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From the 1/21/2022 release of VAERS data:

Found 1,049,249 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 105 out of 10,493

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VAERS ID: 2030278 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Injection site erythema, Injection site pain, Musculoskeletal stiffness
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (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: CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Injection site redness; Felt faint; Stiffness; Pain injection site; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26424438) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness), DIZZINESS (Felt faint), INJECTION SITE PAIN (Pain injection site) and MUSCULOSKELETAL STIFFNESS (Stiffness) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 03-Jul-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, CITALOPRAM from 01-Jun-2021 to an unknown date for Depression. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced INJECTION SITE PAIN (Pain injection site) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant), DIZZINESS (Felt faint) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness), DIZZINESS (Felt faint), INJECTION SITE PAIN (Pain injection site) and MUSCULOSKELETAL STIFFNESS (Stiffness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medication was not reported. Patient last menstrual period date was on 15-DEC-2021. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No report relate to possible inflammation of the heart. Company comment: This Regulatory Authority case concerns a 18-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of Injection site erythema, dizziness, injection site pain and musculoskeletal stiffness. The patient developed injection site pain on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with injection site erythema, dizziness and musculoskeletal stiffness the next day. The patient received as first and second dose of her COVID-19 vaccination schedule two doses Biontech''s COVID-19 vaccine. By the time of the report, the patient was not recovered. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 18-year-old, female patient, with no relevant medical history, who experienced the unexpected, serious (Medically significant) events of Injection site erythema, dizziness, injection site pain and musculoskeletal stiffness. The patient developed injection site pain on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with injection site erythema, dizziness and musculoskeletal stiffness the next day. The patient received as first and second dose of her COVID-19 vaccination schedule two doses Biontech''s COVID-19 vaccine. By the time of the report, the patient was not recovered. Regulatory authority captured the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2030281 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Taking antidepressants Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Nausea; Shivers; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26424446) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Shivers) in a 47-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Taking antidepressants Patient has not had symptoms associated with COVID-19. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability), NAUSEA (Nausea) (seriousness criterion disability) and CHILLS (Shivers) (seriousness criterion disability). At the time of the report, HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Shivers) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient reported taking antidepressants. 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. The patient developed cold and hot sweats, initial does x2 was Pfizer. Pain, weakness and inflammation the size of a small ball on the arm, nausea had got worse. Treatment medications were not reported. Company comment: This is a regulatory case concerning a 47-year-old, male patient with no medical history reported who experienced the unexpected serious events of Headache, Nausea and Chills on the same date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient developed cold and hot sweats, pain, weakness and inflammation the size of a small ball on the arm, however these events were not coded by RA. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per RA.; Sender''s Comments: This is a regulatory case concerning a 47-year-old, male patient with no medical history reported who experienced the unexpected serious events of Headache, Nausea and Chills on the same date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The patient developed cold and hot sweats, pain, weakness and inflammation the size of a small ball on the arm, however these events were not coded by RA. The event terms, event seriousness, rechallenge and action taken with the suspect product were kept as per RA.


VAERS ID: 2030284 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Injection site pain, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (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: CALFOVIT D3; CITALOPRAM; COVID-19 VACCINE ASTRAZENECA; VITAMIN B12 NOS
Current Illness: Depression; Pernicious anaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: nausea; pain around needle site; Fatigue extreme; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424463) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nausea), INJECTION SITE PAIN (pain around needle site) and FATIGUE (Fatigue extreme) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concurrent medical conditions included Pernicious anaemia and Depression. Concomitant products included CITALOPRAM for Depression, VITAMIN B12 NOS for Pernicious anaemia, CALCIUM PHOSPHATE, COLECALCIFEROL (CALFOVIT D3) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 30-Jun-2021 to an unknown date for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced FATIGUE (Fatigue extreme) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant) and INJECTION SITE PAIN (pain around needle site) (seriousness criterion medically significant). At the time of the report, NAUSEA (nausea), INJECTION SITE PAIN (pain around needle site) and FATIGUE (Fatigue extreme) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-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. Unsure if patient had symptoms associated with COVID-19. The concomitant medications taken by patient included Vitamin B12 substances for Pernicious anaemia. The patient had extreme tiredness. Pain around needle site, neck and shoulders. On 01-Jan-2022 still tired and aching. Nausea and abdominal pain. Treatment information was not provided. Company comment: This regulatory authority case concerns a patient of 46-year-old patient of unknown gender, with history of pernicious anaemia and depression, who experienced the serious (medically significant) unexpected events of NAUSEA, INJECTION SITE PAIN and FATIGUE. The event of fatigue occurred one day after receiving a dose of mRNA-1273. No onset date was provided for the other events. Previous vaccination schedule included at least one dose of AstraZeneca COVID 19 vaccine. No further relevant clinical information was provided for medical reviewing. Patient''s history of pernicious anaemia and depression remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory authority case concerns a patient of 46-year-old patient of unknown gender, with history of pernicious anaemia and depression, who experienced the serious (medically significant) unexpected events of NAUSEA, INJECTION SITE PAIN and FATIGUE. The event of fatigue occurred one day after receiving a dose of mRNA-1273. No onset date was provided for the other events. Previous vaccination schedule included at least one dose of AstraZeneca COVID 19 vaccine. No further relevant clinical information was provided for medical reviewing. Patient''s history of pernicious anaemia and depression remains as a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2030292 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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.MOD20224

Write-up: Local swelling; This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Local swelling) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Product used for unknown indication: PENICILLIN. Past adverse reactions to the above products included Allergy with PENICILLIN. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SWELLING (Local swelling) (seriousness criterion medically significant). At the time of the report, SWELLING (Local swelling) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medication details were provided. Company Comment: This case concerns a 19-year-old female patient with medical history of event of Allergy with Penicillin, who experienced the serious unexpected event of Swelling. The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Event seriousness assessed as per Regulatory Authority report and retained for consistency. Medical history of allergy could remain a confounder. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old female patient with medical history of event of Allergy with Penicillin, who experienced the serious unexpected event of Swelling. The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Event seriousness assessed as per Regulatory Authority report and retained for consistency. Medical history of allergy could remain a confounder. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2030299 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Lymphadenopathy, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (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: AMITRIPTYLINE; CITALOPRAM; FEMOSTON; LEVOTHYROXINE; PREGABALIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Swollen glands; Swollen of face feeling; Headache; Swollen lymph nodes; Fatigue; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26424650) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands), SWELLING FACE (Swollen of face feeling), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included PREGABALIN for Fibromyalgia, LEVOTHYROXINE from 1998 to an unknown date for Hypothyroidism, AMITRIPTYLINE from 1992 to an unknown date and CITALOPRAM for Myalgic encephalomyelitis, DYDROGESTERONE, ESTRADIOL (FEMOSTON) from October 2021 to an unknown date for Perimenopause. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), SWELLING FACE (Swollen of face feeling) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue) had not resolved and SWELLING FACE (Swollen of face feeling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had extreme swelling and armpit pain on same side as injection. The patient also had painful lymph node in groin area, armpit, and neck. Patient had Neuralgia and swelling on face which is worse on one side Patient was not tested positive for COVID-19 since having the vaccine Company Comment This case concerns a 50-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of lymphadenopathy, swelling face, headache and fatigue. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant. Patient was not enrolled in clinical trials.; Sender''s Comments: This case concerns a 50-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of lymphadenopathy, swelling face, headache and fatigue. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown since no information regarding the first and second dose was disclosed and as was reported by regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events meet the criteria to be medically significant.


VAERS ID: 2030309 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Flatulence, Head discomfort, Migraine, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness: Headache (used to wear glasses to help with headaches/migraines); Migraine (usually suffers from migraines roughly around once every 3-4 months,usually lasting 8-12 hours)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: gas; Tummy ache; Migraine; Head pressure; Leg pain; This case was received via Agency Regulatory Authority(Reference number: GB-MHRA-ADR 26424731) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FLATULENCE (gas), PAIN IN EXTREMITY (Leg pain), ABDOMINAL PAIN (Tummy ache), MIGRAINE (Migraine) and HEAD DISCOMFORT (Head pressure) in a 25-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Concurrent medical conditions included Headache (used to wear glasses to help with headaches/migraines) and Migraine (usually suffers from migraines roughly around once every 3-4 months,usually lasting 8-12 hours). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 12-Jun-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 27-Mar-2021 to an unknown date for an unknown indication. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced ABDOMINAL PAIN (Tummy ache) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant) and HEAD DISCOMFORT (Head pressure) (seriousness criterion medically significant). On an unknown date, the patient experienced FLATULENCE (gas) (seriousness criterion medically significant). At the time of the report, FLATULENCE (gas) and PAIN IN EXTREMITY (Leg pain) was resolving and ABDOMINAL PAIN (Tummy ache), MIGRAINE (Migraine) and HEAD DISCOMFORT (Head pressure) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2022, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had the jab at around 10:50 on 31-Dec-2021 around 8 hours later he started receiving severe leg pains around the back of his calves. A few hours after that he had to rush home as he could not deal with standing any longer and ended up having his partner massaging his legs with oils to attempt to help, which may have helped. The following morning patient woke up with severe migraine and severe tummy ache. Over the past 24 hours patient had not eaten anything different to what he would normally eat. he ended up lying in bed the entire day, only getting up to urinate as could not release his bowels. The entire day the pain was excruciating in his head and tummy. The following day he managed to release his bowels with one piece roughly 2x1cm. Upon writing this he still have not been and have released some gas since. patient is currently upon writing this, on his way to an urgent treatment centre as advised by emergency number. The patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This is a regulatory case concerning a 25-year-old male patient with relevant medical history of migraine, who experienced the serious unexpected events of pain in extremity, abdominal pain, migraine, head discomfort and flatulence. The events of pain in extremity, abdominal pain, migraine, head discomfort occurred within first 2 days after the third dose of mRNA-1273 vaccine administration and the event of flatulence occurred on unknown day. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the event occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given 2 doses of AstraZeneca COVID-19 vaccine approximately 9 and 6 months prior to mRNA-1273 vaccination. The patient usually suffers from migraines roughly around once every 3-4 months which lasting 8-12 hours; therefore, the medical history of migraines was considered as a confounder for the events of migraine, head discomfort. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 25-year-old male patient with relevant medical history of migraine, who experienced the serious unexpected events of pain in extremity, abdominal pain, migraine, head discomfort and flatulence. The events of pain in extremity, abdominal pain, migraine, head discomfort occurred within first 2 days after the third dose of mRNA-1273 vaccine administration and the event of flatulence occurred on unknown day. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the event occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given 2 doses of AstraZeneca COVID-19 vaccine approximately 9 and 6 months prior to mRNA-1273 vaccination. The patient usually suffers from migraines roughly around once every 3-4 months which lasting 8-12 hours; therefore, the medical history of migraines was considered as a confounder for the events of migraine, head discomfort. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030314 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Insomnia, Pain, Pyrexia
SMQs:, 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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shivers; Pain; Sleeplessness; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424758) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), PAIN (Pain), INSOMNIA (Sleeplessness) and PYREXIA (Fever) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), INSOMNIA (Sleeplessness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 02-Jan-2022, CHILLS (Shivers), PAIN (Pain) and INSOMNIA (Sleeplessness) had resolved and PYREXIA (Fever) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had over 38 degrees fever for two days straight, severe joint and muscle pain. No relief after taking paracetamol nor ibuprofen. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial No report related to possible inflammation of the heart myocarditis or pericarditis. Company comment: This case concerns a 40-year-old, female patient with no medical history, previously vaccinated with TOZINAMERAN, who experienced the unexpected events of chills, pain, insomnia and pyrexia. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, the patient had over 38 degrees fever for two days straight, severe joint and muscle pain. 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 40-year-old, female patient with no medical history, previously vaccinated with TOZINAMERAN, who experienced the unexpected events of chills, pain, insomnia and pyrexia. The events occurred approximately 1 day after the third dose of mRNA-1273. As reported, the patient had over 38 degrees fever for two days straight, severe joint and muscle pain. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030315 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Menstrual disorder, 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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness: Celiac disease; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
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.MOD20224

Write-up: nausea; dizziness; Menstrual flow altered; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26424989) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIZZINESS (dizziness) and MENSTRUAL DISORDER (Menstrual flow altered) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) 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...) and Celiac disease. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 13-Apr-2021 to 04-May-2021 for an unknown indication. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced MENSTRUAL DISORDER (Menstrual flow altered) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant) and DIZZINESS (dizziness) (seriousness criterion medically significant). At the time of the report, NAUSEA (nausea), DIZZINESS (dizziness) and MENSTRUAL DISORDER (Menstrual flow altered) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced Dizziness and a bit of nausea post vaccine have also continued. No treatment medications were reported. Patient last menstrual period date was 24-DEC-2021. Patient had not had symptoms associated with COVID-19. Company Comment - This regulatory authority case concerns a 48 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of. nausea, dizziness and menstrual disorder. The event menstrual disorder occurred 4 days after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 48 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of. nausea, dizziness and menstrual disorder. The event menstrual disorder occurred 4 days after the third dose of mRNA-1273 vaccine, the other events occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2030317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Lymphadenopathy, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424785) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), NAUSEA (Nausea), LYMPHADENOPATHY (Glands swollen), HEADACHE (Headache) and ARTHRALGIA (Aching joints) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. No Medical History information was reported. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), LYMPHADENOPATHY (Glands swollen) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 02-Jan-2022, NAUSEA (Nausea) had resolved. At the time of the report, PYREXIA (High temperature), LYMPHADENOPATHY (Glands swollen), HEADACHE (Headache) and ARTHRALGIA (Aching joints) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had high temperature started post 16 hrs. at 39.8 degrees and at 40 hrs. was at 40 degrees despite medicating with paracetamol. At 47 hrs. temp down to 38.8 degrees. Glands in underarm of injection arm was massive and painful. Patient has not had symptoms associated with COVID-19 and was not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. Company Comment: This case concerns a female patient of an unknown age with no reported medical history, who experienced the serious unexpected events of Pyrexia, Nausea, Lymphadenopathy, Headache, and Arthralgia. The event of Headache occurred the same day after the third dose of mRNA-1273 vaccine while the events of Pyrexia, Nausea, Lymphadenopathy, and Arthralgia, occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a female patient of an unknown age with no reported medical history, who experienced the serious unexpected events of Pyrexia, Nausea, Lymphadenopathy, Headache, and Arthralgia. The event of Headache occurred the same day after the third dose of mRNA-1273 vaccine while the events of Pyrexia, Nausea, Lymphadenopathy, and Arthralgia, occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 2030332 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: aches down left side; Felt ill; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424941) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (aches down left side) and MALAISE (Felt ill) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced MALAISE (Felt ill) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (aches down left side) (seriousness criterion medically significant). At the time of the report, PAIN (aches down left side) and MALAISE (Felt ill) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-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 information was reported Patient experienced aches down left side, neck, arm, back and hip. Rapid heartbeat, sweats, feeling faint with low temperature of 34.1 Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial and Patient was not currently breastfeeding No treatment medication information was reported. Company Comment: This case refers to a 52-year-old female patient with no known medical history who experienced the unexpected events of Malaise and Pain. Malaise occurred approximately 1 day after the third dose of mRNA-1273 vaccine while the event of Pain occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. 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 refers to a 52-year-old female patient with no known medical history who experienced the unexpected events of Malaise and Pain. Malaise occurred approximately 1 day after the third dose of mRNA-1273 vaccine while the event of Pain occurred after an unspecified number of days post exposure to the vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030333 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Sickness; This case was received via the RA (Reference number: GB-MHRA-ADR 26424912) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). At the time of the report, ILLNESS (Sickness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had drunk some alcohol on New Year''s Eve, an amount that patient usually would have been able to handle, however patient seemed to have an adverse reaction to this alcohol and violent sickness occurred throughout that night and the next day. Patient have never been sick through alcohol consumption before the experience patient had is only comparable to when patient was spiked several years ago, the reaction is exactly the same. patient don''t know if something didn''t agree with patient or not, but patient was not warned if it is possible or not that the vaccine might not agree with alcohol? Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. No concomitant medication was reported. No treatment information was provided.; Sender''s Comments: This case concerns a patient, with medical history (not reported), who experienced the serious unexpected event(s) of illness. The event(s) started occurring approximately within 3 day(s) after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered NA. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2030340 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Malaise, SARS-CoV-2 test
SMQs:, Dementia (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: DESOGESTREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: feeling unwell; Headache; Tiredness; Fuzzy head; Feeling hot; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26424972) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 26424972) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (feeling unwell), HEADACHE (Headache), FEELING ABNORMAL (Fuzzy head), FEELING HOT (Feeling hot) and FATIGUE (Tiredness) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included DESOGESTREL for Contraception. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced FEELING ABNORMAL (Fuzzy head) (seriousness criterion medically significant), FEELING HOT (Feeling hot) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (feeling unwell) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 02-Jan-2022, FEELING HOT (Feeling hot) and FATIGUE (Tiredness) had resolved. At the time of the report, MALAISE (feeling unwell), HEADACHE (Headache) and FEELING ABNORMAL (Fuzzy head) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that, within 6 hrs of having the booster (she had at 8am) she started getting a fuzzy head and headache, began burning up and overheating. then began with extreme tiredness, generally feeling unwell. Went to bed 7pm, woke up next morning still fuzzy head and feeling very hot. Was bedridden for whole of the day and slept pretty much on and off for the whole day and night. After 48 hrs started to feel body temperature regulate more normally and less tired, but still had the fuzzy head. Been taking paracetamol every 4hrs since had the jab. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient was not currently breastfeeding.; Sender''s Comments: This is a regulatory case concerning a 49-year-old female patient with no relevant medical history provided, who experienced the serious unexpected events of Malaise, Feeling hot and Feeling abnormal, with expected events of Fatigue and Headache (seriousness criterion medically significant). These events occurred on the same day the patient received the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine).. The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030342 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Axillary pain, Diarrhoea, Eye swelling, Fatigue, Hypopnoea, Illness, Immunisation, Interchange of vaccine products, Migraine with aura, Myocarditis, Off label use, Suspected COVID-19, Visual impairment
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003613

