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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 125 out of 10,493

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VAERS ID: 2023461 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Fatigue, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211225; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Chest pain; Racing heart (tachycardia); Fatigue/unusual tiredness; Fever; Shortness of breath; Chest pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418506) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of the first episode of CHEST PAIN (Chest pain), the second episode of CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), TACHYCARDIA (Racing heart (tachycardia)) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant). On an unknown date, the patient experienced the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant) and FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant). At the time of the report, last episode of CHEST PAIN (Chest pain), PYREXIA (Fever), DYSPNOEA (Shortness of breath), TACHYCARDIA (Racing heart (tachycardia)) and FATIGUE (Fatigue/unusual tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-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. Patient was experienced sharpe chest pains, sweaty, muscle ache and extreme tiredness. No pain killer has helped with the pains Patient has not had symptoms associated with COVID-19 No relevant concomitant and treatment medications were reported; Sender''s Comments: This is a regulatory case concerning a female patient of unknown age with no medical history reported, who experienced the unexpected events of chest pain, pyrexia, dyspnea, tachycardia and fatigue. The event chest pain occurred on the same day after the third dose of mRNA ? 1273 vaccine, while the other events was experienced on an unknown date. Events were reported as medically significant and at time of report outcome was unknown. The rechallenge is unknown since no information about the first two dose were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2023466 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-22
Onset:2021-12-29
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Toothache
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: PARACETAMOL
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Toothache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418606) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TOOTHACHE (Toothache) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Unsure if patient has had symptoms associated with COVID-19. Concomitant products included PARACETAMOL for General body pain. On 22-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced TOOTHACHE (Toothache) (seriousness criterion medically significant). At the time of the report, TOOTHACHE (Toothache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-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 toothache appeared had very bad sensitivity in all teeth and possible abscess forming. Patient had no previous dental problems prior to Moderna booster. Headache and fibro myalgia type pain also prevalent and spinal pain was already but was pretty unbearable. Patient was not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial No treatment medications were reported.; Sender''s Comments: This case concerns a female patient (age not provided) with no relevant medical history, who experienced the unexpected serious event of Toothache. The event occurred approximately 7 days after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). It was reported toothache appeared from nowhere. Very bad sensitivity in all teeth and possible abscess forming, with no previous dental problems prior to Moderna booster. The rechallenge was not applicable as event occurred after a booster dose.. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2023468 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bladder pain, Breast pain, 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), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Bladder pain; Fever; Painful arm; Nausea; Breast pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418704) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BLADDER PAIN (Bladder pain), PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm), NAUSEA (Nausea) and BREAST PAIN (Breast pain) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced BLADDER PAIN (Bladder pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and BREAST PAIN (Breast pain) (seriousness criterion medically significant). At the time of the report, BLADDER PAIN (Bladder pain), PYREXIA (Fever), PAIN IN EXTREMITY (Painful arm) and BREAST PAIN (Breast pain) had not resolved and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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. No concomitant and treatment medications were provided. Patient has not had symptoms associated with COVID-19. Patient was neither pregnant nor breastfeeding. Patient last menstrual period date 25-Dec-2021. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 31-year-old, female patient with no reported medical history, who experienced the unexpected serious events of bladder pain, pyrexia, painful arm, nausea and breast pain. The events bladder pain, pyrexia, painful arm, nausea and breast pain occurred the same day with the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events bladder pain, pyrexia, painful arm and breast pain was not resolved while the event nausea the outcome was resolving from the time of last observation. 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 bladder pain, pyrexia, painful arm, nausea and breast pain. The events bladder pain, pyrexia, painful arm, nausea and breast pain occurred the same day with the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events bladder pain, pyrexia, painful arm and breast pain was not resolved while the event nausea the outcome was resolving from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2023471 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: 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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swollen arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418758) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) in a 22-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) 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 has not tested positive for COVID-19 since having the vaccine. No treatment medication information was reported Company comment This is a regulatory case concerning a 22-year-old female patient with no medical history reported, who experienced the serious unexpected according to CCDS, event of Peripheral swelling. The event occurred on the same day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 22-year-old female patient with no medical history reported, who experienced the serious unexpected according to CCDS, event of Peripheral swelling. The event occurred on the same day after the third dose of mRNA-1273. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2023473 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Immune system disorder, Migraine, Muscle fatigue, Palpitations, Pyrexia, SARS-CoV-2 test, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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 MRNA (BNT162B2)
