALGIA (muscle pain), CHILLS (chills), PYREXIA (High temperature), MYALGIA (Muscle ache) and ASTHENIA (Weakness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Tested negative for COVID-19. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Received jab at 10-15am by 7pm very high temperature. Muscle pain, chills, very red face slightly swollen. 48 hrs on and still unable to get out of bed. Patient had not tested positive for COVID-19 since having the vaccine. Company Comment : This is a regulatory case concerning a male patient of unknown age with no previous relevant medical history, who experienced the unexpected serious events of myalgia, chills, pyrexia, and asthenia. It is unknown the timeframe between the event asthenia and the vaccination with the second or third dose of mRNA-1273 Vaccine. The events myalgia, chills and pyrexia occurred on the same date after the administration of mRNA-1273 vaccine (unknown dose number). The rechallenge was unknown since there''s no information about the first dose, and onset date of events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Both doses has been reported on the same vaccination date, which seems to be unlikely.; Sender''s Comments: This is a regulatory case concerning a male patient of unknown age with no previous relevant medical history, who experienced the unexpected serious events of myalgia, chills, pyrexia, and asthenia. It is unknown the timeframe between the event asthenia and the vaccination with the second or third dose of mRNA-1273 Vaccine. The events myalgia, chills and pyrexia occurred on the same date after the administration of mRNA-1273 vaccine (unknown dose number). The rechallenge was unknown since there''s no information about the first dose, and onset date of events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Both doses has been reported on the same vaccination date, which seems to be unlikely.


VAERS ID: 1908723 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Dizziness, Fatigue, Hypoaesthesia oral, Lip swelling, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Numbness of lips; Light-headed; Body temperature increased; Tiredness; Numb lips; This case was received via regulatory authority (Reference number: -MHRA-ADR 26232243) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIP SWELLING (Numbness of lips), HYPOAESTHESIA ORAL (Numb lips), FATIGUE (Tiredness), DIZZINESS (Light-headed) and BODY TEMPERATURE INCREASED (Body temperature increased) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL) for Backache, INFLUENZA VACCINE (INFLUENZA VIRUS) from 11-Oct-2021 to an unknown date for Influenza. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HYPOAESTHESIA ORAL (Numb lips) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and BODY TEMPERATURE INCREASED (Body temperature increased) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant). On an unknown date, the patient experienced LIP SWELLING (Numbness of lips) (seriousness criterion medically significant). On 19-Nov-2021, HYPOAESTHESIA ORAL (Numb lips) had resolved. On 21-Nov-2021, BODY TEMPERATURE INCREASED (Body temperature increased) had resolved. At the time of the report, LIP SWELLING (Numbness of lips), FATIGUE (Tiredness) and DIZZINESS (Light-headed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The treatment information was not provided. Tingling numbness of lips occurred within 20 mins of jab. Tiredness came on gradually over 24 hours and lightheaded feeling approx 36 hours after. Post vaccination patient not tested positive for COVID-19.Also patient was not enrolled in any clinical trials. Company Comment: This case concerns a 62-year-old female patient, with no relevant medical history, who experienced the unexpected serious events of LIP SWELLING, HYPOAESTHESIA ORAL, FATIGUE, DIZZINESS and BODY TEMPERATURE INCREASED. The events occurred approximately 2 days after the administration of the third dose mRNA-1273 vaccine. The rechallenge was unknown. Patient received INFLUENZA VACCINE approximately 1 month before administration of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient, with no relevant medical history, who experienced the unexpected serious events of LIP SWELLING, HYPOAESTHESIA ORAL, FATIGUE, DIZZINESS and BODY TEMPERATURE INCREASED. The events occurred approximately 2 days after the administration of the third dose mRNA-1273 vaccine. The rechallenge was unknown. Patient received INFLUENZA VACCINE approximately 1 month before administration of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1908727 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle pain; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 26232302) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication details was provided. The patient experienced severe muscle pain along entire arm affecting all aspects of movement.Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not currently breastfeeding. Company Comment : This is a regulatory case concerning a 52 year-old female patient, with no relevant medical history reported , who experienced the serious unexpected event of MYALGIA on the same day after receiving the third dose of mRNA-1273 vaccine. Patient was previously vaccinated with CHADOX1 NCOV-19 Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per regulatory reporting.; Sender''s Comments: This is a regulatory case concerning a 52 year-old female patient, with no relevant medical history reported , who experienced the serious unexpected event of MYALGIA on the same day after receiving the third dose of mRNA-1273 vaccine. Patient was previously vaccinated with CHADOX1 NCOV-19 Rechallenge is not applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per regulatory reporting.


VAERS ID: 1908729 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Lymphadenopathy, Pain in extremity, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYCHLOROQUINE
Current Illness: Immunocompromised (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions: Medical History/Concurrent Conditions: Connective tissue disorder NOS
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Patient tested Negative for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Aching joints; Rash; Swollen glands; Felt faint; Pain in arm; This case was received via RA (Reference number: GB-MHRA-ADR 26232349) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash), DIZZINESS (Felt faint), ARTHRALGIA (Aching joints), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swollen glands) in a 20-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Connective tissue disorder NOS. Concurrent medical conditions included Immunocompromised (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Concomitant products included HYDROXYCHLOROQUINE for Autoimmune disorder. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 21-Nov-2021, DIZZINESS (Felt faint) was resolving. At the time of the report, RASH (Rash), ARTHRALGIA (Aching joints), PAIN IN EXTREMITY (Pain in arm) and LYMPHADENOPATHY (Swollen glands) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested Negative for COVID-19. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The treatment information was not provided. Company Comment: This is a regulatory case concerning a 20-year-old, female patient, with current condition of immunocompromised and Connective tissue disorder, who experienced the serious (medically significant) adverse events of rash, dizziness, arthralgia, pain in extremity and lymphadenopathy. The events pain in extremity and dizziness occurred the same day after the third dose, the events rash and lymphadenopathy, one day after, and the events arthralgia, two days after the third dose of mRNA-1273 vaccine. The concurrent conditions of immunocompromised remain a confounder for the event lymphadenopathy and the condition of Connective tissue disorder, remains a confounder for the event arthralgia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 20-year-old, female patient, with current condition of immunocompromised and Connective tissue disorder, who experienced the serious (medically significant) adverse events of rash, dizziness, arthralgia, pain in extremity and lymphadenopathy. The events pain in extremity and dizziness occurred the same day after the third dose, the events rash and lymphadenopathy, one day after, and the events arthralgia, two days after the third dose of mRNA-1273 vaccine. The concurrent conditions of immunocompromised remain a confounder for the event lymphadenopathy and the condition of Connective tissue disorder, remains a confounder for the event arthralgia. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1908741 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Cold-stimulus headache, Dyspnoea, Hyperhidrosis, Muscle tightness, Myalgia, Pyrexia, SARS-CoV-2 test, Tension headache, Thirst
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BETAMETHASONE; CILOXAN; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: CABG (Full recovery); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201030; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle tightness; Breathlessness; Feeling freezing; Thirsty; Sweating; Headache tension; Joint pain; Fever; Chills; Muscle soreness; This case was received via Regulatory Authority (Reference number: -MHRA-ADR 26232547) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Muscle tightness), DYSPNOEA (Breathlessness), COLD-STIMULUS HEADACHE (Feeling freezing), THIRST (Thirsty), HYPERHIDROSIS (Sweating), TENSION HEADACHE (Headache tension), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped) and CABG (Full recovery) in 2017. Concomitant products included BETAMETHASONE from 17-Nov-2021 to an unknown date for Ear infection, CIPROFLOXACIN HYDROCHLORIDE (CILOXAN) from 17-Nov-2021 to an unknown date, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 18-Feb-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 23-Oct-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced TENSION HEADACHE (Headache tension) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE TIGHTNESS (Muscle tightness) (seriousness criterion medically significant), DYSPNOEA (Breathlessness) (seriousness criterion medically significant), COLD-STIMULUS HEADACHE (Feeling freezing) (seriousness criterion medically significant), THIRST (Thirsty) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating) (seriousness criterion medically significant). At the time of the report, MUSCLE TIGHTNESS (Muscle tightness), DYSPNOEA (Breathlessness), COLD-STIMULUS HEADACHE (Feeling freezing), THIRST (Thirsty), HYPERHIDROSIS (Sweating), TENSION HEADACHE (Headache tension), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle soreness) and ARTHRALGIA (Joint pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Oct-2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication reported. About five hours after vaccination, heI became very chilly and tired and went to bed. He awoke an hour later feeling freezing but sweating and very hot. His appetite for food and drinks went. He was thirsty and continually drinking water on the first day. He started to improve by later on afternoon of 21 Nov 2021. But after a light meal the chills, fever came back with sweating, headach around the side and back of the head, muscle tightness in his legs, joint pain in his hips and hands. A light feeling of nausia occasionally came on. This all feels like his annual dose of man flue except for the breathlessness which came on in the early hours of 20 Nov 2021 and did consciously cause him. It concerned about seeking medical help. It passed by 11 am and he was improved slowly. He felt recovered and he had takin hot lemsip/ paracetamol OTC . Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment : This case concerns a 59-year-old male patient with a history of recent ear infection, who experienced the unexpected events of pyrexia, chills, myalgia, tension headache, arthralgia, muscle tightness, dyspnoea, thirst and hyperhidrosis. The events started the same day after the booster dose of mRNA-1273 administration. The rechallenge was not applicable since the patient received the first two doses with the CHADOX1 NCOV-19 vaccine, and no further doses are expected. The medical history of recent ear infection is confounding factor. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Pyrexia, chills, myalgia and arthralgia are expected events but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 59-year-old male patient with a history of recent ear infection, who experienced the unexpected events of pyrexia, chills, myalgia, tension headache, arthralgia, muscle tightness, dyspnoea, thirst and hyperhidrosis. The events started the same day after the booster dose of mRNA-1273 administration. The rechallenge was not applicable since the patient received the first two doses with the CHADOX1 NCOV-19 vaccine, and no further doses are expected. The medical history of recent ear infection is confounding factor. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Pyrexia, chills, myalgia and arthralgia are expected events but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1908744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chills; Headache dull; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232617) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache dull) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 01-Nov-2021 to an unknown date for Influenza. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). At the time of the report, CHILLS (Chills) and HEADACHE (Headache dull) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient was taking paracetamol. Treatment medication was not reported. Company comment: This case concerns a female patient of an unknown age with no previous relevant medical history reported, who experienced the serious unexpected events of Chills and Headache. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.; Sender''s Comments: This case concerns a female patient of an unknown age with no previous relevant medical history reported, who experienced the serious unexpected events of Chills and Headache. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.


VAERS ID: 1908746 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Contusion, Fatigue, Headache, Maternal exposure during breast feeding, Rash, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN; WARFARIN; ZAPAIN
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: joint pain; Maternal exposure during breast feeding; Vomiting; Rash; Headache; Tiredness; Bruising; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26232643) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), CONTUSION (Bruising), RASH (Rash), HEADACHE (Headache), FATIGUE (Tiredness), VOMITING (Vomiting) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Concurrent medical conditions included Breast feeding. Concomitant products included WARFARIN for Clotting disorder, GABAPENTIN and CODEINE PHOSPHATE, PARACETAMOL (ZAPAIN) for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced CONTUSION (Bruising) (seriousness criteria disability and medically significant), HEADACHE (Headache) (seriousness criteria disability and medically significant) and FATIGUE (Tiredness) (seriousness criteria disability and medically significant). On 20-Nov-2021, the patient experienced RASH (Rash) (seriousness criteria disability and medically significant) and VOMITING (Vomiting) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced ARTHRALGIA (joint pain) (seriousness criteria disability and medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criteria disability and medically significant). At the time of the report, ARTHRALGIA (joint pain) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown, CONTUSION (Bruising) and RASH (Rash) had not resolved, HEADACHE (Headache) and FATIGUE (Tiredness) was resolving and VOMITING (Vomiting) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. Last menstrual period was reported as 09-NOV-2021. Patient has not had symptoms associated with COVID-19. Patient was not pregnant . Joint pain, limb heaviness and dead feeling. Extreme fatigue Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Patient did not have any relate to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This case concerns a 30 year old female , with no relevant medical history reported, who received Covid 19 Vaccine (CHADOX1 NCCOV - 19 ) Astra Zeneca as first and 2nd dose. , who experienced Serious ( Disability , Medically Significant ) , unexpected events of contusion , headache , fatigue the day after vaccination with the 3rd dose of Covid 19 vaccine ( booster dose) . Two days ater vaccination with the 3rd dose , she developed rash , vomiting and on an unknown date experienced serious . unexpected events of Arthralgia and maternal exposure during breastfeeding with the 3rd dose ( booster dose ) . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 30 year old female , with no relevant medical history reported, who received Covid 19 Vaccine (CHADOX1 NCCOV - 19 ) Astra Zeneca as first and 2nd dose. , who experienced Serious ( Disability , Medically Significant ) , unexpected events of contusion , headache , fatigue the day after vaccination with the 3rd dose of Covid 19 vaccine ( booster dose) . Two days ater vaccination with the 3rd dose , she developed rash , vomiting and on an unknown date experienced serious . unexpected events of Arthralgia and maternal exposure during breastfeeding with the 3rd dose ( booster dose ) . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1908753 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Dyspnoea, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Shortness of breath; Weakness; Aching joints; Headache; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232887) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), ASTHENIA (Weakness), ARTHRALGIA (Aching joints), HEADACHE (Headache) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Shortness of breath), ARTHRALGIA (Aching joints), HEADACHE (Headache) and PYREXIA (Fever) had not resolved and ASTHENIA (Weakness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment details not provided. concomitant drug details not provided. Company Comment : This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of dyspnoea, asthenia, arthralgia, headache, and pyrexia. The events of arthralgia, headache, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The events could be in connection to each other. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 55-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of dyspnoea, asthenia, arthralgia, headache, and pyrexia. The events of arthralgia, headache, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The events could be in connection to each other. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908757 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Injection site pain, Lymph node pain, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lymph node pain; Nausea; Headache; Joint pain; Tired out; Fever chills; Injection site pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232965) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain), NAUSEA (Nausea), HEADACHE (Headache), ARTHRALGIA (Joint pain), FATIGUE (Tired out), PYREXIA (Fever chills) and INJECTION SITE PAIN (Injection site pain) in a 53-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), FATIGUE (Tired out) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 21-Nov-2021, NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Tired out) and PYREXIA (Fever chills) had resolved. At the time of the report, LYMPH NODE PAIN (Lymph node pain), ARTHRALGIA (Joint pain) and INJECTION SITE PAIN (Injection site pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient had no reaction to primary vaccine course (Pfizer). The reactions started about 7 hours post vaccination of Moderna and all symptoms began around the same time. Patient has not tested positive for COVID-19 since having the vaccine. It was informed that the patient report was not related to any possible inflammation of heart (myocarditis or pericarditis). Company Comment: This is a regulatory case concerning a 53-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of LYMOPHNODE PAIN , NAUSEA, HEADACHE, ARTHRALGIA , FATIGUE, PYREXIA and INJECTION SITE PAIN on the same after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting; Sender''s Comments: This is a regulatory case concerning a 53-year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of LYMOPHNODE PAIN , NAUSEA, HEADACHE, ARTHRALGIA , FATIGUE, PYREXIA and INJECTION SITE PAIN on the same after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1908918 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Chills, Headache, Palpitations, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Sinus pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chest pain; palpitations; Headache; Fever; Chills; Sinus pain; Hand swelling; Pain chest; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26232577) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), PALPITATIONS (palpitations), CHEST PAIN (Pain chest), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills), SINUS PAIN (Sinus pain) and PERIPHERAL SWELLING (Hand swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 14-Mar-2020 and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Asthma. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced CHEST PAIN (Pain chest) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), SINUS PAIN (Sinus pain) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Hand swelling) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion medically significant) and PALPITATIONS (palpitations) (seriousness criterion medically significant). On 21-Nov-2021, PERIPHERAL SWELLING (Hand swelling) had resolved. At the time of the report, CHEST PAIN (chest pain) and PALPITATIONS (palpitations) had not resolved and CHEST PAIN (Pain chest), HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and SINUS PAIN (Sinus pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter Company Comment : This case concerns a 45-year-old, female patient with previous relevant medical history of asthma, who experienced the unexpected serious events of chest pain (reported as "chest pain"), palpitations, chest pain (reported as "pain chest"), headache, pyrexia, chills, sinus pain, and peripheral swelling. The events of chills, headache, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. On 19-Nov-2021, the patient received a dose of mRNA-1273. The event chest pain (reported as "pain chest") occurred on the same day of vaccination. The events headache, pyrexia, chills, sinus pain, and peripheral swelling occurred one day after vaccination. The date of onset of the events chest pain (reported as "chest pain") and palpitations was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The patient, on unknown date, received two doses of COVID-19 VACCINE ASTRAZENECA, which could be a confounding factor, especially for the events without reported onset date. Patient�s medical history of asthma could be confounder for chest pain. Chest pain could also be in association with palpitations. Headache, pyrexia, chills could be in connection to each other. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting; Sender''s Comments: This case concerns a 45-year-old, female patient with previous relevant medical history of asthma, who experienced the unexpected serious events of chest pain (reported as "chest pain"), palpitations, chest pain (reported as "pain chest"), headache, pyrexia, chills, sinus pain, and peripheral swelling. The events of chills, headache, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. On 19-Nov-2021, the patient received a dose of mRNA-1273. The event chest pain (reported as "pain chest") occurred on the same day of vaccination. The events headache, pyrexia, chills, sinus pain, and peripheral swelling occurred one day after vaccination. The date of onset of the events chest pain (reported as "chest pain") and palpitations was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The patient, on unknown date, received two doses of COVID-19 VACCINE ASTRAZENECA, which could be a confounding factor, especially for the events without reported onset date. Patient�s medical history of asthma could be confounder for chest pain. Chest pain could also be in association with palpitations. Headache, pyrexia, chills could be in connection to each other. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting


