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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 519 out of 10,317

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VAERS ID: 1904626 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNK / 3 - / -
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site pain, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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; COVID-19 VACCINE ASTRAZENECA; DOLUTEGRAVIR; INFLUENZA VACCINE; LAMIVUDINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV positive; Suspected COVID-19; Comments: HIV positive but on treatment since 2011 and consistently undetectable with a CD4 count above 500.
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Yes - Positive COVID-19 test,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202123

Write-up: Chills; Headache; Diarrhea; Tiredness; Injection site pain; Case received on 22nd November 2021. This case was reported by a consumer via regulatory authority and described the occurrence of chills in a 36-year-old male patient who received DTPa-IPV (DTPa-IPV) for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) for prophylaxis. The patient''s past medical history included hiv positive and suspected covid-19. Additional patient notes included HIV positive but on treatment since 2011 and consistently undetectable with a CD4 count above 500.. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA), dolutegravir, INFLUENZA VACCINE and lamivudine. On an unknown date, the patient received DTPa-IPV (unknown). On 20th November 2021, the patient received the 3rd dose of BIONTECH COVID-19 MRNA VACCINE (unknown). On 20th November 2021, unknown after receiving DTPa-IPV, the patient experienced injection site pain (serious criteria other: Serious as per reporter). On 21st November 2021, the patient experienced chills (serious criteria other: Serious as per reporter), headache (serious criteria other: Serious as per reporter), diarrhea (serious criteria other: Serious as per reporter) and tiredness (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the chills, headache, injection site pain, diarrhea and tiredness were not recovered/not resolved. It was unknown if the reporter considered the chills, headache, injection site pain, diarrhea and tiredness to be related to DTPa-IPV. Additional details were provided as follow: The age at vaccination was unknown. On 20th June 2021, patient was tested positive for COVID 19 virus test. Time to onset for reported events was less than a day with respect to suspect COVID-19 VACCINE ASTRAZENECA. It was unknown if the reporter considered the reported events to be related to COVID-19 VACCINE ASTRAZENECA Time to onset for chills, headache, injection site pain, diarrhea and tiredness was less than a day with respect to suspect BIONTECH COVID-19 MRNA VACCINE.. It was unknown if the reporter considered the chills, headache, injection site pain, diarrhea and tiredness to be related to BIONTECH COVID-19 MRNA VACCINE. Note: The reported 1 day time to onset was considered only for BIONTECH COVID-19 MRNA VACCINE as vaccination date for Influenza vaccine was not reported, hence TTO for all the events with respect to Hepatitis A vaccine was captured as unknown. Exact vaccination date for Influenza vaccine to calculated the TTO was expected in follow up. Initial information received from consumer via regulatory authority on 22nd November 2021: Chills, headache, injection site pain, diarrhea and tiredness. Case narrative: 22-NOV-2021 Vaccine booster at 10am on 20/11. Side effects in effect when I woke up on 21/11. 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: 1907329 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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:
Current Illness: Asthma; Depression (Agitated depression); Nasal bleeding (Nasal polops); Steroid therapy (Takes regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Medical History/Concurrent Conditions: Tourette''s syndrome
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: nausea; had sore arm only when went to bed at night; Generalized muscle aches; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26231857) 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), PAIN IN EXTREMITY (had sore arm only when went to bed at night) and MYALGIA (Generalized muscle aches) in a 45-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. The patient''s past medical history included Tourette''s syndrome and Steroid therapy (Takes regular steroid treatment (e.g. orally or rectally)) since an unknown date. Concurrent medical conditions included Nasal bleeding (Nasal polops), Depression (Agitated depression) and Asthma. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced MYALGIA (Generalized muscle aches) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant) and PAIN IN EXTREMITY (had sore arm only when went to bed at night) (seriousness criterion medically significant). At the time of the report, NAUSEA (nausea), PAIN IN EXTREMITY (had sore arm only when went to bed at night) and MYALGIA (Generalized muscle aches) 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) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had no symptoms associated with COVID-19. The patient had sore arm only when went to bed at night, woke up during the night with aches all over, feeling nausea and tired. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: This regulatory authority case concerns a 45-year-old male patient undergoing Steroid therapy, who experienced the unexpected serious events of Nausea, Pain in extremity and Myalgia after mRNA- 1273 Moderna vaccine. The events occurred approximately 1 days after the third dose of mRNA- 1273 vaccine (dosage unknown). Nausea, vaccination site pain and Myalgia 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. Steroid therapy remains a confounder for the events Myalgia and Nausea. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 45-year-old male patient undergoing Steroid therapy, who experienced the unexpected serious events of Nausea, Pain in extremity and Myalgia after mRNA- 1273 Moderna vaccine. The events occurred approximately 1 days after the third dose of mRNA- 1273 vaccine (dosage unknown). Nausea, vaccination site pain and Myalgia 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. Steroid therapy remains a confounder for the events Myalgia and Nausea. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.


VAERS ID: 1907336 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
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: Rash
SMQs:, Anaphylactic reaction (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: Medical History/Concurrent Conditions: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Widespread non-itchy dull red patchy rash; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231960) 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 RASH (Widespread non-itchy dull red patchy rash) in a 62-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 Asthma and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Previously administered products included for Asthma: FOSTAIR; for Irritable bowel syndrome: LACTULOSE; for High cholesterol: Avorostatin; for HRT: Estradiol. Past adverse reactions to the above products included No adverse event with Avorostatin, Estradiol, FOSTAIR and LACTULOSE. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced RASH (Widespread non-itchy dull red patchy rash) (seriousness criterion medically significant). At the time of the report, RASH (Widespread non-itchy dull red patchy rash) 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. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. Painful hot and red patch at point of injection to size of approx. tennis ball. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. Company Comment: This is a regulatory case concerning a 62 years old, female patient with clinical history of asthma who experienced the unexpected event of RASH The event occurred two days 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 62 years old, female patient with clinical history of asthma who experienced the unexpected event of RASH The event occurred two days 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: 1907338 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Chills, Cough, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Rheumatoid arthritis; Comments: Rheumatoid arthiritis. I take methotrexate. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shivering; dry cough; fatigue; High temperature; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231971) 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 CHILLS (shivering), COUGH (dry cough), FATIGUE (fatigue) and PYREXIA (High temperature) in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Rheumatoid arthiritis. I take methotrexate. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s past medical history included Rheumatoid arthritis and Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). Previously administered products included for Rheumatoid arthritis: METHOTREXATE. Past adverse reactions to the above products included No adverse event with METHOTREXATE. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant), COUGH (dry cough) (seriousness criterion medically significant) and FATIGUE (fatigue) (seriousness criterion medically significant). At the time of the report, CHILLS (shivering), COUGH (dry cough), FATIGUE (fatigue) and PYREXIA (High temperature) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. 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 56-year- old female patient, with medical history of Rheumatoid arthritis under treatment with methrotrexate, who experienced the serious unexpected events of CHILLS, COUGH , FATIGUE and PYREXIA one da after receiving the third dose of mRNA-1273 vaccine.. 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 56-year- old female patient, with medical history of Rheumatoid arthritis under treatment with methrotrexate, who experienced the serious unexpected events of CHILLS, COUGH , FATIGUE and PYREXIA one da after receiving the third dose of mRNA-1273 vaccine.. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per regulatory reporting


VAERS ID: 1908709 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Pain in extremity, SARS-CoV-2 test
SMQs:, 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: CODEINE
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions: Medical History/Concurrent Conditions: Surgery (Surgery for prolapsed 482 850 2122 disc resulting in chronic.); Tendonitis; Comments: No medical history reported by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 20211117; 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: Painful arm; This case was received(Reference number: GB-MHRA-ADR 26232258) 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 PAIN IN EXTREMITY (Painful arm) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No medical history reported by the reporter. The patient''s past medical history included Tendonitis and Surgery (Surgery for prolapsed 482 850 2122 disc resulting in chronic.). Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Concomitant products included CODEINE for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 21-Nov-2021, PAIN IN EXTREMITY (Painful arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, 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 medication were reported. As per SD medical history reported as capsulitis in other shoulder, improving following steroid injection and manual therapy. Patient has not had symptoms associated with COVID-19. Company comment : This case concerns a 57-year old, female subject with a medical history of tendonitis in the other shoulder and surgery for a prolapsed disc , who experienced the serious (seriousness criterion= medically significant) unexpected event of Pain in extremity. The event occurred on the same day after the booster dose of mRNA 1273 VACCINE. Symptoms were described as "Very stiff and painful upper arm making it difficult to move limb, sleep, wash and dress." Patient took paracetamol and codeine from his regular medication as treatment. At the time of the report, outcome of the event was Not recovered/Not resolved. Rechallenge is not applicable as no additional dosing is expected to be given. The patient''s medical history of tendonitis in the other shoulder and surgery for a prolapsed disc remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 57-year old, female subject with a medical history of tendonitis in the other shoulder and surgery for a prolapsed disc , who experienced the serious (seriousness criterion= medically significant) unexpected event of Pain in extremity. The event occurred on the same day after the booster dose of mRNA 1273 VACCINE. Symptoms were described as "Very stiff and painful upper arm making it difficult to move limb, sleep, wash and dress." Patient took paracetamol and codeine from his regular medication as treatment. At the time of the report, outcome of the event was Not recovered/Not resolved. Rechallenge is not applicable as no additional dosing is expected to be given. The patient''s medical history of tendonitis in the other shoulder and surgery for a prolapsed disc remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1908717 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (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:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Sore throat; This case was received via RA (Reference number: GB-MHRA-ADR 26231219) 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 OROPHARYNGEAL PAIN (Sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient had not tested positive for COVID-19 since having the vaccine and had not had symptoms associated with COVID-19. Patient not had a COVID-19 test and 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 reported in the case, who experienced the serious unexpected event of Oropharyngeal pain. The event occurred on the same day of the administration of the first dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the event was Not Recovered/Not Resolved. The rechallenge is unknown as the event happened after the first dose of the vaccine and since no information on another dose was provided. The benefit-risk relationship of the mRNA-1273 vaccine 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 in the case, who experienced the serious unexpected event of Oropharyngeal pain. The event occurred on the same day of the administration of the first dose of the mRNA-1273 vaccine. At the time of the report, the outcome of the event was Not Recovered/Not Resolved. The rechallenge is unknown as the event happened after the first dose of the vaccine and since no information on another dose was provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1908720 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-11-20
   Days after vaccination:278
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46663 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: INFLUENZA VIRUS
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: Headache; Tiredness; Muscle soreness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232194) 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 soreness), HEADACHE (Headache) and FATIGUE (Tiredness) in a 55-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 INFLUENZA VACCINE (INFLUENZA VIRUS) from 04-Sep-2021 to an unknown date for COPD. On 15-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 03-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 21-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced MYALGIA (Muscle soreness) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle soreness), HEADACHE (Headache) and FATIGUE (Tiredness) had not resolved. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications were not reported. Concomitant medication include BACILLUS PNEUMONIA . Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Company Comment : This case concerns a 55 year-old female patient with no reported medical history, who experienced the unexpected serious events of Myalgia, Headache, and Fatigue. The event s of Myalgia and Fatigue occurred 9 months 6 days after the second dose of COVID-19 vaccine AstraZeneca and the day before the only dose of mRNA-1273 vaccine. The event of Headache occurred on the same day as the only dose of mRNA-1273 vaccine. Event coding and seriousness criteria were maintained for all events for consistency with the RA report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 55 year-old female patient with no reported medical history, who experienced the unexpected serious events of Myalgia, Headache, and Fatigue. The event s of Myalgia and Fatigue occurred 9 months 6 days after the second dose of COVID-19 vaccine AstraZeneca and the day before the only dose of mRNA-1273 vaccine. The event of Headache occurred on the same day as the only dose of mRNA-1273 vaccine. Event coding and seriousness criteria were maintained for all events for consistency with the RA report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1908722 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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, Fatigue, Headache, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), 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)

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: Headache; Nausea; Diarrhoea; Fever; Fatigue; Pain dull; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26232212) 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), NAUSEA (Nausea), DIARRHOEA (Diarrhoea), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (Pain dull) in a 58-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and PAIN (Pain dull) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea), DIARRHOEA (Diarrhoea), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (Pain dull) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. No concomitant medication was reported. No treatment information was provided. Company Comment: This case concerns a 58-year-old female patient, with no relevant medical history, who experienced the unexpected serious events of HEADACHE, NAUSEA, DIARRHOEA, PYREXIA, FATIGUE and PAIN. The events occurred on the same day after the administration of the third dose mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 58-year-old female patient, with no relevant medical history, who experienced the unexpected serious events of HEADACHE, NAUSEA, DIARRHOEA, PYREXIA, FATIGUE and PAIN. The events occurred on the same day after the administration of the third dose mRNA-1273 vaccine. The rechallenge was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1908728 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: 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? 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: Swelling; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232310) 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 SWELLING (Swelling) in a 45-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications reported by reporter. Swollen arm at the injection site and continuous pain for 24 hours. Patient has not tested positive for COVID-19 since having the vaccine. No treatment medications provided by the reporter. Company Comment: This is a regulatory case concerning a 45 year-old male patient, with no relevant medical history reported , who experienced the serious unexpected event of SWELLING arm on the same day after receiving the third dose of mRNA-1273 vaccine. 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 45 year-old male patient, with no relevant medical history reported , who experienced the serious unexpected event of SWELLING arm on the same day after receiving the third dose of mRNA-1273 vaccine. 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: 1908730 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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, Fatigue, Headache, Myalgia, Nausea, Pyrexia
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)