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome (had endometriosis, CFS/ME and noticed a severe relapse of CFS following all my Covid vaccinations); Endometriosis
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Fever; Immune system disorder; Migraine; Palpitations; Muscle fatigue; Sleep disorder; Ache stomach; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26418893) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), IMMUNE SYSTEM DISORDER (Immune system disorder), MIGRAINE (Migraine), PALPITATIONS (Palpitations), MUSCLE FATIGUE (Muscle fatigue), SLEEP DISORDER (Sleep disorder) and ABDOMINAL PAIN UPPER (Ache stomach) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Chronic fatigue syndrome (had endometriosis, CFS/ME and noticed a severe relapse of CFS following all my Covid vaccinations) and Endometriosis. Concomitant products included COVID-19 VACCINE MRNA (BNT162B2) from 08-May-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), IMMUNE SYSTEM DISORDER (Immune system disorder) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant), MUSCLE FATIGUE (Muscle fatigue) (seriousness criterion medically significant), SLEEP DISORDER (Sleep disorder) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Ache stomach) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), IMMUNE SYSTEM DISORDER (Immune system disorder), MIGRAINE (Migraine), PALPITATIONS (Palpitations), MUSCLE FATIGUE (Muscle fatigue), SLEEP DISORDER (Sleep disorder) and ABDOMINAL PAIN UPPER (Ache stomach) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-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 Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial No possible inflammation of the heart (myocarditis or pericarditis). Company comment: This regulatory case concerns a female patient of unknown age, with history of chronic fatigue syndrome, who experienced the serious (medically significant) unexpected events of PYREXIA, IMMUNE SYSTEM DISORDER, MIGRAINE, PALPITATIONS, MUSCLE FATIGUE, SLEEP DISORDER and ABDOMINAL PAIN UPPER. The events occurred on the same day after receiving a dose of mRNA-1273 and had not resolved by the time of the report. Previous vaccination schedule included two doses of Tozinameran (last dose administered over 4 months prior to mRNA-1273. Patient''s history of chronic fatigue syndrome remains as a confounder. No further clinical information was available for medical reviewing. 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 case concerns a female patient of unknown age, with history of chronic fatigue syndrome, who experienced the serious (medically significant) unexpected events of PYREXIA, IMMUNE SYSTEM DISORDER, MIGRAINE, PALPITATIONS, MUSCLE FATIGUE, SLEEP DISORDER and ABDOMINAL PAIN UPPER. The events occurred on the same day after receiving a dose of mRNA-1273 and had not resolved by the time of the report. Previous vaccination schedule included two doses of Tozinameran (last dose administered over 4 months prior to mRNA-1273. Patient''s history of chronic fatigue syndrome remains as a confounder. No further clinical information was available for medical reviewing. 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: 2023480 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Shivers; Fever; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26419407) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), CHILLS (Shivers), FATIGUE (Fatigue) and PYREXIA (Fever) in a 50-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 10-Mar-2020. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) had not resolved and CHILLS (Shivers) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drug information provided. No treatment drug information provided. Patient felt a bit fatigued on the evening of the booster. All the other symptoms happened at around 12.30 the next day. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Company comment: This case concerns a 50-year-old male patient with no relevant medical history who experienced serious unexpected events of Fatigue, Headache, Pyrexia and Chills. The events occurred on the same day or one day after the third, booster dose of mRNA-1273. At the time of the report, the event Chills was resolving whereas all the other events were still ongoing. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 50-year-old male patient with no relevant medical history who experienced serious unexpected events of Fatigue, Headache, Pyrexia and Chills. The events occurred on the same day or one day after the third, booster dose of mRNA-1273. At the time of the report, the event Chills was resolving whereas all the other events were still ongoing. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Asthma (I take steroid inhalers for asthma.); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Nauseated; Muscle ache; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26419762) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), NAUSEA (Nauseated), MYALGIA (Muscle ache) and FATIGUE (Tiredness) 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 (I take steroid inhalers for asthma.) and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced NAUSEA (Nauseated) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 31-Dec-2021, NAUSEA (Nauseated) had resolved. At the time of the report, HEADACHE (Headache) and FATIGUE (Tiredness) had not resolved and MYALGIA (Muscle ache) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a female patient of an unknown age with no relevant medical history provided who experienced serious unexpected events of Fatigue, Myalgia, Nausea and Headache. The events occurred on the same day or one day after the third dose of mRNA-1273. At the time of the report, Headache and Fatigue were still ongoing whereas Myalgia was resolving while Nausea had resolved. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per and kept as such. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age with no relevant medical history provided who experienced serious unexpected events of Fatigue, Myalgia, Nausea and Headache. The events occurred on the same day or one day after the third dose of mRNA-1273. At the time of the report, Headache and Fatigue were still ongoing whereas Myalgia was resolving while Nausea had resolved. No further information regarding clinical course of the events was provided at this time. The rechallenge and action taken with the suspect product were reported as unknown as per and kept as such. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2023483 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dyspnoea, Immunisation, Interchange of vaccine products, Off label use, Pruritus, SARS-CoV-2 test, Stridor
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AZATHIOPRINE; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Kidney stone; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); SLE; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Urinary retention
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000545