VAERS ID: 1908927 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cough, Fatigue, Lethargy, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: cough; severe tiredness; Red rash; Lethargy; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26232788) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), RASH ERYTHEMATOUS (Red rash), COUGH (cough) and FATIGUE (severe tiredness) in a 62-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion disability). On 20-Nov-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion disability). On an unknown date, the patient experienced COUGH (cough) (seriousness criterion disability) and FATIGUE (severe tiredness) (seriousness criterion disability). At the time of the report, LETHARGY (Lethargy), RASH ERYTHEMATOUS (Red rash), COUGH (cough) and FATIGUE (severe tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Patient also experienced sense of wheeziness within 24 hours. Patient slept for 13 hours and was very tired post vaccination. Also developed red rash with in 48 hours post vaccination on neck, chest, back and lower area. Company Comment : This case concerns a 62-year-old patient with no relevant medical history, who experienced the unexpected serious events of fatigue, cough, lethargy, and rash erythematous. The event of fatigue s unexpected as it is retained as serious per the source document Authority reporting. Lethargy occurred on the same day after the booster dose of mRNA-1273. Rash erythematous occurred one day after vaccination. The date of onset of the events fatigue and cough was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 62-year-old patient with no relevant medical history, who experienced the unexpected serious events of fatigue, cough, lethargy, and rash erythematous. The event of fatigue s unexpected as it is retained as serious per the source document Authority reporting. Lethargy occurred on the same day after the booster dose of mRNA-1273. Rash erythematous occurred one day after vaccination. The date of onset of the events fatigue and cough was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908928 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Influenza, Influenza like illness, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2; INFLUENZA VIRUS
Current Illness: Arrhythmia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Flu like symptoms; Headache; Rash; Fever; Flu symptoms; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232859) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), INFLUENZA (Flu symptoms), RASH (Rash) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Arrhythmia. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) from 24-Feb-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 14-Oct-2021 to an unknown date for Vaccination. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 21-Nov-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache) and RASH (Rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Treatment information was provided paracetamol. Patient developed flu like symptoms the day after her Moderna vaccine. Her limbs and back ached and felt weak. Her arm was painful. She had a headache. The second day her symptoms worsened. She had a fever and developed a rash across the body. She took paracetamol to relieve symptoms. On the third day after the vaccination she started to recover. During the vaccination, some of the vaccine ran down her arm, a decision was made to give her a second jab. This was administered about 15 mins after the first jab. It was not known how much of the first jab was received. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. It was reported that this report was not related to possible inflammation of the heart (myocarditis or pericarditis). Local Evaluator Comment Regulatory Authority Assessment Company Comment: This case concerns a 62-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of influenza like illness, rash, pyrexia, and headache. The events occurred approximately 1 day after the booster dose of mRNA-1273. The rechallenge was not applicable since the patient previously received two doses of COVID-19 mRNA VACCINE BNT162B2, and no further doses are expected. It is to note that the patient mentions that there might have been a wrong technique in device usage or a syringe connection issue, and therefore it was unclear if the patient accidently received an underdose. Because of this event, the patient decided to receive an extra dose, so it is uncertain whether the patient received a vaccine overdose in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of influenza like illness, rash, pyrexia, and headache. The events occurred approximately 1 day after the booster dose of mRNA-1273. The rechallenge was not applicable since the patient previously received two doses of COVID-19 mRNA VACCINE BNT162B2, and no further doses are expected. It is to note that the patient mentions that there might have been a wrong technique in device usage or a syringe connection issue, and therefore it was unclear if the patient accidently received an underdose. Because of this event, the patient decided to receive an extra dose, so it is uncertain whether the patient received a vaccine overdose in this case. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1911577 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dyspnoea, Headache, Hypopnoea, Immunisation, Interchange of vaccine products, Muscle spasms, Night sweats, Off label use, Palpitations, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Respiratory failure (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629227

Write-up: 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination.; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination.; 3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination.; Generalized joint pain; Fever; Fever chills; Light headedness; Headache; Injection site pain; Muscle spasm; Breath shortness; Palpitation; Shallow breathing; Night sweat; This is a spontaneous report received from a contactable consumer from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111200818473010-K5ASI (MHRA). Other Case identifier: GB-MHRA-ADR 26231053 (MHRA). A 62-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Nov2021 (Lot number: FK9413) (at the age of 62-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "3rd dose was administered, and the patient has not previously received the full primary immunization series of BNT162B2 vaccination."; ARTHRALGIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Generalized joint pain"; PYREXIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Fever"; PYREXIA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Fever chills"; DIZZINESS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Light headedness"; HEADACHE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Injection site pain"; MUSCLE SPASMS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Muscle spasm"; DYSPNOEA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Breath shortness"; PALPITATIONS (medically significant) with onset 19Nov2021, outcome "recovering", described as "Palpitation"; HYPOPNOEA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Shallow breathing"; NIGHT SWEATS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Night sweat". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1911583 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-11-19
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Malaise, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric bleeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: generally unwell; headache; shaking; fever; Headache dull; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26232455) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache dull), MALAISE (generally unwell), HEADACHE (headache), TREMOR (shaking) and PYREXIA (fever) in a 62-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Gastric bleeding. Previously administered products included for Reflux gastritis: GAVISCON. Past adverse reactions to the above products included No adverse event with GAVISCON. On 22-May-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (generally unwell) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), TREMOR (shaking) (seriousness criterion medically significant) and PYREXIA (fever) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache dull) had not resolved and MALAISE (generally unwell), HEADACHE (headache), TREMOR (shaking) and PYREXIA (fever) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Reported headache, 24 hours after vaccination, felt sick, extremely tired, fever, shaking, went to bed, vomited 2 hours later, sore bones, still have dull headache, generally unwell, bit nauseas, sore arm, bowel movements are fine and don''t have appetite. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Company comment: This case concerns a 62-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Headache, Malaise, Tremor, and Pyrexia. The events occurred approximately 121 days after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of another dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Headache, Malaise, Tremor, and Pyrexia. The events occurred approximately 121 days after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of another dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1911584 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Malaise, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VACCINE; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Felt unwell about 11 hours after vaccination; Headache; Joint ache; Fever; Shivering; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26232536) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Felt unwell about 11 hours after vaccination), HEADACHE (Headache), ARTHRALGIA (Joint ache), PYREXIA (Fever) and CHILLS (Shivering) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 13-Jan-2021 to 21-Jan-2021. Concomitant products included AMLODIPINE from 05-Feb-2016 to an unknown date for Hypertension, INFLUENZA VACCINE from 02-Oct-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Felt unwell about 11 hours after vaccination) (seriousness criterion medically significant). On 21-Nov-2021, HEADACHE (Headache), ARTHRALGIA (Joint ache), PYREXIA (Fever) and CHILLS (Shivering) had resolved. At the time of the report, MALAISE (Felt unwell about 11 hours after vaccination) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment Medication use information was not provided by reporter. Patient Felt unwell about 11 hours after vaccination, headache like a head in a vice, shivering uncontrollably and then really hot, all joints hurting and was in bed for 24 hours, difficult to get out of bed as giddy. Patient had COVID in January and it felt exactly the same symptoms. Patients son also was felt unwell too had the same vaccination at the same time and same batch number. Patient sons were recover by 20th November 2021. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Company Comment : This case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) events of headache, arthralgia, pyrexia and chills. The events occurred the same day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about the first two doses has not been disclosed and no further doses are expected. Concomitant influenza vaccine administration is a confounding factor. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Pyrexia, arthralgia, headache, and chills are expected events but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 65-year-old female patient with no relevant medical history, who experienced the unexpected, serious (medically significant) events of headache, arthralgia, pyrexia and chills. The events occurred the same day after the booster dose of mRNA-1273. The rechallenge was not applicable since information about the first two doses has not been disclosed and no further doses are expected. Concomitant influenza vaccine administration is a confounding factor. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. Pyrexia, arthralgia, headache, and chills are expected events but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1911588 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Respiratory rate decreased, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthmatic; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Respiratory rate low; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26232899) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (Chest pain) and RESPIRATORY RATE DECREASED (Respiratory rate low) in a 23-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Asthmatic and Suspected COVID-19 since 19-Nov-2021. On 19-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced RESPIRATORY RATE DECREASED (Respiratory rate low) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain) had not resolved and RESPIRATORY RATE DECREASED (Respiratory rate low) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. It was reported that patient developed chest pain, low oxygen levels, flare up of asthma and was hospitalized on 19-Nov-2021. Reaction started 20/25 minutes after vaccine was given. Patient had not tested positive for COVID-19 since having the vaccine and Patient was not enrolled in clinical trial. Company comment: This case concerns a 23-year-old, female subject with a medical history of asthma, who experienced the serious unexpected events of Chest pain and Respiratory rate decreased. The events, which resulted in hospitalization, occurred on the same day after the first dose of mRNA 1273 VACCINE. Low oxygen levels and flare up of asthma are also noted. SARS-CoV-2 test result was negative. At the time of the report, outcome of the event Chest pain was Not Recovered/Not Resolved, Respiratory rate decreased was Recovering/Resolving while Low oxygen levels and Flare up of asthma had Unknown outcomes. Rechallenge is not applicable as events happened after the first dose. The patient''s medical history of asthma remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 23-year-old, female subject with a medical history of asthma, who experienced the serious unexpected events of Chest pain and Respiratory rate decreased. The events, which resulted in hospitalization, occurred on the same day after the first dose of mRNA 1273 VACCINE. Low oxygen levels and flare up of asthma are also noted. SARS-CoV-2 test result was negative. At the time of the report, outcome of the event Chest pain was Not Recovered/Not Resolved, Respiratory rate decreased was Recovering/Resolving while Low oxygen levels and Flare up of asthma had Unknown outcomes. Rechallenge is not applicable as events happened after the first dose. The patient''s medical history of asthma remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1911593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-05
Onset:2021-11-19
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 3 - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Influenza, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Unknown; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBSA2021SA390350

Write-up: lumpy lymph nodes; flu; Enlarged lymph nodes (excl infective); Initial information was received on 23-Nov-2021 and additional information was received on 25-Nov-2021 regarding an unsolicited valid serious case received from consumer/non health care professional via Health Authority (under reference number GB-MHRA-WEBCOVID-202111221140597200-EONVG). This case involves a 37-year-old female patient who experienced lumpy lymph nodes (lymph node pain), flu (influenza) and enlarged lymph nodes (excluding infective) (lymphadenopathy), after receiving INFLUENZA VACCINE and Coronavirus disease of 2019 (COVID-19) VACCINE MRNA (messenger Ribonucleic acid) (BIONTECH). The patient''s medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided. At the time of the event, the patient had ongoing anxiety. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not breastfeeding. On 05-Oct-2021, the patient received dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date: not reported] via an unknown route at left side for prophylactic vaccination. On 17-Nov-2021, the patient received a third (booster) dose of suspect COVID-19 VACCINE MRNA not produced by Sanofi Pasteur [lot number and expiry date was not reported] via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed serious lumpy lymph nodes (lymph node pain) after 24 hours following the administration of INFLUENZA VACCINE and two days following the administration of COVID-19 VACCINE MRNA. On an unknown date, the patient developed serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE and COVID-19 VACCINE MRNA. Patient''s last date of menstrual period was reported as 19-Nov-2021. On 19-Nov-2021, the patient developed serious enlarged lymph nodes (excluding infective) (lymphadenopathy) 1 month 14 days following the administration of INFLUENZA VACCINE and two days following the administration of COVID-19 VACCINE MRNA. All these events were assessed as medically significant. On the 5th October she had her annual flu jab 24 hours later she noticed two slightly lumpy lymph nodes above her left side collarbone. This was the same side that the injection was administered. She had blood tests and her doctor was not concerned. She has had health anxiety so finding a lump makes her very anxious. Two days after her blood test results she had her Pfizer booster vaccine. Two days after this she noticed that the lumps above her collarbone had grown in size and an additional lump could also be felt further towards her shoulder. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Relevant laboratory test results included blood test on an unknown date [results not provided] and severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] on an unknown date [negative]. Patient''s report does not relate to possible inflammation of the heart (myocarditis or pericarditis). It was not reported if the patient received any corrective treatment. At the time of reporting, the patient did not recover from event lymphadenopathy and recovering from rest of the events. There will be no information available on batch number for this case.; Sender''s Comments: This case involves 37-year-old female patient who experienced lymph node pain, influenza and lymphadenopathy, after vaccination with INFLUENZA VACCINE [unknown manufacturer] and COVID-19 VACCINE MRNA [not produced by Sanofi Pasteur]. The time to onset was compatible for lymph node pain and unknown for rest other events. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history and lab tests excluding alternative etiologies for the reported events are needed to fully assess this case. Based upon the reported information, the role of an individual suspect vaccine cannot be assessed.


VAERS ID: 1914700 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; TURMERIC ROOT EXTRACT; VITAMIN D NOS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26228211) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 MRNA VACCINE BIONTECH and COVID-19 MRNA VACCINE BNT162B2. Past adverse reactions to the above products included Adverse drug reaction with COVID-19 MRNA VACCINE BIONTECH and COVID-19 MRNA VACCINE BNT162B2. Concomitant products included AMLODIPINE, CURCUMA LONGA (TURMERIC ROOT EXTRACT) and VITAMIN D NOS for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) had not resolved. Patient felt shocking after both Pfizer vaccinations also for 24 hours. No medical history information was reported. Treatment medication information was not provided by the reporter. Company comment -This is a regulatory authority case concerning a 56-year-old female patient with no relevant medical history who experienced serious, unexpected event of Myalgia. The event is unexpected as it is retained as serious per the source document Authority reporting.The event occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 56-year-old female patient with no relevant medical history who experienced serious, unexpected event of Myalgia. The event is unexpected as it is retained as serious per the source document Authority reporting.The event occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1914706 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; APIXABAN; ATORVASTATIN; LANSOPRAZOLE; PROPRANOLOL HYDROCHLORIDE; VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS; MILK THISTLE [GLYCINE MAX;SILYBUM MARIANUM POWDER]
Current Illness:
Preexisting Conditions: Comments: No medical history reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea; Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26232900) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), VOMITING (Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea) and DIARRHOEA (Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 immunisation. No medical history reported. Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN), APIXABAN, ATORVASTATIN, LANSOPRAZOLE, PROPRANOLOL HYDROCHLORIDE, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and GLYCINE MAX, SILYBUM MARIANUM POWDER (MILK THISTLE [GLYCINE MAX;SILYBUM MARIANUM POWDER]) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability), VOMITING (Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea) (seriousness criterion disability) and DIARRHOEA (Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea) (seriousness criterion disability). At the time of the report, HEADACHE (Headache), VOMITING (Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea) and DIARRHOEA (Headache: Extreme uncontrollable vomitting: Extreme uncontrollabel diarrhea) had not resolved. Treatment information was not provided. Company Comment: This is a regulatory authority case concerning a 57-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of headache, vomiting and diarrhoea which resulted to disability. The events headache, vomiting and diarrhoea occurred the same day with the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 57-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of headache, vomiting and diarrhoea which resulted to disability. The events headache, vomiting and diarrhoea occurred the same day with the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vertigo
SMQs:, Vestibular disorders (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INDAPAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629022

Write-up: Vertigo; patient received third (booster) dose of BNT162b2/not received the full primary immunization series of BNT162b2; patient received third (booster) dose of BNT162b2/not received the full primary immunization series of BNT162b2; patient received third (booster) dose of BNT162b2/not received the full primary immunization series of BNT162b2; This is a spontaneous report received from a contactable reporter (Consumer, patient self) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111201642028240-NN2L3. Other Case identifier(s): GB-MHRA-ADR 26231651. A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: INDAPAMIDE taken for hypertension. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE;Lot number: UNKNOWN), administration date: 17Mar2021, for COVID-19 immunisation, reaction(s): "Vertigo"; Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE;Lot number: UNKNOWN), for COVID-19 immunisation, reaction(s): "Vertigo". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "patient received third (booster) dose of BNT162b2/not received the full primary immunization series of BNT162b2 "; VERTIGO (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Vertigo". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (01Apr2021) no - negative covid-19 test. It was reported patient had the same reaction to the two Astra Zeneca vaccinations that received prior to booster. Each time, the vertigo has come on within a day of receiving the vaccination. The patient''s last menstrual date was on 01Nov2021. The patient was not pregnant and was not breastfeeding at the time of this report. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient had not been tested positive for COVID-19 since the vaccination. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1915049 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Headache, Immunisation, Nightmare, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Fever; Result Unstructured Data: Test Result:Fever; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629319