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: Type 1 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Tiredness; Headache; Nausea; Muscle ache; Chills; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232408) 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 FATIGUE (Tiredness), HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever) in a 44-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concurrent medical conditions included Type 1 diabetes mellitus. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Feb-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 20-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness) was resolving and HEADACHE (Headache), NAUSEA (Nausea), MYALGIA (Muscle ache), CHILLS (Chills) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment details were added. Company Comment: This case concerns a 44-year-old, male patient with previous relevant medical history of Immunodeficiency and Type 1 diabetes mellitus, who experienced the unexpected serious events of fatigue, headache, nausea, myalgia, chills, and pyrexia. The events 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 events occurred 1 day after. The patient previously had two doses of COVID-19 VACCINE ASTRAZENECA: the first one on 19-FEB-2021 and the second one on 6-MAY-2021. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Chills, headache, and myalgia could be in association with pyrexia. Patient�s medical history of Immunodeficiency and Type 1 diabetes mellitus could be confounding factors. 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 44-year-old, male patient with previous relevant medical history of Immunodeficiency and Type 1 diabetes mellitus, who experienced the unexpected serious events of fatigue, headache, nausea, myalgia, chills, and pyrexia. The events 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 events occurred 1 day after. The patient previously had two doses of COVID-19 VACCINE ASTRAZENECA: the first one on 19-FEB-2021 and the second one on 6-MAY-2021. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Chills, headache, and myalgia could be in association with pyrexia. Patient�s medical history of Immunodeficiency and Type 1 diabetes mellitus could be confounding factors. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908739 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Abdominal pain, Ageusia, Arthralgia, Chills, Cough, Diarrhoea, Flushing, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Arthritis (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: CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: shivering; high temperature; Acute diarrhea; Dry cough; Abdominal pain; Loss of taste; Joint ache; Nausea; Flushing of face; Fever; Fever chills; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26232468) 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 ache), DIARRHOEA (Acute diarrhea), COUGH (Dry cough), FLUSHING (Flushing of face), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea), AGEUSIA (Loss of taste), CHILLS (shivering), PYREXIA (high temperature), PYREXIA (Fever) and PYREXIA (Fever chills) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included AMOXICILLIN, CLAVULANATE POTASSIUM (CO-AMOXICLAV [AMOXICILLIN;CLAVULANATE POTASSIUM]) for Inner ear infection. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ARTHRALGIA (Joint ache) (seriousness criterion medically significant), FLUSHING (Flushing of face) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced DIARRHOEA (Acute diarrhea) (seriousness criterion medically significant), COUGH (Dry cough) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant) and AGEUSIA (Loss of taste) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant) and PYREXIA (high temperature) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint ache), DIARRHOEA (Acute diarrhea), COUGH (Dry cough), FLUSHING (Flushing of face), ABDOMINAL PAIN (Abdominal pain), NAUSEA (Nausea) and AGEUSIA (Loss of taste) had not resolved and CHILLS (shivering), PYREXIA (high temperature), PYREXIA (Fever) and PYREXIA (Fever chills) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had no history of illness of any sort and in fact, she has not had any cold or flu- type viruses for many years. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. No Treatment Medication reported. Within 20 hours of the booster patient felt very ill and 3 days on, still unable to get out of bed. Very high temperature and shivering flu-like symptoms, easing a little but stomach pains and diarrhea continued. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 63-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Arhtralgia, Flushing, Nausea, Pyrexia, Diarrhea, Cough, Abdominal pain and Ageusia 1-2 days after the third dose of mRNA-1273 vaccine. The event Chills and another episode of Pyrexia occurred on an unknown date. The re-challenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 63-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Arhtralgia, Flushing, Nausea, Pyrexia, Diarrhea, Cough, Abdominal pain and Ageusia 1-2 days after the third dose of mRNA-1273 vaccine. The event Chills and another episode of Pyrexia occurred on an unknown date. The re-challenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1908740 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: Palpitations; This case was received via regulatory (Reference number: GB-MHRA-ADR 26232480) 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 PALPITATIONS (Palpitations) in a 60-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 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 21-Nov-2021, PALPITATIONS (Palpitations) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Had severe palpitations 22 hours after having booster which after 30 minutes became atrial fibrillation and this lasted for about 12 hours. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Lab test includes blood test which showed raised troponin level. Company Comment : This case concerns a 60-year-old, female patient, with no disclosed medical history, who experienced the serious, unexpected event of palpitations. The event occurred 1 day after the third dose of mRNA 1273 vaccine. The patient experienced palpitations 22 hours after the booster dose which developed into atrial fibrillation 30 minutes after and lasted for 12 hours, no treatment information was given and the symptoms resolved. Patient was said to have increased troponin levels, but no further information was given. 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 60-year-old, female patient, with no disclosed medical history, who experienced the serious, unexpected event of palpitations. The event occurred 1 day after the third dose of mRNA 1273 vaccine. The patient experienced palpitations 22 hours after the booster dose which developed into atrial fibrillation 30 minutes after and lasted for 12 hours, no treatment information was given and the symptoms resolved. Patient was said to have increased troponin levels, but no further information was given. 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: 1908742 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Influenza like illness, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), 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:
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: Vision blurred; Flu-like aching; This case was received via RA (Reference number: GB-MHRA-ADR 26232526) 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 VISION BLURRED (Vision blurred) and INFLUENZA LIKE ILLNESS (Flu-like aching) in a 60-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (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 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced VISION BLURRED (Vision blurred) (seriousness criterion medically significant) and INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant). On 21-Nov-2021, INFLUENZA LIKE ILLNESS (Flu-like aching) had resolved. At the time of the report, VISION BLURRED (Vision blurred) had not resolved. 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. Patient has not 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 case concerns a 60-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of vision blurred and influenza like illness. The events occurred 1 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 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 60-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of vision blurred and influenza like illness. The events occurred 1 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 benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908743 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Insomnia, Pain in extremity, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions:
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: painful arm; insomnia; Palpitations; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232532) 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 PAIN IN EXTREMITY (painful arm), INSOMNIA (insomnia) and PALPITATIONS (Palpitations) in a 67-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 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) (seriousness criterion medically significant) and INSOMNIA (insomnia) (seriousness criterion medically significant). On 20-Nov-2021, PALPITATIONS (Palpitations) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm) and INSOMNIA (insomnia) had 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. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. No concomitant medications reported by reporter. When patient was received the jab sat down for 15 mins patient felt light headed, sick, patient could taste the Vaccine in mouth, when drinking water teeth felt like patient could taste copper, went home became ill with all joints tender, arm painful, 4am the next day, patient woke up unable to sleep insomnia, whole body ached, patient felt sick, had Diarrhoea, tried to walk, but patient feet and toes were too painful, took some Paracetamol which helped, 8pm took Nurofen, went to bed, next day painful arm, but able to walk, some of joints was tender. Patient took paracetamol and nurofen as treatment medication. Company Comment: This is a regulatory case concerning a 67-year-old female patient, withno relevant medical history reported , who experienced the serious unexpected events of PAIN IN EXTREMITY, INSOMNIA and PALPITATIONS one day after receiving 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 67-year-old female patient, withno relevant medical history reported , who experienced the serious unexpected events of PAIN IN EXTREMITY, INSOMNIA and PALPITATIONS one day after receiving 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: 1908745 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-20
   Days after vaccination:19
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, Headache, Myocarditis, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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:
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: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: myocarditis; Fever; Headache; Painful arm; Diarrhea; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232631) 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), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm), DIARRHOEA (Diarrhea) and MYOCARDITIS (myocarditis) in a female patient of an unknown age 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 stopped) on 15-Dec-2020. In November 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), HEADACHE (Headache), PAIN IN EXTREMITY (Painful arm) and MYOCARDITIS (myocarditis) had not resolved and DIARRHOEA (Diarrhea) had 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. No concomitant medications information was reported. No treatment medications were provided. Company''s comment: This is a regulatory case concerning a female patient of an unknown age, with medical history of suspected COVID-19 in December 2020, who experienced the serious unexpected events of Pyrexia, headache, pain in extremity, diarrhoea and the serios expected and AESI event of myocarditis. These events occurred after the third dose of mRNA-1273 vaccine, time to onset is unknown since the date of vaccination was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Significant Follow-up received on 23-NOV-2021 as live follow up, Action taken was changed unknown to Not applicable.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age, with medical history of suspected COVID-19 in December 2020, who experienced the serious unexpected events of Pyrexia, headache, pain in extremity, diarrhoea and the serios expected and AESI event of myocarditis. These events occurred after the third dose of mRNA-1273 vaccine, time to onset is unknown since the date of vaccination was not reported. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1908749 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Fatigue, Headache, Myalgia, Neck pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (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: Chronic fatigue syndrome; Chronic migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Muscle ache; Neck pain; Tiredness; Head pain; This case was received (Reference number: GB-MHRA-ADR 26232722) 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 NECK PAIN (Neck pain), FATIGUE (Tiredness), MYALGIA (Muscle ache) and HEADACHE (Head pain) in a 59-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Chronic fatigue syndrome and Chronic migraine. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination and COVID-19 vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Head pain) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, NECK PAIN (Neck pain), FATIGUE (Tiredness) and MYALGIA (Muscle ache) had not resolved and HEADACHE (Head 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 was not enrolled in clinical trial. Company Comment: This case concerns a 59-year old, female subject with a medical history of chronic migraine and chronic fatigue syndrome, and vaccination with COVID-19 VACCINE ASTRAZENECA ( 2 doses, date of administration unknown), who experienced the serious (seriousness criterion= medically significant) unexpected events of Neck pain, Fatigue, Myalgia, and Headache. Events Fatigue and Headache occurred on the same day after the booster dose of mRNA 1273 VACCINE, Neck pain occurred 1 day after, while Myalgia occurred unknown number of days after the booster dose of mRNA 1273 VACCINE. Information regarding treatment medication taken, if any, was not provided. At the time of the report, outcome of event Neck pain was Recovering/Resolving while outcome of all the other events was Not recovered/Not resolved. Rechallenge is not applicable as no additional dosing is expected to be given. The patient''s medical history of of chronic migraine and chronic fatigue syndrome, and vaccination with COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 59-year old, female subject with a medical history of chronic migraine and chronic fatigue syndrome, and vaccination with COVID-19 VACCINE ASTRAZENECA ( 2 doses, date of administration unknown), who experienced the serious (seriousness criterion= medically significant) unexpected events of Neck pain, Fatigue, Myalgia, and Headache. Events Fatigue and Headache occurred on the same day after the booster dose of mRNA 1273 VACCINE, Neck pain occurred 1 day after, while Myalgia occurred unknown number of days after the booster dose of mRNA 1273 VACCINE. Information regarding treatment medication taken, if any, was not provided. At the time of the report, outcome of event Neck pain was Recovering/Resolving while outcome of all the other events was Not recovered/Not resolved. Rechallenge is not applicable as no additional dosing is expected to be given. The patient''s medical history of of chronic migraine and chronic fatigue syndrome, and vaccination with COVID-19 VACCINE ASTRAZENECA remain as confounders. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1908755 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Fatigue, Feeling of body temperature change, Hot flush, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), 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:
Current Illness: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Preexisting Conditions:
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: Swollen arm; Feeling hot and cold; Aggravation of hot flushes; Tiredness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232906) 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 PERIPHERAL SWELLING (Swollen arm), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), HOT FLUSH (Aggravation of hot flushes) and FATIGUE (Tiredness) in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) (seriousness criterion medically significant), HOT FLUSH (Aggravation of hot flushes) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold), HOT FLUSH (Aggravation of hot flushes) and FATIGUE (Tiredness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment : This is a regulatory case concerning a 49 -year- old female patient, with medical history of Rheumatoid arthritis, who experienced the serious unexpected events of PERIPHERAL SWELLING, FEELING OF BODY TEMPERATURE CHANGE , HOT FLUSH and FATIGUE one day after receiving the third dose of mRNA-1273 vaccine. It was also reported that the patient had tested positive for COVID-19 on an unknown date. 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 49 -year- old female patient, with medical history of Rheumatoid arthritis, who experienced the serious unexpected events of PERIPHERAL SWELLING, FEELING OF BODY TEMPERATURE CHANGE , HOT FLUSH and FATIGUE one day after receiving the third dose of mRNA-1273 vaccine. It was also reported that the patient had tested positive for COVID-19 on an unknown date. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per regulatory reporting


VAERS ID: 1908756 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-20
   Days after vaccination:3
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: Dizziness, Palpitations, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; LISINOPRIL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210920; 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: Dizzy; Dizziness; Palpitations; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26232959) 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 PALPITATIONS (Palpitations), DIZZINESS (Dizziness) and DIZZINESS (Dizzy) in a 55-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. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 20-Sep-2021. Concomitant products included LISINOPRIL for Blood pressure high, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 20-Jan-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 11-Nov-2021 to an unknown date for Vaccination, PARACETAMOL from 17-Nov-2021 to an unknown date for Viral sore throat. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizzy) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Palpitations) and DIZZINESS (Dizziness) had not resolved and DIZZINESS (Dizzy) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient felt lightheaded day before but ok after eating. Next day busy all day then went out. Whilst at the dining table felt dizzy. Palpitations started and these had kept the patient awake night before. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No treatment medications were reported.; Sender''s Comments: This case concerns a 55-year-old female patient with a history of recent viral viral sore throat, who experienced the unexpected, serious (medically significant) events of dizziness and palpitations. The events occurred approximately 3 after the booster dose of mRNA-1273. The rechallenge was not applicable since the patient received the CHADOX1 NCOV-19 vaccine as previous immunization, and no further doses are expected. The medical history of recent viral viral sore throat, and concomitant administration of influenza vaccine, are confounding factors. Seriousness assessments has been retained as per Regulatory Authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1908759 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Ache; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26232971) 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), NAUSEA (Nausea) and PAIN (Ache) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) and PAIN (Ache) was resolving and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. The treatment medication was reported as paracetamol. Patient was sick after taking grapes. Otherwise the patient was taking only water. Post vaccination patient not tested positive for COVID-19. Patient was not enrolled in clinical trial Company Comment : This case concerns a 63-year-old patient with no relevant medical history, who experienced the unexpected serious events of headache, nausea, and pain. The events of headache and nausea are unexpected as they are retained as serious per the source document Authority reporting. The event headache occurred on the same day after the third dose (unknown dosage) of mRNA-1273. The events nausea and pain occurred 1 day after. 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 63-year-old patient with no relevant medical history, who experienced the unexpected serious events of headache, nausea, and pain. The events of headache and nausea are unexpected as they are retained as serious per the source document Authority reporting. The event headache occurred on the same day after the third dose (unknown dosage) of mRNA-1273. The events nausea and pain occurred 1 day after. 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: 1908762 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 discomfort, Abdominal pain upper, Dizziness, Fatigue, Headache, Hyperhidrosis, Influenza like illness, Muscle spasms, Myalgia, Pain in extremity, Photophobia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament 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: IBUPROFEN; OMEPRAZOLE; PARACETAMOL; SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: sweating; cramps; stomach ache; Dizziness; Painful arm; Flu like symptoms; Generalised muscle aches; Headache; Tiredness; Stomach upset; Light sensitivity to eye; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233237) 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 HYPERHIDROSIS (sweating), MUSCLE SPASMS (cramps), ABDOMINAL PAIN UPPER (stomach ache), ABDOMINAL DISCOMFORT (Stomach upset), PHOTOPHOBIA (Light sensitivity to eye), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Painful arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Generalised muscle aches) in a 39-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included SERTRALINE for Anxiety, PARACETAMOL for Hip arthrosis, OMEPRAZOLE for Stomach discomfort, IBUPROFEN for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset) (seriousness criterion medically significant), PHOTOPHOBIA (Light sensitivity to eye) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and MYALGIA (Generalised muscle aches) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), MUSCLE SPASMS (cramps) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach ache) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (sweating), MUSCLE SPASMS (cramps), ABDOMINAL PAIN UPPER (stomach ache), ABDOMINAL DISCOMFORT (Stomach upset), PHOTOPHOBIA (Light sensitivity to eye), DIZZINESS (Dizziness), PAIN IN EXTREMITY (Painful arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), FATIGUE (Tiredness) and MYALGIA (Generalised muscle aches) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. On 20-Nov-2021, patient felt OK after injection at 1.25pm then by 5.45pm started feeling tired, then flu like, light sensitivity, dizziness and stomach ache like got a tens machine on low to medium. He had cramps every few minutes. He had been to the toilet more for number 1 and 2. Patient stated on 21-Nov-21, all above were still there, but then was feeling warm and sweating from around 11am to 2pm. He was more drowsy and needed to sleep from 2-4pm. He still had light sensitivity and stomach issue like tens machine cramp every few minutes. On 22-Nov-2021 at 04:50, patient woke up early and needed toilet. He still had tens like cramp in stomach and flu like light sensitivity / aches. No treatment information was provided. Company Comment : This is a regulatory case concerning a 39-year-old male patient, with medical history of anxiety under treatment with sertraline and use of paracetamol for hip arthrosis and omeprazole for stomach discomfort, who experienced the serious unexpected events of HYPERHIDROSIS, MUSCLE SPASMS, ABDOMINAL PAIN UPPER, FATIGUE, ABDOMINAL DISCOMFORT , PHOTOPHOBIA, HEADACHE, DIZZINESS, PAIN IN EXTREMITY, INFLUENZA LIKE ILLNESS and MYALGIA between a few hours and 1 day after receiving 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 39-year-old male patient, with medical history of anxiety under treatment with sertraline and use of paracetamol for hip arthrosis and omeprazole for stomach discomfort, who experienced the serious unexpected events of HYPERHIDROSIS, MUSCLE SPASMS, ABDOMINAL PAIN UPPER, FATIGUE, ABDOMINAL DISCOMFORT , PHOTOPHOBIA, HEADACHE, DIZZINESS, PAIN IN EXTREMITY, INFLUENZA LIKE ILLNESS and MYALGIA between a few hours and 1 day after receiving 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: 1908763 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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, Chest pain, Epistaxis, Fatigue, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Type 2 diabetes mellitus.
Preexisting Conditions: Medical History/Concurrent Conditions: Antiphospholipid syndrome; Clinical trial participant.
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: Fatigue/unusual tiredness; Chest pain; Fever; Heart palpitations; Racing heart (tachycardia); Nose bleed; Chest pain; Wrist pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233453) 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 EPISTAXIS (Nose bleed), the first episode of CHEST PAIN (Chest pain), ARTHRALGIA (Wrist pain), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. The patient''s past medical history included Antiphospholipid syndrome and Clinical trial participant. Concurrent medical conditions included Type 2 diabetes mellitus. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ARTHRALGIA (Wrist pain) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced EPISTAXIS (Nose bleed) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, EPISTAXIS (Nose bleed) was resolving, ARTHRALGIA (Wrist pain) had not resolved and FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), PYREXIA (Fever), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. 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. No concomitant medication was provided by reporter.No treatment drug was provided by reporter. 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: "Yes" Did the symptoms lead to a hospital stay?: "No", Was a diagnosis made by a medical professional?: "No" Are you happy for us to contact your GP or treating physician?: "No" Were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken?: "No" Company Comment: This case concerns a 31-year-old, female patient with previous relevant medical history of Antiphospholipid syndrome and Type 2 diabetes mellitus, who experienced the unexpected serious events of epistaxis, two events of chest pain, arthralgia, fatigue, pyrexia, palpitations, and tachycardia. The events of arthralgia, fatigue, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The event arthralgia occurred on the same day after the third dose (unknown dosage) of mRNA-1273. One of the events of chest pain, occurred 1 day after the third dose (unknown dosage) of mRNA-1273. Epistaxis occurred 2 days after the third dose (unknown dosage) of mRNA-1273. The date of onset of the events fatigue, chest pain, pyrexia, tachycardia, and palpitations, was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of Antiphospholipid syndrome could be confounder for epistaxis and chest pain. Patient�s medical history of diabetes mellitus could be confounder for fatigue. The events palpitations and tachycardia could be in connection to each other and in association to pyrexia. 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 31-year-old, female patient with previous relevant medical history of Antiphospholipid syndrome and Type 2 diabetes mellitus, who experienced the unexpected serious events of epistaxis, two events of chest pain, arthralgia, fatigue, pyrexia, palpitations, and tachycardia. The events of arthralgia, fatigue, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The event arthralgia occurred on the same day after the third dose (unknown dosage) of mRNA-1273. One of the events of chest pain, occurred 1 day after the third dose (unknown dosage) of mRNA-1273. Epistaxis occurred 2 days after the third dose (unknown dosage) of mRNA-1273. The date of onset of the events fatigue, chest pain, pyrexia, tachycardia, and palpitations, was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of Antiphospholipid syndrome could be confounder for epistaxis and chest pain. Patient�s medical history of diabetes mellitus could be confounder for fatigue. The events palpitations and tachycardia could be in connection to each other and in association to pyrexia. 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: 1908915 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004372 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, 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:
Current Illness: Asthma; Hypertension; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; Muscle pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232339) 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 MYALGIA (Muscle pain) in a 56-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004372) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped) and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)) since an unknown date. Concurrent medical conditions included Hypertension and Asthma. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). At the time of the report, CHILLS (chills) and MYALGIA (Muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Concomitant medication use was not reported. Treatment history was not reported. Company Comment: This case concerns a 56-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of chills and myalgia. The events are unexpected as they are retained as serious per the source document Authority reporting. The event myalgia occurred on the same day after the third dose (booster dosage) of mRNA-1273. As per source document�s narrative, chills occurred approximately 12 hours after vaccination. 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 56-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of chills and myalgia. The events are unexpected as they are retained as serious per the source document Authority reporting. The event myalgia occurred on the same day after the third dose (booster dosage) of mRNA-1273. As per source document�s narrative, chills occurred approximately 12 hours after vaccination. 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: 1908919 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Nausea, Nervousness, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions:
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: shaking; nauseous; Shaking inside; Fever; Nausea; Fever chills; This case was received via the RA (Reference number: GB-MHRA-ADR 26232595) 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 TREMOR (shaking), NAUSEA (nauseous), NERVOUSNESS (Shaking inside), PYREXIA (Fever), NAUSEA (Nausea) and PYREXIA (Fever chills) in a 45-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 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NERVOUSNESS (Shaking inside) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and PYREXIA (Fever chills) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (shaking) (seriousness criterion medically significant) and NAUSEA (nauseous) (seriousness criterion medically significant). At the time of the report, TREMOR (shaking), NAUSEA (nauseous) and NERVOUSNESS (Shaking inside) was resolving and PYREXIA (Fever), NAUSEA (Nausea) and PYREXIA (Fever chills) had not resolved. 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. No concomitant medication details were reported. No treatment medication details were reported. Patient received vaccine at 10 am. Patient had sore arm and went to bed at 10 pm and woke up at 11.30 pm shaking uncontrollably and had fevers, sweats and felt freezing throughout the night. Patient could not get warm and teeth were chattering. Patient also felt really sore all over body since, nauseous and loss of appetite. Patient was not currently breastfeeding. Company comment: This case concerns a 45-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Nervousness, Pyerxia, and Nausea, on the day of the third dose of mRNA-1273 Vaccine. The events Tremor and Nausea occurred on an unknown date. 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 45-year-old, female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Nervousness, Pyerxia, and Nausea, on the day of the third dose of mRNA-1273 Vaccine. The events Tremor and Nausea occurred on an unknown date. 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: 1908925 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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, Feeling abnormal
SMQs:, Dementia (broad), Arthritis (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: pain in arms legs hands and fuzzy head; Joint pain; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26232717) 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 FEELING ABNORMAL (pain in arms legs hands and fuzzy head) and ARTHRALGIA (Joint pain) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (pain in arms legs hands and fuzzy head) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (pain in arms legs hands and fuzzy head) had not resolved and ARTHRALGIA (Joint pain) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications reported by reporter. Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient took paracetamol as treatment medication. Company Comment : This is a regulatory case concerning a 65 year-old female patient, with no relevant medical history reported , who experienced the serious unexpected events of FEELING ABNORMAL and ARTHRALGIA on the same day after receiving the third dose of mRNA1273 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 65 year-old female patient, with no relevant medical history reported , who experienced the serious unexpected events of FEELING ABNORMAL and ARTHRALGIA on the same day after receiving the third dose of mRNA1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1908929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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, Dermatitis, Erythema, Headache, Injection site erythema, Injection site pain, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201208; 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: The skin around injection site is red; Redness; Fever; Skin inflammation; Pain injection site; Joint ache; Chills; Headache NOS; This case was received via regulatory authority (Reference number: -MHRA-ADR 26232882) 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 INJECTION SITE ERYTHEMA (The skin around injection site is red), ERYTHEMA (Redness), PYREXIA (Fever), DERMATITIS (Skin inflammation), INJECTION SITE PAIN (Pain injection site), ARTHRALGIA (Joint ache), CHILLS (Chills) and HEADACHE (Headache NOS) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 MRNA VACCINE BIONTECH (COVID-19 MRNA VACCINE BIONTECH). Past adverse reactions to the above products included No adverse event with COVID-19 MRNA VACCINE BIONTECH. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced DERMATITIS (Skin inflammation) (seriousness criterion medically significant), INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and HEADACHE (Headache NOS) (seriousness criterion medically significant). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (The skin around injection site is red) (seriousness criterion medically significant), ERYTHEMA (Redness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 21-Nov-2021, CHILLS (Chills) and HEADACHE (Headache NOS) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (The skin around injection site is red), ERYTHEMA (Redness), PYREXIA (Fever), DERMATITIS (Skin inflammation) and INJECTION SITE PAIN (Pain injection site) had not resolved and ARTHRALGIA (Joint ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. It was reported that the patient had flu like, aches and fever,red, hot, swollen and very itchy skin around the injection site after the vaccination. Redness was about 7.5 cm in diameter. Patient reported that she also had the same reaction from first dose of Pfizer vaccine in February. She had not had any COVID-19 related symptoms or possible inflammation of heart such as myocarditis or pericarditis. Patient has not tested positive for COVID-19 since having the vaccine. Treatment information was not provided by the reporter. Company Comment: This is a regulatory case concerning a female patient of an unknown age , with no relevant medical history reported , who experienced the serious unexpected events of DERMATITIS, INJECTION SITE PAIN, ARTHRALGIA, CHILLS, HEADACHE 1 day after receiving the third dose of mRNA1273 vaccine. Patient�s also experienced the serious unexpected events of INJECTION SITE ERYTHEMA , ERYTHEMA and PYREXIA but time to onset is unknown. At the time of the report the events had resolved. 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 female patient of an unknown age , with no relevant medical history reported , who experienced the serious unexpected events of DERMATITIS, INJECTION SITE PAIN, ARTHRALGIA, CHILLS, HEADACHE 1 day after receiving the third dose of mRNA1273 vaccine. Patient�s also experienced the serious unexpected events of INJECTION SITE ERYTHEMA , ERYTHEMA and PYREXIA but time to onset is unknown. At the time of the report the events had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1911604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 FH4751 / 3 - / -
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram, Blood test, Chest X-ray, Computerised tomogram, Electrocardiogram, Hypersensitivity, Incontinence, Laboratory test, Loss of consciousness, Poor peripheral circulation, SARS-CoV-2 test, Scan, Seizure, Skin reaction
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
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: Comments: BP tablets Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Angiogram; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: blood test; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: chest x ray; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: ct scan; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: ECG; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: urine sample; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:); Test Date: 20211125; Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:); Test Date: 202111; Test Name: Scan; Result Unstructured Data: (Test Result:no result,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: allergic reaction; Loss of consciousness; Seizure; Incontinence; Skin reaction; Poor peripheral circulation; Case received by a regulatory authority on 28th November 2021 This case was reported by a consumer via regulatory authority and described the occurrence of loss of consciousness in a 44-year-old female patient who received DTPa-IPV (DTPa-IPV) for prophylaxis. Co-suspect products included TOZINAMERAN (BIONTECH COVID-19 MRNA VACCINE) (batch number FH4751, expiry date unknown) for prophylaxis. Previously administered products included Blood pressure tablet (on an unknown date). Additional patient notes included BP tablets Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. On an unknown date, the patient received DTPa-IPV (unknown). On 20th November 2021, the patient received the 3rd dose of BIONTECH COVID-19 MRNA VACCINE (unknown). On 20th November 2021, unknown after receiving DTPa-IPV, the patient experienced seizure (serious criteria hospitalization, a regulatory authority medically significant and life threatening), incontinence (serious criteria hospitalization and life threatening), skin reaction (serious criteria hospitalization and life threatening) and poor peripheral circulation (serious criteria hospitalization and life threatening). On 21st November 2021, unknown after receiving DTPa-IPV, the patient experienced loss of consciousness (serious criteria hospitalization, a regulatory authority medically significant and life threatening). On an unknown date, unknown after receiving DTPa-IPV, the patient experienced allergic reaction (serious criteria hospitalization and life threatening). On an unknown date, the outcome of the loss of consciousness and seizure were recovering/resolving and the outcome of the allergic reaction was not recovered/not resolved and In November 2021, the outcome of the incontinence, skin reaction and poor peripheral circulation were recovered/resolved. It was unknown if the reporter considered the loss of consciousness, seizure, allergic reaction, incontinence, skin reaction and poor peripheral circulation to be related to DTPa-IPV. Additional details were provided as follows: The age at vaccination was unknown. On 20th November 2021, less than a day after receiving Biontech covid 19 MRNA vaccine, the patient experienced seizure, incontinence, skin reaction and poor peripheral circulation. On 21st November 2021, 1 day after receiving Biontech covid 19 MRNA vaccine, the patient experienced loss of consciousness. In November 2021, less than a week after receiving Biontech covid 19 MRNA vaccine, the patient experienced allergic reaction. On 25th November 2021, patient''s covid 19 virus test was performed and result was reported as negative. In November 2021, the patient''s Angiogram, heart scan, ecg scan, blood test, urine sample test, chest x ray and CT scan were performed and results were not reported. The TTO for seizure, incontinence, skin reaction and poor peripheral circulation were reported as 1 day however captured as less than a day as per reported onset date and vaccination date with respect to Biontech covid 19 MRNA vaccine. It was unknown if the reporter considered the loss of consciousness, seizure, allergic reaction, incontinence, skin reaction and poor peripheral circulation to be related to Biontech covid 19 MRNA vaccine. In November 2021, the patient was hospitalized due to the events loss of consciousness, seizure, allergic reaction, incontinence, skin reaction and poor peripheral circulation. Initial information received from consumer via regulatory authority on 28th November 2021: allergic reaction, Loss of consciousness, Seizure, Incontinence, Skin reaction, Poor peripheral circulation. Case narrative : This occurred exactly 24 hours after receiving the vaccine booster. I had a delayed allergic reaction to the first vaccine ( different brand) 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" Suspect Reactions Please provide details of any relevant investigations or tests conducted: "Angiogram, heart scan, ecg scan, blood tests , urine sample, chest x ray, ctc scan "