Write-up: Anaphylaxis; stridor; itching; SOB; patient previously took two doses Covid-19 vaccine astrazeneca, and received bnt162b2; patient previously took two doses Covid-19 vaccine astrazeneca, and received bnt162b2; patient previously took two doses Covid-19 vaccine astrazeneca, and received bnt162b2; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112311001020720-OARCC. Other Case identifier(s): GB-MHRA-ADR 26420534. A 28 year-old female patient received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...; "systemic lupus erythematosus (SLE)" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "urinary retention" (unspecified if ongoing); "renal stones" (unspecified if ongoing). Patient did not have symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included: AZATHIOPRINE; PREDNISOLONE. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 26Mar2021, for Covid-19 immunisation; Covid-19 vaccine astrazeneca, administration date: 11Jun2021, for Covid-19 immunisation. The following information was reported: OFF LABEL USE (caused and prolonged hospitalization, medically significant, life threatening), INTERCHANGE OF VACCINE PRODUCTS (caused and prolonged hospitalization, medically significant, life threatening), IMMUNISATION (caused and prolonged hospitalization, medically significant, life threatening) all with onset 2021, outcome "unknown" and all described as "patient previously took two doses Covid-19 vaccine astrazeneca, and received bnt162b2"; ANAPHYLACTIC REACTION (hospitalization, medically significant, life threatening) with onset 29Dec2021, outcome "recovering", described as "Anaphylaxis"; STRIDOR (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "stridor"; PRURITUS (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "itching"; DYSPNOEA (hospitalization, medically significant, life threatening) with onset 2021, outcome "unknown", described as "SOB". The events "anaphylaxis", "stridor", "itching" and "sob" were evaluated at the physician office visit and emergency room visit. Patient experienced SOB with stridor, itching, following booster dose at General practitioner (GP) ambulance called. Patient was given 3 doses of adrenaline, taken to Accident & Emergency (A&E) and then transferred to intensive care unit (ICU). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative, notes: No - Negative COVID-19 test. Patient did not test positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of anaphylactic reaction, stridor, pruritus, dyspnoea. Clinical course: The report was not related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2023840 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-12-29
   Days after vaccination:177
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: sars-cov-2 PCR test; Test Result: Positive
CDC Split Type: PTPFIZER INC202200002882

Write-up: Vaccination failure, despite two vaccine doses has Covid-19; Vaccination failure, despite two vaccine doses has Covid-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient. A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 05Jul2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single and administration date 14Jun2021 (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 patient had no known allergies. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Vaccination failure, despite two vaccine doses has Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19. The lot number for BNT161B2, was not provided and will be requested during follow up.