Write-up: Headache; Fever; Booster; Tiredness; Nightmares; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111201957126350-NXAQ5 (MHRA). Other Case identifier: GB-MHRA-ADR 26231864 (MHRA). A 41 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Unknown) at the age of 41 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 03Nov2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1 and Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Tiredness"; NIGHTMARE (medically significant) with onset 19Nov2021, outcome "recovering", described as "Nightmares"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; PYREXIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Fever". The patient underwent the following laboratory tests and procedures: body temperature: (20Nov2021) fever; sars-cov-2 test: (unspecified date) no-negative COVID-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1915051 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Hyperhidrosis, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; FLUOXETINE; SERETIDE
Current Illness: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sweating increased armpits; Fever; Chills; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26232275) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and HYPERHIDROSIS (Sweating increased armpits) in a 39-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Previously administered products included for Product used for unknown indication: DEPO-MEDRONE. Past adverse reactions to the above products included No adverse event with DEPO-MEDRONE. Concurrent medical conditions included Asthma and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) for Asthma, FLUOXETINE from 10-Aug-2021 to an unknown date for Depression, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 25-Feb-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 11-May-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced HYPERHIDROSIS (Sweating increased armpits) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever) and CHILLS (Chills) was resolving. At the time of the report, HYPERHIDROSIS (Sweating increased armpits) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant, Patient was not currently breastfeeding. This is a regulatory case concerning a 39 year-old female patient, with medical history of asthma and depression under treatment with fluoxetine, previously vaccinated with 2 doses of CHADOX1 NCOV-19 (feb-2021 and may 2021) , who experienced the serious unexpected events of Pyrexia and chills on the same day after receiving the third dose of mRNA1273 vaccine, and 3 days later the serious unexpected event of hyperhidrosis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting.; Sender''s Comments: This is a regulatory case concerning a 39 year-old female patient, with medical history of asthma and depression under treatment with fluoxetine, previously vaccinated with 2 doses of CHADOX1 NCOV-19 (feb-2021 and may 2021) , who experienced the serious unexpected events of Pyrexia and chills on the same day after receiving the third dose of mRNA1273 vaccine, and 3 days later the serious unexpected event of hyperhidrosis. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1915052 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed mood, Fatigue, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Tinnitus (Developed tinnitus the day after my first Covid-19 vaccine (3/3/21))
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms startedUnsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; Headache; Nausea; Low mood; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232307) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Nausea) and DEPRESSED MOOD (Low mood) in a 64-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms startedUnsure when symptoms stopped). Concurrent medical conditions included Tinnitus (Developed tinnitus the day after my first Covid-19 vaccine (3/3/21)) since 03-Mar-2021. Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 03-Mar-2021 to 20-May-2021 for COVID-19 vaccination. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DEPRESSED MOOD (Low mood) (seriousness criterion medically significant). On 19-Nov-2021, NAUSEA (Nausea) had resolved. On 20-Nov-2021, FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. At the time of the report, DEPRESSED MOOD (Low mood) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. Relevant concomitant product usage were not reported by the reporter. This case concerns a 64-year-old female patient with a medical history of symptoms suspected with Covid-19 and tinnitus, who experienced the unexpected events of fatigue, headache, nausea and depressed mood. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events occurred approximately 1 day after the third dose of mRNA � 1273 vaccine. Events were reported as medically significant but the event nausea resolved on the same day it was experienced, while fatigue and headache had resolved a day after. Only the event depressed mode had not resolved at the time of report. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. No treatment details were added. Reactions 1-3 started after vaccination and lasted for 24-36 hours. Reaction 4 (low mood) still ongoing as at 21/11/21. Patient has not tested positive for COVID-19 since having the vaccine.; Sender''s Comments: This case concerns a 64-year-old female patient with a medical history of symptoms suspected with Covid-19 and tinnitus, who experienced the unexpected events of fatigue, headache, nausea and depressed mood. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events occurred approximately 1 day after the third dose of mRNA � 1273 vaccine. Events were reported as medically significant but the event nausea resolved on the same day it was experienced, while fatigue and headache had resolved a day after. Only the event depressed mode had not resolved at the time of report. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1915053 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Influenza, Myalgia, Nausea, Renal pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NAPROXEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Kidney pain; Flu symptoms; Shortness of breath; Nausea; Headache; Muscle ache; Felt faint; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232308) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain), INFLUENZA (Flu symptoms), DYSPNOEA (Shortness of breath), NAUSEA (Nausea), HEADACHE (Headache), MYALGIA (Muscle ache) and DIZZINESS (Felt faint) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included NAPROXEN from 06-Mar-2021 to an unknown date for Knee pain. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced RENAL PAIN (Kidney pain) (seriousness criterion medically significant), INFLUENZA (Flu symptoms) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and DIZZINESS (Felt faint) (seriousness criterion medically significant). At the time of the report, RENAL PAIN (Kidney pain), INFLUENZA (Flu symptoms), MYALGIA (Muscle ache) and DIZZINESS (Felt faint) had not resolved and DYSPNOEA (Shortness of breath), NAUSEA (Nausea) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was reported. Patient has not had symptoms associated with COVID-19. This case concerns a 65-year-old male, with no relevant medical history reported in this case, who experienced the serious unexpected events of Renal Pain, Influenza, Dyspnoea, Nausea, Headache, Myalgia and Dizziness. The events occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events Renal Pain, Influenza, Myalgia and Dizziness is Not Recovered/Not Resolved and for the events Dyspnoea, Nausea, Headache is Recovering/Resolving. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Based on medical judgment this event is relevant to the case.; Sender''s Comments: This case concerns a 65-year-old male, with no relevant medical history reported in this case, who experienced the serious unexpected events of Renal Pain, Influenza, Dyspnoea, Nausea, Headache, Myalgia and Dizziness. The events occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events Renal Pain, Influenza, Myalgia and Dizziness is Not Recovered/Not Resolved and for the events Dyspnoea, Nausea, Headache is Recovering/Resolving. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Based on medical judgment this event is relevant to the case.


VAERS ID: 1915057 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Diarrhoea; Fever; Shivering; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 26232496) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea), PYREXIA (Fever) and CHILLS (Shivering) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The medical history was not provided by the reporter. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Diarrhoea), PYREXIA (Fever) and CHILLS (Shivering) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medications provided by the reporter. This case concerns a subject of an unknown age and gender, with no relevant medical history reported in this case, who experienced the serious unexpected events of Diarrhoea, Pyrexia and chills. The event Diarrhoea occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine and the events Pyrexia and chills occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events is Recovered/Resolved. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Based on medical judgment this event is relevant to the case.; Sender''s Comments: This case concerns a subject of an unknown age and gender, with no relevant medical history reported in this case, who experienced the serious unexpected events of Diarrhoea, Pyrexia and chills. The event Diarrhoea occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine and the events Pyrexia and chills occurred the same day of the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events is Recovered/Resolved. The rechallenge is not applicable since the events occurred after the 3rd dose of the of the mRNA-1273 vaccine and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Based on medical judgment this event is relevant to the case.


VAERS ID: 1915067 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-12
Onset:2021-11-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Musculoskeletal chest pain, Nausea, SARS-CoV-2 test, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rib pain; Blurry vision; Head pain; Nausea; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26233524) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Head pain), NAUSEA (Nausea), MUSCULOSKELETAL CHEST PAIN (Rib pain) and VISION BLURRED (Blurry vision) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No Medical History information was reported. Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 20-Feb-2021 to an unknown date for an unknown indication. On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (Rib pain) (seriousness criterion medically significant) and VISION BLURRED (Blurry vision) (seriousness criterion medically significant). At the time of the report, HEADACHE (Head pain), NAUSEA (Nausea), MUSCULOSKELETAL CHEST PAIN (Rib pain) and VISION BLURRED (Blurry vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (normal) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient was not breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. This report was not related to possible inflammation of the heart (myocarditis or pericarditis. Patient underwent the following relevant investigations or tests: CT Blood tests. Company Comment: This regulatory authority case concerns a 51-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Musculoskeletal chest pain, Vision blurred, Headache and Nausea after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The event Headache and Nausea occurred approximately 7 days after the dose of mRNA- 1273 vaccine and Musculoskeletal chest pain and Vision blurred occurred approximately 8 days after the dose. CT and laboratory tests were performed, but the results are not available. Headache and Nausea are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 51-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Musculoskeletal chest pain, Vision blurred, Headache and Nausea after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The event Headache and Nausea occurred approximately 7 days after the dose of mRNA- 1273 vaccine and Musculoskeletal chest pain and Vision blurred occurred approximately 8 days after the dose. CT and laboratory tests were performed, but the results are not available. Headache and Nausea are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1915068 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Malaise, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; CORACTEN; COVID-19 VACCINE ASTRAZENECA; FOLIC ACID; IBUPROFEN; INFLUENZA VIRUS; LEVOTHYROXINE; OMEPRAZOLE; VITAMIN B12 NOS
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Mixed connective tissue disease; Scleroderma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Generally unwell; Injection site redness; Injection site pain; Injection site swelling; This case was received via Regulatory Authority. Reference number: GB-MHRA-ADR 26233654) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concurrent medical conditions included Mixed connective tissue disease, Scleroderma and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included CODEINE PHOSPHATE, PARACETAMOL (CO-CODAMOL), NIFEDIPINE (CORACTEN), COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), FOLIC ACID, IBUPROFEN, INFLUENZA VACCINE (INFLUENZA VIRUS), LEVOTHYROXINE, OMEPRAZOLE and VITAMIN B12 NOS for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Patient had Bruse around injection site. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 64-year-old, female patient with concomitant Covid-19 vaccine of another brand (Covid-19 AstraZeneca) and concurrent medical condition of mixed connective tissue disease, scleroderma and immunodeficiency who experienced the unexpected serious events of injection site erythema, injection site pain, injection site swelling and malaise. The events injection site erythema, injection site pain, injection site swelling occurred the same day with the third dose of mRNA-1273 vaccine administration while the event malaise occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The concurrent medical condition of mixed connective tissue disease, scleroderma and immunodeficiency remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 64-year-old, female patient with concomitant Covid-19 vaccine of another brand (Covid-19 AstraZeneca) and concurrent medical condition of mixed connective tissue disease, scleroderma and immunodeficiency who experienced the unexpected serious events of injection site erythema, injection site pain, injection site swelling and malaise. The events injection site erythema, injection site pain, injection site swelling occurred the same day with the third dose of mRNA-1273 vaccine administration while the event malaise occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The concurrent medical condition of mixed connective tissue disease, scleroderma and immunodeficiency remains confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915069 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swelling; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26233611) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling) in a 68-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). On 19-Nov-2021, SWELLING (Swelling) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. List of concomitant medication were not given Patient ate a sandwich 4 hours after vaccination and her whole abdomen got swollen, she passed no flatus for several hours after that, she had the same reaction in 2013 after receiving H1N1 flu vaccine, it resolved itself and although uncomfortable did not unduly concern her to ring for assistance Treatment included inflammatory medicines. Company Comment: This case concerns a 68-year-old female patient, with no relevant medical history, who experienced the unexpected serious event of SWELLING. The event occurred on the same da of the administration of the third dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old female patient, with no relevant medical history, who experienced the unexpected serious event of SWELLING. The event occurred on the same da of the administration of the third dose of mRNA-1273. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915071 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Lethargy, Lymphadenopathy, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; days; lethargy; Swollen glands; Headache; Fever chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26233639) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (days), LETHARGY (lethargy), PYREXIA (Fever chills), LYMPHADENOPATHY (Swollen glands) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant), PYREXIA (days) (seriousness criterion medically significant) and LETHARGY (lethargy) (seriousness criterion medically significant). On 22-Nov-2021, PYREXIA (Fever chills) and LYMPHADENOPATHY (Swollen glands) was resolving. At the time of the report, CHILLS (chills), PYREXIA (days) and LETHARGY (lethargy) was resolving and HEADACHE (Headache) had not resolved. No concomitant medication was reported. It was reported that patient developed fever and chills started 24 hours later, followed by swelling of underarm on side where vaccination given. Headache and lethargy for 3 days Patient had not tested positive for COVID-19 since having the vaccine and patient was not enrolled in clinical trial. No treatment information was reported. Company Comment: This is a regulatory case concerning a 51-year-old female patient with no clinical history who experienced the unexpected events of CHILLS, PYREXIA, LETHARGY, PYREXIA, LYMPHADENOPATHY and HEADACHE The event occurred 2 days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 51-year-old female patient with no clinical history who experienced the unexpected events of CHILLS, PYREXIA, LETHARGY, PYREXIA, LYMPHADENOPATHY and HEADACHE The event occurred 2 days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915079 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysgeusia, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; LOSARTAN POTASSIUM; METFORMIN; STEXEROL D3
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Taste metallic; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26233954) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSGEUSIA (Taste metallic) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included METFORMIN for Diabetes, ATORVASTATIN, LOSARTAN POTASSIUM and COLECALCIFEROL (STEXEROL D3) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DYSGEUSIA (Taste metallic) (seriousness criterion medically significant). At the time of the report, DYSGEUSIA (Taste metallic) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment details were not provided. Patient experienced metallic taste in mouth 20 mins after mRNA-1273 was taken. This case concerns a 62-year-old female patient, with a relevant concomitant drug history of Metformin, who experienced the serious unexpected event of Dysgeusia. The event occurred 20 mins after the third dose of mRNA-1273 vaccine. The medical history Metformin use is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 62-year-old female patient, with a relevant concomitant drug history of Metformin, who experienced the serious unexpected event of Dysgeusia. The event occurred 20 mins after the third dose of mRNA-1273 vaccine. The medical history Metformin use is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1915087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Joint swelling, Joint warmth, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis))
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint swelling; Fever; Joint pain; Tremor; Joint warmth; This case was received via RA (Reference number: GB-MHRA-ADR 26234242) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of JOINT SWELLING (Joint swelling), PYREXIA (Fever), ARTHRALGIA (Joint pain), TREMOR (Tremor) and JOINT WARMTH (Joint warmth) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Ulcerative colitis and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concurrent medical conditions included Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)). On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), TREMOR (Tremor) (seriousness criterion medically significant) and JOINT WARMTH (Joint warmth) (seriousness criterion medically significant). On an unknown date, the patient experienced JOINT SWELLING (Joint swelling) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, JOINT SWELLING (Joint swelling) and PYREXIA (Fever) had not resolved, ARTHRALGIA (Joint pain) and JOINT WARMTH (Joint warmth) was resolving and TREMOR (Tremor) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient woke up at 0100 on 19-Nov-21, approx 16 hours after vaccine with severe joint pain, tremors, fever, joint swelling and warmth. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No concomitant medication details provided. No treatment medication details provided. Company Comment: This is a regulatory case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of JOINT SWELLING, PYREXIA, ARTHRALGIA, TREMOR and JOINT WARMTH The event occurred 1 day after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning an unknown-year-old female patient with no clinical history who experienced the unexpected events of JOINT SWELLING, PYREXIA, ARTHRALGIA, TREMOR and JOINT WARMTH The event occurred 1 day after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915088 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Ache; Pain; Headache; Vomiting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26234317) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (Ache), PAIN (Pain), HEADACHE (Headache) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 21-Mar-2020. On 19-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 20-Nov-2021, VOMITING (Vomiting) was resolving. At the time of the report, PYREXIA (Fever), PAIN (Ache), PAIN (Pain) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company Comment: This case concerns a 54 year-old female patient with a history of suspected COVID-19 in March 2021 who experienced the unexpected serious events of pyrexia, pain, headache, and vomiting. The events occurred approximately 1 day after vaccination with mRNA-1273 vaccine. The rechallenge was unknown as dose sequence information was not provided. The medical history of suspected COVID-19 remains a confounder for pyrexia, pain, headache, and vomiting. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 54 year-old female patient with a history of suspected COVID-19 in March 2021 who experienced the unexpected serious events of pyrexia, pain, headache, and vomiting. The events occurred approximately 1 day after vaccination with mRNA-1273 vaccine. The rechallenge was unknown as dose sequence information was not provided. The medical history of suspected COVID-19 remains a confounder for pyrexia, pain, headache, and vomiting. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting


VAERS ID: 1915091 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache, Nausea, Palpitations, Renal pain, Syncope, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; PARACETAMOL; INFLUENZA VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shaking; Fainting; Nausea; Stomach pain; Vomiting; Shivering; Kidney pain; Heart racing; Generalised joint pains; Head pain; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26234401) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), NAUSEA (Nausea), PALPITATIONS (Heart racing), TREMOR (shaking), ARTHRALGIA (Generalised joint pains), HEADACHE (Head pain), ABDOMINAL PAIN UPPER (Stomach pain), VOMITING (Vomiting), CHILLS (Shivering) and RENAL PAIN (Kidney pain) in a 69-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included PARACETAMOL for Pain neck, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 18-Feb-2021 to an unknown date and INFLUENZA VACCINE from 01-Nov-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant), ARTHRALGIA (Generalised joint pains) (seriousness criterion medically significant), HEADACHE (Head pain) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and RENAL PAIN (Kidney pain) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (shaking) (seriousness criterion medically significant). On 21-Nov-2021, SYNCOPE (Fainting), ABDOMINAL PAIN UPPER (Stomach pain), VOMITING (Vomiting), CHILLS (Shivering) and RENAL PAIN (Kidney pain) had resolved. At the time of the report, NAUSEA (Nausea), PALPITATIONS (Heart racing), TREMOR (shaking), ARTHRALGIA (Generalised joint pains) and HEADACHE (Head pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information includes Prochlorperazine Maleate tablets to ease vomiting. Patient had symptoms associated with COVID-19 Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company Comment: This regulatory case concerns a 69-year-old male patient, with unknown medical history, who experienced the serious unexpected events of SYNCOPE, PALPITATIONS, NAUSEA, TREMOR, ARTRHALGIA, HEADACHE, ABDOMINAL PAIN UPPER, VOMITING, CHILLS and RENAL PAIN. The events of arthralgia, headache, chills and renal pain occurred on the same day after receiving a dose of mRNA-1273. The events of syncope, nausea, palpitations, abdominal pain upper, and vomiting occurred one day after receiving that dose. The event of tremor occurred on an unknown date. Dose number was captured as "3b", however it is uncertain if this is the third dose of mRNA-1273 administered to the patient, since a previous dose of CHADOX1 nCoV-19 dose is reported. The rechallenge is unknown according to the RA assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a 69-year-old male patient, with unknown medical history, who experienced the serious unexpected events of SYNCOPE, PALPITATIONS, NAUSEA, TREMOR, ARTRHALGIA, HEADACHE, ABDOMINAL PAIN UPPER, VOMITING, CHILLS and RENAL PAIN. The events of arthralgia, headache, chills and renal pain occurred on the same day after receiving a dose of mRNA-1273. The events of syncope, nausea, palpitations, abdominal pain upper, and vomiting occurred one day after receiving that dose. The event of tremor occurred on an unknown date. Dose number was captured as "3b", however it is uncertain if this is the third dose of mRNA-1273 administered to the patient, since a previous dose of CHADOX1 nCoV-19 dose is reported. The rechallenge is unknown according to the RA assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1915094 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lethargy, Nausea, Pain in jaw, SARS-CoV-2 test, Sinus headache
SMQs:, Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENDROFLUAZIDE; INFLUENZA VIRUS; LOSARTAN; PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lethargy; Headache sinus; Nausea; Jaw pain; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26234403) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), SINUS HEADACHE (Headache sinus), NAUSEA (Nausea) and PAIN IN JAW (Jaw pain) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included BENDROFLUMETHIAZIDE (BENDROFLUAZIDE) and LOSARTAN for Blood pressure high, PARACETAMOL for Pain, INFLUENZA VACCINE (INFLUENZA VIRUS) from October 2021 to an unknown date for an unknown indication. On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced LETHARGY (Lethargy) (seriousness criterion medically significant), SINUS HEADACHE (Headache sinus) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PAIN IN JAW (Jaw pain) (seriousness criterion medically significant). At the time of the report, LETHARGY (Lethargy), SINUS HEADACHE (Headache sinus), NAUSEA (Nausea) and PAIN IN JAW (Jaw pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was given. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Adverse reaction did not occur as a result of an exposure during pregnancy Company Comment: This case concerns a 65-year-old, female patient with no relevant medical history, who experienced the unexpected events of lethargy, sinus headache, nausea and pain in jaw. The events occurred approximately 1 day after the third dose of mRNA-1273. The rechallenge was not applicable as events were ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 65-year-old, female patient with no relevant medical history, who experienced the unexpected events of lethargy, sinus headache, nausea and pain in jaw. The events occurred approximately 1 day after the third dose of mRNA-1273. The rechallenge was not applicable as events were ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1915098 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3604732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea, Night sweats, Palpitations, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE MODERNA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Palpitations; Headache; Night sweats; Nausea; Nauseous; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234645) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), HEADACHE (Headache), NIGHT SWEATS (Night sweats), NAUSEA (Nauseous) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (Batch no. 3604732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 17-Feb-2021 to an unknown date and ELASOMERAN (COVID-19 VACCINE MODERNA) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NIGHT SWEATS (Night sweats) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 22-Nov-2021, NAUSEA (Nauseous) was resolving. At the time of the report, PALPITATIONS (Palpitations), HEADACHE (Headache), NIGHT SWEATS (Night sweats) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient experienced nausea, headache, palpitations, she was not able to sleep and had night sweats. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company Comment: This is a regulatory case concerning a 60-year-old female patient with no clinical history who experienced the unexpected events of PALPITATIONS, HEADACHE, NIGHT SWEATS, NAUSEA and NAUSEA The event occurred 1 day after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report; Sender''s Comments: This is a regulatory case concerning a 60-year-old female patient with no clinical history who experienced the unexpected events of PALPITATIONS, HEADACHE, NIGHT SWEATS, NAUSEA and NAUSEA The event occurred 1 day after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report


VAERS ID: 1915103 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Headache
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Armpit pain; Frontal headache; This case was received (Reference number: GB-MHRA-ADR 26234797) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frontal headache) and AXILLARY PAIN (Armpit pain) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Mar-2021 to 19-May-2021 for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (Frontal headache) had not resolved and AXILLARY PAIN (Armpit pain) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine.Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not currently breastfeeding Patient was not enrolled in clinical trial. Company comment -This case concerns a 51-year-old female patient with no relevant medical history provided who experienced serious unexpected events of Headache and Axillary pain. The events occurred on the same day or the day after the third dose of COVID-19 vaccine. It should be noted that the patient received two doses of COVID-19 vaccine Astrazeneca followed by the third dose of mRNA-1273. The rechallenge was reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. Very limited information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old female patient with no relevant medical history provided who experienced serious unexpected events of Headache and Axillary pain. The events occurred on the same day or the day after the third dose of COVID-19 vaccine. It should be noted that the patient received two doses of COVID-19 vaccine Astrazeneca followed by the third dose of mRNA-1273. The rechallenge was reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. Very limited information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1915114 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Night sweats, Pain, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; PANADOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20211109; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: the night after the vaccine; Pain; This case was received (Reference number: GB-MHRA-ADR 26235224) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NIGHT SWEATS (the night after the vaccine) and PAIN (Pain) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. No medical history was provided by the reporter. Concomitant products included PARACETAMOL (PANADOL) for Insomnia, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 28-Feb-2021 to an unknown date for Vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant). On an unknown date, the patient experienced NIGHT SWEATS (the night after the vaccine) (seriousness criterion medically significant). On 20-Nov-2021, PAIN (Pain) had resolved. At the time of the report, NIGHT SWEATS (the night after the vaccine) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient was feeling pain in the internal organs in multiple places, throughout the inside of his body. It made the night sleepless. Patient took some Panadol in an attempt to stop the pain but, while this succeeded somewhat in easing the pain, was still feeling enough pain to prevent him from sleeping. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Company comment: This case concerns a 50-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of night sweats (reported as "the night after the vaccine") and pain. On 19-Nov-2021, the patient received a dose (unknown dosage) of mRNA-1273. The event pain occurred on the same day. The date of onset of the event night sweats was not reported. The patient previously had two doses of COVID-19 VACCINE ASTRAZENECA: the first one on 28-FEB-2021 and the second one on 8-MAY-2021. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 50-year-old, male patient with no reported relevant medical history, who experienced the unexpected serious events of night sweats (reported as "the night after the vaccine") and pain. On 19-Nov-2021, the patient received a dose (unknown dosage) of mRNA-1273. The event pain occurred on the same day. The date of onset of the event night sweats was not reported. The patient previously had two doses of COVID-19 VACCINE ASTRAZENECA: the first one on 28-FEB-2021 and the second one on 8-MAY-2021. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events coding, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.


VAERS ID: 1915118 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Erythema, Headache, Infection, Injection site pain, Lethargy, Nausea, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN LYSINE; INFLUENZA VIRUS; PARACETAMOL; SALBUTAMOL
Current Illness:
Preexisting Conditions: Comments: The above is not applicable. Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: aching joints; redness; infection; symptoms started the same day as the injection; headache; lethargic; nausea; Swollen arm; This case was received (Reference number: GB-MHRA-ADR 26235375) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (aching joints), ERYTHEMA (redness), INFECTION (infection), INJECTION SITE PAIN (symptoms started the same day as the injection), HEADACHE (headache), LETHARGY (lethargic), NAUSEA (nausea) and PERIPHERAL SWELLING (Swollen arm) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The above is not applicable. Unsure if patient has had symptoms associated with COVID-19. Concomitant products included SALBUTAMOL for Asthma, IBUPROFEN LYSINATE (IBUPROFEN LYSINE) and PARACETAMOL for Joint pain, INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (aching joints) (seriousness criterion medically significant), ERYTHEMA (redness) (seriousness criterion medically significant), INFECTION (infection) (seriousness criterion medically significant), INJECTION SITE PAIN (symptoms started the same day as the injection) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant), LETHARGY (lethargic) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (aching joints), ERYTHEMA (redness), INFECTION (infection), INJECTION SITE PAIN (symptoms started the same day as the injection), HEADACHE (headache), LETHARGY (lethargic) and NAUSEA (nausea) was resolving and PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient had arm hot to the touch, very red, redness went outside of the penline drawn round it, nausea, headache, incredibly drowsy and lethargic, aching joints all over the body, generally feeling overwhelmingly unwell. The patient''s first two doses were Astra Zennica, felt a bit "ropey" afterwards but nowhere near as bad as this. Symptoms started the same day as the injection, 19-Nov-2021, got progressively worse over the weekend, sought medical attention 22-Nov-2021 due to being too ill to go to work. The patient was prescribed Flucloxacillin 500mg due to suspected infection of the injection site and was really very poorly. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. This case concerns a 52 year old female patient with no relevant medical history, who experienced the serious unexpected events of arthralgia, erythema, infection, injection site pain, headache, lethargy, nausea and peripheral swelling.. The event peripheral swelling occurred on the same day after the third dose of mRNA-1273 vaccine. The other events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 52 year old female patient with no relevant medical history, who experienced the serious unexpected events of arthralgia, erythema, infection, injection site pain, headache, lethargy, nausea and peripheral swelling.. The event peripheral swelling occurred on the same day after the third dose of mRNA-1273 vaccine. The other events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915143 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Prophylaxis
Preexisting Conditions: Comments: Nothing else to add Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GB0095075132111GBR009276

Write-up: Swollen glands; Tiredness; Muscle ache; Pain; This spontaneous report was received from a consumer via The Agency Concerning a 55-year-old female patient. The patient''s concurrent conditions and medical history were not provided. Patient''s concomitant therapies included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA). On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (manufgacturer unknown) and covid-19 vaccine mrna (mrna 1273)(COVID-19 VACCINE MODERNA) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not provided). On 19-NOV-2021, the patient experienced fatigue, pain and myalgia. On 20-NOV-2021, the patient experienced lymphadenopathy. The events were reported as "just a reaction to the booster vaccine" and stated that patient has not tested positive for COVID-19 since having the vaccine. On 21-NOV-2021, the patient recovered from pain; on 22-NOV-2021, recovered from myalgia and fatigue and; on 24-NOV-2021, recovered from lymphadenopathy. The action taken with the suspect vaccines was reported as unkown. The causality assessment between the occurrence of the events and hepatitis a vaccine, inactivated (manufgacturer unknown) administration was not provided. The reporter/agency considered the reported events to be medically significant.


VAERS ID: 1916038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FHU751 / 3 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Erectile dysfunction, Eye pain, Headache, SARS-CoV-2 test
SMQs:, Glaucoma (broad), COVID-19 (broad), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Comments: No health problems. Recent GP routine ''MOT'' check found no issues with heart or circulation etc. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: CT scan; Result Unstructured Data: (Test Result:no issue with heart circulation,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: COVID 19 virus test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: Head pain; Eye pain; impotence; Case received by RA via RA on 25th November 2021. This case was reported by a consumer via regulatory authority and described the occurrence of impotence in a male patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) (batch number FHU751, expiry date unknown) for prophylaxis. The patient''s past medical history included clinical trial participant. Additional patient notes included No health problems. Recent GP routine ''MOT'' check found no issues with heart or circulation etc. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On an unknown date, the patient received Hepatitis A vaccine (unknown). On 19th November 2021, the patient received the 3rd dose of BIONTECH COVID-19 MRNA VACCINE (unknown). On 19th November 2021, unknown after receiving Hepatitis A vaccine, the patient experienced impotence (serious criteria medically significant and other: Serious as per reporter). On 20th November 2021, unknown after receiving Hepatitis A vaccine, the patient experienced eye pain (serious criteria other: Serious as per reporter). On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced head pain (serious criteria other: Serious as per reporter). On 22nd November 2021, the outcome of the eye pain and head pain were recovered/resolved. On an unknown date, the outcome of the impotence was not recovered/not resolved. It was unknown if the reporter considered the impotence, eye pain and head pain to be related to Hepatitis A vaccine. Additional details were provided as follow: The age at vaccination was unknown. In 2021, Computerized tomogram scan performed with result no issues with heart or circulation. In November 2021, Patient had not tested positive for COVID-19 since having the vaccine, hence result was captured negative. The duration for the event eye pain was reported as 2 days. Time to onset for eye pain was 1 day, for impotence it was immediately and for headache it was less than a week with respect to suspect BIONTECH COVID-19 MRNA VACCINE. It was unknown if the reporter considered the impotence, eye pain and headache to be related to BIONTECH COVID-19 MRNA VACCINE. As per case narrative patient had impotence immediately after Covid 19 booster vaccine, hence considering the event onset for impotence was captured same as that of vaccination date for Covid 19 vaccine. The patient''s age was reported as 6 months, height was reporetd as 180 cm, weight was reporeted as 87 kg and the event was reported as impotence which seems discrepant information, hence age of patient was captured in field and accordingly medication error was not taken in consideration. Exact patient''s age was expected in follow up. Note: The reported 1 day time to onset was considered only for BIONTECH COVID-19 MRNA VACCINE as vaccination date for Hepatitis A vaccine was not reported, hence for all the events with respect to Hepatitis A vaccine was captured as unknown. Exact vaccination date for Hepatitis A vaccine to calculate the TTO was expected in follow up Initial information received from consumer via regulatory authority on 25th November 2021: Impotence, eye pain and headache. Case narrative: 25-NOV-2021 Impotence occurred for a few days immediately after receiving the Pfizer booster vaccine. The problem is improving but not back to normal just yet. There was no problem before having the vaccine. Post vaccine eye and head pain disappeared after two days. Patient has not tested positive for COVID-19 since having the vaccine Clinical trial participant. Study details: (PRIVACY). Reaction. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis) If yes, we will ask you some additional questions at the end of this report: No; Reporter''s Comments: .


VAERS ID: 1917440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-11-19
   Days after vaccination:167
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: PCR covid-19 virus test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101634195

Write-up: Covid-19 positive despite vaccination (first dose 15May2021, second dose 05Jun2021); Asymptomatic COVID-19; This is a spontaneous report from a contactable consumer (who is the patient) received via a Pfizer colleague. A 45 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15May2021 (Lot number: EK9788, Expiration Date: 31May2021) as dose 1, single and intramuscular, administration date 05Jun2021 (Lot number: ER9480, Expiration Date: 31Jul2021) as dose 2, single for covid-19 immunisation. Relevant medical history included: "non-smoker" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Covid-19 positive despite vaccination (first dose 15May2021, second dose 05Jun2021)"; ASYMPTOMATIC COVID-19 (medically significant) with onset 19Nov2021, outcome "recovering", described as "Asymptomatic COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) positive. Therapeutic measures were not taken as a result of vaccination failure, asymptomatic covid-19. Investigational report conclusion: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788 and ER9480. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. Follow up activities completed. Information on the batch number received. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1917937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Enlarged uvula, Influenza like illness, Obstructive airways disorder, Pharyngeal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: EGPFIZER INC202101637168