VAERS ID: 1914685 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Groin pain, SARS-CoV-2 test
SMQs:, Osteonecrosis (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: Hernia
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: Pain groin; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233563) 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 Intramuscular Injection) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Hernia. Previously administered products included for Product used for unknown indication: PANTOPRAZOLE (reflux take pantoprazole 20mg). Past adverse reactions to the above products included No adverse event with PANTOPRAZOLE. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. 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 Intramuscular Injection) (Unknown) was unknown. No concomitant products were reported. No treatment drugs were reported 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 authority case concerning a 64-year-old, female patient with relevant medical history of hernia, who experienced the unexpected serious event of groin pain. The event groin pain occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The medical history of hernia remain 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 64-year-old, female patient with relevant medical history of hernia, who experienced the unexpected serious event of groin pain. The event groin pain occurred 1 day after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The medical history of hernia remain confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1914707 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Adverse drug reaction, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Severe headache; Fever chills; Aching in limb; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26233786) 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 ADVERSE DRUG REACTION (Severe headache), PYREXIA (Fever chills) and PAIN IN EXTREMITY (Aching in limb) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for Booster. Previously administered products included for Product used for unknown indication: Astra Zeneca (Had Astra Zeneca for main vaccination initially). Past adverse reactions to the above products included No adverse reaction with Astra Zeneca. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 20-Nov-2021, the patient experienced ADVERSE DRUG REACTION (Severe headache) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Aching in limb) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever chills) and PAIN IN EXTREMITY (Aching in limb) was resolving. On 22-Nov-2021, ADVERSE DRUG REACTION (Severe headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. Concomitant medication not provided. Treatment information not provided. Patient reaction recur on re-administration was unknown. The patient was taking Moderna Vaccine for Booster. Company Comment: This case concerns a 65 year-old, female patient with a history of vaccination with COVID-19 AstraZeneca vaccine, who experienced the serious (due to medically important condition) unexpected events of Adverse drug reaction (reported as severe headache), Pyrexia and Pain in extremity. The events occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of vaccination with COVID-19 AstraZeneca vaccine remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 65 year-old, female patient with a history of vaccination with COVID-19 AstraZeneca vaccine, who experienced the serious (due to medically important condition) unexpected events of Adverse drug reaction (reported as severe headache), Pyrexia and Pain in extremity. The events occurred approximately 1 day after the booster dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The medical history, of vaccination with COVID-19 AstraZeneca vaccine remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915044 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
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: Diarrhoea, Headache, Oral herpes, Pain in extremity, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629032

Write-up: Hand pain; Headache dull; Fever sore; Acute diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111201027487190-BLYQH (RA). Other Case identifier(s): GB-MHRA-ADR 26231176 (RA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 2, 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, SINGLE,LOT NUMBER: UNKNOWN; UNKNOWN MANUFACTURER), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Hand pain"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache dull"; ORAL HERPES (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever sore"; DIARRHOEA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Acute diarrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. 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 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: 1915046 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
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, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; vomitting; joint pain; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231640) 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), VOMITING (vomitting), ARTHRALGIA (joint pain) and NAUSEA (Nausea) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), VOMITING (vomitting) (seriousness criterion medically significant) and ARTHRALGIA (joint pain) (seriousness criterion medically significant). At the time of the report, HEADACHE (headache), VOMITING (vomitting), ARTHRALGIA (joint pain) and NAUSEA (Nausea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product usage were not provided. Patient experienced Vomitting, joint pain, headache. Post vaccination patient not tested positive for COVID-19. Also patient was not enrolled in any clinical trials. Treatment details were not provided. Company comment: This regulatory authority case concerns a 59-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Headache, Vomiting, Arthalgia and Nausea after mRNA- 1273 Moderna vaccine. The event Nausea occurred approximately 1 day after the third dose of mRNA- 1273 vaccine (dosage unknown) and the rest of the events occurred at an unknown date after the third dose. Headache, Vomiting, Arthalgia 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 59-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Headache, Vomiting, Arthalgia and Nausea after mRNA- 1273 Moderna vaccine. The event Nausea occurred approximately 1 day after the third dose of mRNA- 1273 vaccine (dosage unknown) and the rest of the events occurred at an unknown date after the third dose. Headache, Vomiting, Arthalgia 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: 1915048 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-20
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: Fatigue, Immunisation, Influenza like illness, 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: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628938

Write-up: Fever; Muscle ache; Flu like symptoms; Patient received booster dose of COMIRNATY; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111201723493940-KKWK3 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231704 (MHRA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 2021 (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: Bnt162b2 (DOSE 2, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot Number: UNKNOWN; Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; FATIGUE (medically significant) with onset 2021, outcome "not recovered", described as "Tiredness"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever"; MYALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Muscle ache"; INFLUENZA LIKE ILLNESS (medically significant) with onset 2021, outcome "unknown", described as "Flu like symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) no - negative covid-19 test. Clinical course: Patient developed Flu like symptoms which did not experience with previous Pfizer vaccines. The patient did not have symptoms associated with COVID-19 and was not enrolled in the clinical trial. 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 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: 1915050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Arthralgia, SARS-CoV-2 test, Vaccination site movement impairment
SMQs:, Arthritis (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: 20210915; 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: couldn''t lift my arm; Shoulder soreness; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26232184) 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 VACCINATION SITE MOVEMENT IMPAIRMENT (couldn''t lift my arm) and ARTHRALGIA (Shoulder soreness) in a female patient of an unknown age 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 15-Apr-2020. On 20-Nov-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ARTHRALGIA (Shoulder soreness) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (couldn''t lift my arm) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (couldn''t lift my arm) outcome was unknown and ARTHRALGIA (Shoulder soreness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient experienced very sore covid booster jag yesterday (20-Nov-2021), sore when the needle went in. Had 2 jags and 1 flu jag, never experienced needle pain. Arm was sore straight away. Could not lift arm, stretch out to take something. This morning (21-Nov-2021) could lift arm maybe 5 degree. No concomitant medications were reported. No treatment information was reported. This case concerns a female patient of unknown age with relevant medical history of suspected COVID-19, who experienced the unexpected serious events of Arthralgia and Vaccination site movement impairment. The events occurred on the same day after receiving a dose of mRNA-1273 Vaccine with an outcome of Not resolved at the time of report. The rechallenge was unknown since no information about the events of an earlier dose was disclosed. The patient''s medical history of suspected COVID-19, remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age with relevant medical history of suspected COVID-19, who experienced the unexpected serious events of Arthralgia and Vaccination site movement impairment. The events occurred on the same day after receiving a dose of mRNA-1273 Vaccine with an outcome of Not resolved at the time of report. The rechallenge was unknown since no information about the events of an earlier dose was disclosed. The patient''s medical history of suspected COVID-19, remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1915054 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Hallucination, tactile, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: Haptic hallucinations; This case was received Reference number: GB-MHRA-ADR 26232422) 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 HALLUCINATION, TACTILE (Haptic hallucinations) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HALLUCINATION, TACTILE (Haptic hallucinations) (seriousness criterion medically significant). At the time of the report, HALLUCINATION, TACTILE (Haptic hallucinations) 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. Concomitant product was not provided by the reporter. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Treatment information was not provided. This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious events of Hallucination tactile. The events occurred on the day after the third dose of mRNA-1273 Vaccine with an outcome of Resolving at the time of the report. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected serious events of Hallucination tactile. The events occurred on the day after the third dose of mRNA-1273 Vaccine with an outcome of Resolving at the time of the report. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1915055 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
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, Axillary pain, Headache, Lymphadenopathy, Palpitations, Pyrexia, SARS-CoV-2 test
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), 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: EVOREL CONTI
Current Illness:
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: Swollen glands; Aching joints; Armpit pain; Headache; Slight temperature; Heart racing; This case was received(Reference number: GB-MHRA-ADR 26232452) 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 LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Aching joints), AXILLARY PAIN (Armpit pain), HEADACHE (Headache), PYREXIA (Slight temperature) and PALPITATIONS (Heart racing) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Concomitant products included ESTRADIOL, NORETHISTERONE ACETATE (EVOREL CONTI) from 20-Oct-2021 to an unknown date for Menopause. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant), AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Slight temperature) (seriousness criterion medically significant) and PALPITATIONS (Heart racing) (seriousness criterion medically significant). On 21-Nov-2021, PALPITATIONS (Heart racing) had resolved. At the time of the report, LYMPHADENOPATHY (Swollen glands), ARTHRALGIA (Aching joints) and AXILLARY PAIN (Armpit pain) had not resolved, HEADACHE (Headache) was resolving and PYREXIA (Slight temperature) had resolved. 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.. No treatment information was provided. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Company Comment: This case concerns a 50-year-old female patient with no relevant medical history provided, who experienced the unexpected serious events of Lymphadenopathy, Pyrexia, Arthralgia, Axillary pain, Headache and Palpitations. The events occurred one day after the patient had received the third dose of the mRNA-1273 vaccine. At the time of this report, no information regarding the clinical course of the events was provided. The events of Lymphadenopathy, Axillary pain and Arthralgia had not resolved, while the events of Pyrexia and Palpitations had resolved and Headache was resolving. 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 and no additional doses are planned at the moment. Concomitantly used medication (Evorel) is considered as confounding factor for the events of Pyrexia, Arthralgia, Headache and Palpitations. 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 50-year-old female patient with no relevant medical history provided, who experienced the unexpected serious events of Lymphadenopathy, Pyrexia, Arthralgia, Axillary pain, Headache and Palpitations. The events occurred one day after the patient had received the third dose of the mRNA-1273 vaccine. At the time of this report, no information regarding the clinical course of the events was provided. The events of Lymphadenopathy, Axillary pain and Arthralgia had not resolved, while the events of Pyrexia and Palpitations had resolved and Headache was resolving. 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 and no additional doses are planned at the moment. Concomitantly used medication (Evorel) is considered as confounding factor for the events of Pyrexia, Arthralgia, Headache and Palpitations. 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: 1915061 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Chest pain, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Shortness of breath; Acute chest pain; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232820) 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 DYSPNOEA (Shortness of breath), PYREXIA (Fever) and CHEST PAIN (Acute chest pain) in a 68-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced CHEST PAIN (Acute chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On 21-Nov-2021, CHEST PAIN (Acute chest pain) had resolved. At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown and PYREXIA (Fever) was resolving. No concomitant medication was given. No reaction for 12 hours. Then fever onset increasing to peak 5 hours later, accompanied by strong chest pain Patient had virus flu/cold in previous two weeks. No treatment medication was given. This case concerns a 68-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of Dyspnoea, Pyrexia and Chest pain. The event of Pyrexia occurred the same day after the third dose of mRNA-1273 vaccine, Chest pain occurred one day after the third dose of mRNA-1273 vaccine and the event of Dyspnoea occurred after the third dose of mRNA-1273 vaccine. (Start date of event not provided). 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 68-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of Dyspnoea, Pyrexia and Chest pain. The event of Pyrexia occurred the same day after the third dose of mRNA-1273 vaccine, Chest pain occurred one day after the third dose of mRNA-1273 vaccine and the event of Dyspnoea occurred after the third dose of mRNA-1273 vaccine. (Start date of event not provided). 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: 1915062 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pyrexia, SARS-CoV-2 test, Syncope, Tremor, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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:
Preexisting Conditions:
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: Fainted; Shaking; Fever; Headache; Vaccination adverse reaction; This case was received via regulatory authority RA (Reference number: GB-MHRA-ADR 26232921) 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 SYNCOPE (Fainted), TREMOR (Shaking), PYREXIA (Fever), HEADACHE (Headache) and VACCINATION COMPLICATION (Vaccination adverse reaction) in a 65-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. LOT 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 20-Nov-2021, the patient experienced VACCINATION COMPLICATION (Vaccination adverse reaction) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainted), TREMOR (Shaking), PYREXIA (Fever) and HEADACHE (Headache) was resolving and VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. Patient had very bad feverish pains six hours after receiving the Moderna booster jab. Patient had uncontrollable shaking. Next day he had a sore arm and headache but on 21st, he had breakfast, sat down to read newspaper and felt dizzy. Patient mentioned that fainting lasted for seconds but was a bit worrying. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a 65-year-old male, with no relevant medical history reported in this case, who experienced the serious unexpected events of Syncope, Tremor, Pyrexia, Headache and Vaccination complication. The events Syncope, Tremor, Pyrexia and Headache occurred on an unknown date and the event Vaccination complication occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events Syncope, Tremor, Pyrexia and Headache is Recovering/Resolving and for the event Vaccination complication is Unknown. 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; 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 Syncope, Tremor, Pyrexia, Headache and Vaccination complication. The events Syncope, Tremor, Pyrexia and Headache occurred on an unknown date and the event Vaccination complication occurred one day after the administration of the 3rd dose of the mRNA-1273 vaccine. At the time of the report, the outcome for the events Syncope, Tremor, Pyrexia and Headache is Recovering/Resolving and for the event Vaccination complication is Unknown. 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.