Write-up: Swollen eyes; Armpit pain; Sickness; Stomach pain; Poor vision; Migraine with aura; Tired all the time; Loose bowel; Off label use; Interchange of vaccine products; Booster; myocarditis; SARS-CoV-2 infection; Breathing shallow; 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-202201021459223640-RUPL0 (RA). Other Case identifier(s): GB-MHRA-ADR 26424980 (RA). A 27 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY, Solution for injection), administration date 30Dec2021 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing); "Suspected COVID-19" (ongoing), notes: Unsure when symptoms started; "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i... The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, BATCH/LOT NUMBER: UNKNOWN, MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, BATCH/LOT NUMBER: UNKNOWN, MANUFACTUERER UNKNOWN), for COVID-19 immunization. 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"; MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; SUSPECTED COVID-19 (medically significant) with onset 02Jan2022, outcome "not recovered", described as "SARS-CoV-2 infection"; HYPOPNOEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Breathing shallow"; EYE SWELLING (medically significant), outcome "not recovered", described as "Swollen eyes"; AXILLARY PAIN (medically significant), outcome "not recovered", described as "Armpit pain"; ILLNESS (medically significant), outcome "recovering", described as "Sickness"; ABDOMINAL PAIN UPPER (medically significant), outcome "not recovered", described as "Stomach pain"; VISUAL IMPAIRMENT (medically significant), outcome "not recovered", described as "Poor vision"; MIGRAINE WITH AURA (medically significant), outcome "not recovered", described as "Migraine with aura"; FATIGUE (medically significant), outcome "not recovered", described as "Tired all the time"; DIARRHOEA (medically significant), outcome "recovering", described as "Loose bowel". Clinical course: The patient did not had a COVID-19 test. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030352 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 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.MOD20224

Write-up: Swelling NOS; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425064) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling NOS) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SWELLING (Swelling NOS) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling NOS) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date included 8-DEC-2021. Patient has no symptoms associated with COVID-19 , not had a COVID-19 test , patient was not currently breastfeeding. Patient had sore from the injection site right up to head on the left hand side collar bone also has a swell. Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 43-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Swelling. The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Swelling. The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2030353 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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: AMITRIPTYLINE; AMLODIPINE; LIDOCAINE; OMEPRAZOL 1 A PHARMA; PREGABALIN; RAMIPRIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425067) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included AMITRIPTYLINE for Coccyx pain, AMLODIPINE for Hypertension, RAMIPRIL for Hypertension NOS, PREGABALIN for Neuralgia, LIDOCAINE and OMEPRAZOLE (OMEPRAZOL 1 A PHARMA) for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, 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. Patient woke up in the night to go to the toilet and its like have pulled a muscle in left calf, so patient find it difficult to walk, it helps to keep going as every time patient sit down and relax for a bit then really hurts every time you get up again. Patient has not tested positive for COVID-19 since having the vaccine Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Company Comment - This regulatory authority case concerns patient of unknown age and gender with no relevant medical history, who experienced the serious (medically significant) unexpected event of myalgia. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns patient of unknown age and gender with no relevant medical history, who experienced the serious (medically significant) unexpected event of myalgia. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report


VAERS ID: 2030365 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Fatigue, Headache, Lethargy, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Back ache; Lethargic; Headache; Fatigue; Swollen glands; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425155) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache), BACK PAIN (Back ache), FATIGUE (Fatigue) and LETHARGY (Lethargic) in a 44-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), BACK PAIN (Back ache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and LETHARGY (Lethargic) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache), BACK PAIN (Back ache), FATIGUE (Fatigue) and LETHARGY (Lethargic) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment medication was provided. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial Adverse reaction did not occur as a result of an exposure during pregnancy.; Sender''s Comments: This is a regulatory case concerning a 44-year-old female patient with no medical history reported, who experienced the serious unexpected events of Back pain, Lethargy, with the expected events of Lymphadenopathy, Headache, Fatigue(seriousness criterion medically significant). Lymphadenopathy occurred 1 day after the patient received their dose of mRNA-1273 (Moderna CoviD-19 Vaccine), with all other events occurring on the following day. The rechallenge was unknown since there''s only information about one dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030368 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
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.MOD20224

Write-up: fever; Migraine; This case was received via regulatory authority on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (fever) and MIGRAINE (Migraine) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced MIGRAINE (Migraine) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant). On 02-Jan-2022, MIGRAINE (Migraine) had resolved. At the time of the report, PYREXIA (fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient was not pregnant; Patient was not currently breastfeeding. Fever, sore arm, but worst migraine patient ever had. Took paracetamol. Gave blood the day before vaccine. 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 46-year-old female patient with no reported medical history, who experienced the serious unexpected events of Pyrexia, and Migraine. The event of migraine occurred 1 day after the third dose of mRNA-1273 vaccine while the event of Pyrexia occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 46-year-old female patient with no reported medical history, who experienced the serious unexpected events of Pyrexia, and Migraine. The event of migraine occurred 1 day after the third dose of mRNA-1273 vaccine while the event of Pyrexia occurred on an unspecified date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as medically significant per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 2030377 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Maternal exposure during breast feeding, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), 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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211224; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Maternal exposure during breast feeding; Rigors; Aching joints; Vomited; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26425304) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Rigors), ARTHRALGIA (Aching joints), VOMITING (Vomited) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 18-Dec-2021 to 27-Dec-2021. Concurrent medical conditions included Breast feeding. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced CHILLS (Rigors) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). On 31-Dec-2021, VOMITING (Vomited) had resolved. On 01-Jan-2022, CHILLS (Rigors) had resolved. At the time of the report, ARTHRALGIA (Aching joints) was resolving and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-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. Date of LMP was 1 Jan 2022. About 7 hours after receiving the vaccine, Patient began to shaking and feeling feverish. She took paracetamol, but after about an hour she was sick. These both resolved after about an hour. But felt slightly feverish for the next 24 hours and aching joints which was gradually resolving. She had recently had a cold but negative lateral flow tests and symptoms were resolved by the time she had the booster jab. Patient had not tested positive for COVID-19 since having the vaccine. Concomitant product use was not provided by reporter. Company comment: This case concerns a 32-year-old, female patient with no medical history, who experienced the unexpected events of chills, arthralgia and vomiting. Maternal exposure during breastfeeding was also reported. The events occurred on the same day after the third dose of mRNA-1273. As reported, about 7 hours after receiving the vaccine, patient was shaking and feeling feverish. She took paracetamol, but after about an hour she was sick. These both resolved after about an hour, but patient felt slightly feverish for the next 24 hours and had aching joints which was gradually resolving. 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 32-year-old, female patient with no medical history, who experienced the unexpected events of chills, arthralgia and vomiting. Maternal exposure during breastfeeding was also reported. The events occurred on the same day after the third dose of mRNA-1273. As reported, about 7 hours after receiving the vaccine, patient was shaking and feeling feverish. She took paracetamol, but after about an hour she was sick. These both resolved after about an hour, but patient felt slightly feverish for the next 24 hours and had aching joints which was gradually resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030396 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, Dizziness, Fatigue, Headache, Hot flush, Immunisation, Interchange of vaccine products, Myocarditis, Off label use, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20211231; Test Name: LFT; Test Result: Negative ; Test Date: 20220103; Test Name: LFT; Test Result: Positive
CDC Split Type: GBPFIZER INC202200009609

Write-up: dizziness; Myocarditis; SARS-CoV-2 infection; Dizzy spells; Chills; Hot flushes; Off label use; Booster; Interchange of vaccine products; Headache; Started to feel tired that afternoon; 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-202201031130331280-VXV2O (RA). Other Case identifier(s): GB-MHRA-ADR 26427336 (RA). A 43 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 09:10 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 17Feb2020, stop date: 21Feb2020. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021 09:10, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 31Dec2021 09:10, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021 09:10, outcome "unknown", described as "Interchange of vaccine products"; DIZZINESS (medically significant), outcome "recovering", described as "dizziness"; COVID-19 (medically significant) with onset 03Jan2022, outcome "recovering", described as "SARS-CoV-2 infection"; HEADACHE (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Headache"; DIZZINESS (medically significant) with onset 01Jan2022, outcome "recovered" (02Jan2022), described as "Dizzy spells"; CHILLS (medically significant) with onset 01Jan2022, outcome "recovered" (02Jan2022), described as "Chills"; HOT FLUSH (medically significant) with onset 01Jan2022, outcome "recovered" (02Jan2022), described as "Hot flushes"; MYOCARDITIS (medically significant), outcome "recovering", described as "Myocarditis"; FATIGUE (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Started to feel tired that afternoon". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test; (31Dec2021) negative; (03Jan2022) positive. Clinical course: The patient reported that Negative LFT on 31Dec2021 followed by booster jab at 09:10. Started to feel tired that afternoon. Other symptoms came and went as listed and felt 100% recovered by mid-morning on 2Jan2022. Slight dizziness returned on the evening of 2Jan2022 followed by a positive LFT on the morning of 3Jan2022. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Rash papular, Scar
SMQs:, 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: Drug allergy (with pimples, when he was 4 years old)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC202200002893

Write-up: lichen-like rash with irregular size and shape like burning scars at various part of his body (abdomen, chest, back); lichen-like rash with irregular size and shape like burning scars at various part of his body (abdomen, chest, back); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A 13 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 27Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergy to Procef" (unspecified if ongoing), notes: with pimples, when he was 4 years old. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for covid-19 immunization, reaction(s): "no adverse event". The following information was reported: RASH PAPULAR (medically significant), SCAR (medically significant) all with onset 31Dec2021, outcome "not recovered" and all described as "lichen-like rash with irregular size and shape like burning scars at various part of his body (abdomen, chest, back)". Therapeutic measures were taken as a result of rash papular, scar. The pediatrician prescribed him treatment with Xozal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-12-31
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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: 20211231; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202200002681

Write-up: had a confirmed positive PCR test today for COVID-19 infection; had a confirmed positive PCR test today for COVID-19 infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A female patient received bnt162b2 (COMIRNATY), administration date 25Jun2021 (Batch/Lot number: unknown) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "had a confirmed positive PCR test today for COVID-19 infection". Patient was symptomatic. Patient was close contact with another breakthrough infection case. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive. Clinical information: Patients sister-in-law also tested positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101884821 Same reporter, same event, mother-daughter patients


VAERS ID: 2030631 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1014A / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Gastric disorder, Headache, Joint range of motion decreased, Movement disorder, Pain, Tremor, Vaccination site swelling, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LVPFIZER INC202101885423

Write-up: my stomach shrunk; pain started; unstoppable vomiting; body was shaking from pain; could not move stand up or walk; could not move stand up or walk; Afterwards additional headache started; hand where vaccine was administered was swollen, could not lift glass of water; hand where vaccine was administered was swollen, could not lift glass of water; Head is spinning non-stop; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 25 year-old male patient received BNT162B2 (COMIRNATY), administered in arm left, administration date 30Dec2021 00:45 (Lot number: 1F1014A) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: 1F1014A, Location of injection: Arm Left, Vaccine Administration Time: 12:45 AM), administration date: 03Dec2021, for COVID-19 immunisation, at the age of 25 years. There were no other vaccinations within 4 weeks of the COVID-19 vaccine. On 31Dec2021 01:00, the patient experienced "my stomach shrunk"; pain started; unstoppable vomiting; body was shaking from pain (had to scream from pain); could not move stand up or walk; afterwards additional headache started; hand where vaccine was administered was swollen, could not lift glass of water; head is spinning non-stop. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not test for COVID-19. The clinical outcome of the events was not resolved.


VAERS ID: 2030634 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-12-31
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9096 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: COVID-19 (Covid-19 prior vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: MXPFIZER INC202200009701

Write-up: nasal covid PCR test positive; nasal covid PCR test positive; This is a spontaneous report received from a contactable reporter (Physician) from product quality group. The reporter is the patient. A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 11:00 (Lot number: FA9096) at the age of 30 years as dose 2, single and administered in arm left, administration date 22Jun2021 11:00 (Lot number: EY0578) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (not ongoing), notes: Covid-19 prior vaccination. The patient''s concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 31Dec2021, outcome "unknown" and all described as "nasal covid PCR test positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Nasal Swab.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported vaccination failure and COVID-19 cannot be ruled out.


VAERS ID: 2030808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular 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 Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dizzy spells; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26425001) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion disability). At the time of the report, DIZZINESS (Dizzy spells) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. 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 and was not enrolled in clinical trial. The patient had no report related to possible myocarditis or pericarditis. No concomitant medications reported No treatment medications provided Company comment: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (disabling according to Authority report), unexpected event of dizziness. The event occurred 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). At the time of report, event had not resolved. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age, with no reported medical history, who experienced the serious (disabling according to Authority report), unexpected event of dizziness. The event occurred 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). At the time of report, event had not resolved. No further information was provided. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2031089 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Fatigue, Headache, SARS-CoV-2 test, Somnolence, 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? 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: FOSTAIR; INFLUENZA VIRUS; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Vomiting; Drowsiness; Headache; Confusion; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26424134) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), SOMNOLENCE (Drowsiness), HEADACHE (Headache), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue) in a 21-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 05-Jul-2021 to 12-Jul-2021 and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Concomitant products included BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR), INFLUENZA VACCINE (INFLUENZA VIRUS) from 10-Nov-2021 to an unknown date and SALBUTAMOL for Asthma, ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Contraception. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), SOMNOLENCE (Drowsiness) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CONFUSIONAL STATE (Confusion) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). At the time of the report, VOMITING (Vomiting), SOMNOLENCE (Drowsiness), HEADACHE (Headache), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. No treatment medications were reported. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No possible inflammation of the heart (myocarditis or pericarditis). Company Comment: This case concerns a 21-year-old female patient, with relevant medical history of Steroid therapy and concomitant medications Fostair, Influenza vaccination, Salbutamol, and Rigevidon, who experienced the unexpected (medically significant) events of Vomiting, Somnolence, Headache, Confusional state, and Fatigue. The events occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is unknown as per SD. The patient''s medical history of Steroid therapy and concomitant medications Fostair, Influenza vaccination, Salbutamol, and Rigevidon remain as confounders 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 21-year-old female patient, with relevant medical history of Steroid therapy and concomitant medications Fostair, Influenza vaccination, Salbutamol, and Rigevidon who experienced the unexpected (medically significant) events of Vomiting, Somnolence, Headache, Confusional state, and Fatigue. The events occurred on the same day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was not resolved. The rechallenge is unknown as per SD. The patient''s medical history of Steroid therapy and concomitant medications Fostair, Influenza vaccination, Salbutamol, and Rigevidon remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2031092 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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.MOD20224

Write-up: Swelling; Migraine; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424751) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling) and MIGRAINE (Migraine) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and MIGRAINE (Migraine) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling) and MIGRAINE (Migraine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No- Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Concomitant product use was not provided by the reporter. Patient had big sore lump in armpit and swelling across armpit to chest, tight chest and sore to touch collar bone. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company comment: This is a regulatory authority case concerning a 31-year-old, female patient with no reported medical history, who experienced the unexpected serious events of swelling and migraine. The events swelling and migraine occurred the same day with the third dose of mRNA-1273 vaccine administration accompanied by big sore lump in armpit, swelling across armpit to chest, tight chest and sore to touch collar bone. No reported treatment information. The outcome of the events swelling and migraine were not resolved from the time of last observation while big sore lump in armpit, swelling across armpit to chest, tight chest and sore to touch collar bone the outcome were unknown. 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 31-year-old, female patient with no reported medical history, who experienced the unexpected serious events of swelling and migraine. The events swelling and migraine occurred the same day with the third dose of mRNA-1273 vaccine administration accompanied by big sore lump in armpit, swelling across armpit to chest, tight chest and sore to touch collar bone. No reported treatment information. The outcome of the events swelling and migraine were not resolved from the time of last observation while big sore lump in armpit, swelling across armpit to chest, tight chest and sore to touch collar bone the outcome were unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2032998 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Clinical trial participant; Suspected COVID-19 (Unsure when symptoms started and stopped.)
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000294