VAERS ID: 2023990 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Blood pressure increased, Chest pain, Chills, Dyspnoea, Fatigue, Heart rate increased, Limb discomfort, Nausea, Pain in extremity, Palpitations, Pyrexia, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: heavy arm; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Joint pain; Fever; Shivering; Nausea; Weakness; Heart rate high; Elevated BP; Chest ache; Painful arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26414500) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (heavy arm), ARTHRALGIA (Joint pain), the first episode of PYREXIA (Fever), CHILLS (Shivering), NAUSEA (Nausea), ASTHENIA (Weakness), HEART RATE INCREASED (Heart rate high), BLOOD PRESSURE INCREASED (Elevated BP), CHEST PAIN (Chest ache), PAIN IN EXTREMITY (Painful arm), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the second episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 25-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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criteria disability and medically significant), the first episode of PYREXIA (Fever) (seriousness criteria disability and medically significant), CHILLS (Shivering) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant), ASTHENIA (Weakness) (seriousness criteria disability and medically significant), HEART RATE INCREASED (Heart rate high) (seriousness criteria disability and medically significant), BLOOD PRESSURE INCREASED (Elevated BP) (seriousness criteria disability and medically significant), CHEST PAIN (Chest ache) (seriousness criteria disability and medically significant) and PAIN IN EXTREMITY (Painful arm) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced LIMB DISCOMFORT (heavy arm) (seriousness criteria disability and medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criteria disability and medically significant), CHEST PAIN (Chest pain) (seriousness criteria disability and medically significant), the second episode of PYREXIA (Fever) (seriousness criteria disability and medically significant), DYSPNOEA (Shortness of breath) (seriousness criteria disability and medically significant), PALPITATIONS (Heart palpitations) (seriousness criteria disability and medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criteria disability and medically significant). On 30-Dec-2021, CHILLS (Shivering) had resolved. At the time of the report, LIMB DISCOMFORT (heavy arm), ARTHRALGIA (Joint pain), ASTHENIA (Weakness), CHEST PAIN (Chest ache) and PAIN IN EXTREMITY (Painful arm) had not resolved, NAUSEA (Nausea), HEART RATE INCREASED (Heart rate high) and BLOOD PRESSURE INCREASED (Elevated BP) was resolving and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), the last episode of PYREXIA (Fever), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown. 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. No concomitant medication was provided by the reporter. Patient had first 2 jabs were Pfizer and all the patient experienced was a heavy arm, so did not expect to feel this terrible after the Moderna booster. Patient was aware that many of these symptoms were reported as common side effects but if patient had known the extreme to which had experience them, would not have had the booster jab.Patient had not tested positive for COVID-19 since having the vaccine. Patient last menstruation period date was 09-Dec-2021. Patient had not enrolled in clinical trial. The symptoms did not lead to a hospital stay. No treatment medication was provided by the reporter. Company Comment: This is a regulatory case concerns a 25-year-old female patient with no medical history reported, who experienced the unexpected serious events of Limb discomfort, Arthralgia, Pyrexia, Chills, Nausea, Asthenia, Heart rate increased, Blood pressure increased, Chest pain, Pain in extremity, Fatigue, Chest pain, Pyrexia, Dyspnoea, Palpitations and Tachycardia. The events Arthralgia, Pyrexia, Nausea, Asthenia, Heart rate increased, Blood pressure increased, Chest pain and Pain in extremity occurred on the same day, the event Chills occurred 1 day after and events Limb discomfort, Fatigue, Chest pain, Pyrexia, Dyspnoea, Palpitations and Tachycardia occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This is a regulatory case concerns a 25-year-old female patient with no medical history reported, who experienced the unexpected serious events of Limb discomfort, Arthralgia, Pyrexia, Chills, Nausea, Asthenia, Heart rate increased, Blood pressure increased, Chest pain, Pain in extremity, Fatigue, Chest pain, Pyrexia, Dyspnoea, Palpitations and Tachycardia. The events Arthralgia, Pyrexia, Nausea, Asthenia, Heart rate increased, Blood pressure increased, Chest pain and Pain in extremity occurred on the same day, the event Chills occurred 1 day after and events Limb discomfort, Fatigue, Chest pain, Pyrexia, Dyspnoea, Palpitations and Tachycardia occurred on an unknown date after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2023994 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hot flush, Influenza like illness, Lethargy, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: flu like symptoms; lethargy; Muscle ache; Nausea; Hot flush; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26416679) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), LETHARGY (lethargy), MYALGIA (Muscle ache), NAUSEA (Nausea), HOT FLUSH (Hot flush) and HEADACHE (Headache) in a 45-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 21-Mar-2019 to 01-Apr-2019. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HOT FLUSH (Hot flush) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion medically significant) and LETHARGY (lethargy) (seriousness criterion medically significant). On 30-Dec-2021, MYALGIA (Muscle ache), NAUSEA (Nausea), HOT FLUSH (Hot flush) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) and LETHARGY (lethargy) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. Flu like symptoms presented after 15 hours - body aches, hot flushes, headache, nausea and lethargy - and lasted for a further 15 hours. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment:This regulatory authority case concerns a 45-year-old female patient with no medical history, who experienced the unexpected serious events of Influenza like illness, Lethargy, Myalgia, Nausea, Hot Flush and Headache. The events Myalgia, Nausea, Hot Flush and Headache occurred 1 day after and events Influenza like illness and Lethargy occurred on unknown date after the third dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the events Influenza like illness and Lethargy were resolving and other events had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.; Sender''s Comments: This regulatory authority case concerns a 45-year-old female patient with no medical history, who experienced the unexpected serious events of Influenza like illness, Lethargy, Myalgia, Nausea, Hot Flush and Headache. The events Myalgia, Nausea, Hot Flush and Headache occurred 1 day after and events Influenza like illness and Lethargy occurred on unknown date after the third dose of mRNA-1273 Vaccine. No clinical or treatment details were given. It was reported that the events Influenza like illness and Lethargy were resolving and other events had resolved. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority''s report due to important medical condition.