VAERS ID: 1915066 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Nausea, Pyrexia, SARS-CoV-2 test, Syncope, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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:
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: Yes- Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; Syncope; Fever chills; Nausea; Vaccination site pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233520) 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), VACCINATION SITE PAIN (Vaccination site pain), SYNCOPE (Syncope), PYREXIA (Fever chills) and NAUSEA (Nausea) in a 53-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 16-Aug-2021. On 20-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). On 21-Nov-2021, SYNCOPE (Syncope) had resolved. On 22-Nov-2021, PYREXIA (Fever chills) and NAUSEA (Nausea) had resolved. At the time of the report, CHILLS (chills) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had not resolved. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant drug information was provided. Patient had vaccination site pain occurred few hours post procedure. Worsened as evening progressed. Severe pain through night. Awoke with 10/10 pain, nausea and chills. Got out of bed and went to kitchen and fainted . Came to fairly quickly. Very unwell all day with mild fever, chills and general malaise. Continued through the night. Managed with 3 hourly analgesia alternating with paracetamol, ibuprofen and co-codamol. Resolving on 3rd day. 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 53-years-old female patient, with a history of Suspected COVID-19 August 2021, who experienced the serious unexpected events of CHILLS, VACCINATION SITE PAIN, SYNCOPE, PYREXIA and NAUSEA. The event VACCINATION SITE PAIN occurred on the same day of the first dose of the mRNA-1273, the events SYNCOPE, PYREXIA and NAUSEA occurred on the following day of after the first dose of the mRNA-1273, the event CHILLS occurred after an unknown time interval after the first dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of Suspected COVID-19 August 2021 remains a confounder. A SARS-CoV-2 test: positive was done on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 53-years-old female patient, with a history of Suspected COVID-19 August 2021, who experienced the serious unexpected events of CHILLS, VACCINATION SITE PAIN, SYNCOPE, PYREXIA and NAUSEA. The event VACCINATION SITE PAIN occurred on the same day of the first dose of the mRNA-1273, the events SYNCOPE, PYREXIA and NAUSEA occurred on the following day of after the first dose of the mRNA-1273, the event CHILLS occurred after an unknown time interval after the first dose of the mRNA-1273. The rechallenge is not applicable since no information about further dosing has been disclosed. The history of Suspected COVID-19 August 2021 remains a confounder. A SARS-CoV-2 test: positive was done on an unknown date. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1915075 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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, Erythema, Fatigue, Headache, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (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; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Redness; Headache; Tiredness; Shivers; High temperature; Painful arm; This case was received via regulatory authority RA (Reference number: GB-MHRA-ADR 26233922) 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 (High temperature), PAIN IN EXTREMITY (Painful arm), ERYTHEMA (Redness), HEADACHE (Headache), FATIGUE (Tiredness) and CHILLS (Shivers) 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 Suspected COVID-19 from 14-Mar-2020 to 04-Apr-2020. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-Mar-2021 to an unknown date for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 30-Oct-2021 to an unknown date for Influenza immunisation. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced ERYTHEMA (Redness) (seriousness criterion medically significant). On 20-Nov-2021, CHILLS (Shivers) had resolved. On 22-Nov-2021, FATIGUE (Tiredness) had resolved. At the time of the report, PYREXIA (High temperature), PAIN IN EXTREMITY (Painful arm) and ERYTHEMA (Redness) had not resolved and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medication information was not provided by the reporter. Company Comment: This regulatory case concerns a 62-year-old, male patient with no relevant medical history, who experienced the unexpected, serious events of headache, chills, pyrexia, pain in extremity, erythema and fatigue. The events occurred 1 day after third dose of mRNA-1273 vaccine. The patient received previously two doses of AstraZeneca''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. Previous vaccination with AstraZeneca''s COVID-19 and 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 62-year-old, male patient with no relevant medical history, who experienced the unexpected, serious events of headache, chills, pyrexia, pain in extremity, erythema and fatigue. The events occurred 1 day after third dose of mRNA-1273 vaccine. The patient received previously two doses of AstraZeneca''s COVID-19 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. Previous vaccination with AstraZeneca''s COVID-19 and influenza vaccine remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915076 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
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: Abdominal pain upper, Chills, 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:
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: shivering; stomach cramp; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26233861) 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 (shivering), ABDOMINAL PAIN UPPER (stomach cramp) and CHILLS (Chills) in a 64-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 20-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach cramp) (seriousness criterion medically significant). On 22-Nov-2021, CHILLS (Chills) had resolved. At the time of the report, CHILLS (shivering) and ABDOMINAL PAIN UPPER (stomach cramp) 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. The reaction started with feeling very cold and shivering. Then developed a stomach cramp which was painful. The stomach cramp continued the following day and there was some diarrhoea. The reaction subsided through the day and was over by the next morning. No concomitant medication was reported. No treatment information was reported. Company Comment: This case concerns a 64 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected events of chills (reported as Shivering), Abdominal pain upper and chills (reported as chills). The event chills (reported as chills) occurred approximately 2 days after the booster dose of mRNA-1273 vaccine and the events chills (reported as Shivering) and Abdominal pain upper at an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 64 year-old, female patient with no relevant medical history, who experienced the serious (due to medically important condition) unexpected events of chills (reported as Shivering), Abdominal pain upper and chills (reported as chills). The event chills (reported as chills) occurred approximately 2 days after the booster dose of mRNA-1273 vaccine and the events chills (reported as Shivering) and Abdominal pain upper at an unknown date. The rechallenge was not applicable, as the events were reported exclusively after the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915084 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Dizziness, Fatigue, Nausea, Pyrexia, Tremor, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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? 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: Dizziness; Vaccination site tenderness; Tiredness; High temperature; Shaking; Nausea; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26234088) 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 (High temperature), TREMOR (Shaking), NAUSEA (Nausea), DIZZINESS (Dizziness), VACCINATION SITE PAIN (Vaccination site tenderness) and FATIGUE (Tiredness) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: ATORVASTATIN. Past adverse reactions to the above products included No adverse event with ATORVASTATIN. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), TREMOR (Shaking) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VACCINATION SITE PAIN (Vaccination site tenderness) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On 20-Nov-2021, PYREXIA (High temperature) and TREMOR (Shaking) had resolved. On 21-Nov-2021, FATIGUE (Tiredness) had resolved. On 22-Nov-2021, NAUSEA (Nausea), DIZZINESS (Dizziness) and VACCINATION SITE PAIN (Vaccination site tenderness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment Medication reported. It was reported that symptoms started around 12 to 15 hrs after vaccination. Injection site very sore and unable to lie on. Temperature, nausea and shaking started then. Shaking was short term followed by temperature. This disturbed sleep and may have assisted with tiredness but this lasted over around 36 hrs. Nausea lasted approx. the same but then Dizziness started with nausea again around 8hrs later but for about 6 hrs. Company Comment: This is a regulatory case concerning a 53-year-old male patient with no reported medical history, who experienced the serious (medically significant) events pyrexia, tremor, nausea, dizziness, vaccination site pain and fatigue. The events occurred approximately one day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 53-year-old male patient with no reported medical history, who experienced the serious (medically significant) events pyrexia, tremor, nausea, dizziness, vaccination site pain and fatigue. The events occurred approximately one day after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1915093 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-18
Onset:2021-11-20
   Days after vaccination:2
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: Diarrhoea, Dizziness, Illness, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), 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: RAMIPRIL
Current Illness:
Preexisting Conditions: Comments: No Medical History was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Dizziness; Diarrhea; High temperature; Large arm swelling; Sickness; This case was received (Reference number: GB-MHRA-ADR 26234395) 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 ILLNESS (Sickness), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), PYREXIA (High temperature) and PERIPHERAL SWELLING (Large arm swelling) in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. No Medical History was reported. Concomitant products included RAMIPRIL for Blood pressure high. On 18-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Large arm swelling) (seriousness criterion medically significant). On 21-Nov-2021, ILLNESS (Sickness) had resolved. At the time of the report, DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), PYREXIA (High temperature) and PERIPHERAL SWELLING (Large arm swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) COVID-19 test.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment -This case concerns a 49-year-old female, with no relevant medical history reported in this case, who experienced the serious unexpected events of Illness, Dizziness, Diarrhoea, Pyrexia and Peripheral Swelling. The event Illness occurred 2 days after the administration of the 3rd dose of the mRNA-1273 vaccine, the events Dizziness, Diarrhoea, Pyrexia and Peripheral Swelling occurred in an unknown date. At the time of the report, the outcome for the events was 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.; Sender''s Comments: This case concerns a 49-year-old female, with no relevant medical history reported in this case, who experienced the serious unexpected events of Illness, Dizziness, Diarrhoea, Pyrexia and Peripheral Swelling. The event Illness occurred 2 days after the administration of the 3rd dose of the mRNA-1273 vaccine, the events Dizziness, Diarrhoea, Pyrexia and Peripheral Swelling occurred in an unknown date. At the time of the report, the outcome for the events was 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.


VAERS ID: 1915099 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Axillary pain, Lymphadenopathy, Peripheral swelling, Rash erythematous, Skin warm
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Crohn''s disease (Crohn''s disease bit no medication at the moment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Red rash; Skin warm; Swollen arm; Armpit pain; Swollen glands; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234663) 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 RASH ERYTHEMATOUS (Red rash), SKIN WARM (Skin warm), PERIPHERAL SWELLING (Swollen arm), AXILLARY PAIN (Armpit pain) and LYMPHADENOPATHY (Swollen glands) in a 69-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Crohn''s disease (Crohn''s disease bit no medication at the moment). On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant), SKIN WARM (Skin warm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash), SKIN WARM (Skin warm), PERIPHERAL SWELLING (Swollen arm) and AXILLARY PAIN (Armpit pain) had not resolved and LYMPHADENOPATHY (Swollen glands) was resolving. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. No concomitant medication reported. No Treatment Medication reported. Patient reported pain in neck immediate after jab also metallic taste on mouth and pain in area of right kidney 12-24 hours after jab, which got resolved later. Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This case concerns a 69-year- old female, with no relevant medical history reported in this case, who experienced the serious unexpected events of Lymphadenopathy, Rash erythematous, Skin warm, Peripheral swelling and Axillary pain . The event Lymphadenopathy occurred on the same day of the administration of the third dose of mRNA-1273 vaccine and at the time of the report, the outcome was Recovering/Resolving. The events Rash erythematous, Skin warm, Peripheral swelling and Axillary pain occurred 2 days after the administration of the third dose of mRNA-1273 vaccine and at the time of the report, the outcome was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the third dose and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 69-year- old female, with no relevant medical history reported in this case, who experienced the serious unexpected events of Lymphadenopathy, Rash erythematous, Skin warm, Peripheral swelling and Axillary pain . The event Lymphadenopathy occurred on the same day of the administration of the third dose of mRNA-1273 vaccine and at the time of the report, the outcome was Recovering/Resolving. The events Rash erythematous, Skin warm, Peripheral swelling and Axillary pain occurred 2 days after the administration of the third dose of mRNA-1273 vaccine and at the time of the report, the outcome was Not Recovered/Not Resolved. The rechallenge is not applicable since the events occurred after the third dose and another dose will not be administered. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915105 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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, Cough, Influenza like illness
SMQs:, Anaphylactic reaction (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
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: cough; chills; Flu like symptoms; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234843) 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 COUGH (cough), CHILLS (chills) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 71-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 20-Nov-2021 to 22-Nov-2021. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant). On an unknown date, the patient experienced COUGH (cough) (seriousness criterion medically significant) and CHILLS (chills) (seriousness criterion medically significant). On 22-Nov-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) was resolving. At the time of the report, COUGH (cough) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by reporter. The patient had chills then high temperatures feeling sick very achy and severe cough two days very tired and not hungry bad flu like symptoms also horrid dreams Patient has not tested positive for COVID-19 since having the vaccine No treatment medications were provided by reporter. This case concerns a 71 year old female patient with no relevant medical history, who experienced the serious unexpected event of cough, chills and influenza like illness. The events occurred on the same day 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 71 year old female patient with no relevant medical history, who experienced the serious unexpected event of cough, chills and influenza like illness. The events occurred on the same day 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: 1915109 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211115; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Rash pruritic; This case was received (Reference number: GB-MHRA-ADR 26235162) 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 RASH PRURITIC (Rash pruritic) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 23-Oct-2021 to an unknown date for Influenza, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-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 20-Nov-2021, the patient experienced RASH PRURITIC (Rash pruritic) (seriousness criterion medically significant). At the time of the report, RASH PRURITIC (Rash pruritic) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-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. No Treatment medication details were provided. Patient had large bruise (12 cm long 9 cm wide) surrounding painful, itchy rash. 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 63-year-old female patient, with no medical history, who experienced the serious unexpected event of Rash pruritic. The event occurred one day after the third dose of mRNA-1273 vaccine. 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 63-year-old female patient, with no medical history, who experienced the serious unexpected event of Rash pruritic. The event occurred one day after the third dose of mRNA-1273 vaccine. 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: 1915111 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Pain in extremity, SARS-CoV-2 test
SMQs:, 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:
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: Pain in arm; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26235178) 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 (Pain in arm) in a 55-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 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) 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. No concomitant medication information was provided. No treatment medication were provided. This case concerns a 55-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of pain in extremity. The event occurred one 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 benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine; Sender''s Comments: This case concerns a 55-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious event of pain in extremity. The event occurred one 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 benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1915112 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Headache, Pyrexia, SARS-CoV-2 test, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
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: Vomiting; Chronic headaches; Fever chills; Trembling; This case was received (Reference number: GB-MHRA-ADR 26235190) 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 VOMITING (Vomiting), HEADACHE (Chronic headaches), PYREXIA (Fever chills) and TREMOR (Trembling) in a 58-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), HEADACHE (Chronic headaches) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and TREMOR (Trembling) (seriousness criterion medically significant). On 21-Nov-2021, VOMITING (Vomiting), PYREXIA (Fever chills) and TREMOR (Trembling) had resolved. At the time of the report, HEADACHE (Chronic headaches) 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. Patient was not associated with COVID-19 symptoms. Concomitant medication were not provided Treatment medication were not reported. Patient took Dose 3b vaccination and had experienced reactions that were extremely severe. Patient had not tested positive for COVID-19 since having the vaccination and was not enrolled in Clinical trial. Company Comment: This case concerns a 58-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of vomiting, headache, pyrexia, and tremor. The events of headache, pyrexia, and vomiting are unexpected as they are retained as serious per the source document Authority reporting. On 20-Nov-2021, the patient received third dose (unknown dosage) of mRNA-1273. The events occurred on the same day of vaccination. 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 58-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of vomiting, headache, pyrexia, and tremor. The events of headache, pyrexia, and vomiting are unexpected as they are retained as serious per the source document Authority reporting. On 20-Nov-2021, the patient received third dose (unknown dosage) of mRNA-1273. The events occurred on the same day of vaccination. 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: 1915116 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Cough, Feeling abnormal, Gastric antral vascular ectasia, Heart rate, Nausea, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: hours; given; started; Nausea; Heart rate; Vomiting; Fever; This case was received(Reference number: GB-MHRA-ADR 26235336) 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 FEELING ABNORMAL (hours), GASTRIC ANTRAL VASCULAR ECTASIA (given), COUGH (started), NAUSEA (Nausea), PYREXIA (Fever), HEART RATE (Heart rate) and VOMITING (Vomiting) in a 65-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 13-Mar-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), HEART RATE (Heart rate) (seriousness criterion medically significant) and VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (hours) (seriousness criterion medically significant), GASTRIC ANTRAL VASCULAR ECTASIA (given) (seriousness criterion medically significant) and COUGH (started) (seriousness criterion medically significant). On 21-Nov-2021, HEART RATE (Heart rate) and VOMITING (Vomiting) had resolved. On 22-Nov-2021, PYREXIA (Fever) had resolved. At the time of the report, FEELING ABNORMAL (hours), GASTRIC ANTRAL VASCULAR ECTASIA (given), COUGH (started) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication were not reported. 8 hours after administration of COVID-19 Vaccine patient started experiencing fever followed by vomiting which lasted for 8 hours, nausea for 2 days and still ongoing. Fever has gone by now. 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 65-year-old, female patient with no relevant history, who experienced the unexpected serious (medically significant) events of vomiting, pyrexia, nausea, cough, Gastric antral vascular ectasia and feeling abnormal. The events started 8 hours after the booster dose of mRNA-1273 vaccine. It is unknown when the events Gastric antral vascular ectasia and feeling abnormal occurred. Patient''s primary series of COVID vaccine was reported from another pharmaceutical company (AstraZeneca). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the seriousness criteria.; Sender''s Comments: This is a regulatory case concerning a 65-year-old, female patient with no relevant history, who experienced the unexpected serious (medically significant) events of vomiting, pyrexia, nausea, cough, Gastric antral vascular ectasia and feeling abnormal. The events started 8 hours after the booster dose of mRNA-1273 vaccine. It is unknown when the events Gastric antral vascular ectasia and feeling abnormal occurred. Patient''s primary series of COVID vaccine was reported from another pharmaceutical company (AstraZeneca). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting the seriousness criteria.