Write-up: Chest pain; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-APPCOVID-20220101154538. Other Case identifier: GB-MHRA-ADR 26424153. A 40-year-old male patient received BNT162B2 (COMIRNATY), administration date 30Dec2021 (Lot number: unknown) as dose number unknown, single for COVID-19 immunization. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started and stopped.; "Clinical trial participant" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Chest pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jul2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033180 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL9994 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest pain, Cold sweat, Electrocardiogram, Immunisation, PO2, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:unknown results; Test Name: 3 lead ECG; Result Unstructured Data: Test Result:unknown results; Test Name: SPO2; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000402

Write-up: syncope; clammy; chest pain; Acute chest pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112311305587380-FGZX8 Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26421683 Regulatory Authority. A male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FL9994) as dose 3 (booster), single for covid-19 immunisation. The patient had no symptoms associated with COVID-19. Relevant medical history included: "Hypertension" (unspecified if ongoing). The patient''s 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 (hospitalization) with onset 31Dec2021, outcome "unknown", described as "Booster"; SYNCOPE (hospitalization, medically significant), outcome "recovering", described as "syncope"; COLD SWEAT (hospitalization), outcome "recovering", described as "clammy"; CHEST PAIN (hospitalization), outcome "recovering", described as "chest pain"; CHEST PAIN (hospitalization) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Acute chest pain". The patient underwent the following laboratory tests and procedures: blood pressure measurement: unknown results; electrocardiogram: unknown results; po2: unknown results; sars-cov-2 test: no - negative covid-19 test. Clinical course: Patient experienced syncope type symptoms with associated Central chest Pain and also reported grey or clammy skin, LOC for a few seconds. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033181 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000605

Write-up: lightheaded; headache; Felt sick; Fainting; 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-202112311306113810-NM7VH (MHRA). Other Case identifier(s): GB-MHRA-ADR 26421688 (MHRA). A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 31Dec2021, outcome "recovered", described as "Fainting"; DIZZINESS (medically significant), outcome "not recovered", described as "lightheaded"; HEADACHE (medically significant), outcome "not recovered", described as "headache"; MALAISE (medically significant), outcome "unknown", described as "Felt sick". Clinical course: Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced Lightheaded, headache, couldn''t see or hear then lost consciousness. Felt sick when came to. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body mass index, Cold sweat, Dyspnoea, Flushing, Heart rate, Heart rate increased, Immunisation, Malaise, Oxygen saturation, Panic attack, Respiratory rate, Respiratory rate increased, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myelitis
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:90/60; Test Name: BP; Result Unstructured Data: Test Result:120/80; Test Name: BM; Result Unstructured Data: Test Result:5.7; Test Name: HR; Result Unstructured Data: Test Result:145 bpm; Test Name: HR; Result Unstructured Data: Test Result:120 bpm; Test Name: HR; Result Unstructured Data: Test Result:88bpm; Test Name: SATS; Result Unstructured Data: Test Result:99%; Test Name: RR; Result Unstructured Data: Test Result:Increase
CDC Split Type: GBPFIZER INC202200000558

Write-up: unwell; panic attack; increase RR; booster; Faint; Difficulty breathing; Heart rate increased; Skin cold clammy; Flushing; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory number: GB-RA-WEBCOVID-202112311430474630-VJB6T (RA). Other Case identifier(s): GB-RA-ADR 26422269 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "transverse myelitis" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Naproxen; Omeprazole; Gabapentin. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Not had a COVID-19 test. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster"; SYNCOPE (medically significant) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Faint"; DYSPNOEA (non-serious) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Difficulty breathing"; HEART RATE INCREASED (non-serious) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Heart rate increased"; COLD SWEAT (non-serious) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Skin cold clammy"; FLUSHING (non-serious) with onset 31Dec2021, outcome "recovered" (31Dec2021), described as "Flushing"; MALAISE (non-serious), outcome "unknown", described as "unwell"; PANIC ATTACK (non-serious), outcome "unknown", described as "panic attack"; RESPIRATORY RATE INCREASED (non-serious), outcome "unknown", described as "increase RR". Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 90/60; 120/80; body mass index: 5.7; heart rate: 145 bpm; 120 bpm; 88bpm; oxygen saturation: 99%; respiratory rate: increase. Clinical Course: It was reported that no swelling to mucosal membranes, no itching. laid flat with elevated legs. Transferred floor to bed. Paramedics called cat A, 15 mins - assessed, transferred to ambulance. Discharged by crew. The report does not relate to possible blood clots or low platelet counts and myocarditis or pericarditis? No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033228 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Lethargy, Malaise, Myalgia, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (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:
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 INC202200000694

Write-up: very lethargic; aches all over; Dizziness; Feeling sick; Muscle ache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from not seen. Regulatory number: GB-MHRA-WEBCOVID-202112311754505100-YDHRD. Other Case identifier(s): GB-MHRA-ADR 26422959. A 12 year-old female patient received BNT162B2 (COMIRNATY), administration date: 30Dec2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: LETHARGY (medically significant), outcome "recovering", described as "very lethargic"; DIZZINESS (medically significant) with onset 31Dec2021, outcome "recovering", described as "Dizziness"; MALAISE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Feeling sick"; MYALGIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Muscle ache"; PAIN (medically significant), outcome "unknown", described as "aches all over". It was reported that the patient was very lethargic, had aches all over, dizziness, and was feeling sick. She spent all day in bed. Paracetamol did not seem to be helping. The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in a clinical trial. It was also reported that the reaction did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: no - negative covid-19 test. Therapeutic measures were taken as a result of lethargy, dizziness, malaise, myalgia, pain. No follow-up attempts are possible; information about the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033252 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Myocarditis, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (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), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000663

Write-up: Chest pain; Heart palpitations; Myocarditis; Shortness of breath; This is a spontaneous report received from a contactable Consumer from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112312058421300-OTF3U. Other Case identifier(s): GB-MHRA-ADR 26423530. A 30 year-old patient received BNT162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Patient had not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Myocarditis"; DYSPNOEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Shortness of breath"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient was 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: 2033280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Flushing, Headache, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211101; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000761

Write-up: Generalized aching; Tiredness; Headache; Flushed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112312134183100-WT2PD. Other Case identifier(s): GB-MHRA-ADR 26423246. A 29-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 01Nov2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The following information was reported: PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Generalized aching"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Tiredness"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache"; FLUSHING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Flushed". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Nov2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient is not currently breastfeeding. Patient last menstrual period date was 25Dec2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is 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: 2033283 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Fever
Allergies:
Diagnostic Lab Data: Test Date: 20211016; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000767

Write-up: Urticaria; Breathlessness; This is a spontaneous report received from a contactable reporter (Consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112312208322480-QNPAH. Other Case identifier: GB-MHRA-ADR 26423277. A 13-year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FK9707) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fever" (unspecified if ongoing); "Positive COVID-19 test", start date: 16Oct2021 (unspecified if ongoing). Concomitant medication included: PARACETAMOL taken for pyrexia, start date: 01Jan2021. The following information was reported: URTICARIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Urticaria"; DYSPNOEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Breathlessness". The patient underwent the following laboratory test: COVID-19 virus test: (16Oct2021) yes - positive covid-19 test. Patient''s last menstrual period date was on 09Dec2021. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033300 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Rash, 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: METHOTREXATE; NAPROXEN; OMEPRAZOL; RAMIPRIL; VITAMIN B12 [CYANOCOBALAMIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure abnormal; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000806

Write-up: Booster; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory number: GB-RA-WEBCOVID-202201010038104120-OEAQZ (RA). Other Case identifier(s): GB-RA-ADR 26423350 (RA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "blood pressure abnormal" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE; NAPROXEN; OMEPRAZOL; RAMIPRIL taken for blood pressure measurement; VITAMIN B12 [CYANOCOBALAMIN]. Vaccination history included: Bnt162b2 (Dose 1, lot unknown, single), for COVID-19 immunisation; Bnt162b2 (Dose 2, lot unknown, single), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; RASH (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Rash". 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: 2033301 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Immunisation, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200000863

Write-up: Booster; Aching joints; Headache; Shivering; High temperature; Nausea; very sore/heavy arm; This is a spontaneous report received from a contactable reporter (Consumer ) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201010045200380-8BR4K (RA). Other Case identifier: GB-MHRA-ADR 26423352 (RA). A 27 year-old female patient received BNT162B2 (COMIRNATY), administration date 31Dec2021 13:00 (Batch/Lot number: unknown) at the age of 27 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 immunisation; Bnt162b2 (DOSE-2), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Aching joints"; HEADACHE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Headache"; CHILLS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Shivering"; PYREXIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "High temperature"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "unknown", described as "very sore/heavy arm"; NAUSEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Nausea". Clinical course: had the booster around 1pm on the 31Dec2021, very sore/heavy arm an hour after the booster. Shivering, aching joints, headache, nausea and high temp early hours of the morning (01Jan2022). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 test: negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033317 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-31
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Immunisation, Muscle spasms, Pain
SMQs:, Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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 INC202200000255

Write-up: Booster; pain; Chest pain; chest feels as though its cramping; 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-202201010940498540-DW2AP (RA). Other Case identifier(s): GB-MHRA-ADR 26423811 (RA). A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Lot number: FK9712) 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 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; PAIN (medically significant), outcome "recovering", described as "pain"; CHEST PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Chest pain"; MUSCLE SPASMS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "chest feels as though its cramping". The patient heart/middle of the chest feels as though its cramping when she moves shoulder blades closer together. When she stretches the back, the pain subsides. This started on the same day she had the vaccine. The patient has not tested positive for COVID-19 since having the vaccine. The patient has not had symptoms associated with COVID-19, not had a COVID-19 test. The patient is not pregnant and not currently breastfeeding. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033327 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Pain, Vaccination site swelling
SMQs:, 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 INC202200000756

Write-up: Swollen lymph nodes; glands swollen; Swollen arm at the injection point; Pain down the side of body on the left side; This is a spontaneous report received from a contactable consumer from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011043400460-GCFTR. Other Case identifier: GB-MHRA-ADR 26423889. A 15-year-old male patient received BNT162B2 (COMIRNATY), administered in arm, administration date 30Dec2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. 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 immunization. The patient has not had symptoms associated with COVID-19 and had not had a COVID-19 test. The patient is not enrolled in clinical trial. The following information was reported: LYMPHADENOPATHY outcome "not recovered", described as "Swollen lymph nodes; glands swollen"; VACCINATION SITE SWELLING outcome "unknown", described as "Swollen arm at the injection point"; PAIN outcome "unknown", described as "Pain down the side of body on the left side"; all are considered medically significant with onset 31Dec2021. The patient has 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: 2033341 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-31
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Neuralgia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), 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: Raynaud''s syndrome (Patient was diagnosed with Raynaud''s syndrome as a child)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: muscle pain; Nerve pain; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 26423990) on 02-Jan-2022 and was forwarded to Moderna on 02-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain) and NEURALGIA (Nerve pain) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concurrent medical conditions included Raynaud''s syndrome (Patient was diagnosed with Raynaud''s syndrome as a child). On 16-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (muscle pain) (seriousness criterion medically significant). On 01-Jan-2022, NEURALGIA (Nerve pain) was resolving. At the time of the report, MYALGIA (muscle pain) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. The patient had excrutiating pain in the jabbed arm on day 16 after the booster. Pain emanating from the vaccine point on her arm, but extending all down the arm. Pain initially felt like muscle pain but gradually worsened to extreme pain, and feeling of swelling (but no actual swelling). She had severe pain deep within the arm and pins and needles in little finger/side of hand. Patient called for medical advice, and received call back from out of hours from doctor who advised her to go to the Accident and Emergency department. All test results came back fine, and pain gradually relieved after about 6 to 7 hours. Laboratory tests performed included, blood test checking for clotting / oxygen levels etc. Results were not reported. She was not currently breastfeeding. She has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. Company Comment: This regulatory case concerns a 38-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious events of myalgia and neuralgia. The event neuralgia occurred 15 days after administration of the booster dose of the Moderna mRNA-1273 vaccine. The start date of the event myalgia was not provided. Treatment information was not provided. However, the event neuralgia was resolving at the time of the report. The event myalgia had not resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 38-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious events of myalgia and neuralgia. The event neuralgia occurred 15 days after administration of the booster dose of the Moderna mRNA-1273 vaccine. The start date of the event myalgia was not provided. Treatment information was not provided. However, the event neuralgia was resolving at the time of the report. The event myalgia had not resolved at the time of the report. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000653

Write-up: Palsy Bells; This is a spontaneous report received from a contactable reporter(s) (Physician) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011332060080-FEXJF. Other Case identifier(s): GB-MHRA-ADR 26424047. A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date 24Dec2021 (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 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: BELL''S PALSY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Palsy Bells". Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. 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: 2033356 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry mouth, Dyspnoea, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Muscle fatigue, Muscular weakness, Off label use
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DULOXETINE; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Esophageal acid reflux (ESOMEPRAZOLE); Fibromyalgia syndrome (DULOXETINE)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000805

Write-up: Swollen glands; Short of breath; Muscle fatigue; Weakness of arms; Headache temporal; Mouth dry; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011337000930-T5BON. Other Case identifier: GB-MHRA-ADR 26424061. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Fibromyalgia syndrome", start date: 11Sep2019 (unspecified if ongoing), notes: DULOXETINE; "Esophageal acid reflux", start date: 09Feb2018 (unspecified if ongoing), notes: ESOMEPRAZOLE. Date of last menstrual period: 14Jun2021. Concomitant medications included: DULOXETINE taken for fibromyalgia, start date: 11Sep2019; ESOMEPRAZOLE taken for gastrooesophageal reflux disease, start date: 09Feb2018. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen glands"; DYSPNOEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Short of breath"; MUSCLE FATIGUE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Muscle fatigue"; MUSCULAR WEAKNESS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Weakness of arms"; HEADACHE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Headache temporal"; DRY MOUTH (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Mouth dry". Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033368 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyst, Pain, Pruritus, Rash, Rash pruritic, SARS-CoV-2 test, Vaccination site rash, Vaccination site swelling
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hereditary spherocytosis; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Splenectomy; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000407

Write-up: itchy rash; itching; pain; swelling around area of injection; cysts; rash around area of injection.; Rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201011455591150-VGGOK. Other Case identifier(s): GB-MHRA-ADR 26424118. A 18 year-old patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (Lot number: FN5254) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hereditary spherocytosis" (unspecified if ongoing); "Splenectomy" (unspecified if ongoing); "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef... The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization. The following information was reported: RASH PRURITIC (medically significant), outcome "not recovered", described as "itchy rash"; PRURITUS (medically significant), outcome "not recovered", described as "itching"; PAIN (medically significant), outcome "not recovered", described as "pain"; RASH (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Rash"; VACCINATION SITE SWELLING (medically significant), outcome "not recovered", described as "swelling around area of injection"; CYST (medically significant), outcome "not recovered", described as "cysts"; VACCINATION SITE RASH (medically significant), outcome "not recovered", described as "rash around area of injection.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of rash pruritic, pruritus, pain, rash, vaccination site swelling, cyst, vaccination site rash. Clinical course: Mild hereditary spherocytosis diagnosed following blood tests as a baby in response to jaundice at birth. Mother and her brothers all had splenectomy as children. Paracetamol, Ibuprofen and allergy relief medication were taken to help with the pain, itching, etc. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chest pain, Dizziness, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, Piloerection, Pyrexia, 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), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Emphysema (have copd and emphysema, both under control, so no treatement needed currently.); Miscarriage; Pneumonia; Pneumothorax; Polycystic ovarian syndrome (multiple gynae issues inc miscarriage associated with the PCOS.)
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: Body temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202200000317