Write-up: airway obstruction due to severe swelling to soft uvula and pharyngeal walls; airway obstruction due to severe swelling to soft uvula and pharyngeal walls; airway obstruction due to severe swelling to soft uvula and pharyngeal walls; flu like symptoms; This is a spontaneous report received from a contactable reporter(s) (Physician) from escalation team for a Pfizer sponsored program. A female patient of an unspecified age (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "flu like symptoms"; OBSTRUCTIVE AIRWAYS DISORDER (hospitalization) with onset 21Nov2021, outcome "unknown", described as "airway obstruction due to severe swelling to soft uvula and pharyngeal walls". UVULA SWELLING (hospitalization) with onset 21Nov2021, outcome "unknown", described as "airway obstruction due to severe swelling to soft uvula and pharyngeal walls". PHARYNGEAL SWELLING (hospitalization) with onset 21Nov2021, outcome "unknown", described as "airway obstruction due to severe swelling to soft uvula and pharyngeal walls". The events "airway obstruction due to severe swelling to soft uvula and pharyngeal walls" was evaluated at the emergency room visit. Additional information: The patient received second dose of pfizer vaccine on Wednesday 17Nov2021 and 2 days later she started to develop flu like symptoms and today at early morning she had airway obstruction due to severe swelling to soft uvula and pharyngeal walls she went to ER received management But as a physician she had to inform you to try searching for any other cases or was it non related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events obstructive airways disorder, Uvula swelling and Pharyngeal swelling cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1918152 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Feeling cold, Headache, Hypersomnia, Malaise, Nausea, Pain, Pain in extremity, Peripheral coldness, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALIN; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Felt very unwell for two weeks).
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: General body pain; Joint pain; Pain in arm; Malaise; Exhaustion; Dizziness; Headache; Fatigue; Syncope; Near fainting; Hypersomnia; Ache; Shivering; Feeling cold; Cold hands; Nausea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231921) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Syncope), HYPERSOMNIA (Hypersomnia), PAIN (Ache), CHILLS (Shivering), FEELING COLD (Feeling cold), PERIPHERAL COLDNESS (Cold hands), PAIN (General body pain), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Pain in arm), MALAISE (Malaise), FATIGUE (Exhaustion), DIZZINESS (Dizziness), HEADACHE (Headache), FATIGUE (Fatigue), NAUSEA (Nausea) and PRESYNCOPE (Near fainting) in a 47-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (Felt very unwell for two weeks) from 14-Oct-2021 to 28-Oct-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) for Flu vaccination, SERTRALIN for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Parenteral) 1 dosage form. On 19-Nov-2021, the patient experienced HYPERSOMNIA (Hypersomnia) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), FEELING COLD (Feeling cold) (seriousness criterion medically significant), PERIPHERAL COLDNESS (Cold hands) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), PAIN (General body pain), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), MALAISE (Malaise) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 20-Nov-2021, PRESYNCOPE (Near fainting) had resolved. At the time of the report, SYNCOPE (Syncope), HYPERSOMNIA (Hypersomnia), PAIN (Ache), CHILLS (Shivering), FEELING COLD (Feeling cold), PERIPHERAL COLDNESS (Cold hands), PAIN (General body pain), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (Pain in arm), MALAISE (Malaise), FATIGUE (Exhaustion), DIZZINESS (Dizziness), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown and NAUSEA (Nausea) was resolving. The treatment information was not provided. It was reported that after having the booster injection patient experienced several symptoms that were very uncomfortable and for 24 hours could do very little except sleep. No side effects with the flu vaccination. No side effects with previous covid vaccines either they were Astra Zeneca. Moderna Vaccination site- Left arm It was reported that, patient waited in the recover position and don''t really remember how long for it was a blank so not sure if she slept or was unconscious for a bit. It was all quite frightening because she felt like her whole body had been taken over and she had no control over it. This case concerns a 47-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected event of syncope. The event occurred on the same day after third (booster) dose of mRNA 1273 vaccine. The patient received Astra Zeneca Covid-19 vaccine for her primary series and felt unwell for two weeks. The night after the vaccine, the patient felt sick and fainted, she was not sure if she was unconscious or slept, patient has been feeling better after 24 hours. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old, female patient, with no relevant medical history, who experienced the serious, unexpected event of syncope. The event occurred on the same day after third (booster) dose of mRNA 1273 vaccine. The patient received Astra Zeneca Covid-19 vaccine for her primary series and felt unwell for two weeks. The night after the vaccine, the patient felt sick and fainted, she was not sure if she was unconscious or slept, patient has been feeling better after 24 hours. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1918154 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Blood pressure measurement, Body temperature, Chest pain, Dizziness, Headache, Heart rate, Joint stiffness, Myositis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADIOL; EZETIMIBA; FEXOFENADINE HYDROCHLORIDE; OPATANOL; RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]; RHINOCORT AQUA; MOMETASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Comments: Astma/ chemical intolerence/ Ascending Aortic Aneurysm, some changes to the heart spinal foramin stenosis mod /severe C5/C6 hEDS
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: 177/95; Test Name: Blood pressure; Result Unstructured Data: 125/75; Test Name: Body temperature; Result Unstructured Data: 35.1 degree Celsius; Test Name: Body temperature; Result Unstructured Data: 38 degree Celsius; Test Name: Heart rate; Result Unstructured Data: 71
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Joint inflammation; Chest pain; Fever chills; Dizziness; Headache; Muscle inflammation; Joint stiffness; This case was received via regulatory authority (Reference number: -MHRA-ADR 26232488) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PYREXIA (Fever chills), MYOSITIS (Muscle inflammation), JOINT STIFFNESS (Joint stiffness), ARTHRITIS (Joint inflammation), HEADACHE (Headache) and DIZZINESS (Dizziness) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. Astma/ chemical intolerence/ Ascending Aortic Aneurysm, some changes to the heart spinal foramin stenosis mod /severe C5/C6 hEDS. Concurrent medical conditions included Asthma. Concomitant products included ESTRADIOL from 12-Dec-2017 to 21-Nov-2021, EZETIMIBA from 31-Aug-2021 to 21-Nov-2021, FEXOFENADINE HYDROCHLORIDE from 01-Jan-2002 to 21-Nov-2021, OLOPATADINE HYDROCHLORIDE (OPATANOL) from 06-Nov-2011 to 21-Nov-2021, FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (RELVAR ELLIPTA [FLUTICASONE FUROATE;VILANTEROL TRIFENATATE]) from 06-Jun-2018 to 21-Nov-2021, BUDESONIDE (RHINOCORT AQUA) and MOMETASONE for an unknown indication. On 19-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 19-Nov-2021, the patient experienced MYOSITIS (Muscle inflammation) (seriousness criterion medically significant), JOINT STIFFNESS (Joint stiffness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRITIS (Joint inflammation) (seriousness criterion medically significant). At the time of the report, CHEST PAIN (Chest pain) had not resolved and PYREXIA (Fever chills), MYOSITIS (Muscle inflammation), JOINT STIFFNESS (Joint stiffness), ARTHRITIS (Joint inflammation), HEADACHE (Headache) and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) 177/95 and normal (normal) 125/75. On an unknown date, Body temperature: abnormal (abnormal) 35.1 degree Celsius and abnormal (abnormal) 38 degree Celsius. On an unknown date, Heart rate: normal (normal) 71. mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) dosing remained unchanged. No treatment information was reported. Vaccine to left upper arm, swelling along arm into the hand and fingers, into the neck and armpit, into the chest and back. Felt like I had been gripped buy very tight constricting garment - have ascending arotic aneurysm 42mm- was very light headed and had rigours again. Seek Advice Details: Temperature at [Hospital initials] Urgent care Tuesday 35.1- temps yesterday peaked at 38- Blood pressure (BP) rose to 177/95. Heart rate (HR) 62 pm -am BP125/75-HR 71 Company comment; This is a regulatory authority case concerning a 63-year-old, female patient with medical history of spinal foramina and use of concomitant medication ezetimibe, who experienced the unexpected events of Chest pain, Pyrexia, myositis, Joint stiffness, Arthritis, Headache, Dizziness. The events occurred approximately on the same day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The medical history, of spinal foramina and use of concomitant medication ezetimibe remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 63-year-old, female patient with medical history of spinal foramina and use of concomitant medication ezetimibe, who experienced the unexpected events of Chest pain, Pyrexia, myositis, Joint stiffness, Arthritis, Headache, Dizziness. The events occurred approximately on the same day after the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The medical history, of spinal foramina and use of concomitant medication ezetimibe remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918469 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Dizziness, Fatigue, Headache, Heart rate increased, Nausea, Palpitations, Pyrexia, Tachycardia, Thirst
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TELMISARTAN; ASPIRINE; ATORVASTATIN; BISOPROLOL; ISOSORBIDE MONONITRATE; SERTRALINE; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronavirus disease 2019; Fatigue; Tinnitus; Comments: Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; Fatigue/unusual tiredness; Chest pain; Fever; Racing heart (tachycardia); Increased thirst; Joint pain; Heart pounding; Heart rate; Light-headed; Nausea; This case was received via regulatory authority (Reference number: -MHRA-ADR 26231190) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), NAUSEA (Nausea), HEART RATE INCREASED (Heart rate), DIZZINESS (Light-headed), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), TACHYCARDIA (Racing heart (tachycardia)), THIRST (Increased thirst), ARTHRALGIA (Joint pain) and PALPITATIONS (Heart pounding) in a 50-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test. The patient''s past medical history included Coronavirus disease 2019, Fatigue and Tinnitus. Concomitant products included TELMISARTAN, ACETYLSALICYLIC ACID (ASPIRINE), ATORVASTATIN, BISOPROLOL, ISOSORBIDE MONONITRATE, SERTRALINE and LANSOPRAZOLE for Coronary heart disease. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced HEART RATE INCREASED (Heart rate) (seriousness criterion medically significant) and DIZZINESS (Light-headed) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant), THIRST (Increased thirst) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and PALPITATIONS (Heart pounding) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), TACHYCARDIA (Racing heart (tachycardia)), THIRST (Increased thirst), ARTHRALGIA (Joint pain) and PALPITATIONS (Heart pounding) outcome was unknown and NAUSEA (Nausea), HEART RATE INCREASED (Heart rate) and DIZZINESS (Light-headed) was resolving. Patient recent or ongoing illness that haven''t already mentioned were reported as Other Covid related symptoms not mentioned above, fatigue, tinnitus. It was reported that patient developed chest pain, fatigue/unusual tiredness, fever, hear rate, light-headed, nausea, racing heart (tachycardia). Patient woke several times during the night thirsty and needing pain relief (paracetamol) for aches and pains in joints and headache and during this time his heart rate was rapid and poundaing. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. It was reported that patient report relates to possible inflammation of the heart (myocarditis or pericarditis as Yes. Company comment: This is a regulatory case concerning a 50-year-old male patient with clinical history of Coronavirus disease in 2019 who experienced the unexpected events of HEADACHE, NAUSEA, HEART RATE INCREASED, DIZZINESS, FATIGUE, CHEST PAIN, PYREXIA, TACHYCARDIA, THIRST, ARTHRALGIA and PALPITATIONS The event occurred 1 days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 50-year-old male patient with clinical history of Coronavirus disease in 2019 who experienced the unexpected events of HEADACHE, NAUSEA, HEART RATE INCREASED, DIZZINESS, FATIGUE, CHEST PAIN, PYREXIA, TACHYCARDIA, THIRST, ARTHRALGIA and PALPITATIONS The event occurred 1 days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918478 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chest pain, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use, Pain in extremity, Peripheral swelling, Product use issue, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211018; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101628895

Write-up: Armpit pain; Chest pain; Painful arm; Swollen arm; Lethargic; Headache; Off label use; Interchange of vaccine products; Booster; Product use for unapproved combination; This is a spontaneous report received from a contactable consumer from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111201509134920-SRECM (MHRA). Safety Report Unique Identifier: GB-MHRA-ADR 26231532 (MHRA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH4751) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history included: "Suspected COVID-19", start date: 16Oct2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. Patient was not pregnant and not currently breastfeeding. Concomitant medication(s) included: INFLUENZA VIRUS vaccine taken for influenza, administration date 19Nov2021. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, SINGLE, Batch/lot number: unknown), administration date: 26Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2, SINGLE, Batch/lot number: unknown), administration date: 21Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (non-serious) with onset 19Nov2021, outcome "unknown", described as "Product use for unapproved combination",AXILLARY PAIN (medically significant) with onset 20Nov2021, outcome "not recovered"; described as "Armpit pain"; CHEST PAIN (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Chest pain"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Painful arm"; PERIPHERAL SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen arm"; LETHARGY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Lethargic"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Oct2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). No follow up attempts are possible. No further information is expected.


VAERS ID: 1918479 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Palpitations, Pyrexia, SARS-CoV-2 test, Sensitive skin, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue/unusual tiredness; Fever; Heart palpitations; Racing heart (tachycardia); Hypersensitive skin; Headache; Generalised joint pains; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231538) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Hypersensitive skin), HEADACHE (Headache), ARTHRALGIA (Generalised joint pains), FATIGUE (Fatigue/unusual tiredness), PYREXIA (Fever), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 26-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SENSITIVE SKIN (Hypersensitive skin) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Generalised joint pains) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations) (seriousness criterion medically significant). At the time of the report, SENSITIVE SKIN (Hypersensitive skin), HEADACHE (Headache) and ARTHRALGIA (Generalised joint pains) had not resolved, FATIGUE (Fatigue/unusual tiredness), PYREXIA (Fever) and PALPITATIONS (Heart palpitations) outcome was unknown and TACHYCARDIA (Racing heart (tachycardia)) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. No concomitant and treatment medication was reported by patient. Patient had not tested positive for COVID-19 since taken the vaccine. Patient was not enrolled in clinical trial. Patient had no symptoms associated with Covid 19, patient was not pregnant and was not currently breastfeeding. Patient reported that she relate possible inflammation of the heart but diagnosis was not made by a medical professional and no such protein test called troponin was conducted by patient. Company comment: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of Sensitive skin, Headache, Arthralgia, and Tachycardia approximately 1 day after the second dose of mRNA-1273 Vaccine. The events Fatigue, Pyrexia, Palpitations occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 26-year-old, female patient with no relevant medical history, who experienced the unexpected events of Sensitive skin, Headache, Arthralgia, and Tachycardia approximately 1 day after the second dose of mRNA-1273 Vaccine. The events Fatigue, Pyrexia, Palpitations occurred on an unknown date. The rechallenge was unknown since no information about the events of the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1918481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Immunisation, Migraine, Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629104

Write-up: Migraine headache; Red rash; Tiredness; Booster; Generalised chest pain; Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111201606421460-3VN4B (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231596 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: Unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptom associated with COVID-19. The patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot/Batch Number: Unknown), for COVID-19 immunisation; Bnt162b2 (Dose, 2, Single, Lot/Batch Number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization) with onset 19Nov2021, outcome "unknown", described as "Booster"; CHEST PAIN (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Generalised chest pain"; DIZZINESS (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Dizziness"; MIGRAINE (hospitalization) with onset 20Nov2021, outcome "not recovered", described as "Migraine headache"; RASH ERYTHEMATOUS (hospitalization) with onset 19Nov2021, outcome "not recovered", described as "Red rash"; FATIGUE (hospitalization) with onset 19Nov2021, outcome "recovering", described as "Tiredness". The patient was hospitalized for immunisation, chest pain, dizziness, migraine, rash erythematous, fatigue (start date: Nov2011). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: no - negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918486 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Hallucination, Headache, Immunisation, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101628923