VAERS ID: 1915125 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Eye pain
SMQs:, Glaucoma (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: Eye pain; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26235577) 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 EYE PAIN (Eye pain) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced EYE PAIN (Eye pain) (seriousness criterion medically significant). At the time of the report, EYE PAIN (Eye pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported. Company comment: This case concerns a 24-year-old female patient, with no relevant medical history, who experienced the serious unexpected event of Eye pain. The event occurred the same day after the third dose of mRNA-1273 vaccine. 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 24-year-old female patient, with no relevant medical history, who experienced the serious unexpected event of Eye pain. The event occurred the same day after the third dose of mRNA-1273 vaccine. 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: 1915126 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
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: Fatigue, Headache, 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: tiredness; Fever; Headache; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26235659) 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 (tiredness), PYREXIA (Fever) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-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 20-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (tiredness) 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. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Combination of headache/fever/tiredness lasting around 24 hrs from morning after vaccination. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 63 year old male patient with no relevant medical history, who experienced the serious unexpected events of pyrexia, headache and fatigue. The events pyrexia and headache occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The event fatigue occurred on an unknown date after the third dose. 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 63 year old male patient with no relevant medical history, who experienced the serious unexpected events of pyrexia, headache and fatigue. The events pyrexia and headache occurred approximately 1 day after the third dose of mRNA-1273 vaccine. The event fatigue occurred on an unknown date after the third dose. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915135 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Dysgeusia, Headache, Rash pruritic, Upper gastrointestinal haemorrhage, Vaccination site erythema, Vaccination site mass
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Taste and smell disorders (narrow), Gastrointestinal haemorrhage (narrow), 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Upper; Red; Small; Itchy rash; Taste metallic; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26236611) 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 UPPER GASTROINTESTINAL HAEMORRHAGE (Upper), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE MASS (Small), RASH PRURITIC (Itchy rash), DYSGEUSIA (Taste metallic) and HEADACHE (Headache) in a 64-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 23-Feb-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced DYSGEUSIA (Taste metallic) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced UPPER GASTROINTESTINAL HAEMORRHAGE (Upper) (seriousness criterion medically significant), VACCINATION SITE ERYTHEMA (Red) (seriousness criterion medically significant) and VACCINATION SITE MASS (Small) (seriousness criterion medically significant). At the time of the report, UPPER GASTROINTESTINAL HAEMORRHAGE (Upper), VACCINATION SITE ERYTHEMA (Red), VACCINATION SITE MASS (Small) and RASH PRURITIC (Itchy rash) had not resolved and DYSGEUSIA (Taste metallic) and HEADACHE (Headache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. Patient had Itchy rash on upper chest with small red spots and body, head itching. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in the clinical trial. Company Comment: This is a regulatory case concerning a 64-year-old female patient with no clinical history who experienced the unexpected event of UPPER GASTROINTESTINAL HAEMORRHAGE, VACCINATION SITE ERYTHEMA, VACCINATION SITE MASS, RASH PRURITIC, DYSGEUSIA and HEADACHE The events occurred 1 day after the 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 64-year-old female patient with no clinical history who experienced the unexpected event of UPPER GASTROINTESTINAL HAEMORRHAGE, VACCINATION SITE ERYTHEMA, VACCINATION SITE MASS, RASH PRURITIC, DYSGEUSIA and HEADACHE The events occurred 1 day after the 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: 1915137 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675-L1058 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 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: Shivers; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26236625) 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 (Shivers) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675-L1058) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 25-Mar-2020 to 15-Apr-2020. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant). On 22-Nov-2021, CHILLS (Shivers) 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. No relevant concomitant and treatment medications were reported This case concerns a 54-year-old, female patient with no reported medical history, who experienced the unexpected serious event of chills. The event is unexpected as it is retained as serious per the source document Authority reporting. The event 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 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 54-year-old, female patient with no reported medical history, who experienced the unexpected serious event of chills. The event is unexpected as it is retained as serious per the source document Authority reporting. The event 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 benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1915139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / 3 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Balance disorder, Fatigue, Pain in extremity, SARS-CoV-2 test, Tinnitus
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (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: AMLODIPINE SANDOZ
Current Illness: Hypertension
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: GBGLAXOSMITHKLINEGB202124

Write-up: tinnitus; Fatigue; Balance disorder; Tinnitus aggravated; Painful arm; Case received by This case was reported by a consumer via regulatory authority and described the occurrence of tinnitus in a 61-year-old male patient who received Hepatitis A vaccine for prophylaxis. Co-suspect products included COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) for prophylaxis. Previously administered products included COVID-19 VACCINE ASTRAZENECA (on 05th March 2021) and COVID-19 VACCINE ASTRAZENECA (on 21st May 2021). Concurrent medical conditions included hypertension. Additional patient notes included Patient has not had symptoms associated with COVID-19. Concomitant products included amlodipine (Amlodipine Sandoz). On 20th November 2021, the patient received the 3rd dose of COVID-19 VACCINE MODERNA (unknown). On an unknown date, the patient received Hepatitis A vaccine (unknown). In November 2021, unknown after receiving Hepatitis A vaccine, the patient experienced tinnitus (serious criteria other: serious as per reporter). On 20th November 2021, unknown after receiving Hepatitis A vaccine, the patient experienced painful arm (serious criteria other: serious as per reporter). On 21st November 2021, unknown after receiving Hepatitis A vaccine, the patient experienced fatigue (serious criteria other: serious as per reporter), balance disorder (serious criteria other: serious as per reporter) and tinnitus aggravated (serious criteria other: serious as per reporter). On 22nd November 2021, the outcome of the painful arm was recovered/resolved. On an unknown date, the outcome of the tinnitus and fatigue were recovering/resolving and the outcome of the balance disorder and tinnitus aggravated were not recovered/not resolved. It was unknown if the reporter considered the tinnitus, pain in arm, fatigue, balance disorder and tinnitus aggravated to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was unknown. In November 2021, less than a week after receiving COVID-19 VACCINE MODERNA, the patient experienced tinnitus. On 20th November 2021, less than a day after receiving COVID-19 VACCINE MODERNA, the patient experienced painful arm. On 21st November 2021, 1 day after receiving COVID-19 VACCINE MODERNA, the patient experienced fatigue, balance disorder and tinnitus aggravated. The duration for the event painful arm was reported as 2 days. The TTO for painful arm was 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. On 20th November 2021, the patient''s Covid 19 virus test was performed and result was reported as negative. It was unknown if the reporter considered the tinnitus, painful arm, fatigue, balance disorder and tinnitus aggravated to be related to COVID-19 VACCINE MODERNA. Initial information received from consumer via regulatory authority on 24th November 2021: tinnitus, Painful arm, Fatigue, Balance disorder, Tinnitus aggravated. Case narrative: Significant pain in upper arm developed over a number of hours following administration. Extreme fatigue developed subsequently, requiring bed rest for approximately 24 hours. Residual effects noted as balance disturbance, and significantly exacerbated tinnitus, not persisting 72 hours post administration of the booster vaccine dose. 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: 1918156 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Wheezing; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234135) 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 WHEEZING (Wheezing) in a 53-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included SERTRALINE 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 20-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced WHEEZING (Wheezing) (seriousness criterion medically significant). At the time of the report, WHEEZING (Wheezing) had not resolved. Treatment information was not provided Company Comment: This case concerns a 53-year-old female patient, with no relevant medical history, who experienced the serious unexpected event of Wheezing. The event occurred one day after the third dose of mRNA-1273 vaccine. 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 53-year-old female patient, with no relevant medical history, who experienced the serious unexpected event of Wheezing. The event occurred one day after the third dose of mRNA-1273 vaccine. 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: 1918520 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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, Nausea, Pyrexia
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)