VAERS ID: 2024303 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative.
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Headache; Ache; Chills; Stomach ache; This case was received via the Regulatory Authority (Reference number GB-MHRA-ADR 26417773) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER, HEADACHE, PAIN, and CHILLS in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Immunodeficiency. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (seriousness criterion medically significant), PAIN (seriousness criterion medically significant), and CHILLS (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER, HEADACHE, PAIN, and CHILLS had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, SARS-CoV-2 test Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided by the reporter. This regulatory case concerns a 43-year-old, female patient with no relevant medical history reported, who experienced the unexpected, serious events of abdominal pain upper, headache, pain and chills. The event abdominal pain upper 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. Treatment information was not provided. The events 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: 2024321 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Idiopathic urticaria, Lip swelling, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: lips swelled; hives; Urticaria idiopathic; Pyrexia; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26415645) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIP SWELLING (lips swelled), URTICARIA (hives), IDIOPATHIC URTICARIA (Urticaria idiopathic) and PYREXIA (Pyrexia) in a 22-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 Suspected COVID-19 from 01-Feb-2020 to 10-Feb-2020. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 22-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced IDIOPATHIC URTICARIA (Urticaria idiopathic) (seriousness criterion medically significant) and PYREXIA (Pyrexia). On an unknown date, the patient experienced LIP SWELLING (lips swelled) (seriousness criterion medically significant) and URTICARIA (hives) (seriousness criterion medically significant). On 29-Dec-2021, IDIOPATHIC URTICARIA (Urticaria idiopathic) had resolved. At the time of the report, LIP SWELLING (lips swelled) and URTICARIA (hives) had resolved and PYREXIA (Pyrexia) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment medications were not reported. It was stated that the patient had experienced Urticaria idiopathic- 8hrs after vaccine administration- rash, hives, intense itching covered feet, back of knees, back of thighs, waistline, side of torso, below breasts, arms, neck, face, lips swelled, including turning blue. Patient had taken 1 10mg Loratadine tablet resolved in 1.5hrs after administration. Pyrexia was reoccurring for every 9 hours after vaccine. Patient had taken two 500mg paracetamol tablets. Company Comment: This regulatory case concerns a 22-year-old, female patient with no relevant medical history reported, with an Interchange of vaccine products TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) 4 months before the current vaccination, who experienced the unexpected serious events of lip swelling, urticaria, idiopathic urticaria and pyrexia. The events idiopathic urticaria and pyrexia occurred on the same day, the events lip swelling and urticaria on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the events lip swelling, urticaria and idiopathic urticaria was reported as resolved and pyrexia is reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This regulatory case concerns a 22-year-old, female patient with no relevant medical history reported, with an Interchange of vaccine products TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) 4 months before the current vaccination, who experienced the unexpected serious events of lip swelling, urticaria, idiopathic urticaria and pyrexia. The events idiopathic urticaria and pyrexia occurred on the same day, the events lip swelling and urticaria on an unknown date after the third dose of mRNA-1273 vaccine. The outcome of the events lip swelling, urticaria and idiopathic urticaria was reported as resolved and pyrexia is reported as resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2024325 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Lymphadenopathy, Pyrexia, Rash pruritic, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis (not treated); Nasal polyps (treated with nasal steroids); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
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.MOD20214

Write-up: Swollen lymph nodes; Dizziness; Itchy rash; High temperature; Shivering; Tiredness; This case was received via RA (Reference number: GB-MHRA-ADR 26418150) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), RASH PRURITIC (Itchy rash), PYREXIA (High temperature), CHILLS (Shivering), FATIGUE (Tiredness) and DIZZINESS (Dizziness) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concurrent medical conditions included Endometriosis (not treated), Nasal polyps (treated with nasal steroids), Suspected COVID-19 since 29-Dec-2021 and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and PYREXIA (High temperature) had not resolved and RASH PRURITIC (Itchy rash), CHILLS (Shivering), FATIGUE (Tiredness) and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-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. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not pregnant, Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. No treatment medications were reported. Company comment: This case concerns a 36-year-old female patient with relevant medical history of Suspected COVID-19 who experienced serious unexpected events of Pyrexia, Rash pruritic, Chills, Fatigue, Lymphadenopathy and Dizziness. The events occurred on the same day or one day after the third dose of mRNA-1273. At the time of the report, Lymphadenopathy and Pyrexia were still ongoing whereas Rash pruritic, Chills, Fatigue and Dizziness were resolving. No further information regarding clinical course of the events was provided at this time. Causality is confounded with patient''s reported medical history, however, it should be noted that the patient tested negative for COVID-19 one day after the vaccination. The rechallenge and action taken with the suspect product were reported as unknown as per Agency and kept as such. Event terms, onset dates and outcomes captured per Agency Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old female patient with relevant medical history of Suspected COVID-19 who experienced serious unexpected events of Pyrexia, Rash pruritic, Chills, Fatigue, Lymphadenopathy and Dizziness. The events occurred on the same day or one day after the third dose of mRNA-1273. At the time of the report, Lymphadenopathy and Pyrexia were still ongoing whereas Rash pruritic, Chills, Fatigue and Dizziness were resolving. No further information regarding clinical course of the events was provided at this time. Causality is confounded with patient''s reported medical history, however, it should be noted that the patient tested negative for COVID-19 one day after the vaccination. The rechallenge and action taken with the suspect product were reported as unknown as per Agency and kept as such. Event terms, onset dates and outcomes captured per Agency Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2024398 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615 / 2 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005792 / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Pruritus, Swelling, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had Moderna booster on 17th Dec. 12-13 days later, swelling hives started to develop on my thighs and stomach and they''re very itchy then spread to legs and hands. Saw a GP and he prescribed Loratadine. After that the hives are no more swelling and not very itchy but still on my body After 2 or 3 days later, saw a dermatologist and prescribed Telfast. But I can still draw the things on my skin.