Write-up: dizziness; all joints below waist are aching; nausea; headache; Fever; Shaking; goosebumps; Chest ache; 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 a regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201011459228550-N9IUZ. Other Case identifier(s): GB-MHRA-ADR 26424122. A 51 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Miscarriage" (unspecified if ongoing); "Pneumonia" (unspecified if ongoing); "Emphysema" (unspecified if ongoing), notes: have copd and emphysema, both under control, so no treatement needed currently.; "Chronic obstructive pulmonary disease" (unspecified if ongoing); "lung collapse" (unspecified if ongoing); "PCOS" (unspecified if ongoing), notes: multiple gynae issues inc miscarriage associated with the PCOS. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), for COVID-19 Immunization, reaction(s): "no reaction"; Covid-19 vaccine astrazeneca (DOSE 2), for COVID-19 Immunization, reaction(s): "no reaction". The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; DIZZINESS (medically significant), outcome "recovered", described as "dizziness"; CHEST PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Chest ache"; ARTHRALGIA (medically significant), outcome "recovered", described as "all joints below waist are aching"; NAUSEA (medically significant), outcome "recovered", described as "nausea"; HEADACHE (medically significant), outcome "recovered", described as "headache"; PYREXIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Fever"; TREMOR (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Shaking"; PILOERECTION (medically significant) with onset 01Jan2022, outcome "not recovered", described as "goosebumps". Patient had booster jab at noon on dec 31st. Woke up early hours of 01Jan2022 with high temp, goosebumps an uncontrollable shaking. Lasted several hours then went away but keeps coming back. Accompanioed by mild cramps in chest that lasted seconds each. No cough nausea dizziness etc. All joints below waist are aching, above the waist seems fine. Also have headache that wont shift. The patient underwent the following laboratory tests and procedures: body temperature: (01Jan2022) high. Therapeutic measures were taken as a result of dizziness, chest pain, arthralgia, nausea, headache, pyrexia, tremor, piloerection and medicated with paracetamol and codeine so no idea how much more uncomfortable or how much hotter she would be without it. Patient has not tested positive for COVID-19 since having the vaccine. Report not related to possible inflammation of the heart (myocarditis or pericarditis). There was not any relevant investigations or tests conducted. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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 INC202200000815

Write-up: off label use; Interchange of vaccine products; booster; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201011609153090-WSI8F. Other Case identifier(s): GB-MHRA-ADR 26424173. A female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: Fk9706) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster"; PYREXIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Fever". Therapeutic measures were taken as a result of pyrexia (Fluids and paracetamol). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL9994 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Pain, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000452

Write-up: Pain; Pain and swelling under armpit; swelling under armpit; Swelling arm; Booster; 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-202201012000102400-T3ROI. Other Case identifier(s): GB-MHRA-ADR 26424341. A 41 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FL9994) 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 immunisation; Bnt162b2 (Dose-2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swelling arm"; PAIN (medically significant), outcome "unknown", described as "Pain"; AXILLARY PAIN (medically significant), outcome "unknown", described as "Pain and swelling under armpit"; SWELLING (medically significant), outcome "unknown", described as "swelling under armpit". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Pain and swelling under armpit. 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: 2033426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema multiforme, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Skin mass, Skin warm
SMQs:, Severe cutaneous adverse reactions (narrow), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000368

Write-up: Arm was sore; It is hot to the touch; slightly raised; Erythema multiforme; 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-202201012126119360-RWRMI. Other Case identifier(s): GB-MHRA-ADR 26424403. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 14Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN.), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; ERYTHEMA MULTIFORME (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Erythema multiforme"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm was sore"; SKIN WARM (non-serious), outcome "unknown", described as "It is hot to the touch"; SKIN MASS (non-serious), outcome "unknown", described as "slightly raised". Clinical course: Not had a COVID-19 test, Patient was not currently breastfeeding. Patient last menstrual period date was 31Dec2021. Arm was sore as with previous vaccine but when undressing noticed a dark red pinprick type centre with a radiating red circle around it. It is hot to the touch and slightly raised. Patient has not tested positive for COVID-19 since having the vaccine. Patient was 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: 2033428 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL9994 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Immunisation, Interchange of vaccine products, Muscle fatigue, Off label use, Peripheral swelling, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000380

Write-up: Swollen arm; Muscle fatigue; Headache; Shivers; Joint pain; Exhaustion; 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 (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201012130019710-WW212 (RA). Other Case identifier(s): GB-MHRA-ADR 26424408 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FL9994) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. Vaccination history included: Novavax vaccine, administration date: Nov2020, for COVID-19 immunisation; Novavax vaccine, administration date: Dec2020, for COVID-19 immunisation; Comirnaty (DOSE NUMBER UNKNOWN), administration date: Sep2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen arm"; MUSCLE FATIGUE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Muscle fatigue"; HEADACHE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Headache"; CHILLS (medically significant) with onset 01Jan2022, outcome "recovered" (01Jan2022), described as "Shivers"; ARTHRALGIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Joint pain"; FATIGUE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Exhaustion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033435 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Malaise, Off label use, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Medication errors (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 Date: 20211108; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200000251

Write-up: Lymph nodes enlarged; Joint pain; Sleepy; General malaise; Headache; Off label use; Interchange of vaccine products; Booster; Fatigue; 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-202201012218094420-NOLFL (RA). Other Case identifier(s): GB-MHRA-ADR 26424451 (RA). A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3, (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 08Nov2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. 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: Covid-19 vaccine (Dose 1, single, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, single, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Fatigue"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Lymph nodes enlarged"; ARTHRALGIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Joint pain"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache"; SOMNOLENCE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Sleepy"; MALAISE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "General malaise". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Nov2021) positive, notes: Yes - Positive COVID-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033448 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000814

Write-up: Swollen arm; off label use; booster; 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-202201020000312920-VOZKY (RA). Other Case identifier(s): GB-MHRA-ADR 26424551 (RA). A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient is not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 1(single)), for COVID-19 immunization; Bnt162b2 (DOSE 2(single)), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "off label use"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen arm". The swelling was further described as: Circular red lump on arm at injection site. The lump was red and warm to the touch. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. 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: 2033458 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Limb discomfort, Lymphadenopathy, Off label use, Pain in extremity, SARS-CoV-2 test, Swelling, Vaccination site mass, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (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: Medical History/Concurrent Conditions: Graves'' disease; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000748

Write-up: heavy arm feeling in my right arm; right arm where it was administered also lump/swelling around the site; Painful arm; lump/swelling in my right armpit; my right armpit that is tender; swelling in my right armpit that is tender; Off label use; Interchange of vaccine products; Booster; Injection site lump; 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-202201020055473050-JXBGR (RA). Other Case identifier(s): GB-MHRA-ADR 26424584 (RA). A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 31Dec2021 (Lot number: FN3543) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "Graves'' disease" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization and Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; VACCINATION SITE MASS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Injection site lump"; LIMB DISCOMFORT (medically significant), outcome "unknown", described as "heavy arm feeling in my right arm"; VACCINATION SITE SWELLING (medically significant), outcome "unknown", described as "right arm where it was administered also lump/swelling around the site"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Painful arm"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "lump/swelling in my right armpit"; AXILLARY PAIN (medically significant), outcome "unknown", described as "my right armpit that is tender"; SWELLING (medically significant), outcome "unknown", described as "swelling in my right armpit that is tender". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: After receiving the booster, the patient had a heavy arm feeling in her right arm where it was administered also lump/swelling around the site. Painful arm now have a lump/swelling in her right armpit that was tender and painful too hurts to lift her arm straight above her head. Patient has not had symptoms associated with COVID-19. Patient is not pregnant her last menstrual period date was on 20Dec2021. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2033464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Interchange of vaccine products, Off label use, SARS-CoV-2 test negative
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000864

Write-up: Swollen eyes; 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-202201020327556800-XBTC5 (RA). Other Case identifier(s): GB-MHRA-ADR 26424598 (RA). A 50 year-old female patient (not pregnant) received BNT162B2 (COMIRNATY), administration date: 31Dec2021 (Lot number: FN5254) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; EYE SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen eyes". The patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in a clinical trial. It was reported that the reaction did not relate to possible inflammation of the heart (myocarditis or pericarditis). 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. No further information is expected.


VAERS ID: 2033471 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymphadenopathy
SMQs:, 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 INC202200003458

Write-up: Enlarged lymph nodes (excl infective); Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201021024558640-64Z1M. Other Case identifier(s): GB-MHRA-ADR 26424755. A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 nor had a COVID-19 test also did not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. 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 31Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Enlarged lymph nodes (excl infective)". The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast inflammation, Dyspnoea, Fatigue, Immunisation, Inflammation, Lymphadenopathy, Myalgia, Pain in extremity, Paraesthesia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), 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:
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: GBPFIZER INC202200003549

Write-up: Inflammation; Pain at vaccination site; Tingling in hand (on side of vaccine); Muscle pain; Fatigue; Breathlessness; Swelling in glands under armpit; Pain in hand (on side of vaccine); Breast inflammation; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201021201345290-F1AWC (RA). Other Case identifier: GB-MHRA-ADR 26424855 (RA). A 42 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19, not had a COVID-19 test, not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. 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 31Dec2021, outcome "unknown", described as "Booster"; BREAST INFLAMMATION (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Breast inflammation"; INFLAMMATION (medically significant), outcome "not recovered", described as "Inflammation"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "Pain at vaccination site"; PARAESTHESIA (medically significant), outcome "unknown", described as "Tingling in hand (on side of vaccine)"; MYALGIA (medically significant), outcome "unknown", described as "Muscle pain"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue"; DYSPNOEA (medically significant), outcome "unknown", described as "Breathlessness"; LYMPHADENOPATHY (medically significant), outcome "unknown", described as "Swelling in glands under armpit"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Pain in hand (on side of vaccine)". 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: 2033483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Hypokinesia, Immunisation, Interchange of vaccine products, Off label use, Swelling, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (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 INC202200003584

Write-up: difficulty lifting arm; swollen injection site; Armpit pain; Swelling/swollen armpit; 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. Regulatory number: GB-MHRA-WEBCOVID-202201021206458450-HZMLN. Other Case identifier(s): GB-MHRA-ADR 26424861. A 49 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not currently breastfeeding. The patient last menstrual period date on 24-DEC-2021. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Armpit pain"; SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swelling/swollen armpit"; HYPOKINESIA (medically significant), outcome "unknown", described as "difficulty lifting arm"; VACCINATION SITE SWELLING (medically significant), outcome "not recovered", described as "swollen injection site". Additional Information: The patient did not relate the report 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: 2033488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Illness, Immunisation, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003480

Write-up: Sickness; Dizziness; Sweating; Muscle pain; 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. Regulatory number: GB-MHRA-WEBCOVID-202201021242249070-DKELK (Agency). Other Case identifier(s): GB-MHRA-ADR 26424879 (Agency). A female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not symptoms associated with COVID-19, not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (Dose number unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose number unknown, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; ILLNESS (medically significant) with outcome "not recovered", described as "Sickness"; DIZZINESS (medically significant) with outcome "not recovered", described as "Dizziness"; HYPERHIDROSIS (medically significant) with outcome "not recovered", described as "Sweating"; MYALGIA (medically significant) with outcome "not recovered", described as "Muscle pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033499 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Breast pain, Immunisation, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Lipodystrophy (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003500

Write-up: Booster; Swollen lymph nodes/ Swollen and pain in the armpit; Breast pain; Pain in the armpit; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201021419497120-MEGNZ. Other Case identifier(s): GB-MHRA-ADR 26424947. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 32 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 Immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. Patient last menstrual period date was 14Dec2021. Patient had no symptoms associated with COVID-19 and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was is not enrolled in clinical trial. The following information was reported: IMMUNISATION (disability, medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen lymph nodes/ Swollen and pain in the armpit"; BREAST PAIN (disability, medically significant) with onset 31Dec2021, outcome "not recovered", described as "Breast pain"; AXILLARY PAIN (disability, medically significant) with onset 31Dec2021, outcome "unknown", described as "Pain in the armpit". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) no - negative COVID-19 test. Clinical course: It was reported that the patient experienced swelling and pain in the armpit and breast on the side of injection. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033500 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Dizziness, Fatigue, Headache, Immunisation, Investigation, Nausea, Pyrexia, Vaccination site pain, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; PROPRANOLOL; NEXPLANON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Generalised anxiety disorder
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Name: Lateral flow tests; Test Result: Negative ; Comments: done daily until day of booster vaccination due to travel; Test Date: 20220102; Test Name: Lateral flow tests; Test Result: Negative
CDC Split Type: GBPFIZER INC202200003561

Write-up: Vomiting; Pain stomach/Stomach cramps; Diarrhoea; Dizziness; High temperature; Chills; Booster; Nausea; Headache; Tiredness; Injection site pain; 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-202201021426190710-FZCKF. Other Case identifier(s): GB-MHRA-ADR 26424958. A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Generalised anxiety disorder" (unspecified if ongoing). Patient had no symptoms associated with COVID-19, not had a COVID-19 test, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient was not currently breastfeeding. Patient last menstrual period date was Oct2021. Concomitant medication(s) included: CITALOPRAM taken for generalised anxiety disorder, start date: 01Aug2020; PROPRANOLOL taken for generalised anxiety disorder, start date: 15Sep2021; NEXPLANON taken for contraception, start date: 01Nov2021. Vaccination history included: Bnt162b2 (Dose 1), administration date: 08Jun2021, for COVID-19 immunisation, reaction(s): "tiredness", "headache"; Comirnaty (Dose 2), administration date: 03Aug2021, for COVID-19 immunisation, reaction(s): "tiredness", "headache", "enlarged tender lymph nodes under the arm in the side the injection", "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Tiredness"; VACCINATION SITE PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Injection site pain"; VOMITING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Vomiting"; ABDOMINAL PAIN UPPER (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Pain stomach/Stomach cramps"; DIARRHOEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Diarrhoea"; DIZZINESS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Dizziness"; PYREXIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "High temperature"; CHILLS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Chills". The patient underwent the following laboratory tests and procedures: body temperature: (01Jan2022) high; investigation: (unspecified date) negative, notes: done daily until day of booster vaccination due to travel; (02Jan2022) negative. Clinical course: Symptoms began in the evening approximately 36 hours after the booster injection and we were significantly worse the next day (48 hours after booster injection). The report of the patient was not related to possible inflammation of the heart (myocarditis or pericarditis). Liver Function Test not done on 1st Jan. 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-202200020890 same reporter/patient, different dose;GB-PFIZER INC-202200020889 same reporter/patient, different dose


VAERS ID: 2033518 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dyspnoea, Erythema, Feeling hot, Hyperhidrosis, Hypersensitivity, Malaise, SARS-CoV-2 test, Skin burning sensation, Swelling, Swollen tongue, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; VALNI
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure
Allergies:
Diagnostic Lab Data: Test Date: 20211106; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003481

Write-up: coughing; Allergy; hives; redness down my arm in my arm pit and spreading across my chest; became hot; sweating; sick feeling; chest tight; throat tight; difficult to breath; swellings around eyes and lips; tongue was swelled up; burning feel under the skin mainly on the left side of my body close where the injection was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201021725120340-X1OOB (MHRA). Other Case identifier(s): GB-MHRA-ADR 26425097 (MHRA). A 35 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for blood pressure measurement, start date: 12Oct2019; VALNI taken for blood pressure measurement, start date: 12Oct2019. Patient was not enrolled in clinical trial. The following information was reported: HYPERSENSITIVITY (medically significant) with onset 31Dec2021, outcome "recovering", described as "Allergy"; URTICARIA (medically significant) with onset 31Dec2021, outcome "unknown", described as "hives"; ERYTHEMA (medically significant) with onset 31Dec2021, outcome "unknown", described as "redness down my arm in my arm pit and spreading across my chest"; FEELING HOT (medically significant) with onset 2021, outcome "unknown", described as "became hot"; HYPERHIDROSIS (medically significant) with onset 2021, outcome "unknown", described as "sweating"; MALAISE (medically significant) with onset 2021, outcome "unknown", described as "sick feeling"; COUGH (medically significant), outcome "unknown", described as "coughing"; CHEST DISCOMFORT (medically significant) with onset 2021, outcome "unknown", described as "chest tight"; THROAT TIGHTNESS (medically significant) with onset 2021, outcome "unknown", described as "throat tight"; DYSPNOEA (medically significant) with onset 2021, outcome "unknown", described as "difficult to breath"; SWELLING (medically significant) with onset 2021, outcome "unknown", described as "swellings around eyes and lips"; SWOLLEN TONGUE (medically significant) with onset 2021, outcome "unknown", described as "tongue was swelled up"; SKIN BURNING SENSATION (medically significant) with onset 2021, outcome "unknown", described as "burning feel under the skin mainly on the left side of my body close where the injection was given". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Nov2021) yes - positive covid-19 test. Therapeutic measures were taken as a result of hypersensitivity, urticaria, erythema, feeling hot, hyperhidrosis, malaise, cough, chest discomfort, throat tightness, dyspnoea, swelling, swollen tongue, skin burning sensation and included treatment with shoot of steroids and antihistamines. Clinical Course: It was reported that the reaction settled to a safe state to go home after about 3 hours. Patient was given steroids and strong antihistamines to take for the next few days but still had random swellings around my eyes and lips. Patient tongue was swelled up this morning but wasn''t causing breathing issues. Patient skin was getting hives on and off and was still had a burning feel under the skin mainly on the left side of my body close where the injection was given. Patient reaction was just short of anaphylaxis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
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, Lymph node pain, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain (Taking co codamol 50/500mg for pain); Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003562