Write-up: Hallucination; Joint pain; Headache; Fever chills and fever; Fatigue; Booster; This is a spontaneous report received from a Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26231699. A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Booster"; HALLUCINATION (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Hallucination"; ARTHRALGIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Joint pain"; HEADACHE (non-serious) with onset 19Nov2021, outcome "recovering", described as "Headache"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Fever chills and fever"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course: The patient had fever chills on 19Nov2021 and recovered on 20Nov2021, had fever on 20Nov2021 and recovering. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The reporter did not consider the event related to possible blood clots or low platelet counts or possible myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918522 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, C-reactive protein increased, Chest X-ray, Chills, Dizziness, Echocardiogram, Heart rate, Hypotension, Inflammation, Loss of consciousness, Nausea, Oxygen saturation, Pain in extremity, Palpitations, SARS-CoV-2 test, Syncope, Tachycardia, Troponin, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADCAL D3; COLCHICINE; FEXOFENADINE HYDROCHLORIDE; IBUPROFEN; INFLUENZA VIRUS; NARATRIPTAN HYDROCHLORIDE; PREDNISONE
Current Illness: Steroid therapy (Taking regular steroid treatment orally or rectally.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: normal; Test Name: C-reactive protein; Result Unstructured Data: Current-11; Test Date: 20211117; Test Name: C-reactive protein; Test Result: Inconclusive ; Result Unstructured Data: 2; Test Name: Cardiac ultrasound; Result Unstructured Data: no fluid; Test Name: Heart rate; Result Unstructured Data: Resting Heart rate 135 bpm; Test Name: Heart rate; Result Unstructured Data: After discharge resting HR was110; Test Name: Oxygen saturation; Result Unstructured Data: 98 percent; Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No, Negative COVID-19 test; Test Name: Troponin; Result Unstructured Data: normal
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: bloods revealed elevated crp of 11; Low blood pressure; Heart palpitations; dizziness; Inflammation; Passed out; Chills; Nausea; Vertigo; Fainting; Pain in arm; Tachycardia; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233945) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), LOSS OF CONSCIOUSNESS (Passed out), C-REACTIVE PROTEIN INCREASED (bloods revealed elevated crp of 11), INFLAMMATION (Inflammation), HYPOTENSION (Low blood pressure), PALPITATIONS (Heart palpitations), DIZZINESS (dizziness), TACHYCARDIA (Tachycardia), CHILLS (Chills), SYNCOPE (Fainting), NAUSEA (Nausea) and VERTIGO (Vertigo) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concurrent medical conditions included Steroid therapy (Taking regular steroid treatment orally or rectally.). Concomitant products included FEXOFENADINE HYDROCHLORIDE for Allergy, IBUPROFEN and NARATRIPTAN HYDROCHLORIDE for Migraine with aura, COLCHICINE for Pericarditis, CALCIUM CARBONATE, COLECALCIFEROL (ADCAL D3), INFLUENZA VACCINE (INFLUENZA VIRUS) and PREDNISONE for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and medically significant) and SYNCOPE (Fainting) (seriousness criteria hospitalization and medically significant). On 20-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant) and DIZZINESS (dizziness) (seriousness criteria hospitalization and medically significant). 20-Nov-2021, the patient experienced INFLAMMATION (Inflammation) (seriousness criteria hospitalization and medically significant), CHILLS (Chills) (seriousness criteria hospitalization and medically significant), NAUSEA (Nausea) (seriousness criteria hospitalization and medically significant) and VERTIGO (Vertigo) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced C-REACTIVE PROTEIN INCREASED (bloods revealed elevated crp of 11) (seriousness criteria hospitalization and medically significant), HYPOTENSION (Low blood pressure) (seriousness criteria hospitalization and medically significant) and PALPITATIONS (Heart palpitations) (seriousness criteria hospitalization and medically significant). On 20-Nov-2021, SYNCOPE (Fainting), NAUSEA (Nausea) and VERTIGO (Vertigo) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved, LOSS OF CONSCIOUSNESS (Passed out), C-REACTIVE PROTEIN INCREASED (bloods revealed elevated crp of 11), INFLAMMATION (Inflammation), HYPOTENSION (Low blood pressure), PALPITATIONS (Heart palpitations) and DIZZINESS (dizziness) outcome was unknown, TACHYCARDIA (Tachycardia) was resolving and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, C-reactive protein: 2 (Inconclusive) 2. On 20-Nov-2021, SARS-CoV-2 test: negative (Negative) No, Negative COVID-19 test. On an unknown date, C-reactive protein: 11 (abnormal) Current-11. On an unknown date, Chest X-ray: normal (normal) normal. On an unknown date, Echocardiogram: no fluid (normal) no fluid. On an unknown date, Heart rate: 135 (abnormal) Resting Heart rate 135 bpm and 110 (abnormal) After discharge resting HR was110. On an unknown date, Oxygen saturation: 98 (normal) 98 percent. On an unknown date, Troponin: normal (normal) normal. Patient has not had symptoms associated with COVID-19. Patient had resting heart rate normally between 60 and 70 beats per minute (bpm).Saturation (Sats) meter showed O2 saturation 98%. Patients Blood pressure was a bit lower than normal, can''t remember the reading but not low enough to cause fainting. Treatment medication were not reported. Patient had woke about 4 am on 20-NOV-2021 with chills and again at 8 am on 20-NOV-21 with dizziness, nausea and tachycardia. Patient caused hospital stay for 8 hours. Patient had tested positive for COVID-19 since having the vaccination and was not enrolled in Clinical trial. Company comment: This regulatory case concerns a patient of unknown age and gender, with no reported medical history, who experienced the serious (important medical event and hospitalization) unexpected events of: PAIN IN EXTREMITY, LOSS OF CONSCIOUSNESS, INFLAMMATION, HYPOTENSION, PALPITATIONS, DIZZINESS, TACHYCARDIA, CHILLS, SYNCOPE, NAUSEA and VERTIGO. The events of Pain in extremity, tachycardia and syncope occurred on the same day after receiving a third dose of mRNA-1273. The events of loss of consciousness, dizziness, inflammation, chills, nausea, and vertigo occurred on the day after receiving said dose. The date of occurrence of the events of hypotension, and palpitations, was not provided. No further information about previous dosing schedule has been provided. The rechallenge was captured as unknown as per the Regulatory Authority assessment. The day after vaccination, patient consulted in the Emergency Department and blood revealed elevated C-reactive protein. Cardiac ultrasound, troponin and chest X-ray were normal. No final diagnosis regarding reported events was provided at this time. Patient stayed for 8 hours in the Emergency department and then was discharged. Concomitant drugs indications include pericarditis and migraine with aura, so even if these conditions are not reported as medical history, they could be considered as confounders. The benefit-risk relation of mRNA-1273 is not affected by this report.; Sender''s Comments: This regulatory case concerns a patient of unknown age and gender, with no reported medical history, who experienced the serious (important medical event and hospitalization) unexpected events of: PAIN IN EXTREMITY, LOSS OF CONSCIOUSNESS, INFLAMMATION, HYPOTENSION, PALPITATIONS, DIZZINESS, TACHYCARDIA, CHILLS, SYNCOPE, NAUSEA and VERTIGO. The events of Pain in extremity, tachycardia and syncope occurred on the same day after receiving a third dose of mRNA-1273. The events of loss of consciousness, dizziness, inflammation, chills, nausea, and vertigo occurred on the day after receiving said dose. The date of occurrence of the events of hypotension, and palpitations, was not provided. No further information about previous dosing schedule has been provided. The rechallenge was captured as unknown as per the Regulatory Authority assessment. The day after vaccination, patient consulted in the Emergency Department and blood revealed elevated C-reactive protein. Cardiac ultrasound, troponin and chest X-ray were normal. No final diagnosis regarding reported events was provided at this time. Patient stayed for 8 hours in the Emergency department and then was discharged. Concomitant drugs indications include pericarditis and migraine with aura, so even if these conditions are not reported as medical history, they could be considered as confounders. The benefit-risk relation of mRNA-1273 is not affected by this report.