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 other medical history was reported. Unsure if patient has 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: This case was received via Regulatory Authority 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 (shivering), FATIGUE (Tiredness), PYREXIA (Fever) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No other medical history was reported.Unsure if patient has had symptoms associated with COVID-19 and Not had a COVID-19 test. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 03-Mar-2021 to an unknown date for COVID-19. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant). On 21-Nov-2021, PYREXIA (Fever) had resolved. On 22-Nov-2021, NAUSEA (Nausea) had resolved. At the time of the report, CHILLS (shivering) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that vaccine given at 10:26am. Symptoms started around 10:00pm same day. Shivering but very hot to touch. Tiredness, nausea, aching, very thirsty and drinking a lot of water, very dark urine. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial.Treatment information was not reported. Company comment: This is a regulatory case concerning a 64-year-old female patient with no clinical history who experienced the unexpected events of CHILLS, FATIGUE, PYREXIA and NAUSEA. 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 64-year-old female patient with no clinical history who experienced the unexpected events of CHILLS, FATIGUE, PYREXIA and NAUSEA.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: 1918524 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Arthralgia, Fatigue, Myalgia, Tongue disorder, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (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: BETNOVATE; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; OVESTIN
Current Illness: Hypermobility syndrome; Varicose vein
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebellar stroke; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26233977) 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 TONGUE DISORDER, URTICARIA, MYALGIA, ARTHRALGIA, and FATIGUE in a 56-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cerebellar stroke in 2013 and Suspected COVID-19 in March 2020. Concurrent medical conditions included Hypermobility syndrome and Varicose vein. Concomitant products included BETNOVATE from 11-Oct-2021 to 17-Oct-2021 for Atopic eczema, COVID-19 VACCINE NRVV AD (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, INFLUENZA VACCINE from 23-Jan-2021 to 23-Jan-2021 for Flu vaccination, OVESTIN from 01-Jun-2020 to an unknown date for Menopause. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced URTICARIA (seriousness criterion medically significant) and FATIGUE (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced MYALGIA (seriousness criterion medically significant) and ARTHRALGIA (seriousness criterion medically significant). On an unknown date, the patient experienced TONGUE DISORDER (seriousness criterion medically significant). At the time of the report, TONGUE DISORDER outcome was unknown and URTICARIA, MYALGIA, ARTHRALGIA, and FATIGUE was resolving. It was reported that the patient had long recovery to regain connection to muscles. Patient not had any symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not tested positive for COVID-19 since she had the vaccine. It was reported that the patient''s tongue felt similar to when she had probable Covid in Mar-2020. Hives started to subside 2 hours after onset. Only 3 areas were came up, the one was on underside right forearm and two on left knee. She did not took any antihistamine when she realized that more were not coming up. This regulatory authority case concerns a 56-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Tongue disorder, Urticaria, Myalgia, Arthralgia, and Fatigue after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient received initial schedule of vaccination with COVID-19 AstraZeneca vaccine. The event Urticaria occurred on the day after the dose of mRNA- 1273 vaccine and started to subside 2 hours after onset. Myalgia and Arthralgia occurred approximately 1 day after the dose and tongue disorder was reported on an unknown date after the dose of mRNA- 1273 vaccine. Myalgia and Arthralgia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. It was reported that the patient''s tongue felt similar to when she had probable Covid in Mar-2020. At the time of the report, the events were resolving. The rechallenge is 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. This regulatory authority case concerns a 56-year-old female patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Tongue disorder, Urticaria, Myalgia, Arthralgia, and Fatigue after mRNA- 1273 Moderna vaccine, third dose of the vaccination schedule (dosage unknown). The patient received initial schedule of vaccination with COVID-19 AstraZeneca vaccine. The event Urticaria occurred on the day after the dose of mRNA- 1273 vaccine and started to subside 2 hours after onset. Myalgia and Arthralgia occurred approximately 1 day after the dose and tongue disorder was reported on an unknown date after the dose of mRNA- 1273 vaccine. Myalgia and Arthralgia are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. It was reported that the patient''s tongue felt similar to when she had probable Covid in Mar-2020. At the time of the report, the events were resolving. The rechallenge is 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: 1918534 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Headache, Influenza like illness, Paraesthesia, Pyrexia, SARS-CoV-2 test, Sweating fever, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: High temperature; Flu-like aching; Sweating fever; Shaking; Tingling; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234497) 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 (High temperature), INFLUENZA LIKE ILLNESS (Flu-like aching), HEADACHE (Headache), SWEATING FEVER (Sweating fever), PARAESTHESIA (Tingling) and TREMOR (Shaking) in a 44-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 10-Apr-2020 to an unknown date for Asthma. On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and PARAESTHESIA (Tingling) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant), SWEATING FEVER (Sweating fever) (seriousness criterion medically significant) and TREMOR (Shaking) (seriousness criterion medically significant). On 21-Nov-2021, PARAESTHESIA (Tingling) and TREMOR (Shaking) had resolved. At the time of the report, PYREXIA (High temperature), INFLUENZA LIKE ILLNESS (Flu-like aching), HEADACHE (Headache) and SWEATING FEVER (Sweating fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment Medication reported. According to the patient, shaking limbs were pretty scary where he had no control over his arms and legs for around 30 mins. This case concerns a 44-year-old, male patient with relevant medical history of vaccination with COVID-19 Vaccine Astrazeneca, who experienced the unexpected events of Headache, Paraesthesia, Pyrexia, influenza like illness, Sweating fever and Tremor. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. The rechallenge wasnot applicable since the earlier doses were from another manufacturer. The patient''s medical history of vaccination with COVID-19 Vaccine Astrazeneca remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 44-year-old, male patient with relevant medical history of vaccination with COVID-19 Vaccine Astrazeneca, who experienced the unexpected events of Headache, Paraesthesia, Pyrexia, influenza like illness, Sweating fever and Tremor. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. The rechallenge wasnot applicable since the earlier doses were from another manufacturer. The patient''s medical history of vaccination with COVID-19 Vaccine Astrazeneca remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1918540 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Dizziness, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypoglycaemia (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: FLUOXETINE
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211121; 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; Dizziness; Shaking; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26234807) 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 (Dizziness), TREMOR (Shaking) and ABDOMINAL PAIN UPPER (Stomach cramps) in a 23-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. . Concomitant products included FLUOXETINE for Obsessive-compulsive disorder. On 20-Nov-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and TREMOR (Shaking) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) (seriousness criterion medically significant). At the time of the report, DIZZINESS (Dizziness), TREMOR (Shaking) and ABDOMINAL PAIN UPPER (Stomach cramps) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-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. Treatment Medication use information was not provided by reporter. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial Company Comment : This case concerns a 23-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Dizziness, Tremor and Abdominal pain upper. The events of Dizziness and Tremor occurred the same day after the first dose of mRNA-1273 vaccine while the event of Abdominal pain upper started one day after the first dose of mRNA-1273 vaccine. 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 23-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Dizziness, Tremor and Abdominal pain upper. The events of Dizziness and Tremor occurred the same day after the first dose of mRNA-1273 vaccine while the event of Abdominal pain upper started one day after the first dose of mRNA-1273 vaccine. 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: 1918546 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Fatigue, Headache, Peripheral swelling, Pruritus, Rash, SARS-CoV-2 test, Vaccination site pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: BENADRYL ALLERGY RELIEF; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter.
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: Rash; Swelling of fingers; Itching; Headache; Tiredness; Very sore arm at sight of injection for two days; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26235544) 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 HEADACHE (Headache), FATIGUE (Tiredness), VACCINATION SITE PAIN (Very sore arm at sight of injection for two days), PRURITUS (Itching), RASH (Rash) and PERIPHERAL SWELLING (Swelling of fingers) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 06-Oct-2021 to 06-Oct-2021 for Flu vaccination, ACRIVASTINE (BENADRYL ALLERGY RELIEF) 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 20-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant). On 22-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling of fingers) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE PAIN (Very sore arm at sight of injection for two days) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 22-Nov-2021, RASH (Rash) had resolved. At the time of the report, HEADACHE (Headache), FATIGUE (Tiredness) and PRURITUS (Itching) was resolving, VACCINATION SITE PAIN (Very sore arm at sight of injection for two days) had resolved and PERIPHERAL SWELLING (Swelling of fingers) 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. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient did not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient had itching, rash. Patient had very sore arm at site of injection for two days, slight headache on day one, and tired. On day two, the itching began on thighs, buttocks. Patient developed a rash there which had gone. On day three, the hands were very itchy, and fingers swollen, and had to remove the rings. Still felt swollen but did not itch as much but patient had taken antihistamine as advised by pharmacist. Company comment: This is a regulatory authority case concerning a 65-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Headache, Fatigue, Vaccination site pain, Pruritus , Rash, Peripheral swelling . The events occurred approximately 1 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 65-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Headache, Fatigue, Vaccination site pain, Pruritus , Rash, Peripheral swelling . The events occurred approximately 1 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: 1918554 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Headache, Illness, 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
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back injury
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative for COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26236867) 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 HEADACHE and ILLNESS in a 61-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Back injury. Previously administered products included for Back injury, Co-codolmol treatment. Concomitant products included COVID-19 VACCINE NRVV AD (COVID-19 VACCINE ASTRAZENECA) from 06-Mar-2021 to an unknown date for Vaccination. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (seriousness criterion medically significant) and ILLNESS (seriousness criterion medically significant). At the time of the report, HEADACHE had not resolved and ILLNESS had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) included on 17-Nov-2021, SARS-CoV-2 test Negative for COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. Treatment information was not provided. Patient had coughing up muck, ache through body sickness and loose bowl. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This is a regulatory authority case concerning a 61-year-old, male patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious events of illness and headache. The events illness and headache 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. This is a regulatory authority case concerning a 61-year-old, male patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca), who experienced the unexpected serious events of illness and headache. The events illness and headache 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: 1918560 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Heart rate increased; Heart rate; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237170) 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 HEART RATE INCREASED (Heart rate increased) and HEART RATE (Heart rate) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. No medical history was reported by the reporter. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 06-Mar-2021 to 08-May-2021 for COVID-19. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEART RATE (Heart rate) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate increased) (seriousness criterion hospitalization). On 21-Nov-2021, HEART RATE (Heart rate) had resolved. At the time of the report, HEART RATE INCREASED (Heart rate increased) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. Patient did not had symptoms associated with COVID-19 nor had a COVID-19 test. Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Patient''s heart rate increased from 75 beats resting heart rate to 132 beats and continued at that rate for almost 6 hours and had to admitted to A&E (emergency department or casualty) and put on a ECG and bloods were taken. Company comment: This is a regulatory authority case concerning a 53-year-old, male patient with concomitant product use of Covid -19 vaccine AstraZeneca, who experienced the unexpected serious events of increased heart rate and heart rate. The events occurred approximately 1 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 concomitant product use of Covid -19 vaccine AstraZeneca 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 53-year-old, male patient with concomitant product use of Covid -19 vaccine AstraZeneca, who experienced the unexpected serious events of increased heart rate and heart rate. The events occurred approximately 1 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 concomitant product use of Covid -19 vaccine AstraZeneca remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918562 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 4675 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
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: Fever; Head pain; Dizziness; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26237277) 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 PYREXIA (Fever), HEADACHE (Head pain), DIZZINESS (Dizziness) and FATIGUE (Fatigue) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 4675) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 20-Oct-2021 to 29-Oct-2021. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) from 25-Sep-2021 to an unknown date for an unknown indication. On 20-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion disability), HEADACHE (Head pain) (seriousness criterion disability), DIZZINESS (Dizziness) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). At the time of the report, PYREXIA (Fever), HEADACHE (Head pain), DIZZINESS (Dizziness) and FATIGUE (Fatigue) had not resolved. 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 (COVID 19 Vaccine Moderna) (Unknown Route) was unknown. No treatment information mentioned. Company Comment: This is a regulatory authority case concerning a 53-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of pyrexia, headache, dizziness and fatigue. The events pyrexia, headache, dizziness and fatigue occurred the same day with the second 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 53-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of pyrexia, headache, dizziness and fatigue. The events pyrexia, headache, dizziness and fatigue occurred the same day with the second 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: 1918564 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 4675 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cytomegalovirus infection reactivation, Fatigue, Headache, Myocarditis, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (narrow), Immune-mediated/autoimmune 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: COVID-19 VACCINE MODERNA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response e.g. immunodef); Post viral fatigue syndrome (Post viral syndrome five and half years)
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: cmv reactivation; myocarditis; Head pain; Fatigue; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237479) 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 HEADACHE (Head pain), FATIGUE (Fatigue), PYREXIA (Fever), CYTOMEGALOVIRUS INFECTION REACTIVATION (cmv reactivation) and MYOCARDITIS (myocarditis) in a 50-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 4675) for an unknown indication. The patient''s past medical history included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response e.g. immunodef) and Post viral fatigue syndrome (Post viral syndrome five and half years). Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) for an unknown indication. On 20-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced HEADACHE (Head pain) (seriousness criterion disability), FATIGUE (Fatigue) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). On an unknown date, the patient experienced CYTOMEGALOVIRUS INFECTION REACTIVATION (cmv reactivation) (seriousness criterion disability) and MYOCARDITIS (myocarditis) (seriousness criteria disability and medically significant). At the time of the report, HEADACHE (Head pain) and FATIGUE (Fatigue) had not resolved, PYREXIA (Fever) was resolving and CYTOMEGALOVIRUS INFECTION REACTIVATION (cmv reactivation) and MYOCARDITIS (myocarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. Treatment medication was not provided by the reporter. Patient had post viral sydrome (ME/CFS), developed in 2016 after CMV reactivation. She was improving during the summer of 2021 and hoping that she would soon recover. After the first moderna jab, patient suffered a strong CMV reactivation within a few hours. She was unable to work or perform normal functions for over four weeks and then slowly started to improve. By the time of the second jab, She was better, but not back to her state of health in the summer. Patient had now as a result of the symptoms described from the second vaccine, experienced a further setback in recovery from the last CMV reactivation. This vaccine has made her condition worse for over two months and she was no longer hopeful of eventually recovering from ''long CMV''. Patient have been directly exposed to Covid from other family members and friends and had always tested negative. Patient has not had symptoms associated with COVID-19. Company Comment: This is a regulatory case concerning a 50-year-old female patient with relevant medical history of immunocompromised and post viral fatigue syndrome who experienced the serious and unexpected events of fatigue, pyrexia, headache, headache, CMV infection reactivation and the AESI myocarditis. The events myocarditis and CMV infection reactivation occurred the same day after a second dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable. Medical history of immunocompromised and post viral fatigue syndrome remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Nov-2021: Follow-up information received includes patient medical history and action taken for suspect product updated from unknown to not applicable.; Sender''s Comments: This is a regulatory case concerning a 50-year-old female patient with relevant medical history of immunocompromised and post viral fatigue syndrome who experienced the serious and unexpected events of fatigue, pyrexia, headache, headache, CMV infection reactivation and the AESI myocarditis. The events myocarditis and CMV infection reactivation occurred the same day after a second dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable. Medical history of immunocompromised and post viral fatigue syndrome remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918571 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Contusion, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Tendinopathies and ligament 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: Gallstones (Have gall stones); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Thyroid activity decreased (Have an under active thyroid)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: bruised arm very soon after vaccination; Aching pain in hands, forearms, elbows; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237619) 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 CONTUSION (bruised arm very soon after vaccination) and PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...), Thyroid activity decreased (Have an under active thyroid) and Gallstones (Have gall stones). On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced CONTUSION (bruised arm very soon after vaccination) (seriousness criteria disability and medically significant). At the time of the report, CONTUSION (bruised arm very soon after vaccination) had not resolved and PAIN IN EXTREMITY (Aching pain in hands, forearms, elbows) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Patient had bruised arm very soon after vaccination, arm ached from top of shoulder to finger tips unable to lift it at all very painful couldnot sleep with the pain took paracetamol felt very unwell in herself a little achey all over ,was in bed for 24 hours. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This regulatory authority case concerns a 63-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of contusion and pain in extremity. The event pain in extremity occurred on the same day after the third dose (unknown dosage) of mRNA-1273. The date of onset of contusion was not reported. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. 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 regulatory authority case concerns a 63-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of contusion and pain in extremity. The event pain in extremity occurred on the same day after the third dose (unknown dosage) of mRNA-1273. The date of onset of contusion was not reported. Regulatory authority reported the rechallenge as unknown, however, the outcome of the events is not recovered. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918576 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Chills, Constipation, Decreased appetite, Dehydration, Diarrhoea, Food craving, Headache, Hyperhidrosis, Infection, Lymphadenopathy, Nausea, Pain, Peripheral coldness, Pyrexia, SARS-CoV-2 test, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow), 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
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
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: warm sweats; infection; Sweating; Appetite lost; Diarrhea; Constipation; Swelling; Swollen glands; Cold hands and feet; Nausea; Headache; Shivering; Fever; Food craving; Dehydration; Ache; This case was received via RA (Reference number: GB-MHRA-ADR 26237859) 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 CONSTIPATION (Constipation), SWELLING (Swelling), LYMPHADENOPATHY (Swollen glands), PERIPHERAL COLDNESS (Cold hands and feet), SKIN WARM (warm sweats), INFECTION (infection), NAUSEA (Nausea), HEADACHE (Headache), CHILLS (Shivering), PYREXIA (Fever), FOOD CRAVING (Food craving), DIARRHOEA (Diarrhea), HYPERHIDROSIS (Sweating), DECREASED APPETITE (Appetite lost), DEHYDRATION (Dehydration) and PAIN (Ache) in a 51-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 Suspected COVID-19 from 19-Mar-2020 to 17-Mar-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 17-Mar-2021 to 17-May-2021 and INFLUENZA VACCINE (INFLUENZA VIRUS) from 20-Nov-2021 to 20-Nov-2021 for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion disability), LYMPHADENOPATHY (Swollen glands) (seriousness criterion disability), PERIPHERAL COLDNESS (Cold hands and feet) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), CHILLS (Shivering) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), FOOD CRAVING (Food craving) (seriousness criterion disability), DEHYDRATION (Dehydration) (seriousness criterion disability) and PAIN (Ache) (seriousness criterion disability). On 21-Nov-2021, the patient experienced CONSTIPATION (Constipation) (seriousness criterion disability), DIARRHOEA (Diarrhea) (seriousness criterion disability) and DECREASED APPETITE (Appetite lost) (seriousness criterion disability). On 22-Nov-2021, the patient experienced HYPERHIDROSIS (Sweating) (seriousness criterion disability). On an unknown date, the patient experienced SKIN WARM (warm sweats) (seriousness criterion disability) and INFECTION (infection) (seriousness criterion disability). On 20-Nov-2021, FOOD CRAVING (Food craving) had resolved. On 21-Nov-2021, CHILLS (Shivering) and DIARRHOEA (Diarrhea) had resolved. On 22-Nov-2021, NAUSEA (Nausea) and PAIN (Ache) had resolved. On 23-Nov-2021, HEADACHE (Headache), PYREXIA (Fever), HYPERHIDROSIS (Sweating), DECREASED APPETITE (Appetite lost) and DEHYDRATION (Dehydration) had resolved. At the time of the report, CONSTIPATION (Constipation), SWELLING (Swelling), LYMPHADENOPATHY (Swollen glands) and PERIPHERAL COLDNESS (Cold hands and feet) had not resolved and SKIN WARM (warm sweats) and INFECTION (infection) outcome was unknown. 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. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient mild return of sense of smell and taste prev lost to suspect covid infection estim Oct 21. Negative lateral flow but COVID symptoms of loss of smell. Same happened with first AZ vaccine 17Mar21 suspect prev covid infection 19 Mar 2020. Patient could not keep anything down not even water until latter part 22 Nov 2021. All over body aches and could not get warm easily. Patient got warm sweats in the head would break out. Pain and swelling at the injection site on left arm 5cm deep and 10cm across. Painful to touch. Impossible to do any work 20-22 Nov inclusive. Coupled with swelling in armpit prohibited even walking around it was so tender. Patient not tested positive for COVID-19 since having the vaccine. Company Comment: This is a regulatory authority case concerning a 51-year-old female patient with no relevant medical history, who experienced seious, unexpected events of Constipation, Swelling, Lymphadenopathy, Peripheral coldness, Skin warm, Infection, Nausea, Headache, Chills, Pyrexia, Food craving, Diarrhea, Hyperhidrosis, Decreased appetite, Dehydration and Pain. The events 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 51-year-old female patient with no relevant medical history, who experienced seious, unexpected events of Constipation, Swelling, Lymphadenopathy, Peripheral coldness, Skin warm, Infection, Nausea, Headache, Chills, Pyrexia, Food craving, Diarrhea, Hyperhidrosis, Decreased appetite, Dehydration and Pain. The events 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: 1918577 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cellulitis, 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:
Current Illness: Clotting disorder; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Protein S deficiency; Type 2 diabetes mellitus
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: Cellulitis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26237684) 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 CELLULITIS (Cellulitis) in a 53-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for an unknown indication. Previously administered products included for Product used for unknown indication: PROTEIN S. Past adverse reactions to the above products included No adverse event with PROTEIN S. Concurrent medical conditions included Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)), Type 2 diabetes mellitus, Clotting disorder and Protein S deficiency. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (Cellulitis) had not resolved. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications were not reported. The reporter stateed that the patient had developed cellulitis at injection site and red sore hot and spreading, Patient currently started a course of antibiotics but it''s still continues to spread. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 53-year-old female patient with a history of Immunodeficiency and Type 2 diabetes mellitus, who experienced the serious unexpected event of cellulitis. The event occurred two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of Immunodeficiency and Type 2 diabetes mellitus remain as confounders for the event. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 53-year-old female patient with a history of Immunodeficiency and Type 2 diabetes mellitus, who experienced the serious unexpected event of cellulitis. The event occurred two days after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The medical history of Immunodeficiency and Type 2 diabetes mellitus remain as confounders for the event. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1918582 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Chills, Dizziness, Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211123; 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: dizziness; Chills; Nausea; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238010) 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 DIZZINESS (dizziness), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Immunization. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant). On 21-Nov-2021, CHILLS (Chills) and NAUSEA (Nausea) had resolved. At the time of the report, DIZZINESS (dizziness) was resolving and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-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 medications were not reported. First 18hrs was OK apart from arm pain, patient then had severe chills and aches for 12 hours, nausea and dizziness. Slight headache after 18 hours which has gradually grown worse, still have headache now 23/11/2021. Patient has not tested positive for COVID-19 since having the vaccine Patient usually very fit and healthy and had no trouble with first 2 vaccinations of AstraZeneca. Patient has not had symptoms associated with COVID-19. Company comment: This is a regulatory authority case concerning a 56-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness, Chills, Nausea, Headache. The events occurred approximately 1 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 56-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness, Chills, Nausea, Headache. The events occurred approximately 1 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: 1918608 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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: Amnesia, Confusional state, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
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: CERAZETTE [DESOGESTREL]
Current Illness:
Preexisting Conditions: Comments: No relevant medical history was provided by the reporter.
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: 16 hours after the booster; memory loss; confused; Confusion; This case was received via regulatory authority(Reference number: GB-MHRA-ADR 26239957) 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 CONFUSIONAL STATE (Confusion), VOMITING (16 hours after the booster), AMNESIA (memory loss) and CONFUSIONAL STATE (confused) in a 46-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No relevant medical history was provided by the reporter. . Concomitant products included DESOGESTREL (CERAZETTE [DESOGESTREL]) from 01-Feb-2005 to an unknown date for Birth control. On 19-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced CONFUSIONAL STATE (Confusion) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced VOMITING (16 hours after the booster) (seriousness criteria medically significant and life threatening), AMNESIA (memory loss) (seriousness criteria medically significant and life threatening) and CONFUSIONAL STATE (confused) (seriousness criteria medically significant and life threatening). On 22-Nov-2021, CONFUSIONAL STATE (Confusion) had resolved with sequelae. At the time of the report, VOMITING (16 hours after the booster), AMNESIA (memory loss) and CONFUSIONAL STATE (confused) had resolved. 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. The treatment history was not reported. Patient reported that 16 hours after the booster, She became confused, could not hold a thought or find vocabulary to express. Patient was unable to place geographically and felt asleep for two hours and woke feeling more lucid but having memory loss of the previous evening which had not yet fully resolved. Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a 46-year-old, female patient with no medical history, who experienced the unexpected events of confusional state, vomiting and amnesia, which were assessed as life-threatening and medically significant by the Regulatory authority. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, 16 hours after the booster, the patient became confused, could not hold a thought or find vocabulary to express. Patient was unable to place geographically and felt asleep for two hours and woke feeling more lucid but having memory loss of the previous evening which had not yet fully resolved. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. 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 46-year-old, female patient with no medical history, who experienced the unexpected events of confusional state, vomiting and amnesia, which were assessed as life-threatening and medically significant by the Regulatory authority. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, 16 hours after the booster, the patient became confused, could not hold a thought or find vocabulary to express. Patient was unable to place geographically and felt asleep for two hours and woke feeling more lucid but having memory loss of the previous evening which had not yet fully resolved. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1918626 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lethargy, Peripheral swelling, 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), Haemodynamic oedema, effusions and fluid overload (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: COVID-19 VACCINE ASTRAZENECA
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: Headache; Lethargy; Swollen arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26240226) 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 PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache) and LETHARGY (Lethargy) in a 64-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) for an unknown indication. On 20-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and LETHARGY (Lethargy) (seriousness criterion medically significant). On 22-Nov-2021, HEADACHE (Headache) and LETHARGY (Lethargy) had resolved. At the time of the report, PERIPHERAL SWELLING (Swollen arm) had not resolved. 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 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. The swollen arm was not improving in fact 3 days after the vaccination it was getting worst and covers quite a bit of the upper arm around the vaccination site. The skin is very tight and feels very hot to the touch. Considering contacting doctors if it does not improve in the next day. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report was not related to possible inflammation of the heart myocarditis or pericarditis. The treatment information were unknown. Company comment: This case concerns a 64 year old female with no reported medical history, previous Covid 19 vaccine was , COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA , who experienced , Serious ( medically significant ) , unexpected event of peripheral swelling which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The day after the vaccination she experienced Serious ( medically significant ) , unexpected events of Lethargy , headache . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no other 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 64 year old female with no reported medical history, previous Covid 19 vaccine was , COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA , who experienced , Serious ( medically significant ) , unexpected event of peripheral swelling which occurred on the same day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The day after the vaccination she experienced Serious ( medically significant ) , unexpected events of Lethargy , headache . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no other doses will be administered. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 1918646 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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: Abdominal discomfort, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Feverish; Tiredness; Upset stomach; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26241847) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), FATIGUE (Tiredness) and ABDOMINAL DISCOMFORT (Upset stomach) in a 60-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 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced PYREXIA (Feverish) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 22-Nov-2021, PYREXIA (Feverish) and FATIGUE (Tiredness) had resolved. On 23-Nov-2021, ABDOMINAL DISCOMFORT (Upset stomach) had resolved. 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 60-year-old female patient, with no relevant medical history reported, who experienced the unexpected events of pyrexia, fatigue and abdominal discomfort. The event abdominal discomfort occurred on the same day after the third dose of mRNA � 1273 vaccine. Pyrexia and fatigue was experienced a day after. Events were reported medically significant but 2-3days after events started, all the events resolved. 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.; Sender''s Comments: This case concerns a 60-year-old female patient, with no relevant medical history reported, who experienced the unexpected events of pyrexia, fatigue and abdominal discomfort. The event abdominal discomfort occurred on the same day after the third dose of mRNA � 1273 vaccine. Pyrexia and fatigue was experienced a day after. Events were reported medically significant but 2-3days after events started, all the events resolved. 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: 1918733 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-11-20
   Days after vaccination:186
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 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: 20211113; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211120; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: collected upon arrival. Ct value was less than 30 and his specimen carried the L452R mutant strain (but was negative for the N501Y and E484K strains).
CDC Split Type: HKPFIZER INC202101691549

Write-up: Confirmed case of COVID-19 /imported case with mutant strain of L452R; Confirmed case of COVID-19 /imported case with mutant strain of L452R; This is a spontaneous report received from non-contactable Other HCP from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS005407 (RA). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 22-Nov-2021, RA announced that one additional confirmed case of COVID-19 after Comirnaty vaccination. A 23-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 27-Apr-2021 and 18-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 14-Nov-2021, the patient departed a foreign country after he tested negative for COVID-19 on 13-Nov-2021. He arrived in foreign country on 20-Nov-2021 by flight and his specimen collected upon arrival tested positive for COVID-19. His Ct value was less than 30 and his specimen carried the L452R mutant strain (but was negative for the N501Y and E484K strains). On 22-Nov-2021, the patient had symptoms and was confirmed as COVID-19 with mutant strain of L452R. The adverse event ''confirmed case of COVID-19 /imported case with mutant strain of L452R'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 22-Nov-2021 and 23-Nov-2021. Follow-up closed, no further information is possible. Causality assessment provided by company (RA) and reporter for all reported events was Possible. BNT162B2 is under agreement with RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1921361 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-11-20
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Fatigue, Headache, Nausea, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: covid-19 antigen rapid test; Result Unstructured Data: Test Result:positive; Test Date: 20211120; Test Name: PCR covid-19 virus test; Result Unstructured Data: Test Result:positive
CDC Split Type: ATPFIZER INC202101641898

Write-up: Covid-19 after 2 vaccinations confirmed by PCR-Test result on 21Nov2021; Covid-19 after 2 vaccinations confirmed by PCR-Test result on 21Nov2021; headache; mild nausea; mild cough; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. A 51 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Jun2021 (Lot number: ER9480, Expiration Date: 31Jul2021) as dose 2, single and administered in arm left, administration date 15May2021 (Lot number: ET3674, Expiration Date: 31Jul2021) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Covid-19 after 2 vaccinations confirmed by PCR-Test result on 21Nov2021"; HEADACHE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "headache"; NAUSEA (non-serious) with onset 20Nov2021, outcome "not recovered", described as "mild nausea"; COUGH (non-serious) with onset 20Nov2021, outcome "not recovered", described as "mild cough"; FATIGUE (non-serious) with onset 20Nov2021, outcome "not recovered", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive; (20Nov2021) positive. Therapeutic measures were taken as a result of headache, nausea, cough, fatigue. Additional information: As a treatment for the symptoms the patient took Ibuprofen 2x400 mg. The patient did not go to see a physician regarding her symptoms, the course was mild without no fever. The patient did not have any concomitant medications, any medical history, nor received another vaccine 4 weeks prior to Comirnaty. Follow up activities completed. Information on the batch number obtained.