Write-up: Diarrhoea; Swollen lymph nodes/Swollen and painful lymph node on same arm as injection site; Swollen and painful lymph node on same arm as injection site; Diarrhoea; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201022209510890-IIQHS. Other Case identifier(s): GB-MHRA-ADR 26425296. A 53 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Pain" (unspecified if ongoing), notes: Taking co codamol 50/500mg for pain; "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication(s) included: CO-CODAMOL taken for pain. Vaccination history included: COVID-19 vaccine astrazeneca (Dose number unknown), administration date: 08May2021, for COVID-19 immunisation; COVID-19 vaccine (Dose number unknown, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 01Jan2022, outcome "recovering", LYMPHADENOPATHY (medically significant) with onset 02Jan2022, outcome "not recovered" and all described as "Swollen lymph nodes/Swollen and painful lymph node on same arm as injection site"; LYMPH NODE PAIN (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Swollen and painful lymph node on same arm as injection site"; DIARRHOEA (medically significant), outcome "unknown", described as "Diarrhoea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033553 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Lymphadenopathy, Peripheral swelling, SARS-CoV-2 test, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200003441

Write-up: Red and inflamed jab site and sore; Red and inflamed jab site and sore; Red and inflamed jab site and sore; Booster; Swollen glands; Swollen arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201022335543050-MOCXJ Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26425399 Regulatory Authority. A 34 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization; Bnt162b2 (Dose 2, single), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen glands"; PERIPHERAL SWELLING (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Swollen arm"; VACCINATION SITE ERYTHEMA (medically significant), VACCINATION SITE INFLAMMATION (medically significant), VACCINATION SITE PAIN (medically significant), outcome "unknown" and all described as "Red and inflamed jab site and sore". The patient underwent the following laboratory tests and procedures: SARS-COV-2 test: (02Jan2022) negative. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033554 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202200003778

Write-up: Chest pain; 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-202201030130561960-9U9QN (RA). Other Case identifier(s): GB-MHRA-ADR 26425513 (RA). A 16 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, Lot number: Not known), for COVID-19 immunisation. The following information was reported: CHEST PAIN (medically significant) with onset 31Dec2021, outcome "recovering", described as "Chest pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative covid-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033565 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211130; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Stomach pain; Nausea; Fever; Headache; Muscle ache; Shivers; Painful arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26426682) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), NAUSEA (Nausea), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle ache), CHILLS (Shivers) and PAIN IN EXTREMITY (Painful arm) in a 55-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 28-Nov-2021. Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 23-Mar-2021 to an unknown date, COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 29-Dec-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). On 01-Jan-2022, CHILLS (Shivers) had resolved. On 02-Jan-2022, PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) had not resolved and PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No health conditions. Patient was not currently breastfeeding. It was reported that, patient tested positive for COVID-19 on 30-Nov-2021 so moved to her booster 28 days after the test. No other members of patient''s family had such a bad reaction, but they did not had COVID-19. Patient was quite a healthy, strong, busy person but she was completely knocked out of action for 3 days. Patient did not test positive for COVID-19 after she took the vaccine. No treatment medications were provided. Company comment This case concerns a 55-year-old female patient, with medical history of COVID19 approximately 1-month prior vaccination and INFLUENZA VACCINE 2 days prior vaccination with mRNA-1273 vaccine, who experienced the unexpected serious events of ABDOMINAL PAIN UPPER, NAUSEA, PYREXIA, HEADACHE, MYALGIA, CHILLS and PAIN IN EXTREMITY. The events on the same day and on the following 2 days after the administration of the third dose of mRNA-1273 vaccine. Patient?s history of COVID19 approximately 1-month prior vaccination and INFLUENZA VACCINE 2 days prior vaccination with mRNA-1273 vaccine, remains as a confounder. Patient had received COVID-19 VACCINE ASTRAZENECA as previous vaccination. 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 medical history of COVID19 approximately 1-month prior vaccination and INFLUENZA VACCINE 2 days prior vaccination with mRNA-1273 vaccine, who experienced the unexpected serious events of ABDOMINAL PAIN UPPER, NAUSEA, PYREXIA, HEADACHE, MYALGIA, CHILLS and PAIN IN EXTREMITY. The events on the same day and on the following 2 days after the administration of the third dose of mRNA-1273 vaccine. Patient?s history of COVID19 approximately 1-month prior vaccination and INFLUENZA VACCINE 2 days prior vaccination with mRNA-1273 vaccine, remains as a confounder. Patient had received COVID-19 VACCINE ASTRAZENECA as previous vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033585 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary pain, Blister, Peripheral swelling, Tongue disorder
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26427219) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of BLISTER (blisters), AXILLARY PAIN (swelling and tenderness in armpit), PERIPHERAL SWELLING (Swelling arm) and TONGUE DISORDER (Bumps tongue) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. Concurrent medical conditions included Suspected COVID-19 since 02-Jan-2022. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant) and TONGUE DISORDER (Bumps tongue) (seriousness criterion medically significant). On an unknown date, the patient experienced BLISTER (blisters) (seriousness criterion medically significant) and AXILLARY PAIN (swelling and tenderness in armpit) (seriousness criterion medically significant). At the time of the report, BLISTER (blisters), AXILLARY PAIN (swelling and tenderness in armpit) and PERIPHERAL SWELLING (Swelling arm) had not resolved and TONGUE DISORDER (Bumps tongue) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient had no COVID-19 test. Patient was not pregnant and was not breastfeeding. The patient experienced swelling and tenderness in armpit, as well as swelling and hotness at injection site, and issue was ongoing at the time of report and was on 4th day. Also blisters/spots and soreness of tongue, again ongoing at the time of report. 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 49-year-old, female patient, with medical history of suspected COVID-19, who experienced the unexpected, serious (Medically significant) events of blister, axillary pain, peripheral swelling and tongue disorder. The patient developed swelling and tenderness in armpit, as well as swelling and hotness at injection site on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with blisters, spots and soreness of tongue. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The medical history of suspected COVID-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.; Sender''s Comments: This Regulatory Authority case concerns a 49-year-old, female patient, with medical history of suspected COVID-19, who experienced the unexpected, serious (Medically significant) events of blister, axillary pain, peripheral swelling and tongue disorder. The patient developed swelling and tenderness in armpit, as well as swelling and hotness at injection site on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved with blisters, spots and soreness of tongue. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. Regulatory authority captured the rechallenge as unknown. The medical history of suspected COVID-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant was maintained for the events for consistency with the RA report.


VAERS ID: 2033587 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-23
Onset:2021-12-31
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRANEXAMIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dysmenorrhea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26427270) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Dysmenorrhea) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TRANEXAMIC ACID from 08-Aug-2018 to an unknown date for Dysmenorrhea. On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced DYSMENORRHOEA (Dysmenorrhea) (seriousness criterion medically significant). At the time of the report, DYSMENORRHOEA (Dysmenorrhea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that, patient had much heavier and longer period than normal, three days of heavy bleeding instead of one, painkillers not as effective. Dosage text :Dose 3b She did not had symptoms associated with COVID-19 nor had a COVID-19 test neither she tested positive for COVID-19 after taking the vaccine. She was not pregnant nor she was breastfeeding. She was not enrolled in clinical trial. It was reported that, her reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory case concerning a 33 year-old, female patient with a history of Dysmenorrhea, who experienced the serious (due to medically important condition) unexpected, event of Dysmenorrhoea, the patient reported a heavier and longer menstrual period. Event was assessed as serious by the Regulatory Authority. The event occurred approximately 8 days after the third dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the third dose. The medical history, of Dysmenorrhea remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 33 year-old, female patient with a history of Dysmenorrhea, who experienced the serious (due to medically important condition) unexpected, event of Dysmenorrhoea, the patient reported a heavier and longer menstrual period. Event was assessed as serious by the Regulatory Authority. The event occurred approximately 8 days after the third dose of mRNA-1273 vaccine. The outcome of the event was reported as not recovered. The rechallenge was not applicable, as the event was reported exclusively after the third dose. The medical history, of Dysmenorrhea remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2033589 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, SARS-CoV-2 test
SMQs:, 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: Fibromyalgia (I have fibromyalgia)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; This case was received via RA (Reference number: GB-MHRA-ADR 26427338) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Previously administered products included for Product used for unknown indication: COVID-19 vaccine AstraZeneca (very bad reaction to first vaccine which had me off of work for 2 weeks.) and Second vaccine (Second vaccine was ok). Past adverse reactions to the above products included Adverse event with COVID-19 vaccine AstraZeneca; and No adverse event with Second vaccine. Concurrent medical conditions included Fibromyalgia (I have fibromyalgia). On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion disability). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by reporter. Patient was experienced awful headache like a migraine especially in eye and socket. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient last menstruation period date was 2-JAN-2022. No treatment medications provided by the reporter. Company comment: This case concerns a 47-year-old female patient, with medical history of fibromyalgia, who experienced the serious (disability according to Authority report), unexpected event of headache. The event occurred 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine), which had not resolved at the time of report. The patient received two doses of AstraZeneca vaccine on unspecified date prior to the mRNA 1273 booster. The patient''s history of fibryomalgia remain as confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old female patient, with medical history of fibromyalgia, who experienced the serious (disability according to Authority report), unexpected event of headache. The event occurred 1 day after the third dose of mRNA-1273 (Moderna CoviD-19 Vaccine), which had not resolved at the time of report. The patient received two doses of AstraZeneca vaccine on unspecified date prior to the mRNA 1273 booster. The patient''s history of fibryomalgia remain as confounder to the event. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 2033612 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Malaise, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.); Comments: No known illnesses or allergies. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: unwell; Maternal exposure during pregnancy; Miscarriage; This case was received via Regulatory Authority, MHRA (Reference number: GB-MHRA-ADR 26428349) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of MALAISE (unwell), ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. No known illnesses or allergies. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. The patient''s past medical history included Pregnancy (Patient no longer pregnant at the time of reporting.). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 14-May-2021 to an unknown date for COVID-19 vaccination, FOLIC ACID for Folic acid supplementation. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. The patient''s last menstrual period was on 31-Oct-2021 and the estimated date of delivery was 07-Aug-2022. On 31-Dec-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criteria medically significant and congenital anomaly). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criteria medically significant and congenital anomaly) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criteria medically significant and congenital anomaly). The patient received mRNA-1273 (Moderna CoviD-19 Vaccine) beginning around the eighth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion w Cong Anomaly. At the time of the report, MALAISE (unwell) had not resolved, ABORTION SPONTANEOUS (Miscarriage) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Treatment medications were reported. Spotting of old blood started approx 27 hours after receiving the vaccine. This then progressed to a miscarriage over the next 48 hours. Patient felt mildly unwell the evening of the vaccine but had no temperature. Pregnancy adverse effects details: Miscarriage started 24 hours after receiving the booster Details of scans or investigations: I had a scan at 7 weeks pregnant, 2 weeks before my booster (privately so outside of NHS records), indicating that all was as it should be at that stage. Company Comment: This maternal exposure during pregnancy case concerns a 39 year-old female patient with a history of 2 doses of tozinameran COVID-19 vaccine who experienced the unexpected serious events of spontaneous abortion which occurred 2 days after vaccination with mRNA-1273 administered as a booster third dose and the unexpected serious event of malaise which occurred on an unknown date relative to vaccination. The use of concomitant medication tozinameran COVID-19 vaccine remains a confounder for the events. 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 maternal exposure during pregnancy case concerns a 39 year-old female patient with a history of 2 doses of tozinameran COVID-19 vaccine who experienced the unexpected serious events of spontaneous abortion which occurred 2 days after vaccination with mRNA-1273 administered as a booster third dose and the unexpected serious event of malaise which occurred on an unknown date relative to vaccination. The use of concomitant medication tozinameran COVID-19 vaccine remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting


VAERS ID: 2033613 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fibromyalgia; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); Rheumatoid arthritis; Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Eye disorder (Dry eye disease)
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: High temperature; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26428905) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. The patient''s past medical history included Eye disorder (Dry eye disease). Concurrent medical conditions included Rheumatoid arthritis, Suspected COVID-19 since 03-Dec-2021, Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...) and Fibromyalgia. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Immunosuppression. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 03-Jan-2022, PYREXIA (High temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. After vaccination patient experienced Tickly Cough, Fever, Headache, Fatigue, High Temperature, Nausea, No Energy and very unwell feeling. Patient''s Arthritis began to play up (feeling stiff & in pain). Patient was not tested positive for COVID-19 since the vaccine. Treatment Medication use information was not provided by reporter. COMPANY COMMENT: This is a Regulatory case concerning 56-years-old female patient with no clinical history who experienced the unexpected event of PYREXIA The event occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a Regulatory case concerning 56-years-old female patient with no clinical history who experienced the unexpected event of PYREXIA The event occurred 2 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2033623 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Malaise, Rash erythematous, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: feel sick; Red rash; Appetite lost; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26429441) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (feel sick), RASH ERYTHEMATOUS (Red rash) and DECREASED APPETITE (Appetite lost) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (feel sick) (seriousness criterion medically significant). At the time of the report, MALAISE (feel sick) was resolving and RASH ERYTHEMATOUS (Red rash) and DECREASED APPETITE (Appetite lost) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2022, 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 details not provided. concomitant drug details not provided. Arm sore worse pain than when I recently had arm surgery. Opposite arm not so weakness just comparing the pain level, Armpit swollen, Feel sick and No appetite. Not taking any medication. No illness. Patient has not had symptoms associated with COVID-19.five days now of rest and no sign of it lifting. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. 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 Company comment: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant) events of malaise, rash erythematous and decreased appetite. The events occurred the next day after the booster dose of mRNA-1273. The patient also reports vaccination site pain and vaccination site lymphadenopathy. Events persisted 5 days later. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (medically significant) events of malaise, rash erythematous and decreased appetite. The events occurred the next day after the booster dose of mRNA-1273. The patient also reports vaccination site pain and vaccination site lymphadenopathy. Events persisted 5 days later. Information regarding clinical presentation, diagnostic tests and treatment provided has not been disclosed. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2033701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Insomnia, Lymphadenopathy, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202200019130

Write-up: Swollen lymph nodes; armpit swelled; Insomnia; patient received booster dose of comirnaty.; 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-202201052321434270-GXNFJ. Other Case identifier(s): GB-MHRA-ADR 26441527. A 32 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (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, reaction(s): "Insomnia", "Local swelling"; Bnt162b2 (DOSE 1, SINGLE,Lot Number: unknown, Route of administration: unspecified.), for COVID-19 immunisation, reaction(s): "Insomnia". The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "patient received booster dose of comirnaty."; LYMPHADENOPATHY (medically significant) with onset 02Jan2022, outcome "recovered" (04Jan2022), described as "Swollen lymph nodes"; INSOMNIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Insomnia"; SWELLING (medically significant) with onset 02Jan2022, outcome "unknown", described as "armpit swelled". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200051692 same patient/drug/different dose/ event;GB-PFIZER INC-202200051691 same patient/drug/different dose/ event


VAERS ID: 2033761 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eczema, Immunisation, SARS-CoV-2 test
SMQs:, Hypersensitivity (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIGEVIDON
Current Illness: Eczema (had as an infant, returned in 2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200022933

Write-up: Eczema; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Eczema" (ongoing), notes: had as an infant, returned in 2021; "Contraception" (unspecified if ongoing). Concomitant medication(s) included: RIGEVIDON taken for contraception. Vaccination history included: Bnt162b2 (1ST DOSE), administration date: 04Jun2021, for COVID-19 Vaccination, reaction(s): "Eczema"; Bnt162b2 (2ND DOSE), administration date: 06Aug2021, for COVID-19 vaccination, reaction(s): "Eczema". Patient had not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; ECZEMA (medically significant), outcome "not recovered", described as "on reflection, skin started having problems after 1st dose of vaccine, then flared again after second dose and again after booster. Had never cleared since starting in 2021 but had greatly improved by Dec2021. Since receiving booster dose yesterday skin has had a considerable eczema flare again at the reporting day". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient had not tested 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). Phone consultations with general practitioner/pictures reviewed. 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-202200003684 same patient, different dose/event


VAERS ID: 2033787 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Back pain, Chills, Fatigue, Headache, Hypothermia, Joint range of motion decreased, Myalgia, Pain in extremity, Pruritus, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), 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: LEVOTHYROXINE
Current Illness: Hashimoto''s thyroiditis (under levothyroxine); Migraine (She has a history of migraines when she she is expecting her period); Tension headache (had a history of tension headache due to an accident in the past.)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Food allergy (Some food allergies nothing serious)
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: Fever; Result Unstructured Data: Test Result:38 Centigrade; Comments: she started having a fever up to 38 C; Test Date: 20220102; Test Name: Fever; Result Unstructured Data: Test Result:35.5 Centigrade; Comments: She had 35.5 C (not recovered)
CDC Split Type: GRPFIZER INC202200007724