VAERS ID: 1918526 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hormone replacement therapy, Premature menopause
SMQs:, Fertility disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Menopause symptoms; HRT; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233990) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HORMONE REPLACEMENT THERAPY (HRT) and PREMATURE MENOPAUSE (Menopause symptoms) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HORMONE REPLACEMENT THERAPY (HRT) (seriousness criterion disability). On an unknown date, the patient experienced PREMATURE MENOPAUSE (Menopause symptoms) (seriousness criterion disability). At the time of the report, HORMONE REPLACEMENT THERAPY (HRT) had not resolved and PREMATURE MENOPAUSE (Menopause symptoms) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. Treatment information was not provided by the reporter. It was reported that the menopause symptoms returned completely overnight after having the moderna booster. 1000''s of women are reporting the same thing that their HRT is failing after certain covid jabs. Patient reported that she had no any COVID-19 related symptoms or not had an COVID-19 test also. Patient had no any possible inflammation related to heart and was not enrolled in clinical trial also. Company comment: This case concerns a female patient of an unknown age, with no relevant medical history reported, who experienced the serious unexpected event of PREMATURE MENOPAUSE. The event occurred after an unknown time interval after the third dose of the mRNA-1273. The rechallenge was not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age, with no relevant medical history reported, who experienced the serious unexpected event of PREMATURE MENOPAUSE. The event occurred after an unknown time interval after the third dose of the mRNA-1273. The rechallenge was not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1918530 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Pyrexia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diarrhea (Currently being investigated for Bile Acid Diarrhea.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: rigours; Rigors; Pyrexia; Tachycardia; Arthralgia; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26234368) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (rigours), CHILLS (Rigors), PYREXIA (Pyrexia), TACHYCARDIA (Tachycardia) and ARTHRALGIA (Arthralgia) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Diarrhea (Currently being investigated for Bile Acid Diarrhea.). Concomitant products included BISOPROLOL for Abnormal ECG, OMEPRAZOLE for Hyperacidity. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced CHILLS (Rigors) (seriousness criterion medically significant), PYREXIA (Pyrexia) (seriousness criterion medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion medically significant) and ARTHRALGIA (Arthralgia) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (rigours) (seriousness criterion medically significant). On 20-Nov-2021, CHILLS (Rigors), PYREXIA (Pyrexia), TACHYCARDIA (Tachycardia) and ARTHRALGIA (Arthralgia) had resolved. At the time of the report, CHILLS (rigours) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication were not reported. The vaccination was given at 10.00am and the pain at the injection site started at about 16..00. The rigours started at about 22.30 followed by the pyre ja. Patients heart rate was about 55 and the tachycardia raised to 98. Arthralgia lasted throughout the night. Pyrexia lasted until 07.00 and the tachycardia slowly resolved throughout the 20th of November. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Company Comment: This is a regulatory case concerning a 67-year-old male patient with no relevant medical history reported who experienced the unexpected and serious event of chills (reported as rigours and rigors), pyrexia, tachycardia and arthralgia. The event chills (reported as rigours) occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered and the rest of the events occurred the same day after vaccine was given. The rechallenge was not applicable since events happened after third dose and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 67-year-old male patient with no relevant medical history reported who experienced the unexpected and serious event of chills (reported as rigours and rigors), pyrexia, tachycardia and arthralgia. The event chills (reported as rigours) occurred on an unknown day after a third dose of mRNA-1273 vaccine was administered and the rest of the events occurred the same day after vaccine was given. The rechallenge was not applicable since events happened after third dose and no further dose is expected. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918537 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Dizziness, Fatigue, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: High temperature; Headache; Appetite lost; Felt faint; Tiredness; This case was received via RA (Reference number: GB-MHRA-ADR 26234712) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Felt faint), FATIGUE (Tiredness), PYREXIA (High temperature), HEADACHE (Headache) and DECREASED APPETITE (Appetite lost) in a 73-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 19-Nov-2021, DIZZINESS (Felt faint) had resolved. On 20-Nov-2021, FATIGUE (Tiredness), PYREXIA (High temperature), HEADACHE (Headache) and DECREASED APPETITE (Appetite lost) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. On the 19-Nov-2021, morning patient got up nearly fainted. She Went to bed for the Whole day on 19-Nov-2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reporters causality assessment was not provided. Company comment This case concerns a 73-year-old female patient with no relevant medical history provided, who experienced the unexpected serious events of Dizziness, Fatigue, Decreased appetite, Pyrexia and Headache. The events of Dizziness, Fatigue, Headache and Decreased appetite occurred one day after the administration of the third dose of the mRNA-1273 vaccine, while the event of Pyrexia occurred two days following the vaccination. At the time of this report, all events were reported as resolved ad no further information regarding the clinical course of the events was provided. The rechallenge and action taken with the suspect drug were reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine and no additional doses are expected at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 73-year-old female patient with no relevant medical history provided, who experienced the unexpected serious events of Dizziness, Fatigue, Decreased appetite, Pyrexia and Headache. The events of Dizziness, Fatigue, Headache and Decreased appetite occurred one day after the administration of the third dose of the mRNA-1273 vaccine, while the event of Pyrexia occurred two days following the vaccination. At the time of this report, all events were reported as resolved ad no further information regarding the clinical course of the events was provided. The rechallenge and action taken with the suspect drug were reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine and no additional doses are expected at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918538 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest pain, Chills, Fatigue, Headache, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type I diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Racing heart (tachycardia); Fatigue/unusual tiredness; Muscle pain; Chills; High temperature; Nausea; Headache; Abdominal pain; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234750) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Abdominal pain), CHEST PAIN (Chest pain), TACHYCARDIA (Racing heart (tachycardia)), NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (Fatigue/unusual tiredness), MYALGIA (Muscle pain), CHILLS (Chills) and PYREXIA (High temperature) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Type I diabetes mellitus. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). 19-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant) and FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN (Abdominal pain), CHEST PAIN (Chest pain), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved, TACHYCARDIA (Racing heart (tachycardia)) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown, MYALGIA (Muscle pain) and CHILLS (Chills) was resolving and PYREXIA (High temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. Patient experienced chest pain around 12 hours after vaccine was administered, medical professional identified rapid heartbeat Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. No Treatment Information was provided. Company comment: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the serious unexpected events of Chills, Pyrexia, Nausea, Headache, Abdominal pain, Myalgia, Chest pain, Fatigue and Tachycardia. The events of Chills, Pyrexia, Nausea, Headache, Abdominal pain, Myalgia, and Chest pain occurred on the same day after the third dose of mRNA-1273 vaccine while the events of Fatigue and Tachycardia occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a female patient of an unknown age with no relevant medical history, who experienced the serious unexpected events of Chills, Pyrexia, Nausea, Headache, Abdominal pain, Myalgia, Chest pain, Fatigue and Tachycardia. The events of Chills, Pyrexia, Nausea, Headache, Abdominal pain, Myalgia, and Chest pain occurred on the same day after the third dose of mRNA-1273 vaccine while the events of Fatigue and Tachycardia occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1918547 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Confusional state, Dizziness, Dyspnoea, Fatigue, Myalgia, Pain in extremity, Pyrexia, Rash, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Autism; Depression; Dyspraxia
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: leg pain; shivering; Labored breathing; Rash; Vomiting; Muscle pain; Fatigue; Fever; Confusion; Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26236221) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), CHILLS (shivering), CONFUSIONAL STATE (Confusion), DIZZINESS (Dizziness), RASH (Rash), MYALGIA (Muscle pain), DYSPNOEA (Labored breathing), FATIGUE (Fatigue), PYREXIA (Fever) and VOMITING (Vomiting) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Lot 3004732) for an unknown indication. The patient''s past medical history included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Previously administered products included for Product used for unknown indication: VENLAFAXINE. Past adverse reactions to the above products included No adverse reaction with VENLAFAXINE. Concurrent medical conditions included Depression, Autism and Dyspraxia. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Feb-2021 to an unknown date for COVID-19 vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced DYSPNOEA (Labored breathing) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain) (seriousness criterion medically significant) and CHILLS (shivering) (seriousness criterion medically significant). On 21-Nov-2021, CONFUSIONAL STATE (Confusion) had resolved. At the time of the report, PAIN IN EXTREMITY (leg pain), CHILLS (shivering) and DIZZINESS (Dizziness) was resolving, RASH (Rash), MYALGIA (Muscle pain), DYSPNOEA (Labored breathing), FATIGUE (Fatigue) and PYREXIA (Fever) had not resolved and VOMITING (Vomiting) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided Patient reported that he was awaiting delivery of PCR tests and awaiting call from 111 clinician. Patient reported that he noticed muscle pain was on right leg, bellow right knee, above right ankle. Patient reported that red rash on leg is hot to the touch. Company comment This case concerns a 29 year-old male patient with a history of immunodeficiency and 2 doses of Chadox 1 NCOV-19 vaccine in February and May 2021 who experienced the unexpected serious events of vomiting, pyrexia, fatigue, myalgia, rash, dizziness, confusional state, chills, and pain in extremity. The events occurred approximately 1 to 4 days after vaccination with mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The medical history of immunodeficiency and 2 doses of Chadox 1 NCOV-19 vaccine remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 29 year-old male patient with a history of immunodeficiency and 2 doses of Chadox 1 NCOV-19 vaccine in February and May 2021 who experienced the unexpected serious events of vomiting, pyrexia, fatigue, myalgia, rash, dizziness, confusional state, chills, and pain in extremity. The events occurred approximately 1 to 4 days after vaccination with mRNA-1273 vaccine. The rechallenge was not applicable as no additional dosing will be administered. The medical history of immunodeficiency and 2 doses of Chadox 1 NCOV-19 vaccine remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1918548 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chills, Diarrhoea, Facial asymmetry, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Endometriosis
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic rupture; Laparotomy; Nephrectomy
Allergies:
Diagnostic Lab Data: Test Date: 20211122; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No-Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: stomach cramps; please note; Chills; Diarrhea; Joint pain; Pain in arm; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26236616) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER, FACIAL ASYMMETRY, PAIN IN EXTREMITY, CHILLS, DIARRHOEA, and ARTHRALGIA in a 53-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Aortic rupture, Nephrectomy, and Laparotomy. Concurrent medical conditions included Endometriosis. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN IN EXTREMITY (seriousness criterion disability). On 20-Nov-2021, the patient experienced ARTHRALGIA (seriousness criterion disability). On 21-Nov-2021, the patient experienced CHILLS (seriousness criterion disability) and DIARRHOEA (seriousness criterion disability). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (seriousness criterion disability) and FACIAL ASYMMETRY (seriousness criterion disability). At the time of the report, ABDOMINAL PAIN UPPER, FACIAL ASYMMETRY, CHILLS, and DIARRHOEA had not resolved and PAIN IN EXTREMITY and ARTHRALGIA was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 22-Nov-2021, SARS-CoV-2 test no-negative covid-19 test, No-Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. No concomitant medications were reported. No treatment medications were reported. The patient had never known such extreme chills and fever. Her elbows felt as though they were going to explode. The diarrhea and stomach cramps was the worst she had ever had and was not showing any signs of abating. Patient stated that she would never have this vaccine again. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. This case concerns a 53 year-old, female patient with a history of Endometriosis, Nephrectomy and Laparotomy, who experienced the serious (due to disability) unexpected events of Abdominal pain upper, Facial asymmetry, Pain in extremity, chills, Diarrhoea, and Arthralgia. The events Abdominal pain upper and Facial asymmetry occurred on an unknown date after the booster dose of mRNA-1273 vaccine, the event pain in extremity on the same day and the rest of the events 1 to 2 days after. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of Endometriosis, Nephrectomy, and Laparotomy remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This case concerns a 53 year-old, female patient with a history of Endometriosis, Nephrectomy, and Laparotomy, who experienced the serious unexpected events of Abdominal pain upper, Facial asymmetry, Pain in extremity, chills, Diarrhoea, and Arthralgia. The events Abdominal pain upper and Facial asymmetry occurred on an unknown date after the booster dose of mRNA-1273 vaccine, the event pain in extremity on the same day and the rest of the events 1 to 2 days after. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of Endometriosis, Nephrectomy, and Laparotomy remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918556 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA BN3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dizziness exertional, Dysphagia, Fatigue, Gastrooesophageal reflux disease, Hallucination, Headache, Hyperhidrosis, Limb discomfort, Memory impairment, Muscular weakness, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; SERTRALIN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter
Allergies:
Diagnostic Lab Data: Test Date: 20211105; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: I feel completely unable to concentrate on anything; The evening following the booster i was too hot to touch; Dizziness exertional; Muscle weakness; Hallucinating; Memory impairment; Acid reflux (esophageal); Chest pain; Fatigue extreme; Sweating; Arm discomfort; High temperature; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26237042) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), LIMB DISCOMFORT (Arm discomfort), DIZZINESS EXERTIONAL (Dizziness exertional), FATIGUE (Fatigue extreme), DYSPHAGIA (I feel completely unable to concentrate on anything), DIZZINESS (The evening following the booster i was too hot to touch), PYREXIA (High temperature), HEADACHE (Headache), MUSCULAR WEAKNESS (Muscle weakness), HALLUCINATION (Hallucinating), MEMORY IMPAIRMENT (Memory impairment), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and CHEST PAIN (Chest pain) in a 58-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (batch no. BN3004732) for an unknown indication. No medical history was provided by the reporter. Concomitant products included SERTRALIN from 03-Apr-2020 to an unknown date for Depressed mood, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 26-Mar-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 11-Nov-2021 to an unknown date for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion disability), LIMB DISCOMFORT (Arm discomfort) (seriousness criterion disability), FATIGUE (Fatigue extreme) (seriousness criterion disability), PYREXIA (High temperature) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) (seriousness criterion disability) and CHEST PAIN (Chest pain) (seriousness criterion disability). On 20-Nov-2021, the patient experienced DIZZINESS EXERTIONAL (Dizziness exertional) (seriousness criterion disability), MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion disability), HALLUCINATION (Hallucinating) (seriousness criteria disability and medically significant) and MEMORY IMPAIRMENT (Memory impairment) (seriousness criterion disability). On an unknown date, the patient experienced DYSPHAGIA (I feel completely unable to concentrate on anything) (seriousness criterion disability) and DIZZINESS (The evening following the booster i was too hot to touch) (seriousness criterion disability). On 21-Nov-2021, CHEST PAIN (Chest pain) had resolved. At the time of the report, HYPERHIDROSIS (Sweating), LIMB DISCOMFORT (Arm discomfort), DIZZINESS EXERTIONAL (Dizziness exertional) and FATIGUE (Fatigue extreme) had not resolved, DYSPHAGIA (I feel completely unable to concentrate on anything), DIZZINESS (The evening following the booster i was too hot to touch), PYREXIA (High temperature), HEADACHE (Headache), MUSCULAR WEAKNESS (Muscle weakness), HALLUCINATION (Hallucinating) and GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) was resolving and MEMORY IMPAIRMENT (Memory impairment) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. No treatment medications were provided. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment: This is a regulatory case concerning a 58-year-old female patient of, with no relevant medical history o reported , who has experienced the serious unexpected events of HYPERHIDROSIS, LIMB DISCOMFORT, DIZZINESS EXERTIONAL, FATIGUE, DYSPHAGIA, DIZZINESS, PYREXIA, HEADACHE, MUSCULAR WEAKNESS, HALLUCINATION, MEMORY IMPAIRMENT, GASTROOESOPHAGEAL REFLUX DISEASE and CHEST PAIN between the same day and 2 days after receiving the third dose of mRNA-1273. Influenza vaccine application on the same date remains as a confounder/co-suspect for these events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting.; Sender''s Comments: This is a regulatory case concerning a 58-year-old female patient of, with no relevant medical history o reported , who has experienced the serious unexpected events of HYPERHIDROSIS, LIMB DISCOMFORT, DIZZINESS EXERTIONAL, FATIGUE, DYSPHAGIA, DIZZINESS, PYREXIA, HEADACHE, MUSCULAR WEAKNESS, HALLUCINATION, MEMORY IMPAIRMENT, GASTROOESOPHAGEAL REFLUX DISEASE and CHEST PAIN between the same day and 2 days after receiving the third dose of mRNA-1273. Influenza vaccine application on the same date remains as a confounder/co-suspect for these events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1918573 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diplopia, SARS-CoV-2 test
SMQs:, Ocular motility disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; ROSUVASTATIN
Current Illness:
Preexisting Conditions: Comments: No medical history was provided.
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Double vision; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237648) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIPLOPIA (Double vision) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No medical history was provided. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 17-Feb-2021 to an unknown date and ROSUVASTATIN for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criteria hospitalization, disability and medically significant). At the time of the report, DIPLOPIA (Double vision) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has continuous double vision (vertical double vision) since woke up on the morning of 19-Nov-2021. Admitted to A and E that evening, vital stats normal, CT scan normal. MRI ordered. Neurologist does not think patient suffered a stroke but cannot rule out completely until MRI. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial No treatment medication details was provided. Company Comment: This case concerns a 53-year-old male patient, with no relevant medical history reported, who experienced the serious unexpected event of diplopia. The event occurred three days after the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The concomitant use of PFIZER BIONTECH COVID-19 VACCINE and ROSUVASTATIN remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 53-year-old male patient, with no relevant medical history reported, who experienced the serious unexpected event of diplopia. The event occurred three days after the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The concomitant use of PFIZER BIONTECH COVID-19 VACCINE and ROSUVASTATIN remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1918575 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle spasms, SARS-CoV-2 test
SMQs:, Dystonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30004675) for an unknown indication. Previously administered products included for Product used for unknown indication: Omeprazole (taking 2 omeprazole a day and have been since may 2021. previously just one tablet for 4 years or so.) until May 2021, Aloe vera colon cleanse tablet (Aloe vera colon cleanse tablet), Zinc tablet, COD LIVER OIL, VITAMIN C and VITAMIN D [VITAMIN D NOS]. Past adverse reactions to the above products included No adverse event with Aloe vera colon cleanse tablet, COD LIVER OIL, Omeprazole, VITAMIN C, VITAMIN D [VITAMIN D NOS] and Zinc tablet. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient has not had symptoms associated with COVID-19. Patient almost immediately had bad pain in the left arm. much quicker than previous vaccine which was astra zeneca. Patient had pain in the other arm same position as the jab on the other arm. in the evening got terrible pain in the toe on right foot, jab was given in left arm. as that eased, it moved to other toes.4 days later it has eased a lot. arm a bit painful at times when lying in bed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 54-year-old, male patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious event of muscle spasms (toe cramps). The event muscle spasms (toe cramps) occurred the same day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender''s Comments: This is a regulatory authority case concerning a 54-year-old, male patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious event of muscle spasms (toe cramps). The event muscle spasms (toe cramps) occurred the same day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918578 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-20
Onset:2021-11-19
   Days after vaccination:272
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46664 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Balance disorder, Chills, Dyspnoea, Headache, Lymphadenopathy, Myalgia, Nausea, Rash, Swelling face, Syncope, Wound complication
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAZEPAM; ESOMEPRAZOLE; EVENING PRIMROSE OIL [OENOTHERA BIENNIS]; GLUCOSAMINE; IRON; MENOPACE [AMINOBENZOIC ACID;ASCORBIC ACID;BIOTIN;BORON;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;; MIRTAZAPINE; OXYCONTIN; PROPRANOLOL HYDROCHLORIDE; SE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Unsteady on feet; Faint; Shortness of breath; Swelling face; Rash; Stomach pain; Glands swollen; Chills; Wound itching; Headache; Nausea; Muscle ache; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26238065) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Unsteady on feet), SYNCOPE (Faint), DYSPNOEA (Shortness of breath), SWELLING FACE (Swelling face), RASH (Rash), ABDOMINAL PAIN UPPER (Stomach pain), LYMPHADENOPATHY (Glands swollen), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache), CHILLS (Chills) and WOUND COMPLICATION (Wound itching) in a 60-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Concomitant products included DIAZEPAM from 01-Jan-2000 to an unknown date for Anxiety, GLUCOSAMINE from 01-Jan-2009 to an unknown date for Arthritis, MIRTAZAPINE from 01-Jan-2005 to an unknown date for Depression, OENOTHERA BIENNIS (EVENING PRIMROSE OIL [OENOTHERA BIENNIS]) from 01-Jan-1982 to an unknown date and MENOPACE [AMINOBENZOIC ACID;ASCORBIC ACID;BIOTIN;BORON;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;MANGANESE;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;SELENIUM;THIAMINE HYDROCHLOR from 01-Jan-2010 to an unknown date for Postmenopause, OXYCODONE HYDROCHLORIDE (OXYCONTIN) from 01-Jun-2001 to an unknown date for Spinal pain, ESOMEPRAZOLE from 01-Sep-2007 to an unknown date for Stomach biopsy, IRON from 01-Jan-2016 to an unknown date for Tiredness, PROPRANOLOL HYDROCHLORIDE from 01-Sep-2001 to an unknown date, SENNA [SENNA ALEXANDRINA] from an unknown date to 01-Jan-2018 and SERTRALINE (SERTRALIN [SERTRALINE]) from 01-Sep-2010 to an unknown date for an unknown indication. On 20-Feb-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 14-May-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced SYNCOPE (Faint) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), SWELLING FACE (Swelling face) (seriousness criterion medically significant), RASH (Rash) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and WOUND COMPLICATION (Wound itching) (seriousness criterion medically significant). On an unknown date, the patient experienced BALANCE DISORDER (Unsteady on feet) (seriousness criterion medically significant). On 20-Nov-2021, HEADACHE (Headache) had resolved. On 21-Nov-2021, RASH (Rash) and NAUSEA (Nausea) had resolved. On 22-Nov-2021, SWELLING FACE (Swelling face), ABDOMINAL PAIN UPPER (Stomach pain) and CHILLS (Chills) had resolved. On 23-Nov-2021, LYMPHADENOPATHY (Glands swollen), MYALGIA (Muscle ache) and WOUND COMPLICATION (Wound itching) had resolved. At the time of the report, BALANCE DISORDER (Unsteady on feet) and SYNCOPE (Faint) was resolving and DYSPNOEA (Shortness of breath) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient stated that her symptoms started the morning after the vaccine, grew worse the same day, repeated the 2nd day after vaccine. The patient started to feel better on day 3 after vaccine. By day 4 she was nearly back to normal but the following side effects are still troublesome- feeling faint, unsteady on feet, sore arm of injection site, nausea. No treatment medications were reported. Company comment: This regulatory case concerns a 60-year-old, female patient with no reported medical history, who experienced the unexpected serious events of balance disorder, syncope, dyspnoea, swelling face, rash, abdominal pain upper, lymphadenopathy, headache, nausea, myalgia, chills and wound complication. The events occurred the morning after the vaccine, after one dose of mRNA-1273 vaccine, considered as third dose of her COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca''s COVID-19 vaccine as the first and second dose of the schedule. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. Headache is listed for concomitant diazepam, esomeprazole, oxycodone and sertraline. Nausea is listed for concomitant sertraline, oxycodone esomeprazole and glucosamine. Abdominal pain is listed for concomitant esomeprazole. Previous administration of co-suspect AstraZeneca''s COVID-19 vaccine remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 60-year-old, female patient with no reported medical history, who experienced the unexpected serious events of balance disorder, syncope, dyspnoea, swelling face, rash, abdominal pain upper, lymphadenopathy, headache, nausea, myalgia, chills and wound complication. The events occurred the morning after the vaccine, after one dose of mRNA-1273 vaccine, considered as third dose of her COVID-19 vaccine schedule. The patient received previously two doses of AstraZeneca''s COVID-19 vaccine as the first and second dose of the schedule. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. Headache is listed for concomitant diazepam, esomeprazole, oxycodone and sertraline. Nausea is listed for concomitant sertraline, oxycodone esomeprazole and glucosamine. Abdominal pain is listed for concomitant esomeprazole. Previous administration of co-suspect AstraZeneca''s COVID-19 vaccine remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 1918580 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN; ISOPROPANOL; OMEPRAZOLE; PARACETAMOL; TRAMADOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cough
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Feverish; Pain; Swelling; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238099) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain), SWELLING (Swelling) and PYREXIA (Feverish) in a 66-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Cough. Previously administered products included for Prophylactic vaccination: whooping cough vaccine and whooping cough vaccine (As a child I reacted to course of 3 x whooping cough vaccine - arm swelled painfully and became stiff for a day or 2 with each injection.). Past adverse reactions to the above products included Stiffness with whooping cough vaccine; and Swelling arm with whooping cough vaccine. Concomitant products included ISOPROPANOL for Anxiety, PARACETAMOL for Pain, GABAPENTIN and TRAMADOL for Spinal fusion, OMEPRAZOLE for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PAIN (Pain) (seriousness criterion medically significant) and SWELLING (Swelling) (seriousness criterion medically significant). On 21-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant). On 22-Nov-2021, PYREXIA (Feverish) had resolved. At the time of the report, PAIN (Pain) was resolving and SWELLING (Swelling) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient''s outer injected arm was swelled, her arm was very painful all around, could not tolerate any pressure was lying down to sleep. She experienced extreme fatigue and within 24 hours, large, painful swelling developed underarm, spreading towards breast. She felt unwell, feverish, bad headaches, and pains in stomach. She mentioned that day 3 she realized that her stomach slightly distended, and feeling slight pressure at base of lungs. There was an increase in normal medication plus some ibuprofen to cope with pain. This was reported to general physician (GP) after 5 days. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: This is a regulatory authority case concerning a 66-year-old, female patient with relevant medical history of painful arm swelling with the whooping cough vaccine, who experienced the unexpected serious events of pain, swelling and pyrexia. The events pain and swelling occurred the same day with the third dose of mRNA-1273 vaccine administration while the event pyrexia occurred 2 days after the third dose of mRNA-1273 vaccine administration. The rechallenge not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 66-year-old, female patient with relevant medical history of painful arm swelling with the whooping cough vaccine, who experienced the unexpected serious events of pain, swelling and pyrexia. The events pain and swelling occurred the same day with the third dose of mRNA-1273 vaccine administration while the event pyrexia occurred 2 days after the third dose of mRNA-1273 vaccine administration. The rechallenge not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918600 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Malaise, Pain, Paraesthesia, Suicidal ideation
SMQs:, Peripheral neuropathy (broad), Suicide/self-injury (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; COVID-19 VACCINE ASTRAZENECA; FUCIBET; METFORMIN; SITAGLIPTIN
Current Illness: Diabetic (relatively high HBA1c)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Suicidal ideation; Malaise; Dizziness; Pins and needles; Pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238971) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of SUICIDAL IDEATION (Suicidal ideation), MALAISE (Malaise), DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles) and PAIN (Pain) in a 52-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Diabetic (relatively high HBA1c). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 12-Feb-2021 to an unknown date for COVID-19 vaccination, METFORMIN and SITAGLIPTIN for Diabetes, ATORVASTATIN for Hypercholesteremia, BETAMETHASONE VALERATE, FUSIDIC ACID (FUCIBET) for Impetigo. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced SUICIDAL IDEATION (Suicidal ideation) (seriousness criterion medically significant), MALAISE (Malaise) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). At the time of the report, SUICIDAL IDEATION (Suicidal ideation), MALAISE (Malaise), DIZZINESS (Dizziness), PARAESTHESIA (Pins and needles) and PAIN (Pain) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. patient had those described symptoms for about 48hrs after vaccine. resolved quickly after that Unsure if patient is enrolled in clinical trial Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Company comment: This case concerns a 52-year-old male patient, with a history of diabetes, who experienced the serious unexpected events of SUICIDAL IDEATION, MALAISE, DIZZINESS, PARAESTHESIA and PAIN. The events occurred on the same day of the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of diabetes and the concomitant COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old male patient, with a history of diabetes, who experienced the serious unexpected events of SUICIDAL IDEATION, MALAISE, DIZZINESS, PARAESTHESIA and PAIN. The events occurred on the same day of the third dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of diabetes and the concomitant COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1918602 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache, Pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (steroid inhaler)
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Dizzy spells; Headache; Headache NOS; Pain; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26239045) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 40-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Steroid therapy. Concurrent medical conditions included Asthma (steroid inhaler). On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) included on an unknown date, SARS-CoV-2 test No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Patient were experienced with Dizzy spells, with pounding headache or migraines. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. This is a regulatory authority case concerning a 40-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of headache, pain, dizziness, headache. The events headache and pain occurred 1 day after the third dose of mRNA-1273 vaccine administration while the events dizziness and headache occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. This is a regulatory authority case concerning a 40-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of headache, pain, dizziness, and headache. The events headache and pain occurred 1 day after the third dose of mRNA-1273 vaccine administration while the events dizziness and headache occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918625 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004674 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry skin, Injection site pruritus, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Scab, Skin burning sensation
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALENDRONIC ACID; AMITRIPTYLINE; BACLOFEN; CAPSAICIN; CARBOCISTEINE; CINNARIZINE; CODEINE; DESOGESTREL; DUORESP SPIROMAX; ETORICOXIB; FEXOFENADINE; GABAPENTIN; LANSOPRAZOLE; LOSARTAN; MAROL PROLONGED RELEASE; MOMETASONE; MONTELUKAST; NYSTAN;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (I have a rarer form of asthma that is non atopic non eosinophilic asthma with fixed airways.); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Osteoarthritis (I take regular steroid injections in all lower joints and upper joints for osteoarthritis, most months I have 1 or 2 and they are all staggered so I have them every 4 months in all major lower joints and smaller doses in smaller joints.); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally). I take regular steroid injections in all lower joints and upper joints for osteoarthritis, most months I have 1 or 2 and they are all staggered so I have them every 4 months in all major lower joints and smaller doses in smaller joints.)
Allergies:
Diagnostic Lab Data: Test Date: 20211114; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SCAB (Scab), PERIPHERAL SWELLING (Swelling arm), DRY SKIN (Hot dry skin), PAIN IN EXTREMITY (Painful arm), INJECTION SITE PRURITUS (Injection site itching) and SKIN BURNING SENSATION (Burning skin) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004674) for an unknown indication. The patient''s past medical history included Osteoarthritis (I take regular steroid injections in all lower joints and upper joints for osteoarthritis, most months I have 1 or 2 and they are all staggered so I have them every 4 months in all major lower joints and smaller doses in smaller joints.), Asthma (I have a rarer form of asthma that is non atopic non eosinophilic asthma with fixed airways.), Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally). I take regular steroid injections in all lower joints and upper joints for osteoarthritis, most months I have 1 or 2 and they are all staggered so I have them every 4 months in all major lower joints and smaller doses in smaller joints.) and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...).Concomitant products included CARBOCISTEINE, BUDESONIDE, FORMOTEROL FUMARATE DIHYDRATE (DUORESP SPIROMAX), MONTELUKAST, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) and SALBUTAMOL, SALBUTAMOL BASE, SALBUTAMOL SULPHATE, SALBUTAMOL SULPHATE MICRONISED (VENTOLIN) for Asthma chronic, DESOGESTREL for Birth control, CALCIUM CARBONATE, COLECALCIFEROL CONCENTRATE (POWDER FORM) (THEICAL-D3) for Bone loss, BACLOFEN and CODEINE for Chronic back pain, ETORICOXIB, GABAPENTIN and PARACETAMOL for Chronic pain, AMITRIPTYLINE for Fibromyalgia, LOSARTAN for Hypertension, LANSOPRAZOLE for Inflammation stomach, NYSTATIN (NYSTAN) for Oral pain, CAPSAICIN and TRAMADOL HYDROCHLORIDE (MAROL PROLONGED RELEASE) for Osteoarthritis, ALENDRONIC ACID for Osteoporosis, FEXOFENADINE and MOMETASONE for Rhinosinusitis, CINNARIZINE for Vestibular migraine. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), DRY SKIN (Hot dry skin) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), INJECTION SITE PRURITUS (Injection site itching) (seriousness criterion medically significant) and SKIN BURNING SENSATION (Burning skin) (seriousness criterion medically significant). On an unknown date, the patient experienced SCAB (Scab) (seriousness criterion medically significant). At the time of the report, SCAB (Scab) had not resolved and PERIPHERAL SWELLING (Swelling arm), DRY SKIN (Hot dry skin), PAIN IN EXTREMITY (Painful arm), INJECTION SITE PRURITUS (Injection site itching) and SKIN BURNING SENSATION (Burning skin) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication were not reported.The patient experienced pain on moving arm and touching arm big hard lump size of her palm in the centre of the injection site and redness and swelling to skin surrounding the lump most of outside upper arm affected with itching and burning and redness. The scab was formed over the injection site. The patient couldn''t hold arm up without pain and didn''t drive once home because of it. The patient also couldn''t sleep on it. The patient had not had symptoms associated with COVID-19. Patient was not pregnant, patient was not currently breastfeeding. Company comment: This is a regulatory authority case concerning a 54-year-old female patient with relevant medical history of osteoarthritis, who experienced serious, unexpected events of Pain in extremity, Peripheral swelling, Dry Skin, Injection site pruritus, Skin burning sensation and Scab. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. It was reported that patient experienced pain on moving arm and touching arm, big hard lump in the centre of the injection site and redness and swelling to skin surrounding the lump. The scab was formed over the injection site. The patient couldn''t hold arm up without pain and didn''t drive once home because of it. The patient also couldn''t sleep on it. Medical history of osteoarthritis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 54-year-old female patient with relevant medical history of osteoarthritis, who experienced serious, unexpected events of Pain in extremity, Peripheral swelling, Dry Skin, Injection site pruritus, Skin burning sensation and Scab. The events occurred approximately 1 day after the third dose of mRNA-1273 vaccine. It was reported that patient experienced pain on moving arm and touching arm, big hard lump in the centre of the injection site and redness and swelling to skin surrounding the lump. The scab was formed over the injection site. The patient couldn''t hold arm up without pain and didn''t drive once home because of it. The patient also couldn''t sleep on it. Medical history of osteoarthritis remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918627 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Nausea, Pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Suspected COVID-19 (Unsure when symptoms stopped)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201229; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Headache; Ache; Fatigue; Chills; Nauseous; This case was received via RA (Reference number: GB-MHRA-ADR 26240257) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), NAUSEA (Nauseous), PAIN (Ache), FATIGUE (Fatigue) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 (Unsure when symptoms stopped) since 27-Dec-2020. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). On 20-Nov-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 21-Nov-2021, NAUSEA (Nauseous) had resolved. At the time of the report, CHILLS (Chills) had resolved, PAIN (Ache) and FATIGUE (Fatigue) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. Company comment: This is a regulatory case concerning a 56-year-old female patient with a medical history of having symptoms suspected of Covid-19 and tested positive for Covid-19, who experienced the events of chills, nausea, pain, fatigue and headache. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events chills and nausea occurred on the same day after the third dose of mRNA � 1273 vaccine, while pain and fatigue was experienced a day after, then the event headache the following day. Events were reported medically significant but at the time of report only the event headache had not resolved. The rechallenge was unknown since the other doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 56-year-old female patient with a medical history of having symptoms suspected of Covid-19 and tested positive for Covid-19, who experienced the events of chills, nausea, pain, fatigue and headache. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events chills and nausea occurred on the same day after the third dose of mRNA � 1273 vaccine, while pain and fatigue was experienced a day after, then the event headache the following day. Events were reported medically significant but at the time of report only the event headache had not resolved. The rechallenge was unknown since the other doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1918655 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / -
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Feeding disorder, Headache, Malaise, Mouth ulceration, Nausea, Oral herpes, Pain, Pyrexia, Retching, SARS-CoV-2 test, Sinus pain, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BUTEC; CELECOXIB; CO-CODAMOL; GABAPENTIN; NATRILIX SR; OMEPRAZOLE; ORAMORPH
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain; Blood pressure high; Fibromyalgia; Joint pain; Sciatica; Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Body temperature; Result Unstructured Data: (Test Result:39.8,Unit:degree C,Normal Low:,Normal High:); Test Date: 202111; Test Name: Body temperature; Result Unstructured Data: (Test Result:38,Unit:degree C,Normal Low:,Normal High:); Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: feeling sick; headache; unable to eat; retching; pain; shivering; Mouth ulceration; Cold sores lip; Sinus pain; Vomiting; High temperature; Head pain; Nausea; Case received by GSK via RA on 25th November 2021 This case was reported by a consumer via regulatory authority and described the occurrence of feeling sick in a 57-year-old female patient who received DTPa-IPV (DTPa-IPV) for prophylaxis. Co-suspect products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) (batch number 3004675, expiry date unknown) for prophylaxis. The patient''s past medical history included fibromyalgia, painful joints and back pain. Previously administered products included COVID-19 VACCINE ASTRAZENECA (on 24th February 2021) and COVID-19 VACCINE ASTRAZENECA (on 07th May 2021). Concurrent medical conditions included sciatica and blood pressure high. Additional patient notes included :Patient has not had symptoms associated with COVID-19. Concomitant products included buprenorphine hydrochloride (Butec), celecoxib, codeine phosphate + paracetamol (Co-Codamol), gabapentin, indapamide (Natrilix Sr), omeprazole and morphine sulfate (Oramorph). On an unknown date, the patient received DTPa-IPV (unknown). On 19th November 2021, the patient received the 3rd dose of COVID-19 VACCINE MODERNA (unknown). On 19th November 2021, unknown after receiving DTPa-IPV, the patient experienced high temperature (serious criteria other: serious as per reporter), head pain (serious criteria other: serious as per reporter) and nausea (serious criteria other: serious as per reporter). On 20th November 2021, unknown after receiving DTPa-IPV, the patient experienced vomiting (serious criteria other: serious as per reporter) and sinus pain (serious criteria other: serious as per reporter). On 21st November 2021, unknown after receiving DTPa-IPV, the patient experienced mouth ulceration (serious criteria other: serious as per reporter) and cold sores lip (serious criteria other: serious as per reporter). On an unknown date, unknown after receiving DTPa-IPV, the patient experienced feeling sick (serious criteria other: serious as per reporter), headache (serious criteria other: serious as per reporter), unable to eat (serious criteria other: serious as per reporter), retching (serious criteria other: serious as per reporter), pain (serious criteria other: serious as per reporter) and shivering (serious criteria other: serious as per reporter). The patient was treated with codeine phosphate + paracetamol (Cocodamol). On an unknown date, the outcome of the feeling sick, headache, unable to eat, retching, pain, shivering, head pain, sinus pain, mouth ulceration, cold sores lip and nausea were not recovered/not resolved and In November 2021, the outcome of the vomiting and high temperature were recovered/resolved. It was unknown if the reporter considered the feeling sick, headache, unable to eat, retching, pain, shivering, vomiting, high temperature, head pain, sinus pain, mouth ulceration, cold sores lip and nausea to be related to DTPa-IPV. Additional details were provided as follows: The age at vaccination was unknown. In November 2021, the patient''s body temperature was measured and result were reported as 39.8 and 38 degree Celsius. On an unknown date, patient''s Covid 19 virus test was performed and result was reported as negative. On 19th November 2021, less than a day after receiving COVID-19 VACCINE MODERNA, the patient experienced high temperature, head pain and nausea. On 20th November 2021, 1 day after receiving COVID-19 VACCINE MODERNA, the patient experienced vomiting and sinus pain. On 21st November 2021, 2 days after receiving COVID-19 VACCINE MODERNA, the patient experienced mouth ulceration and cold sores lip. In November 2021, less than a week after receiving COVID-19 VACCINE MODERNA, the patient experienced feeling sick, headache, unable to eat, retching, pain and shivering. It was unknown if the reporter considered the feeling sick, headache, unable to eat, retching, pain, shivering, vomiting, high temperature, head pain, sinus pain, mouth ulceration, cold sores lip and nausea to be related to COVID-19 VACCINE MODERNA. The TTO for high temperature, head pain and nausea were reported as 1 day however captured as less than a day as per reported onset date and vaccination date with respect to COVID-19 VACCINE MODERNA vaccine. The concomitant product COVID-19 VACCINE ASTRAZENECA were captured as historical drugs, as per the coding convention. Initial information received from consumer via regulatory authority on 25th November 2021: feeling sick, headache, unable to eat, retching, pain, shivering, vomiting, high temperature, head pain, sinus pain, mouth ulceration, cold sores lip and nausea. Case narrative : My arm became very painful a couple of hours after vaccine booster. Had really bad headache and went to bed early. Woke in the early hours feeling really unwell, shivering like mad and feeling sick. Temperature was 39.8 so i took cocodamol but started vomiting immediately could not even keep a sip of water down. Had a shower and back in bed with fan on bring temp down. Eventually stopped retching and bringing up bile by mid day. Temp now 38 so tried pain relief again and managed to keep this down. By 6pm started to feel a bit better. The next day my mouth had loads and i mean loads of ulcers and my lips are covered in coldsores. I am unable to eat because it is too painful. My head still feels like it is going to explode and i am exhausted. If we have to have a booster next year i am not having the moderna one. I had no problem with astra zenica. Patient has not tested positive for COVID-19 since having the vaccine.Patient is not enrolled in clinical trial, Reaction, Does your report relate to possible inflammation of the heart (myocarditis or pericarditis If yes, we will ask you some additional questions at the end of this report: "No"