VAERS ID: 2025695 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5108 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Headache, Immunisation, Interchange of vaccine products, Off label use, Vaccination site pain
SMQs:, Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic; Hypertensive
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101878233

Write-up: vision loss; I took 2 doses of Astra Zeneca''s; I took 2 doses of Astra Zeneca''s; took the booster dose; headache; pain in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 52 year-old patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FF5108) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing); "hypertensive" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (1st dose), for immunization, reaction(s): "no adverse effect"; Covid-19 vaccine (2nd dose), for immunization, reaction(s): "no adverse effect". The following information was reported: BLINDNESS (medically significant) with onset 29Dec2021, outcome "unknown", described as "vision loss"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "I took 2 doses of Astra Zeneca''s"; IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "took the booster dose"; HEADACHE (non-serious) with onset 29Dec2021, outcome "unknown", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 29Dec2021, outcome "unknown", described as "pain in the arm". The reporter reported that patient was diabetic and hypertensive. Patient took 2 doses of Astra Zeneca''s covid vaccine and took the booster dose today around noon. When it was around 1 and little in the afternoon gave patient vision loss, headache, and pain in the arm (at the injection site). Patient had received Tylenol as treatment for the event and patient was having tea now. The loss of vision that worried the patient.Therapeutic measures were taken as a result of blindness, headache, vaccination site pain.


VAERS ID: 2026021 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ACB4447 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Facial paralysis, Muscular weakness, Myalgia, Neuralgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hearing impairment (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoimmune disorder NOS.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202200004119

Write-up: facial paralysis on the left side; shivering like in a known episode of her as yet undiagnosed disease; Nerve pain; muscle pain; a foot lifting weakness on the left side; feverish; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient. Other Case identifier(s): 111901 (Biontech). A 28 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: ACB4447) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspicion of autoinflammatory syndrome, something rheumatic or also MS" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "facial paralysis on the left side"; CHILLS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "shivering like in a known episode of her as yet undiagnosed disease"; NEURALGIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "Nerve pain"; MYALGIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "muscle pain"; MUSCULAR WEAKNESS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "a foot lifting weakness on the left side"; PYREXIA (non-serious) with onset 29Dec2021, outcome "not recovered", described as "feverish". The events "facial paralysis on the left side", "shivering like in a known episode of her as yet undiagnosed disease", "nerve pain", "muscle pain", "a foot lifting weakness on the left side" and "feverish" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of facial paralysis, chills, neuralgia, myalgia, muscular weakness, pyrexia. Clinical course: The patient was refused vaccination several times because autoinflammatory syndrome is suspected, something rheumatic or MS. The final diagnose is still unknown. She has consulted 2 other doctors who refused to vaccinate her. Today, she went to vaccination center and got the vaccination end experienced adverse events: facial paralysis on the left side, shivering like in a known episode of her as yet undiagnosed disease, nerve pain, muscle pain, a foot lifting weakness on the left side, she starts to get feverish. She did not want to take cortisone because she did not want to stop the immune reaction of the vaccination. Treatment was pregabalin, novamine and ibuprofen. The pain is still there. She has also been to the doctor today, who has ordered hospitalization if it gets worse. The vaccination may have triggered an episode. Patient can no longer be heard clearly because of the paralysis, start of the reaction: 20 to 30 minutes after and evolved to facial paralysis afterwards.