Write-up: Exhaustion; mild hypothermia 35.5 degrees C; fever up to 38 degrees C; rigors; pain in legs / pain in her right leg behind the knee; arthralgia; myalgia; lower back pain; pain in deep in her right armpit (she doesn''t feel swelling or a lymph node); difficulty in moving her arm; headache; pain in the vaccinated arm; itchiness that started from the legs and then moved all over the body; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administered in deltoid right, administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 39 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "migraine" (ongoing), notes: She has a history of migraines when she she is expecting her period; "tension headache due to accident" (ongoing), notes: had a history of tension headache due to an accident in the past.; "hashimoto''s" (ongoing), notes: under levothyroxine; "Some food allergies" (unspecified if ongoing), notes: Some food allergies nothing serious; "allergic rhinitis" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis. Vaccination history included: Comirnaty, administration date: 10Dec2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "she had pain in the vaccinated arm and she could not lift it and move", "pain in the vaccinated arm and she could not lift it and move", "she felt a very strong pain to the back of her head on the", "she started having dizziness", "she felt that her mind was foggy", "she was forgetting things", "it was difficult for her to drive", "she was not fully functional", "exhaustion". The following information was reported: HYPOTHERMIA (medically significant) with onset 02Jan2022, outcome "not recovered", described as "mild hypothermia 35.5 degrees C"; PAIN IN EXTREMITY (non-serious) with onset 31Dec2021, outcome "recovered", described as "pain in the vaccinated arm"; PRURITUS (non-serious) with onset 31Dec2021, outcome "recovered", described as "itchiness that started from the legs and then moved all over the body"; PYREXIA (non-serious) with onset 01Jan2022, outcome "recovered", described as "fever up to 38 degrees C"; CHILLS (non-serious) with onset 01Jan2022, outcome "recovered", described as "rigors"; PAIN IN EXTREMITY (non-serious) with onset 01Jan2022, outcome "unknown", described as "pain in legs / pain in her right leg behind the knee"; ARTHRALGIA (non-serious) with onset 01Jan2022, outcome "unknown", described as "arthralgia"; MYALGIA (non-serious) with onset 01Jan2022, outcome "unknown", described as "myalgia"; BACK PAIN (non-serious) with onset 01Jan2022, outcome "unknown", described as "lower back pain"; AXILLARY PAIN (non-serious) with onset 01Jan2022, outcome "not recovered", described as "pain in deep in her right armpit (she doesn''t feel swelling or a lymph node)"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 01Jan2022, outcome "not recovered", described as "difficulty in moving her arm"; HEADACHE (non-serious) with onset 01Jan2022, outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "recovering", described as "Exhaustion". The patient underwent the following laboratory tests and procedures: body temperature: (01Jan2022) 38 Centigrade, notes: she started having a fever up to 38 C; (02Jan2022) 35.5 Centigrade, notes: She had 35.5 C (not recovered). Therapeutic measures were taken as a result of pain in extremity, pruritus, pyrexia, chills, pain in extremity, arthralgia, back pain, axillary pain. Additional information: The patient took Depon And aspirin (following doctor''s orders - a friend of hers who is a neurosurgeon advised her to take the anticoagulant). 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) : GR-PFIZER INC-202200000891 Same reporter, patient, suspect product/ different event and dose


VAERS ID: 2033803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-12-31
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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 Name: COVID-19 virus test; Test Result: Positive ; Comments: in a Regulatory Authority
CDC Split Type: HKPFIZER INC202200048947

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y+T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y+T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000031. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. As of 0:00 am, 01-Jan-2022, DH announced that two additional confirmed cases of COVID-19 and six additional asymptomatic cases of COVID-19 after Comirnaty vaccination. This case was split for 1 of 2 confirmed cases of COVID-19 after Comirnaty vaccination. A 20-year-old female patient started to receive first dose of Tozinameran (COMIRNATY) (lot number: unknown) on 31-May-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. The patient received second dose of Tozinameran (COMIRNATY) (lot number: unknown) on 08-Jul-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 28-Dec-2021, the patient arrived from traveling. On 31-Dec-2021, the patient developed symptoms. On an unknown date, the patient tested positive. The patient was confirmed as COVID-19 with mutant strain of N501Y+T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y+T478K'' 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 02-Jan-2022. This case was split from a Regulatory Authority 2021FOS007569 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Reporter''s and company''s (BIONTECH SE) assessment of causal relationship for COMIRNATY with the event Confirmed case of covid-19/imported case with mutant strain of n501y+t478k was reported as possible. COMIRNATY is under agreement with BIONTECH SE. Follow-up closed, no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200027217 same reporter/product, different event/patient


VAERS ID: 2033804 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-12-31
   Days after vaccination:200
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Gene sequencing, 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: 202201; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron and genetic; Comments: carried the Variant of Concern Omicron and genetic sequences of the patient and other cases tested positive related were highly similar.; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:44 environmental samples collected earlier; Comments: 44 environmental samples collected earlier had no positive test result; Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20220103; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:among the 46 environmental samples ; Comments: among the 46 environmental samples, none tested positive
CDC Split Type: HKPFIZER INC202200048294

Write-up: CONFIRMED CASE OF COVID-19/POSSIBLY IMPORT-RELATED CASE WITH MUTANT STRAINS OF N501Y AND T478K; CONFIRMED CASE OF COVID-19/POSSIBLY IMPORT-RELATED CASE WITH MUTANT STRAINS OF N501Y AND T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000032 (Fosun). This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. A 50-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 24-May-2021 and 14-Jun-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient had no travel history recently. On 27-Dec-2021, the patient patronised from around 12 noon to 2 pm. On 30-Dec-2021, the patient developed cough and runny nose. On 31-Dec-2021, the patient was arranged to quarantine and her specimen collected on the same day tested positive. On 01-Jan-2022, the patient tested positive for SARS-CoV-2 virus. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. In Jan-2022, the whole genome sequencing analysis conducted by the Public Health Laboratory Services Branch showed that the patient carried the Variant of Concern Omicron and the genetic sequences of the patient and other cases tested positive related to were highly similar. On 03-Jan-2022, among the 46 environmental samples collected by the Centre for Health Protection (CHP) none tested positive. The 44 environmental samples collected earlier also had no positive test result. On 04-Jan-2022, the patient''s daughter who had the meal with the patient tested preliminarily positive. The adverse event ''confirmed case of COVID-19/possibly import-related case with mutant strains of N501Y and T478K'' 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 02-Jan-2022, 03-Jan-2022, 04-Jan-2022 and 05-Jan-2022. This case was split from AER 2021FOS007611 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessments: Drug: COMIRNATY Asymptomatic COVID-19, Vaccination failure Per Primary reporter: Possible Per Company (BioNTech SE): Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200023006 same reporter/product, different event/patient


VAERS ID: 2033808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-12-31
   Days after vaccination:146
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20211231; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Positive carrying mutant strai; Comments: upon arrival in the collection center
CDC Split Type: HKPFIZER INC202200048413

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS; This is a spontaneous report received from non-contactable reporter (Other HCP) from License Party (BioNTech SE) and Regulatory Authority . Other Case identifier: HK-Fosun-2022FOS000039 (regulatory authority). On 02Jan2022 at 00:00, regulatory authority announced that seven additional confirmed cases of COVID-19 and nine additional asymptomatic cases of COVID-19 after Comirnaty vaccination. This report was split for one of the 16 patients. A 27-year-old female patient received BNT162B2 (COMIRNATY), administration date 17Jul2021 (Lot number: unknown) as dose 1, single and administration date 07Aug2021 (Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ASYMPTOMATIC COVID-19 (hospitalization, medically significant) with onset 31Dec2021, outcome "unknown", described as "CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS" and VACCINATION FAILURE (hospitalization) with onset 31Dec2021, outcome "unknown", described as "CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAINS". The patient was hospitalized for these events on an unspecified date. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) negative; (31Dec2021) positive carrying mutant strains, notes: upon arrival in the collection center. The causality assessment between the events vaccination failure and asymptomatic COVID-19 and BNT162B2 was reported as possible. This case was split from 2021FOS007647 due to same reporter/product, different event/patient. 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) : HK-PFIZER INC-202200030977 same reporter/product, different event/patient.


VAERS ID: 2033829 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-16
Onset:2021-12-31
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: 20211231; Test Name: COVID-19 Virus test; Test Result: Positive; Comments: Covid-19 with confirmed positive.
CDC Split Type: IEPFIZER INC202200007143

Write-up: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient. A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1), administration date: 01Apr2021, for COVID-19 Immunisation; Comirnaty (DOSE 2), administration date: 20Apr2021, for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster"; COVID-19 (medically significant) with onset 31Dec2021, outcome "unknown", described as "Contracted Covid-19"; VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", described as "drug ineffective"; NASAL CONGESTION (non-serious), outcome "unknown", described as "blocked nose"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Mild sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) positive, notes: Covid-19 with confirmed positive. Clinical course: It was reported that patient did not have underlying conditions. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2033986 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-12-31
   Days after vaccination:258
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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: Breast cancer recurrent (recurrent, currently under treatment chemotherapy).
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Her daughter got Covid-19); Diabetes; Hypertension.
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: Covid-19 PCR test; Test Result: Negative; Test Date: 20211231; Test Name: Covid-19 PCR test; Test Result: Positive.
CDC Split Type: PTPFIZER INC202200002675

Write-up: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 17Apr2021 (Batch/Lot number: unknown) at the age of 55 years as dose 2, single and intramuscular, administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation. Relevant medical history included: "hypertension" (unspecified if ongoing); "diabetes" (unspecified if ongoing); "breast cancer" (ongoing), notes: recurrent, currently under treatment chemotherapy. Family history included: "Covid-19" (unspecified if ongoing), notes: Her daughter got Covid-19. The patient''s concomitant includes several unspecified drugs for hypertension and diabetes. The following information was reported: VACCINATION FAILURE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Vaccination failure"; COVID-19 (medically significant) with onset 31Dec2021, outcome "unknown", described as "Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative; (31Dec2021) positive. Clinical course: It was reported that the patient has Covid-19, had a PCR test positive on 31Dec2021. She had some symptoms (not specified). Her daughter got Covid-19 and apparently infected the rest of the family. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender''s Comments: Linked Report(s): PT-PFIZER INC-2021428104 Past drug event, same patient and product; PT-PFIZER INC-2021428057 Past drug event, same patient and product.


VAERS ID: 2036479 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Burning sensation, Immunisation, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (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: INDAPAMIDE HEMIHYDRATE; PLAVIX; RAMIPRIL; NIFEDIPINE; ROSUVASTATIN; ASPIRINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High cholesterol; Hypertension; Stent placement (9-10 years ago and 7 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202200009062

Write-up: terribly itchy and sort of burny too; Hives all over body; terribly itchy and sort of burny too; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 31Dec2021 13:30 (Batch/Lot number: unknown) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "2 Stents" (unspecified if ongoing), notes: 9-10 years ago and 7 years ago. Family medical history relevant to adverse events was none. Concomitant medications included: INDAPAMIDE HEMIHYDRATE taken for hypertension (ongoing); PLAVIX taken for hypertension (ongoing); RAMIPRIL taken for hypertension (ongoing); NIFEDIPINE (ongoing); ROSUVASTATIN taken for blood cholesterol increased (ongoing); ASPIRINE. Vaccination history included: Comirnaty (dose 1, lot number ER1742, right deltoid), administration date: 29Mar2021, for Covid-19 immunisation; Comirnaty (dose 2, lot number FA9091, right deltoid ), administration date: 01Jul2021, for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; PRURITUS (medically significant), BURNING SENSATION (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "terribly itchy and sort of burny too"; URTICARIA (non-serious) with onset Jan2022, outcome "not recovered", described as "Hives all over body". Therapeutic measures were taken as a result of pruritus, urticaria, burning sensation. About 36 hours after the 3rd dose, she broke out into hives all over her body (except arms and legs). It was terribly itchy and sort of burny too. She went to the pharmacy and the pharmacist told her to take diphenhydramine (BENADRYL). It had not gotten worse or better ever since (as of 04Jan2022). Diphenhydramine alleviated the itchiness temporarily. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender''s Comments: Linked Report(s) : CA-PFIZER_INC-202200009061 ;CA-PFIZER INC-202200009061 Same patient/ same product/ Different event and dose


VAERS ID: 2036770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye swelling, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 Date: 20210903; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009614

Write-up: Off-label use; Interchange of vaccine products; Booster; Swollen eyes; This is a spontaneous report received from a contactable consumer from a Regulatory Authority. Regulatory number: GB-MHRA-APPCOVID-202201030902203740-66QQ1. Other Case identifier: GB-MHRA-ADR 26426408. A 37 year-old female patient received bnt162b2 (COMIRNATY), administration date 30Dec2021 (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: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. Patient had 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. 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"; EYE SWELLING (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Swollen eyes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Sep2021) yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036780 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, 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: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fever chills; Tiredness; Nausea; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26429674) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever chills), FATIGUE (Tiredness) and NAUSEA (Nausea) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. Concomitant products included SERTRALINE for Ill-defined disorder. On 31-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 31-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced PYREXIA (Fever chills) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 02-Jan-2022, HEADACHE (Headache) was resolving, PYREXIA (Fever chills) had resolved and FATIGUE (Tiredness) and NAUSEA (Nausea) had resolved with sequelae. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. No treatment information was provided. Company comment: This case concerns a 25-year-old, female patient with medical history of ill defined disorder, who experienced the unexpected events of headache, pyrexia, fatigue and nausea. The events occurred on the same day or 1 day after a dose of mRNA-1273. Above mentioned medical history of ill defined disorder and use of sertraline confounds causality. 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 25-year-old, female patient with medical history of ill defined disorder, who experienced the unexpected events of headache, pyrexia, fatigue and nausea. The events occurred on the same day or 1 day after a dose of mRNA-1273. Above mentioned medical history of ill defined disorder and use of sertraline confounds causality. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2036854 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Chills, Diarrhoea, Fatigue, Headache, Immunisation, Maternal exposure during breast feeding, Myalgia, Nausea, Off label use, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), 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: Breast feeding
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 INC202200000281

Write-up: Maternal exposure during breast feeding; Pain in arm; My skin was very hot to touch; Diarrhea; Tiredness/ Fatigue; Nausea; Body ache; Headache; Off label use; Booster; Chills; Joint pain; Muscle pain; 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-202201012311540250-CRNKU (RA). Other Case identifier(s): GB-MHRA-ADR 26424522 (RA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 10:10 (Batch/Lot number: unknown) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose :1, Lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose :2, Lot number unknown), for covid-19 immunization. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021 10:10, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 31Dec2021 10:10, outcome "unknown", described as "Booster"; MATERNAL EXPOSURE DURING BREAST FEEDING (medically significant), outcome "unknown", described as "Maternal exposure during breast feeding"; HEADACHE (medically significant) with onset 31Dec2021 20:30, outcome "recovered", described as "Headache"; CHILLS (medically significant) with onset 31Dec2021, outcome "recovered", described as "Chills"; ARTHRALGIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Joint pain"; MYALGIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Muscle pain"; NAUSEA (medically significant) with onset 31Dec2021 23:00, outcome "recovered" (01Jan2022 01:30), described as "Nausea"; DIARRHOEA (medically significant) with onset 01Jan2022 01:30, outcome "recovered" (01Jan2022 14:00), described as "Diarrhea"; FATIGUE (medically significant) with onset 01Jan2022, outcome "recovering", described as "Tiredness/ Fatigue"; PAIN IN EXTREMITY (medically significant), outcome "recovered", described as "Pain in arm"; PAIN (medically significant) with onset 31Dec2021 20:30, outcome "unknown", described as "Body ache"; BODY TEMPERATURE INCREASED (medically significant), outcome "unknown", described as "My skin was very hot to touch". 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: 2036859 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Illness, Immunisation, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and I..)
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003656

Write-up: Booster; Sickness; Body temperature; Diarrhoea; Headache; Shivering; 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-202201020756301570-0ZYIA (RA). Other Case identifier(s): GB-MHRA-ADR 26424670 (RA). A 52 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and I.. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot number: unknown), for COVID-19 immunization; Bnt162b2 (Dose 2, Batch/Lot number: unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; ILLNESS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sickness"; BODY TEMPERATURE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Body temperature"; DIARRHOEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Diarrhoea"; HEADACHE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Headache"; CHILLS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Shivering". The patient underwent the following laboratory tests and procedures: body temperature: (31Dec2021) unknown; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. Clinical course: Patient did not have symptoms associated with COVID-19. Patient was not breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This 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: 2036864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 000014A / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Immunisation, Interchange of vaccine products, Migraine, Musculoskeletal stiffness, Myalgia, Off label use, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: ESCITALOPRAM; LEVOTHYROXINE; NUROFEN COLD & FLU; OMEPRAZOL; PARACETAMOL; PROPRANOLOL; VENLAFAXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Hiatus hernia; Hypothyroidism; Migraine prophylaxis; Obesity; Pain; Suspected COVID-19 (isolated; had not taken a test; assumed that would still be positive; unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003810