VAERS ID: 1922079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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 FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
SMQs:, Arthritis (broad), Medication errors (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: GBPFIZER INC202101637773

Write-up: Off-label use; Interchange of vaccine products; Booster; Headache; Aching joints; Swollen glands; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-APPCOVID-202111211455250830-LTOZK (RA). Other Case identifier(s): GB-MHRA-ADR 26232539 (RA). A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: FL1939) 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 astrazeneca (Dose 1, LOT 4120z001), Primary Immunization series complete but ASTRAZENECA manufacturer), administration date: 15Mar2021, for COVID-19 immunisation; Covid-19 vaccine (Dose 2 , Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "Headache"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Aching joints"; LYMPHADENOPATHY (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swollen glands". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1922264 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 FH4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: GBPFIZER INC202101629402

Write-up: Blacked out; Body temperature; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111201233324440-MRZS4. Other Case identifier(s): GB-MHRA-ADR 26231321 . A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) at the age of 32 years 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: LOSS OF CONSCIOUSNESS (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Blacked out"; BODY TEMPERATURE (non-serious) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Body temperature". Clinical course: Patient has no underlying health conditions. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test .Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report does not relate to possible inflammation of the blood clots or low platelet counts and heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922275 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Immunisation, Pharyngeal swelling, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629440

Write-up: Booster; Throat swelling; throat felt restricted or sensation of fullness; swallowing was harder than usual; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111201503462030-XNH7D. Other Case identifier(s): GB-MHRA-ADR 26231521. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose-1), for COVID-19 immunization; Bnt162b2 (Dose-2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PHARYNGEAL SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Throat swelling"; THROAT TIGHTNESS (medically significant) with onset 20Nov2021, outcome "unknown", described as "throat felt restricted or sensation of fullness"; DYSPHAGIA (medically significant) with onset 20Nov2021, outcome "unknown", described as "swallowing was harder than usual". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Approximately 5 hours after receiving vaccination throat felt restricted, or a sensation of fullness and swallowing was harder than usual. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922277 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Dizziness, Hypoglycaemia, Immunisation, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (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: Alopecia scarring; Palpitations; Type 1 diabetes mellitus (She was on insulin pump)
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: Blood sugar; Result Unstructured Data: Test Result:10.6; Comments: she was not hypo 15 mins after the vaccine; Test Date: 20211120; Test Name: Blood sugar; Result Unstructured Data: Test Result:2.9; Comments: She had a bad hypo, two hrs after the vaccine; Test Date: 20210920; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629507

Write-up: hypo; Dizziness; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111201601004230-1QPYA (RA). Other Case identifier(s): GB-MHRA-ADR 26231600 (RA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 12:10 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Alopecia scarring" (unspecified if ongoing); "Type 1 diabetes" (unspecified if ongoing), notes: She was on insulin pump; "Palpitations" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Bisoprolol, reaction(s): "palpitations", notes: 1.25mg/day; Insulin degludec for Type 1 diabetes; Convulex for seizures, notes: 300mg x 1/day (No seizures in 25 years though); Oestrogel for HRT, notes: HRT, symptoms have started re-occurring after the vaccines; Utrogestan for HRT, notes: HRT, symptoms have started re-occurring after the vaccines; Vagifem for HRT, notes: HRT, symptoms have started re-occurring after the vaccines; Simvastatin, notes: 40mg x 1/day; Bisoprolol, reaction(s): "Ventricular Ectopic Beats", notes: 1.25mg/day; Androfeme for HRT, notes: HRT, symptoms have started re-occurring after the vaccines. 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 20Nov2021, outcome "unknown", described as "Booster"; HYPOGLYCAEMIA (medically significant) with onset 20Nov2021 14:10, outcome "not recovered", described as "hypo"; DIZZINESS (medically significant) with onset 20Nov2021 12:25, outcome "recovered" (20Nov2021), described as "Dizziness". The patient underwent the following laboratory tests and procedures: blood glucose: (20Nov2021) 10.6, notes: she was not hypo 15 mins after the vaccine; (20Nov2021) 2.9, notes: She had a bad hypo, two hrs after the vaccine; sars-cov-2 test: (20Sep2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of hypoglycaemia. Patient took a lot of Lucozade to bring it back up. Clinical information: She had an episode of a few minutes of dizziness ca. 15 mins after the vaccine. Her blood sugar was 10.6 when she tested 15 mins after the vaccine and suddenly, without reason (she ate), she went 2.9 and took treatment. It happened twice since (it was 16:12 at the time of report and she had the vaccine at 12:10 pm). She kept going low. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient last menstrual period date: 5Nov2021. She had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). She tested her blood sugars regularly and took readings from her Libre 2 sensor. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922279 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lip swelling, Malaise, Off label use, Pruritus, SARS-CoV-2 test, Throat irritation
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201220; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101629504

Write-up: Off label use; Booster; Swollen lips; Itchy throat; Itchy skin; Feeling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111201609090460-NHDPW (RA). Other Case identifier(s): GB-MHRA-ADR 26231599 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Suspected COVID-19", start date: 28Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Past drug history included: Seretide. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability), outcome "unknown", described as "Off label use"; IMMUNISATION (disability), outcome "unknown", described as "Booster"; LIP SWELLING (disability) with onset 20Nov2021, outcome "not recovered", described as "Swollen lips"; THROAT IRRITATION (disability) with onset 20Nov2021, outcome "not recovered", described as "Itchy throat"; PRURITUS (disability) with onset 20Nov2021, outcome "not recovered", described as "Itchy skin"; MALAISE (disability) with onset 20Nov2021, outcome "not recovered", described as "Feeling sick". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2020) positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of lip swelling, throat irritation, pruritus, malaise. Clinical course: Every time patient has had the Pfizer vaccine all three doses, her lips and mouth feel unrated within 20 mins and throat gets scratchy. Patient took antihistamine and it has not helped. Patient also has a lot of allergies that present like this. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does 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: 1922280 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cold sweat, Immunisation, Interchange of vaccine products, Loss of consciousness, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (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), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629526

Write-up: Shivers; Clammy; Pain in leg; Off label use; Interchange of vaccine products; Booster; Blackout; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111201625192420-50AKB. Other Case identifier(s): GB-MHRA-ADR 26231622. A 63-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 63 years 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 astrazeneca (dose 1), for COVID-19 Immunization; Covid-19 vaccine astrazeneca (dose 2), for COVID-19 Immunization. The patient has not had symptoms associated with COVID-19. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Blackout"; CHILLS (medically significant), outcome "not recovered", described as "Shivers"; COLD SWEAT (medically significant), outcome "not recovered", described as "Clammy"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Pain in leg". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The patient has not tested positive for COVID-19 since having the vaccine. It was unsure if patient is enrolled in clinical trial. The report does 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: 1922305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, SARS-CoV-2 test, Tension headache
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: Medical History/Concurrent Conditions: Clinical trial participant (Clinical trial participant Study details: Novavax)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629468

Write-up: Headache tension; Ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111202205195030-T7JQI (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231965 (MHRA). A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Clinical trial participant Study details: Novavax. Date of last menstrual period: 27Oct2021. The patient''s concomitant medications were not reported. The following information was reported: TENSION HEADACHE (medically significant) with onset 20Nov2021, outcome "recovered with sequelae", described as "Headache tension"; PAIN (medically significant) with onset 20Nov2021, outcome "recovering", described as "Ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: 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: 1922312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 PV46688 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Cough, Immunisation, Interchange of vaccine products, Off label use, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Medication errors (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: Chest infection; Cold; Cough
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629043

Write-up: Off label use; Interchange of vaccine products; Booster; Wheezy; Cough; Wheezy bronchitis; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111210627569140-BBHLJ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232139 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: PV46688) as dose 3 (booster), single for covid-19 immunization. Relevant medical history included: "Cough" (unspecified if ongoing); "chest infections" (unspecified if ongoing); "cold" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine AstraZeneca (Dose number: 01), for COVID-19 immunization, reaction(s): "cough", "wheezy"; Covid-19 vaccine AstraZeneca (Dose number: 02), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; WHEEZING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Wheezy"; COUGH (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Cough"; BRONCHITIS (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Wheezy bronchitis". Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922315 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Feeling hot, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test, Skin burning sensation, Skin warm, Thermal burns of eye, Thirst
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (broad), Arthritis (broad), Medication errors (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: Medical History/Concurrent Conditions: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Ulcerative colitis (35 years ago and under control at the moment)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637752

Write-up: joint pain; hot eyes; Burning skin; Eye burns; Skin warm; Pain joint; Excessive thirst; Nausea; Headache; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Authority; GB-MHRA-WEBCOVID-202111210923216790-RXIJJ. Other Case identifier(s): GB-MHRA-ADR 26232276. A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: 35 years ago and under control at the moment; "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; ARTHRALGIA (medically significant), outcome "not recovered", described as "joint pain"; FEELING HOT (medically significant), outcome "not recovered", described as "hot eyes"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Headache"; THERMAL BURNS OF EYE (medically significant) with onset 21Nov2021, outcome "recovered", described as "Eye burns"; SKIN WARM (medically significant) with onset 21Nov2021, outcome "recovering", described as "Skin warm"; ARTHRALGIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Pain joint"; THIRST (medically significant) with onset 20Nov2021, outcome "recovering", described as "Excessive thirst"; NAUSEA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Nausea"; SKIN BURNING SENSATION (medically significant), outcome "unknown", described as "Burning skin". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, SARS-CoV-2 test, Swelling, Vaccination site pain
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Clinical trial participant (Study details: Study app)
Allergies:
Diagnostic Lab Data: Test Date: 20211112; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646278

Write-up: Booster; pain underarm on the same arm as vaccinated; Swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority; GB-MHRA-APPCOVID-202111221909503800-GI5EV. Other Case identifier(s): GB-MHRA-ADR 26235389. A 69 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 19Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. It was unsure if patient has had symptoms associated with COVID-19. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: study app; "Blood Pressure" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VIRUS taken for influenza immunisation, administration date 03Nov2021; and medication for Blood Pressure. Vaccination history included: Bnt162b2 (Dose 1), administration date: 17Feb2021, for COVID-19 immunisation; Bnt162b2 (Dose 2), administration date: 06May2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; SWELLING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Swelling"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "pain underarm on the same arm as vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Nov2021) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926492 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Breast swelling, Chest pain, Feeling of body temperature change, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain, Pharyngeal swelling, Swelling, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Just I have an asthma); Pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101646576

Write-up: off label use; Interchange of vaccine products; Booster; Feeling of body temperature change; body pain/ it''s hurting; headache; vomiting; back pain; Chest pain; throat swollen up; my left breast swollen up; under my arm swollen up; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-APPCOVID-20211122230317. Other Case identifier: GB-MHRA-ADR 26236192. A 37 year-old female patient received BNT162B2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) at the age of 37 years as dose 3 (booster) single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Just I have an asthma; "Pain" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 nor had a COVID-19 test and not enrolled in clinical trial. Patient was not pregnant and was not currently breastfeeding. Concomitant medication included: CO-CODAMOL taken for pain; IBUPROFEN taken for pain; PARACETAMOL taken for pain. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE-1 ,single, lot number-AB0013, Primary Immunization series complete), administration date: 28Feb2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (DOSE-2, single, lot number-PV46685, Primary Immunization series complete), administration date: 16May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (hospitalization, medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; FEELING OF BODY TEMPERATURE CHANGE (hospitalization, medically significant) with onset 20Nov2021, outcome "recovered" (22Nov2021), described as "Feeling of body temperature change"; PAIN (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "body pain/ it''s hurting"; HEADACHE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "headache"; VOMITING (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "vomiting"; BACK PAIN (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "back pain"; CHEST PAIN (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Chest pain"; PHARYNGEAL SWELLING (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "throat swollen up"; BREAST SWELLING (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "my left breast swollen up"; SWELLING (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "under my arm swollen up". No follow up attempts are possible. No further information is expected.


VAERS ID: 1926566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Immunisation, Interchange of vaccine products, Malaise, Off label use
SMQs:, Retroperitoneal fibrosis (broad), Arthritis (broad), Medication errors (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: Iron overload; Psoriatic arthritis (onset after 1st vaccine (perhaps a coincidence)); Sleeve gastrectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637744

Write-up: Chills; Fatigue; Joint ache; Back ache; Malaise; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111210932183870-JFPJP (RA). Other Case identifier(s): GB-MHRA-ADR 26232280 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing), notes: onset after 1st vaccine (perhaps a coincidence); "Iron overload" (unspecified if ongoing); "Gastric sleeve", start date: 2020 (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Vitamin b6. Vaccination history included: Covid-19 vaccine (MANUFACTURER UNKNOWN, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine astrazeneca, for COVID-19 immunization. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; CHILLS (medically significant), outcome "not recovered", described as "Chills"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue"; ARTHRALGIA (medically significant), outcome "not recovered", described as "Joint ache"; BACK PAIN (medically significant), outcome "not recovered", described as "Back ache"; MALAISE (medically significant), outcome "not recovered", described as "Malaise". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926580 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Headache, Immunisation, Influenza like illness, Musculoskeletal stiffness, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: Medical History/Concurrent Conditions: Coeliac disease; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Interstitial lung disease; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20211121; Test Name: temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101637720

Write-up: Headache; High temperature; Flu-like aching; Neck stiff; Shooting pain; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111211100249730-Y1MUQ. Other Case identifier(s): GB-MHRA-ADR 26232361. A 27 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Interstitial lung disease" (unspecified if ongoing); "Suspected COVID-19", start date: 30Sep2021, stop date: 20Oct2021; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef); "Coeliac disease" (unspecified if ongoing). Concomitant medication included: INFLUENZA VIRUS taken for immunisation, administration date 06Nov2021. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. Patient was not pregnant. Patient was not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Headache"; PYREXIA (medically significant) with onset 21Nov2021, outcome "not recovered", described as "High temperature"; INFLUENZA LIKE ILLNESS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Flu-like aching"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Neck stiff"; PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Shooting pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Oct2021) negative, notes: No - Negative COVID-19 test; body temperature: (21Nov2021) high. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The reporter did not relate the event 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: 1926581 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-19
Onset:2021-11-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL1939 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dizziness, Fatigue, Heart rate, Myocarditis, Pain, Pericarditis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune 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 (Mild but no inhaler required for over 5 years.)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Pulse rate; Result Unstructured Data: Test Result:97; Test Date: 20211111; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646518

Write-up: Fatigue; Chest pain; myocarditis; pericarditis; pain; unusual tiredness; feeling faint; Chest pressure; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111211107102010-7RGLH. Other Case identifier(s): GB-MHRA-ADR 26232379. A 13 year-old male patient received bnt162b2 (COMIRNATY), administration date 19Nov2021 (Lot number: Fl1939) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing), notes: Mild but no inhaler required for over 5 years; "Suspected COVID-19", start date: 11Nov2021, stop date: 15Nov2021. The patient''s concomitant medications were not reported. The following information was reported: DIZZINESS (medically significant), outcome "not recovered", described as "feeling faint"; CHEST DISCOMFORT (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Chest pressure"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue"; CHEST PAIN (medically significant), outcome "not recovered", described as "Chest pain"; MYOCARDITIS (medically significant), outcome "unknown", described as "myocarditis"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; PAIN (medically significant), outcome "unknown", described as "pain"; FATIGUE (medically significant), outcome "unknown", described as "unusual tiredness". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) 97; COVID-19 virus test: (11Nov2021) positive, no - negative covid-19 test. Patient had chest presssure/pain 24 hours after vaccination. 1 episode of feeling faint. Oximeter reading 97. No palpitations. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The report related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms led to a hospital stay. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926610 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pain in extremity, Product use issue
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637864

Write-up: Shivers; Painful arm; Armpit pain; Muscle pain; Headache; Off-label use; Interchange of vaccine products; Booster; Drug use in unapproved population; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111211352262480-IWUXV. Other Case identifier(s): GB-MHRA-ADR 26232495. A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant. Patient has not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but manufacture unknown.), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but manufacture unknown.), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PRODUCT USE ISSUE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Drug use in unapproved population"; CHILLS (medically significant), outcome "not recovered", described as "Shivers"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Painful arm"; AXILLARY PAIN (medically significant), outcome "not recovered", described as "Armpit pain"; MYALGIA (medically significant), outcome "not recovered", described as "Muscle pain"; HEADACHE (medically significant), outcome "not recovered", described as "Headache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101646981 baby case.