VAERS ID: 2026202 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCVD1 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Limb discomfort, Loss of consciousness, Paraesthesia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101877394

Write-up: He passed out during the injection.; Feel tingling in the left leg, numbness, heaviness; Feel tingling in the left leg, numbness, heaviness; Feel tingling in the left leg, numbness, heaviness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Dec2021 10:30 (Lot number: SCVD1) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Aug2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 29Dec2021, outcome "unknown", described as "He passed out during the injection."; HYPOAESTHESIA (non-serious), LIMB DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "Feel tingling in the left leg, numbness, heaviness". Additional information: On the way home, he started to feel tingling in his left leg, numbness, heaviness in his leg. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2026498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Bone pain, Musculoskeletal chest pain, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteonecrosis (broad), 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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; Back pain (Pain during COVID); Bone pain (Pain during COVID); COVID-19 (Unsure when symptoms stopped, Got ill with COVID in July2021.); Joint pain (Pain during COVID); Rib pain (Pain during COVID)
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101882466

Write-up: Rib pain; Bone pain; Joint pain; Nausea; Back ache; 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-202112290757253970-WBG23. Other Case identifier(s): GB-MHRA-ADR 26406922. A 18 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 21Jul2021 (unspecified if ongoing), notes: Unsure when symptoms stopped,, Got ill with COVID in July2021.; "Anxiety disorder" (unspecified if ongoing); "Rib pain" (unspecified if ongoing); "Bone pain" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "Joint pain" (unspecified if ongoing), notes: Pain during COVID. Patient last menstrual period date was 04Dec2021 and not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. Concomitant medication(s) included: SERTRALINE taken for anxiety disorder, start date: 2016. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL CHEST PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Rib pain"; BONE PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Bone pain"; ARTHRALGIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Joint pain"; NAUSEA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Nausea"; BACK PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Back ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jul2021) yes - positive COVID-19 test. It was reported that rib, back, bone, and joint pain the patient was experiencing after the vaccine was pretty much identical to the pain during COVID (if not worse). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026500 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Hyperhidrosis, Presyncope, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20211223; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: sweating; clammy; Near fainting; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26407303) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), COLD SWEAT (clammy) and PRESYNCOPE (Near fainting) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was reported. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant) and COLD SWEAT (clammy) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (sweating) and COLD SWEAT (clammy) outcome was unknown and PRESYNCOPE (Near fainting) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-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 unsure if patient has had symptoms associated with COVID-19 Patient was not pregnant and was not currently breastfeeding Patient had the moderna booster on 28/12/21 at 9am. Felt fine rest of day, except sore arm and a little headachy. Woke up 29/12/21 at 6am, went to the loo for a pee and felt so lightheaded and body heavy and patient thought she was going to pass out. Only way of calming it down was to lie on the cold bathroom floor. It took her about 10 minutes of lying down, feeling clammy, sweating before she could get up again and go back to bed Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial Patient did not had possible inflammation of the heart like myocarditis or pericarditis Treatment information was not provided. Company Comment : This RA case concerns a 30 year old female with no medical history reported, vaccinated initially using Tozinameran ( details not reported ) who experienced serious ( medically significant ) unexpected event of Pre-syncope which occurred one day after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) On an unknown date post vaccination with the 3rd dose , this patient experienced Serious ( medically significant ) unexpected events of hyperhidrosis and cold sweat. The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 30 year old female with no medical history reported, vaccinated initially using Tozinameran ( details not reported ) , who experienced serious ( medically significant ) , unexpected event of Pre-syncope which occurred one day after the vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) On an unknown date post vaccination with the 3rd dose , this patient experienced Serious ( medically significant ) , unexpected events of hyperhidrosis and cold sweat. The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2026545 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Cold sweat, Dizziness, Feeling hot, Immunisation
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882442

Write-up: Booster; anaphylaxis; clammy; Felt faint/ felt dizzy; felt very hot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112291900321880-DTSVL. Other Case identifier(s): GB-MHRA-ADR 26411020. A 23 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: fk9712) at the age of 23 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 01), for COVID-19 Immunization; Bnt162b2 (Dose 02), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; ANAPHYLACTIC REACTION (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "anaphylaxis"; COLD SWEAT (non-serious) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "clammy"; DIZZINESS (non-serious) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Felt faint/ felt dizzy"; FEELING HOT (non-serious) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "felt very hot". Therapeutic measures were taken as a result of anaphylactic reaction, cold sweat, dizziness, feeling hot. Clinical information: About 10 minutes after the vaccine the patient said that they felt very hot and was clammy and felt dizzy. They were assessed for anaphylaxis but not showing any symptoms. Given some water and chocolate and lied down on the floor with legs elevated. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. 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: 2026555 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Immunisation, Migraine, 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 INC202101882474

Write-up: Booster; Chills; Migraine headache; 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-202112292059404000-ZQQ2L (MHRA). Other Case identifier(s): GB-MHRA-ADR 26411695 (MHRA). A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 29 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. Patient 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 29Dec2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Chills"; MIGRAINE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Migraine headache". The patient underwent the following laboratory tests and procedures: COVID-19 virus test and result showed no - negative COVID-19 test. 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: 2026562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Breast pain, Chills, Lymphadenopathy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Lipodystrophy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV positive (HIV-positive with symptoms or reduction in immune response)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882506