Write-up: migraine; muscle ache; tiredness; light-headed; stiffness; high temperature; off label use; interchange of vaccine products; immunisation; 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-202201020919171970-VQRQP (RA). Other Case identifier(s): GB-MHRA-ADR 26424725 (RA). A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (batch/lot number: 000014A) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "suspected COVID-19", start date: 24Nov2021 (unspecified if ongoing), notes: isolated; had not taken a test; assumed that would still be positive; unsure when symptoms stopped; "anxiety" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hiatus hernia" (unspecified if ongoing); "pain" (unspecified if ongoing); "migraine prophylaxis" (unspecified if ongoing); "morbidly obese" (unspecified if ongoing). The patient had not had a COVID-19 test, not currently breastfeeding, unsure if patient was enrolled in clinical trial. Concomitant medications included: ESCITALOPRAM taken for anxiety, start date: 2018; LEVOTHYROXINE taken for hypothyroidism; NUROFEN COLD & FLU; OMEPRAZOL taken for hiatus hernia; PARACETAMOL taken for pain relief; PROPRANOLOL taken for migraine prophylaxis; VENLAFAXIN taken for anxiety, start date: 2001. Vaccination history included: Covid-19 vaccine Astrazeneca (dose 1), administration date: Mar2021, for COVID-19 immunisation; Covid-19 vaccine Astrazeneca (dose 2), administration date: Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "immunisation"; MIGRAINE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "migraine"; MYALGIA (medically significant) with onset 01Jan2022, outcome "recovered", described as "muscle ache"; FATIGUE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "tiredness"; DIZZINESS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "light-headed"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 01Jan2022, outcome "recovering", described as "stiffness"; PYREXIA (medically significant) with onset 01Jan2022, outcome "recovering", described as "high temperature". The patient has not tested positive for COVID-19 since having the vaccine. Additional information: The patient felt worse since she had the booster than when she had Covid-19 (in Nov2021). The patient just wanted to feedback that if she had known how the booster would make her feel, she probably wouldn''t have had it and it will certainly put her off having another booster vaccination. The patient did not relate the report to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036865 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Nausea, Night sweats, Off label use, Palpitations, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Medication errors (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: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003824

Write-up: Night sweat; Nausea; Headache; Heart pounding; Anxiety attack; Swollen lymph nodes; 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-202201020926470360-SJXEB. Other Case identifier(s): GB-MHRA-ADR 26424721. A 27 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (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: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; PALPITATIONS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Heart pounding"; ANXIETY (medically significant) with onset 01Jan2022, outcome "recovered", described as "Anxiety attack"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen lymph nodes"; NIGHT SWEATS (medically significant) with onset 02Jan2022, outcome "recovered", described as "Night sweat"; NAUSEA (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Nausea"; HEADACHE (medically significant) with onset 01Jan2022, outcome "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''s Last Menstrual Period date: 05Dec2021. Patient has not had symptoms associated with COVID-19 Patient was not pregnant. Patient was not breastfeeding. Patient has 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 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: 2036868 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2021-0069403 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Hypoaesthesia, Lymphadenopathy, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Depression; Lactose intolerant; Comments: Taking Sertraline for anxiety and depression, lactose intollerant. Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003731

Write-up: Swollen lymph nodes; Numbness in fingers; Pain in arm; Chest pain; Pain in my chest and side; 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-202201020959073000-E3VVI (RA). Other Case identifier(s): GB-MHRA-ADR 26424740 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: 2021-0069403) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lactose intolerant" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Past drug history included: Sertraline for Anxiety; Sertraline for depression. The following information was reported: LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen lymph nodes"; CHEST PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Chest pain"; PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Pain in my chest and side"; HYPOAESTHESIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Numbness in fingers"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Pain in arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Additional information: patient was seeking advice from G.P. Patient has not tested positive for COVID-19 since having the vaccine. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Chills, Headache, Immunisation, Lymphadenopathy, Pain, Peripheral swelling, Rash erythematous, SARS-CoV-2 test, Somnolence
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003621

Write-up: shivering; pain; Shivers; Chest pain; Swollen arm; Red rash; Swollen glands; Aching joints; Sleepiness; Headache; 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-202201021043415880-J6FJ2 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26424784 (MHRA). A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (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 1), for COVID-19 immunization; Bnt162b2 (DOSE 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; CHILLS (medically significant), outcome "recovered", described as "shivering"; PAIN (medically significant), outcome "recovered", described as "pain"; CHILLS (medically significant) with onset 01Jan2022, outcome "recovering", described as "Shivers"; CHEST PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Chest pain"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "recovering", described as "Swollen arm"; RASH ERYTHEMATOUS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Red rash"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen glands"; ARTHRALGIA (medically significant) with onset 01Jan2022, outcome "recovering", described as "Aching joints"; SOMNOLENCE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Sleepiness"; HEADACHE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Headache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of pain, chest pain, arthralgia, headache. Additional information: Patient had no symptoms associated with COVID-19. She was not pregnant. she was not currently breastfeeding. She had not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. Patient reported that reactions started about 15 hours after vaccination. Shivering, aching heightened the day after vaccination. Had paracetamol to help with pain. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Chills, Dizziness, Fatigue, Headache, Hot flush, Immunisation, Interchange of vaccine products, Lymphadenopathy, Nausea, Neuralgia, Off label use, Peripheral swelling, Rash, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (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), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200003816

Write-up: Glands swollen; Nerve pain; Dizziness; Nausea; Fatigue; Headache; Armpit pain; Swollen arm; Hot flushes; Chills; Skin rash; 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 (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201021101476830-UK8NX (MHRA). Other Case identifier(s): GB-MHRA-ADR 26424807 (MHRA). A 47-year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FN3543) 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), administration date: 28Apr2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 16Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Glands swollen"; NEURALGIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Nerve pain"; DIZZINESS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Dizziness"; NAUSEA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Nausea"; FATIGUE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Fatigue"; HEADACHE (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Headache"; AXILLARY PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Armpit pain"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen arm"; HOT FLUSH (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Hot flushes"; CHILLS (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Chills"; RASH (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Skin rash". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course- Unsure if patient has had symptoms associated with COVID-19. Patient is not currently breastfeeding. 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. No further information is expected.


VAERS ID: 2036876 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Feeling abnormal, Headache, Illness, Insomnia, Malaise, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Flu vaccination; Suspected COVID-19 (Patient became positive on 30Sep2021)
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210930; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003762

Write-up: Sickness/09:00 was violently sick; Headache/05:00 had a Acute headache; High temperature/woke up at 01:00 with a high temperature; Chills/woke up at 01:00 with chills; unable to sleep; Feeling bad; Nausea; Patient began to feel unwell 12 hrs after receiving the vaccine; 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-202201021114400730-AGRE0. Other Case identifier(s): GB-MHRA-ADR 26424833. A 15-year-old male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FN5254) at the age of 15 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 30Sep2021, stop date: 03Oct2021, notes: Patient became positive on 30Sep2021; "Flu vaccination" (unspecified if ongoing). Concomitant medication(s) included: FLUENZ TETRA taken for influenza immunisation, administration date Nov2021. The following information was reported: PYREXIA (medically significant) with onset 01Jan2022 01:00, outcome "recovering", described as "High temperature/woke up at 01:00 with a high temperature"; HEADACHE (medically significant) with onset 01Jan2022 05:00, outcome "recovering", described as "Headache/05:00 had a Acute headache"; ILLNESS (medically significant) with onset 01Jan2022 09:00, outcome "not recovered", described as "Sickness/09:00 was violently sick"; CHILLS (medically significant) with onset 01Jan2022 01:00, outcome "recovered", described as "Chills/woke up at 01:00 with chills"; FEELING ABNORMAL (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Feeling bad"; NAUSEA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Nausea"; MALAISE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Patient began to feel unwell 12 hrs after receiving the vaccine"; INSOMNIA (medically significant) with onset 01Jan2022, outcome "unknown", described as "unable to sleep". The patient underwent the following laboratory tests and procedures: body temperature: (01Jan2022) 38 Centigrade; sars-cov-2 test: (30Sep2021) positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of pyrexia, headache, illness, chills, feeling abnormal, nausea, malaise, insomnia. Clinical course: Patient began to feel unwell 12 hours after receiving the vaccine, fell asleep on bed about 2200 hours, woke up at 0100 with a high temperature and chills unable to sleep. 0500 had a Acute headache with high temp 38c. 0900 was violently sick still with temp and headache. Administered paracetamol every 4hrs. 48 hours later patient still feels nauseous and general feeling of unwell. Headache and temp have subsided. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Oedema, Off label use, Pain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), 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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started; Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202200003757

Write-up: This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202201021740441340-ESMRL (RA). Other Case identifier(s): GB-MHRA-ADR 26425101 (RA). A 46-year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FN3543) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started; Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1), administration date: 18Apr2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (dose 2), administration date: 29Jun2021, for COVID-19 immunisation. The patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; OEDEMA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Oedema"; PERIPHERAL SWELLING (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Swollen arm"; PAIN (medically significant) with onset 01Jan2022, outcome "recovered with sequelae" (Jan2022), described as "Pain"; PAIN IN EXTREMITY (medically significant), MUSCULOSKELETAL STIFFNESS (medically significant), outcome "unknown" and all described as "Strong pain and stiffness in upper arm"; SWELLING (medically significant), outcome "unknown", described as "some swelling in arm pit". The events were reported as: Oedema breakouts in feet and gullet. Strong pain and stiffness in upper arm and some swelling in arm pit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jul2021) positive, notes: Yes - Positive COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Off label use
SMQs:, 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 INC202200003699

Write-up: Headache; 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. Regulatory number: GB-MHRA-WEBCOVID-202201022219358910-NXJ8V. Other Case identifier(s): GB-MHRA-ADR 26425312. A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 01Jan2022, outcome "recovering", described as "Headache". 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. 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: 2036980 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Insomnia, 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009338

Write-up: Booster; Difficulty sleeping/Whole nights of no sleep. Clear/calm mind but can''t fall asleep.; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201030926341740-S0T6E (RA). Other Case identifier(s): GB-MHRA-ADR 26426548 (RA). A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19 and was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; INSOMNIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Difficulty sleeping/Whole nights of no sleep. Clear/calm mind but can''t fall asleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Feeling hot, Hyperhidrosis, Pain of skin, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (Asthma inhalers daily); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211203; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: feeling hot; sweating; Tight chest; Shaking; Fever; Skin pain; This case was received via RA (Reference number: GB-MHRA-ADR 26426568) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot), HYPERHIDROSIS (sweating), PYREXIA (Fever), PAIN OF SKIN (Skin pain), CHEST DISCOMFORT (Tight chest) and TREMOR (Shaking) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Asthma (Asthma inhalers daily) and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). On 31-Dec-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion disability), PAIN OF SKIN (Skin pain) (seriousness criterion disability) and TREMOR (Shaking) (seriousness criterion disability). On 02-Jan-2022, the patient experienced CHEST DISCOMFORT (Tight chest) (seriousness criterion disability). On an unknown date, the patient experienced FEELING HOT (feeling hot) (seriousness criterion disability) and HYPERHIDROSIS (sweating) (seriousness criterion disability). On 31-Dec-2021, TREMOR (Shaking) had resolved. On 01-Jan-2022, PAIN OF SKIN (Skin pain) had resolved. On 02-Jan-2022, PYREXIA (Fever) and CHEST DISCOMFORT (Tight chest) had resolved. At the time of the report, FEELING HOT (feeling hot) and HYPERHIDROSIS (sweating) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Dec-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine, Patient had not had symptoms associated with COVID-19, Patient was not enrolled in clinical trial. Reporter mentioned that patient stated that she did not find paracetamol made any difference, her skin felt like it was being stabbed with needles that lasted 24 hours, normal tasks for 24 hours as struggled to get out of bed. The fever started 12 hours after patient had the vaccine, over night she was sweating consistently switching between feeling hot and cold. This continued for a further 24 hours. She did not find paracetamol made any difference. The skin pain was difficult to describe, every time anything touched her skin felt like it was being stabbed with needles. This lasted 24 hours. The tight chest was after these other symptoms had subsided and was only for a short period 48 hours after the vaccine. Patient was unable to perform normal tasks for 24 hours as struggled to get out of bed. Concomitant medication information was not provided by the reporter. Treatment medication information was not provided by the reporter. Company Comment: This case concerns a female patient of an unknown age, with no relevant medical history, who experienced the unexpected events of Pyrexia, Pain of skin, Tremor, Chest discomfort and Feeling hot. The events occurred approximately 1-2 days after receiving the first dose of mRNA-1273 Vaccine which resulted in a debilitating condition. At the time of the report the outcome of the events was resolved. The rechallenge is unknown as per SD. The benefit-risk relationship of 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, who experienced the unexpected events of Pyrexia, Pain of skin, Tremor, Chest discomfort and Feeling hot. The events occurred approximately 1-2 days after receiving the first dose of mRNA-1273 Vaccine which resulted in a debilitating condition. At the time of the report the outcome of the events was resolved. The rechallenge is unknown as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2037001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Headache, Hypokinesia, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, Pyrexia, SARS-CoV-2 test, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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: Body temperature; Result Unstructured Data: Test Result:mild; Test Date: 20211231; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009260

Write-up: headache; Mild fever; Joint pain; Unable to lower arm fully without pain; Sleeping problems now for 3 consecutive nights; Lymph node under left underarm (same side as vaccine was given) now extremely swollen; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201031348064760-UWBAA (RA). The reporter is the patient. Other Case identifier(s): GB-MHRA-ADR 26428162 (RA). A 44 year-old male patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FN3543) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, not had symptoms associated with COVID-19. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN) for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 01Jan2022, outcome "not recovered", described as " Lymph node under left underarm (same side as vaccine was given) now extremely swollen"; HEADACHE (medically significant), outcome "recovered", described as "headache"; PYREXIA (medically significant), outcome "recovered", described as "Mild fever"; ARTHRALGIA (medically significant), outcome "recovered", described as "Joint pain"; HYPOKINESIA (medically significant), outcome "unknown", described as "Unable to lower arm fully without pain"; SLEEP DISORDER (medically significant), outcome "unknown", described as "Sleeping problems now for 3 consecutive nights". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Dec2021) no - negative COVID-19 test; body temperature: (unspecified date) mild. Clinical course : Lymph node under left underarm (same side as vaccine was given) now extremely swollen - approximately the size of a tennis ball and was unable to lower his arm fully without pain. Had caused sleeping problems then for 3 consecutive nights. This reaction was accompanied by headache, joint pain and a mild fever however these had all subsided leaving an extremely swollen lymph node. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037018 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Decreased appetite, Diarrhoea, Fatigue, Immunisation, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), 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:
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 INC202200009321