VAERS ID: 1926612 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Malaise, Off label use, Pain, Pain in extremity, Pain of skin
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (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: GBPFIZER INC202101637862

Write-up: headache; aching; unwell; aching arm; skin hurts to touch; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111211355372880-XICOH (RA). Other Case identifier(s): GB-MHRA-ADR 26232500 (RA). A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596) 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 astrazeneca (dose 1, Batch/lot number: 51202001), administration date: 15Mar2021, for COVID-19 immunisation, reaction(s): "Headache"; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer.), for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; PAIN (medically significant), outcome "not recovered", described as "aching"; MALAISE (medically significant), outcome "not recovered", described as "unwell"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "aching arm"; PAIN OF SKIN (medically significant), outcome "unknown", described as "skin hurts to touch". Clinical course: Headache, aching arm very bad, skin hurts to touch, just general unwell. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926614 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637875

Write-up: Off label use; Interchange of vaccine products; Booster; Tiredness; Fever; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-RA-WEBCOVID-202111211421120710-3PBYV (RA). Other Case identifier(s): GB-RA-ADR 26232511 (RA). A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH4751) at the age of 51 years 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, SINGLE, Primary Immunization series complete but MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Tiredness"; PYREXIA (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Fever"; 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: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report did not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926636 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details:)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637559

Write-up: shivering; Dizziness; Off label use; Booster; Interchange of vaccine products; headache; aching; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111211623351560-I16FR. Other Case identifier: GB-MHRA-ADR 26232621. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: Zoe. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. Patient has not had symptoms associated with COVID-19 The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; HEADACHE (medically significant) with onset 20Nov2021, outcome "recovering", described as "headache"; PAIN (medically significant) with onset 20Nov2021, outcome "unknown", described as "aching"; CHILLS (medically significant) with onset 21Nov2021, outcome "recovering", described as "shivering"; DIZZINESS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. The reporter did not relate the event to possible inflammation of the heart (myocarditis or pericarditis). Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926639 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Immunisation, Menstrual disorder, Nausea, Off label use, SARS-CoV-2 test, Sudden hearing loss
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), 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: RAMIPRIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637617

Write-up: sudden period onset; nausea; dizziness; Off label use; Booster; Menstruation abnormal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111211632104530-XTUTP. Other Case identifier(s): GB-MHRA-ADR 26232642. A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Date of last menstrual period: 20Nov2021. Concomitant medication(s) included: INFLUENZA VIRUS, administration date 30Oct2021; RAMIPRIL taken for hypertension. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1, lot number Unknown), administration date: 15Feb2021, for covid-19 immunization; Bnt162b2 (Dose 2, lot number Unknown), administration date: 07May2021, for covid-19 immunization. The following information was reported: SUDDEN HEARING LOSS (medically significant), outcome "recovering", described as "sudden period onset"; NAUSEA (medically significant), outcome "recovering", described as "nausea"; DIZZINESS (medically significant), outcome "recovering", described as "dizziness", just before period started; MENSTRUAL DISORDER (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Menstruation abnormal", 2 days early with sudden period onset (unusual for patient); OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster". Patient had similar response after 2nd vaccine dose but did not report it. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: 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: 1926662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Flatulence, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637507

Write-up: Diarrhea; Stomach pain; Nausea; Flatulence; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111211843490740-YKYB7 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232787 (MHRA). A 28-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (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. Additional information: Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 20Nov2021, outcome "unknown", described as "Booster"; DIARRHOEA (disability) with onset 21Nov2021, outcome "not recovered", described as "Diarrhea"; ABDOMINAL PAIN UPPER (disability) with onset 21Nov2021, outcome "not recovered", described as "Stomach pain"; NAUSEA (disability) with onset 21Nov2021, outcome "not recovered", described as "Nausea"; FLATULENCE (disability) with onset 21Nov2021, outcome "not recovered", described as "Flatulence". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) no - negative covid-19 test. Additional information: Patient has not tested positive for COVID-19 since having the vaccine. Case reported as serious by health authority (disability). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926665 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest pain, Contusion, Eye pain, Fatigue, Headache, Immunisation, Insomnia, Interchange of vaccine products, Musculoskeletal stiffness, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637676

Write-up: sore eyes; tiredness; pains around the heart; couldn''t sleep; bruised; Chest pain; Stiff neck/stiff arm; Painful arm; Headache; off label use; interchange of vaccine product; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111211918127930-HDR9F (MHRA). Other Case identifier(s): GB-MHRA-ADR 26232828 (MHRA). A 68 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) at the age of 68 years 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 astrazeneca (DOSE UNKNOWN), administration date: 09Feb2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE: UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "interchange of vaccine product"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "booster"; EYE PAIN (medically significant), outcome "recovering", described as "sore eyes"; CHEST PAIN (medically significant) with onset 20Nov2021, outcome "recovered" (21Nov2021), described as "Chest pain"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 20Nov2021, outcome "recovering", described as "Stiff neck/stiff arm"; PAIN IN EXTREMITY (medically significant) with onset 20Nov2021, outcome "recovering", described as "Painful arm"; HEADACHE (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant), outcome "unknown", described as "tiredness"; ANGINA PECTORIS (medically significant), outcome "unknown", described as "pains around the heart"; INSOMNIA (medically significant), outcome "unknown", described as "couldn''t sleep"; CONTUSION (medically significant), outcome "unknown", described as "bruised". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Nov2021) no - negative covid-19 test. Clinical course: Very stiff neck, painful arm, headache, pains around the heart and left arm all night, couldn''t sleep for the pain, very tired, eyes painful. Pain in chest subsided feels bruised now. Headache, stiff arm and very sore eyes still ongoing. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1926682 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Grip strength decreased, Headache, Immunisation, Interchange of vaccine products, Malaise, Monoparesis, Movement disorder, Neck pain, Off label use, Pain, Paraesthesia, Periarthritis, Peripheral swelling, Vaccination site pain, Vaccination site swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Arthritis (narrow), Medication errors (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: AMITRIPTYLINE; NAPROXEN; PREGABALIN; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Fibromyalgia; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef)); Myalgic encephalomyelitis; Pancreatic insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637933

Write-up: pins and needles; swelling around injection site; woke up unable to fully use left arm due to pain and swelling around injection site; burning pain; Whole shoulder has pain; unable to fully grip; feel very unwell; Left arm paresis; Neck pain (with radiation); Frozen shoulder; Head pain; Decreased arm swing; Swollen arm; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111212124268410-INN5Q. Other Case identifier(s): GB-MHRA-ADR 26232920. A 46-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Post viral fatigue syndrome" (unspecified if ongoing), notes: Myalgic encephalomyelitis; "Fibromyalgia" (unspecified if ongoing); "Pancreatic failure" (unspecified if ongoing), notes: Pancreatic insufficiency; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef); "Depression" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE; NAPROXEN taken for post viral fatigue syndrome; PREGABALIN taken for fibromyalgia; SERTRALINE taken for depression. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PARAESTHESIA (medically significant), outcome "recovering", described as "pins and needles"; VACCINATION SITE SWELLING (medically significant), outcome "recovering", described as "swelling around injection site"; VACCINATION SITE PAIN (medically significant), outcome "recovering", described as "woke up unable to fully use left arm due to pain and swelling around injection site"; MONOPARESIS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Left arm paresis"; NECK PAIN (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Neck pain (with radiation)"; PERIARTHRITIS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Frozen shoulder"; HEADACHE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Head pain"; MOVEMENT DISORDER (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Decreased arm swing"; PERIPHERAL SWELLING (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Swollen arm"; PAIN (medically significant), outcome "unknown", described as "burning pain"; ARTHRALGIA (medically significant), outcome "unknown", described as "Whole shoulder has pain"; GRIP STRENGTH DECREASED (medically significant), outcome "unknown", described as "unable to fully grip"; MALAISE (medically significant), outcome "unknown", described as "feel very unwell". Clinical course: It was reported that woke up unable to fully use left arm due to pain and swelling around injection site, patient have pain going both up and down left arm and into neck and base of head, sharp burning pain constantly. Whole shoulder has pain radiating around the back of her neck and shoulder blade, unable to fully grip or use arm due to severe excruciating pain when attempted. Unable to look to her left again the pain. Generally, feel very unwell more so than her usual unwell. Pins and needles appearing toward early evening in her left hand. Patient stated that the event impacted her as bad as one of her worst days and has thrown her into a bad flare up of fibromyalgia and myalgic emphasilitus. Patient has not tested positive for covid 19 since having the vaccine and patient was not enrolled in clinical trial. Report 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: 1926685 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
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, Pain, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Medication errors (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: Endometriosis; Pierre Robin syndrome; Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101637916

Write-up: very painful to touch; Off label use; Interchange of vaccine products; Booster; Swollen arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111212151557740-Q8UKN. Other Case identifier(s): GB-MHRA-ADR 26232936. A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Pierre Robin syndrome" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose 2), for COVID-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, dose 1), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 20Nov2021, outcome "recovering", described as "Swollen arm"; PAIN (medically significant), outcome "unknown", described as "very painful to touch". Clinical coarse: She had Pierre Robin Syndrome, PCOS and Endometriosis. Patient had not symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Her arm swelled up dramatically around 5 hours post vaccine. It was still swollen now but not as much. It was very painful to touch. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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: 1926697 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Feeling abnormal, Headache, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637725

Write-up: Muscle ache; Headache; Foggy feeling in head; Chills; Dizziness; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111212304518460-IQ4HZ (RA). Other Case identifier(s): GB-MHRA-ADR 26233003 (RA). A 17 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 17 years as dose 2, 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. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not pregnant. Patient was not currently breastfeeding. The following information was reported: MYALGIA (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Muscle ache"; HEADACHE (disability, medically significant) with onset 21Nov2021, outcome "recovering", described as "Headache"; FEELING ABNORMAL (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Foggy feeling in head"; DIZZINESS (disability, medically significant) with onset 20Nov2021, outcome "recovering", described as "Dizziness"; CHILLS (disability, medically significant) with onset 21Nov2021, outcome "not recovered", described as "Chills". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of myalgia, headache, feeling abnormal, dizziness, chills. The patient took common painkillers eg ibruprofen and paracetamol had no effect, patient remained very hydrated and drank lots of water after the vaccine and the following days, muscle ache through entire body, and was unable to work. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The reporter did not relate the event 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: 1926704 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Chest discomfort, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Peak expiratory flow rate, Photophobia, Vaccination site discomfort, Vaccination site pain, Wheezing
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: FEXOFENADINE HYDROCHLORIDE; FOSTAIR; MOMETASONE; MONTELUKAST; SALBUTAMOL; TACROLIMUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Eczema; Hay fever; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Oral allergy syndrome; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: Peak flow for asthma; Result Unstructured Data: Test Result:385L/min; Comments: was slightly lower; Test Name: Peak flow for asthma; Result Unstructured Data: Test Result:400-420L/min; Comments: well-controlled
CDC Split Type: GBPFIZER INC202101637886

Write-up: asthma; Discomfort and the intensity of pain have remained consistent around the injection site; dull ache to the neck and shoulder area on the side of injection.; Light sensitivity to eye; Headache; Off label use; Interchange of vaccine products; Booster; Muscle pain; Wheezing; Chest tightness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111220154153220-1VXX5 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26233100 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FH3220) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Oral allergy syndrome", start date: 2011 (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "hayfever" (unspecified if ongoing). Concomitant medication(s) included: FEXOFENADINE HYDROCHLORIDE taken for multiple allergies; FOSTAIR taken for asthma; INFLUENZA VIRUS taken for influenza immunisation, administration date 09Oct2021; MOMETASONE taken for eczema; MONTELUKAST taken for asthma; SALBUTAMOL taken for asthma; TACROLIMUS taken for eczema. Past drug history included: Epipen. Vaccination history included: Covid-19 vaccine (Dose 1), administration date: 13Mar2021, for COVID-19 immunisation; Covid-19 vaccine (Dose 2), administration date: 22May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; ASTHMA (medically significant), outcome "recovering", described as "asthma"; MYALGIA (medically significant) with onset 20Nov2021, outcome "recovering", described as "Muscle pain"; WHEEZING (medically significant) with onset 20Nov2021, outcome "recovered" (20Nov2021), described as "Wheezing"; CHEST DISCOMFORT (medically significant) with onset 20Nov2021, outcome "recovering", described as "Chest tightness"; PHOTOPHOBIA (medically significant) with onset 21Nov2021, outcome "recovered" (21Nov2021), described as "Light sensitivity to eye"; HEADACHE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Headache"; VACCINATION SITE DISCOMFORT (medically significant), outcome "unknown", described as "Discomfort and the intensity of pain have remained consistent around the injection site"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "dull ache to the neck and shoulder area on the side of injection.". The patient underwent the following laboratory tests and procedures: peak expiratory flow rate: 385l/min, notes: was slightly lower; 400-420l/min, notes: well-controlled. Therapeutic measures were taken as a result of photophobia, headache. Clinical information: Muscle pain around the injection site within five minutes of the booster being administered. Discomfort and the intensity of pain have remained consistent around the injection site, before spreading as a dull ache to the neck and shoulder area on the side of injection. Chest tightness and discomfort have remained constant and present since booster was administered. Wheezing began several hours after the vaccine was administered, but subsided by the morning after. Peak flow for asthma the morning after was slightly lower (385L/min) than other readings earlier on in the week. Asthma is generally well-controlled, between 400-420L/min on a good day. Headache and sensitivity to light were present upon waking up the morning after the booster was administered and was of pain intensity that required remaining in bed for rest. Paracetamol and ibuprofen combination was taken to reduce the intensity, reducing to a duller ache, but the headache still remains. Light sensitivity to eyes subsided after several hours. Asthma since childhood that has significantly worsened since 2018. Also suffers from hayfever and eczema since childhood. Oral Allergy Syndrome diagnosis in 2011 and previously an EpiPen carrier following allergy hospitalisation in 2011. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow up attempts are needed. No further information is expected.


VAERS ID: 1926713 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Influenza like illness, SARS-CoV-2 test, Vomiting
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Taken steroids to assist with asthma); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101637668

Write-up: Flu-like aching; Patient received booster dose of COMIRNATY; Vomiting; 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-202111220712522210-RTXFB (MHRA). Other Case identifier(s): GB-MHRA-ADR 26233456 (MHRA). A 46 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Asthma" (unspecified if ongoing), notes: Taken steroids to assist with asthma. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: UNKNOWN), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: UNKNOWN), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Patient received booster dose of COMIRNATY"; VOMITING (medically significant) with onset 20Nov2021, outcome "not recovered", described as "Vomiting"; INFLUENZA LIKE ILLNESS (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Flu-like aching". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: Last menstrual period date was 03Nov2021. 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 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: 1926728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Body temperature increased, Feeling cold, Headache, Immunisation, Influenza like illness, Interchange of vaccine products, Malaise, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Medication errors (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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211121; Test Name: Body temperature; Result Unstructured Data: Test Result:Increased
CDC Split Type: GBPFIZER INC202101646099

Write-up: High temperature; Flu like symptoms; Headache/pounding headache; Aching joints; Coldness; Body temperature increased; Felt ill / Feeling slightly sick; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY; The patient received dose3(booster) Comirnaty; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111220857467690-V0XLM (MHRA). Other Case identifier(s): GB-MHRA-ADR 26233756 (MHRA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 20Mar2020, stop date: 15Apr2020. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The patient was fit and healthy. The patient not had a COVID-19 test and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "Primary immunisation series: Non-Pfizer manufacturer; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "The patient received dose3(booster) Comirnaty"; PYREXIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "High temperature"; INFLUENZA LIKE ILLNESS (medically significant) with onset 21Nov2021, outcome "recovering", described as "Flu like symptoms"; HEADACHE (medically significant) with onset 21Nov2021, outcome "recovering", described as "Headache/pounding headache"; ARTHRALGIA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Aching joints"; FEELING COLD (medically significant) with onset 21Nov2021, outcome "recovering", described as "Coldness"; BODY TEMPERATURE INCREASED (medically significant) with onset 21Nov2021, outcome "recovering", described as "Body temperature increased"; MALAISE (medically significant) with onset 21Nov2021, outcome "unknown", described as "Felt ill / Feeling slightly sick". On 21Nov2021, the patient woke up morning after having booster jab felt ill with the symptoms above, it lasted most of the day now left with pounding headache an feeling slightly sick. The patient underwent the following laboratory tests and procedures: body temperature: (21Nov2021) increased. The patient had not tested positive for COVID-19, since having the vaccine. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1926729 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646678

Write-up: Severe diarrhoea, Diarrhea; primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY; primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY; primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111220900553690-EDJHB (RA). Other Case identifier(s): GB-MHRA-ADR 26233752 (RA). A 62 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 20Nov2021, outcome "unknown" and all described as "primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine; Booster: COMIRNATY"; DIARRHOEA (medically significant) with onset 21Nov2021, outcome "recovering", described as "Severe diarrhoea, Diarrhea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) no - negative covid-19 test. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1926730 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-20
Onset:2021-11-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596/FJ5782 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use, Presyncope, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
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 INC202101646340

Write-up: faint; Problem started with a desire to breathe more heavily; This was followed by slight balance problem; Near fainting; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable Consumer from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111220905121880-TMVNI (MHRA). Other Case identifier(s): GB-MHRA-ADR 26233810 (MHRA). A 66 year-old male patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Lot number: FK0596/FJ5782) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included: INFLUENZA VIRUS taken for immunisation, administration date 25Sep2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-1), administration date: 18Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose-2), administration date: 06May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 20Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 20Nov2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant), outcome "recovering", described as "faint"; PRESYNCOPE (medically significant) with onset 21Nov2021, outcome "not recovered", described as "Near fainting"; DYSPNOEA (medically significant), outcome "unknown", described as "Problem started with a desire to breathe more heavily"; BALANCE DISORDER (medically significant), outcome "unknown", described as "This was followed by slight balance problem". Problem started with a desire to breathe more heavily. This was followed by slight balance problem. The patient then felt he was about to faint and had to lie down. The problem has occurred again approximately 20 hours later. Patient has not tested positive for COVID-19 since having the vaccine The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are needed. No further information is expected.


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