VAERS ID: 1921392 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-11-19
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: BEPFIZER INC202101701413

Write-up: COVID-19; vaccination failure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Apr2021 (Lot number: EL1484) as dose 2, single and administered in arm left, administration date 29Mar2021 (Lot number: EL0725) as dose 1, single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date Nov2021 (Batch/Lot number: unknown) as single dose. Relevant medical history included: "Non-smoker" (unspecified if ongoing). There were no concomitant medications. The following information was reported: COVID-19 (medically significant) with onset 19Nov2021, outcome "recovered", described as "COVID-19"; VACCINATION FAILURE (medically significant) with onset 19Nov2021, outcome "unknown", described as "vaccination failure". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) positive. Therapeutic measures were not taken as a result of covid-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1921815 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-11-19
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: rapid tests; Test Result: Positive ; Comments: 2 tests; Test Date: 20211124; Test Name: PCR Test; Test Result: Positive
CDC Split Type: DEPFIZER INC202101634851

Write-up: 2 rapid tests positive; 2 rapid tests positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group and License Party. Other Case identifier(s): 100484. A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Jun2021 (Lot number: EX8679) dose 2, single and administration date 17May2021 at the age of 58 years (Lot number: EX8679) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 19Nov2021, outcome "unknown" and all described as "2 rapid tests positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) positive, notes: 2 tests; sars-cov-2 test: (24Nov2021) positive. 2 rapid tests positive - both tests were performed with SARS-CoV-2 Antigen Rapid Test Kit von Lepu Medical, expiration date: 21FEB2022 lot: 21CG2708X.


VAERS ID: 1921820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ataxia, Facial paralysis, Immunisation, Nervous system disorder, Speech disorder
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101645914

Write-up: booster; neurologic deficits; hemifacial paralysis; speech disorder; ataxia; This is a spontaneous report received from a contactable reporter(s) (Physician). A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (first dose), for COVID-19 immunization; Comirnaty (second dose), for COVID-19 immunization, reaction(s): "neurological disorder". The following information was reported: IMMUNISATION (hospitalization), outcome "unknown", described as "booster"; NERVOUS SYSTEM DISORDER (hospitalization) with onset 19Nov2021, outcome "recovering", described as "neurologic deficits"; FACIAL PARALYSIS (hospitalization, medically significant) with onset 19Nov2021, outcome "recovering", described as "hemifacial paralysis"; SPEECH DISORDER (hospitalization) with onset 19Nov2021, outcome "recovering", described as "speech disorder"; ATAXIA (hospitalization) with onset 19Nov2021, outcome "recovering", described as "ataxia". Clinical Information: It was a very strong and immediate reaction. The symptoms occurred within minutes after vaccination. The next day the patient had partly recovered. The patient had already reacted in a significantly milder form to the second vaccination. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : DE-PFIZER INC-202101682819 same reporter, same patient, similar event


VAERS ID: 1922064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-11-19
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endoscopy, Lung neoplasm malignant, SARS-CoV-2 test, Scan, X-ray
SMQs:, Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-tobacco user (smoked in his youth but stopped for years)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: fiberoscopy; Result Unstructured Data: Test Result:diagnosis of lung cancer; Test Date: 2021; Test Name: COVID test; Test Result: Negative ; Test Date: 20211119; Test Name: scan; Result Unstructured Data: Test Result:diagnosis of lung cancer; Test Date: 20211119; Test Name: X-ray; Result Unstructured Data: Test Result:diagnosis of lung cancer
CDC Split Type: FRPFIZER INC202101638001

Write-up: Lung cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. A 71 year-old male patient received bnt162b2 (COMIRNATY), administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Ex-tobacco user" (unspecified if ongoing), notes: smoked in his youth but stopped for years. The patient''s concomitant medications were not reported. Vaccination history included: COMIRNATY (dose 1, lot/batch number: unknown), administration date: Jun2021, for COVID-19 immunisation. The following information was reported: LUNG NEOPLASM MALIGNANT (medically significant) with onset 19Nov2021, outcome "unknown", described as "Lung cancer". The patient underwent the following laboratory tests and procedures: endoscopy: (19Nov2021) diagnosis of lung cancer; sars-cov-2 test: (2021) negative; scan: (19Nov2021) diagnosis of lung cancer; x-ray: (19Nov2021) diagnosis of lung cancer. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1922142 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Pain, Pyrexia, Retching, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629200

Write-up: Vomiturition; Diarrhea; General body pain; Fever; This is a spontaneous report received from a contactable Consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111190948200380-EJXG4. Other Case identifier(s): GB-MHRA-ADR 26226307. A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: Unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The following information was reported: RETCHING (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Vomiturition"; DIARRHOEA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Diarrhea"; PAIN (medically significant) with onset 19Nov2021, outcome "not recovered", described as "General body pain"; PYREXIA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Fever". The patient underwent the following laboratory tests and procedures: body temperature: (19Nov2021) fever; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. Clinical course reported as: Patient had not tested positive for COVID-19 since having the vaccine. Patient involved as clinical trial participant for Pfizer study. The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aura, Dizziness, Feeling abnormal, Immunisation, Interchange of vaccine products, Off label use, Partial seizures
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOBAZAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101628939

Write-up: Primary immunisation: Astrazeneca; Booster: COMIRNATY; Primary immunisation: Astrazeneca; Booster: COMIRNATY; Patient received booster dose of COMIRNATY; Dizziness; Focal seizures; Could see an aura; Feeling funny; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111191121084660-HMLPI. Other Case identifier(s): GB-MHRA-ADR 26226715. A female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: CLOBAZAM taken for epilepsy. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLE; Lot Number: UNKNOWN;), administration date: 13May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLE; Lot Number: UNKNOWN;), administration date: 25Feb2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 19Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Nov2021, outcome "unknown", described as "Primary immunisation: Astrazeneca; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 19Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; DIZZINESS (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Dizziness"; PARTIAL SEIZURES (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Focal seizures"; AURA (medically significant) with onset 19Nov2021, outcome "unknown", described as "Could see an aura"; FEELING ABNORMAL (medically significant) with onset 19Nov2021, outcome "unknown", described as "Feeling funny". Therapeutic measures were taken as a result of partial seizures. Clinical course: The patient complained of dizziness a minute or so after jab was given. She said she was feeling ''funny''. She laid on hospital-style bed and she started having minour fits. She said she could see an aura. Once feeling better, she was given a clobazam tablet, fit lasted less than 5 mins. she sat and waited for 15 mins once better and went home. Patient did not have symptoms associated with COVID-19. Patient did not have a COVID-19 test. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. No follow-up attempts are needed. No further information is expected.


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