Write-up: Exhaustion; Booster; Diarrhoea; Tiredness; Loss of balance; Loss of energy; Appetite impaired; 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-202201031653055460-4MO3H. Other Case identifier(s): GB-MHRA-ADR 26429734. A 83 year-old female patient received bnt162b2 (COMIRNATY), administration date 31Dec2021 (Lot number: FK9712) at the age of 83 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19, had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "no after-effects"; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s): "no after-effects". The following information was reported: IMMUNISATION (medically significant) with onset 31Dec2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 31Dec2021, outcome "recovered" (01Jan2022), described as "Diarrhoea"; FATIGUE (medically significant) with onset 31Dec2021, outcome "recovered with sequelae", described as "Tiredness"; BALANCE DISORDER (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Loss of balance"; ASTHENIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Loss of energy"; DECREASED APPETITE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Appetite impaired"; FATIGUE (medically significant) with onset 01Jan2022, outcome "recovering", described as "Exhaustion". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test and result showed no - negative COVID-19 test. Reportedly, reactions came on quickly about 2-3 hours after vaccination. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037071 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dehydration, Insomnia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HRT (Patient take HRT.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Insomnia; Dehydration; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26431797) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) and DEHYDRATION (Dehydration) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included HRT (Patient take HRT.). Previously administered products included for Product used for unknown indication: UTROGESTAN and ESTROGEL. Past adverse reactions to the above products included No adverse event with ESTROGEL and UTROGESTAN. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced INSOMNIA (Insomnia) (seriousness criterion medically significant) and DEHYDRATION (Dehydration) (seriousness criterion medically significant). At the time of the report, INSOMNIA (Insomnia) had not resolved and DEHYDRATION (Dehydration) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. Treatment information was not provided. Patient had no symptoms associated with COVID-19 and 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. Patient and the partner had the Moderna vaccine at the same time and had suffered the same symptoms. They didn''t read dehydration or insomnia in the official list of side effects hence reported. The insomnia is particularly tedious. They both slept well and had no trouble getting to sleep. They both slept not a wink the first night and since then it had taken them somewhere between 2-3hrs to get to sleep each night, plus initially they were constantly woken by the need to drink water, something in the order of 3-4 pints per night which was ridiculous. Last night, 03-Jan-2022 they both went to bed at 23.15 and it took the patient until 2am to get to sleep but partner was up until 3am. If they known that this was a side effect, they would never had moderna vaccine. Patient re-start work today, 05-Jan-2022 very much not rested. Company comment This case concerns a 47-year-old female patient, with no reported relevant medical history, who experienced the unexpected serious events of INSOMNIA and DEHYDRATION. The events occurred on the same day after the administration of 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 case concerns a 47-year-old female patient, with no reported relevant medical history, who experienced the unexpected serious events of INSOMNIA and DEHYDRATION. The events occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2037088 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Injection site inflammation, Magnetic resonance imaging, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (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: INFLUENZA VIRUS
Current Illness: Allergy to metals; Drug allergy (Septrin); Latex allergy; Small vessel disease of diabetes mellitus (Suspected small vessel disease (lesions on brain scan :MRI)); TIA
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (Anaphylaxis: possibly to Aspirin); Asthma (Asthma associated with cold/flu); Cold; Migraine (Migraines : occasional)
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Suspected small vessel disease (lesions on brain scan)
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shortness of breath; Injection site inflammation; Fever; This case was received via Agency Regulatory Authority(Reference number: GB-MHRA-ADR 26432918) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE INFLAMMATION (Injection site inflammation), PYREXIA (Fever) and DYSPNOEA (Shortness of breath) in a 50-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Asthma (Asthma associated with cold/flu), Cold and Migraine (Migraines : occasional). Previously administered products included for Product used for unknown indication: SEPTRIN. Past adverse reactions to the above products included No adverse event with SEPTRIN. Concurrent medical conditions included Small vessel disease of diabetes mellitus (Suspected small vessel disease (lesions on brain scan :MRI)), TIA, Anaphylaxis (Anaphylaxis: possibly to Aspirin), Drug allergy (Septrin), Allergy to metals and Latex allergy. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 29-Oct-2021 to an unknown date for Vaccination. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced INJECTION SITE INFLAMMATION (Injection site inflammation) (seriousness criterion medically significant). On 04-Jan-2022, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On 02-Jan-2022, PYREXIA (Fever) had resolved. At the time of the report, INJECTION SITE INFLAMMATION (Injection site inflammation) and DYSPNOEA (Shortness of breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) Suspected small vessel disease (lesions on brain scan). The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient medical history details: includes NON-DROWSY HAYFEVER AND ALLERGY RELIEF. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. Fever, inflammation at injection site, shortness of breath. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 50-year-old female patient, with reported history of Small vessel disease of diabetes mellitus, Transient ischaemic attack, Drug hypersensitivity, Anaphylactic reaction, Allergy to metals, Latex Allergy, Asthma, Cold and Migraine, who experience the serious unexpected events of Injection site inflammation, Pyrexia and Dyspnoea. The event Injection site inflammation occurred approximately 3 days after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved; the event Pyrexia occurred 2 days after the 3rd dose and the outcome was Recovered/Resolved; the event Dyspnoea occurred 5 days after the vaccination and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The reported medical history of the patient remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 50-year-old female patient, with reported history of Small vessel disease of diabetes mellitus, Transient ischaemic attack, Drug hypersensitivity, Anaphylactic reaction, Allergy to metals, Latex Allergy, Asthma, Cold and Migraine, who experience the serious unexpected events of Injection site inflammation, Pyrexia and Dyspnoea. The event Injection site inflammation occurred approximately 3 days after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Not Recovered/Not Resolved; the event Pyrexia occurred 2 days after the 3rd dose and the outcome was Recovered/Resolved; the event Dyspnoea occurred 5 days after the vaccination and the outcome at the time of the report was Not Recovered/Not Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The reported medical history of the patient remains as a confounder for the events. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2037115 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-31
Onset:2021-12-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Cerebrovascular accident, Facial paralysis, Fatigue, Fibrin D dimer, Muscular weakness, Platelet factor 4, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high; Coronary heart disease (Monomil 60mg once a day); Heart failure; Osteoporosis (using pain killers); Type 2 diabetes mellitus (Sukkarto (metformin) 500 mg once a day.)
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Fibrin D dimer; Result Unstructured Data: D-dimer was not $g4000; Test Name: Platelet factor 4; Result Unstructured Data: Anti-PF4 antibodies were not identified
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: platelet count <150 A? 109/L; weakness; Fatigue; Facial droop; Weakness of limbs; Stroke; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26434278) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THROMBOCYTOPENIA (platelet count <150 A? 109/L), ASTHENIA (weakness), MUSCULAR WEAKNESS (Weakness of limbs), FATIGUE (Fatigue) and FACIAL PARALYSIS (Facial droop) in a 93-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. The patient''s past medical history included Non-smoker. Concurrent medical conditions included Coronary heart disease (Monomil 60mg once a day), Heart failure, Osteoporosis (using pain killers), Type 2 diabetes mellitus (Sukkarto (metformin) 500 mg once a day.) and Blood pressure high. On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, disability and life threatening), MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criteria hospitalization, disability and life threatening) and FACIAL PARALYSIS (Facial droop) (seriousness criteria hospitalization, disability and life threatening). On an unknown date, the patient experienced THROMBOCYTOPENIA (platelet count <150 A? 109/L) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (Fatigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), ASTHENIA (weakness), MUSCULAR WEAKNESS (Weakness of limbs) and FACIAL PARALYSIS (Facial droop) had not resolved and THROMBOCYTOPENIA (platelet count <150 A? 109/L) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Fibrin D dimer: d-dimer was not $g4000 D-dimer was not $g4000. On an unknown date, Platelet factor 4: anti-pf4 antibodies were not identified Anti-PF4 antibodies were not identified. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient took pain killers for Osteoporosis and no medications took for Heart Failure and High blood pressure. Patient took Sukkarto (metformin) 500 mg once a day for Type 2 Diabetes. Patient had the vaccine administered on 31-Dec-2021 and was taken into hospital the same day later with weakness in the limbs followed by a Stroke. Had CT scan of head and that found an inclusion in the Middle artery. Stroke was identified through CT Scan on 31-Dec-2021 at 03:05 pm. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The lowest platelet count after vaccination was 324. The last platelet count before vaccination was not checked. The report was related to possible blood clots or low platelet counts. The report was related to possible myocarditis or pericarditis. Patient was still at hospital. The troponin levels were not measured. Patient had Medical history of Heart attack 1970m that was related to previous venous or arterial thromboses. Patient not had previous reactions to medications, especially heparin or anticoagulants. Patient had no confirmed or suspected autoimmune or inflammatory disease, including vasculitis. Patient had no history of, or current, malignancy. Patient had no history of intracranial malignancy. Patient had no concurrent or recent intracranial infections. Patient had no recent surgical or medical interventions to the central nervous system (including lumbar puncture). Patient had no recent trauma/head injury. Patient was not seen by a Cardiologist. Concomitant product details was not reported. Treatment details was not reported . Company Comment- This regulatory case concerns a 93-year-old, female patient with relevant medical history of Heart Failure (HF), previous Myocardial Infarction (MI) and Type 2 Diabetes Mellitus (T2DM), who experienced the unexpected, serious AESI of cerebrovascular accident and thrombocytopenia, the expected, serious AESI of facial paralysis, and the unexpected, serious events of asthenia, muscular weakness and fatigue. The events were life-threatening, debilitating and resulted in hospitalization. The events cerebrovascular accident, facial paralysis and muscular weakness occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The start dates of the other events were not provided. The patient presented to the hospital with weakness of the limbs followed by a Stroke. Computerized Tomogram Scan of the Head showed an ''inclusion in the middle artery''. The platelet count was noted to be ''324''. No further details were provided. Treatment information was also not provided. The events cerebrovascular accident, facial paralysis, asthenia and muscular weakness had not resolved at the time of the report. The outcomes of the events thrombocytopenia and fatigue were unknown at the time of the report. The medical history of HF, previous MI and T2DM remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 93-year-old, female patient with relevant medical history of Heart Failure (HF), previous Myocardial Infarction (MI) and Type 2 Diabetes Mellitus (T2DM), who experienced the unexpected, serious AESI of cerebrovascular accident and thrombocytopenia, the expected, serious AESI of facial paralysis, and the unexpected, serious events of asthenia, muscular weakness and fatigue. The events were life-threatening, debilitating and resulted in hospitalization. The events cerebrovascular accident, facial paralysis and muscular weakness occurred on the same day after administration of the third dose of the Moderna mRNA-1273 vaccine. The start dates of the other events were not provided. The patient presented to the hospital with weakness of the limbs followed by a Stroke. Computerized Tomogram Scan of the Head showed an ''inclusion in the middle artery''. The platelet count was noted to be ''324''. No further details were provided. Treatment information was also not provided. The events cerebrovascular accident, facial paralysis, asthenia and muscular weakness had not resolved at the time of the report. The outcomes of the events thrombocytopenia and fatigue were unknown at the time of the report. The medical history of HF, previous MI and T2DM remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2037130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Fatigue, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 Date: 20211110; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Racing heart (tachycardia); Heart palpitations; Fever; Fatigue/unusual tiredness; Abdominal pain; Diarrhoea; Palpitations; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26435082) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Palpitations), PALPITATIONS (Heart palpitations), ABDOMINAL PAIN (Abdominal pain), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and FATIGUE (Fatigue/unusual tiredness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant) and DIARRHOEA (Diarrhoea) (seriousness criterion medically significant). On an unknown date, the patient experienced TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). On 03-Jan-2022, PALPITATIONS (Palpitations), ABDOMINAL PAIN (Abdominal pain) and DIARRHOEA (Diarrhoea) had resolved. At the time of the report, TACHYCARDIA (Racing heart (tachycardia)), PALPITATIONS (Heart palpitations), PYREXIA (Fever) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2021, SARS-CoV-2 test: positive covid-19 test (Positive) Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. No concomitant medications were reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was reported that the report was related to possible inflammation of the heart (myocarditis or pericarditis). The symptoms did not lead to a hospital stay and the diagnosis was not made by a medical professional. There were no blood tests performed for this symptoms. No treatment medications were reported. Company comment This is a regulatory case concerning a female patient of an unknown age with medical history of Positive COVID-19 test approximately a month and a half before events who experienced unexpected serious events of Tachycardia, Palpitations (two events), Abdominal pain, Diarrhoea, Pyrexia and Fatigue. The events Abdominal pain, Diarrhoea and Palpitations occurred one day after the third dose of mRNA-1273 vaccine, while onset dates of other events were not reported. It was reported that the report was related to possible inflammation of the heart (myocarditis or pericarditis), however this diagnosis was not confirmed. The medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a female patient of an unknown age with medical history of Positive COVID-19 test approximately a month and a half before events who experienced unexpected serious events of Tachycardia, Palpitations (two events), Abdominal pain, Diarrhoea, Pyrexia and Fatigue. The events Abdominal pain, Diarrhoea and Palpitations occurred one day after the third dose of mRNA-1273 vaccine, while onset dates of other events were not reported. It was reported that the report was related to possible inflammation of the heart (myocarditis or pericarditis), however this diagnosis was not confirmed. The medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness of the events, rechallenge and action taken with the suspect product were kept as per Regulatory Authority reporting.


VAERS ID: 2037134 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-21
Onset:2021-12-31
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Skin rash; This case was received via the RA (Reference number: GB-MHRA-ADR 26435369) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of RASH (Skin rash) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced RASH (Skin rash) (seriousness criterion medically significant). At the time of the report, RASH (Skin rash) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was mentioned by reporter Patient had urticarial type rash which moves and had raised patches which are well defined. Unsure if patient was enrolled in clinical trial. No treatment medication information was mentioned by reporter Company comment: This is a regulatory case concerning a 20-year-old, male patient with no medical history reported, who experienced the serious unexpected , according CCDS, event of Rash. The event occurred approximately 10 days after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. No treatment was provided for the reported event. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 20-year-old, male patient with no medical history reported, who experienced the serious unexpected , according CCDS, event of Rash. The event occurred approximately 10 days after the third dose of mRNA-1273 vaccine. The rechallenge was reported as unknown. No treatment was provided for the reported event. The case was assessed as serious as per Regulatory Authority?s report due to important medical event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2037140 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000059A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Infection, Peripheral coldness, SARS-CoV-2 test, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (narrow), 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: AMITRIPTYLIN; PFIZER BIONTECH COVID-19 VACCINE; DULOXETINE; IMIPRAMINE; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Irritable bowel syndrome (diagnosed with fibromyalgia since 2014 along side irritable bowel syndrome)
Allergies:
Diagnostic Lab Data: Test Date: 20220104; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: infection; swelling; Cold hands; Cold feet; Joint inflammation; This case was received (Reference number: GB-MHRA-ADR 26435829) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of INFECTION (infection), SWELLING (swelling), ARTHRITIS (Joint inflammation), PERIPHERAL COLDNESS (Cold hands) and PERIPHERAL COLDNESS (Cold feet) in a 37-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000059A) for an unknown indication. The patient''s past medical history included Irritable bowel syndrome (diagnosed with fibromyalgia since 2014 along side irritable bowel syndrome) and Fibromyalgia. Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN) from 01-Feb-2014 to an unknown date, DULOXETINE from 01-Feb-2014 to an unknown date and IMIPRAMINE from 01-Feb-2014 to an unknown date for Fibromyalgia, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 06-Aug-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 01-Oct-2021 to an unknown date for an unknown indication. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced ARTHRITIS (Joint inflammation) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced PERIPHERAL COLDNESS (Cold hands) (seriousness criterion medically significant) and PERIPHERAL COLDNESS (Cold feet) (seriousness criterion medically significant). On an unknown date, the patient experienced INFECTION (infection) (seriousness criterion medically significant) and SWELLING (swelling) (seriousness criterion medically significant). At the time of the report, INFECTION (infection), SWELLING (swelling), ARTHRITIS (Joint inflammation), PERIPHERAL COLDNESS (Cold hands) and PERIPHERAL COLDNESS (Cold feet) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, 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. Patient left ring finger inflated very badly and been swelling and painful since the day after the vaccine. she had attended on the 3th and been seen buy hand consultant on morning of the 4th. although infection has not been confirmed but she had been given antibiotics for 7 days No treatment information was provided. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial This report does not relate to possible inflammation of the heart (myocarditis or pericarditis) General checkup as well as Blood test and x-ray from the finger was taken. Company comment: This is a regulatory case concerning a 37-year-old male patient with medical history of fibromyalgia and irritable bowel syndrome, who experienced the serious unexpected, events of infection, swelling, arthritis, peripheral coldness (cold feet and hands). The event arthritis occurred the day after the third dose of mRNA-1273 vaccine. The event peripheral coldness occurred approximately 2 days after the third dose of mRNA-1273 vaccine. Infection and swelling occurred on an unknown date after the third dose. The rechallenge was unknown according. The medical history of fibromyalgia and irritable bowel syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 37-year-old male patient with medical history of fibromyalgia and irritable bowel syndrome, who experienced the serious unexpected, , events of infection, swelling, arthritis, peripheral coldness (cold feet and hands). The event arthritis occurred the day after the third dose of mRNA-1273 vaccine. The event peripheral coldness occurred approximately 2 days after the third dose of mRNA-1273 vaccine. Infection and swelling occurred on an unknown date after the third dose. The rechallenge was unknown according. The medical history of fibromyalgia and irritable bowel syndrome remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2037182 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-30
Onset:2021-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: shivers; Nausea; Stomach pain; Light-headed; This case was received (Reference number: GB-MHRA-ADR 26438162) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DIZZINESS (Light-headed), CHILLS (shivers) and NAUSEA (Nausea) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), DIZZINESS (Light-headed) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivers) (seriousness criterion medically significant). On 03-Jan-2022, ABDOMINAL PAIN UPPER (Stomach pain) had resolved with sequelae, DIZZINESS (Light-headed) and NAUSEA (Nausea) had resolved. At the time of the report, CHILLS (shivers) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was reported that vaccine administered, sore arm followed approx. 6 hours later, shivers and temperature followed approx. 18 hours later, together with nausea, crippling stomach pains and light headedness, the shivers and temp stopped but the extra side-effects carried on for 3 days. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test, patient was not currently breastfeeding and not pregnant Patient was not enrolled in clinical trial Report not related to possible inflammation of the heart (myocarditis or pericarditis) Relevant concomitant medications were not provided by the reporter Treatment medication was not reported. Company Comment: This case concerns a 35-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Abdominal pain upper, Dizziness, Chills and Nausea. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 35-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Abdominal pain upper, Dizziness, Chills and Nausea. The events occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Events seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


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