Write-up: Joint pain; Nausea; Breast pain; Chills; Swollen glands; This is a spontaneous report received from a contactable Consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112292152271910-J4JL3. Other Case identifier(s): GB-MHRA-ADR 26412114. A 54 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "HIV positive , notes: HIV-positive with symptoms or reduction in immune response. Patient has not had symptoms associated with COVID-19 and was not currently breastfeeding. Patient last menstrual period date was in 2019. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: ARTHRALGIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Joint pain"; NAUSEA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Nausea"; BREAST PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Breast pain"; CHILLS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Chills"; LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen glands". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The reporter did not consider the event related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026580 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Pain in arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26412991) on 30-Dec-2021 and was forwarded to Moderna on 30-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had not had 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 vaccination. Patient was not enrolled in clinical trial. Concomitant and treatment medications were not reported. Company comment This case concerns a 42-year-old female patient, with no reported medical history, who experienced the unexpected serious event of PAIN IN EXTREMITY. The event occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. At the time of the report, PAIN IN EXTREMITY had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 42-year-old female patient, with no reported medical history, who experienced the unexpected serious event of PAIN IN EXTREMITY. The event occurred on the same day after the administration of the third dose of mRNA-1273 vaccine. At the time of the report, PAIN IN EXTREMITY had not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2026582 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Heart rate, Heart rate increased, Hyperhidrosis, Muscle twitching, Myalgia, Off label use, Product use issue, Pyrexia, Skin warm, Sweating fever
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dyskinesia (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: CHOLESTYRAMINE
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Bile acid malabsorption; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: Fever; Result Unstructured Data: Test Result:39; Comments: measuring 39 on digital in ear thermometer; Test Date: 20211230; Test Name: Heart rate; Result Unstructured Data: Test Result:at 130 when lying down (usual base BPM of 62)
CDC Split Type: GBPFIZER INC202101882472

Write-up: Fever/Fever chills/very sudden extreme fever measuring 39 on digital in ear thermometer; Heart rate high/Heart rate extremely elevated at 130 when lying down (usual base BPM of 62); Muscle ache; Skin warm/Skin warm to the touch all over; Muscle twitching; Sharp headache; Sweating fever; Off label use; Drug use in unapproved population; Strong chills; Extreme sweating; 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-202112300554163100-TLK1S (RA). Other Case identifier(s): GB-MHRA-ADR 26413339 (RA). A 30-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing); "Suspected COVID-19", start date: 15Jan2020, stop date: 20Mar2020; "Bile acid malabsorption" (unspecified if ongoing). Patient did not have COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient last menstrual date was 26Dec2020.Concomitant medication(s) included: CHOLESTYRAMINE taken for bile acid malabsorption. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever/Fever chills/very sudden extreme fever measuring 39 on digital in ear thermometer"; HEART RATE INCREASED (medically significant) with onset 30Dec2021, outcome "recovering", described as "Heart rate high/Heart rate extremely elevated at 130 when lying down (usual base BPM of 62) "; MYALGIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Muscle ache"; SKIN WARM (medically significant) with onset 30Dec2021, outcome "recovering", described as "Skin warm/Skin warm to the touch all over"; MUSCLE TWITCHING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Muscle twitching"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Sharp headache"; SWEATING FEVER (medically significant) with onset 30Dec2021, outcome "recovering", described as "Sweating fever"; CHILLS (medically significant) with onset 2021, outcome "unknown", described as "Strong chills"; HYPERHIDROSIS (medically significant) with onset 2021, outcome "unknown", described as "Extreme sweating"; OFF LABEL USE (non-serious) with onset 29Dec2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 29Dec2021, outcome "unknown", described as "Drug use in unapproved population". The patient underwent the following laboratory tests and procedures: body temperature: (30Dec2021) 39, notes: measuring 39 on digital in ear thermometer; heart rate: (30Dec2021) at 130 when lying down (usual base bpm of 62). The report of the patient 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: 2026592 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymph node pain, SARS-CoV-2 test
SMQs:, 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 Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Lymph node pain; This case was received via RA (Reference number: GB-MHRA-ADR 26414725) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (Lymph node pain) in a 51-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. 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 29-Dec-2021, the patient experienced LYMPH NODE PAIN (Lymph node pain) (seriousness criterion disability). At the time of the report, LYMPH NODE PAIN (Lymph node pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The concomitant medications were not reported. The treatment information was not provided. Patient had swollen and extremely painfully under arm. Patient had not tested positive for COVID-19 post vaccination.Patient was not enrolled in clinical trials.It was reported that adverse reactions were not developed as a result of an exposure during pregnancy Company Comment: This is a regulatory case concerning a 51-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Lymph node pain. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report due to disability.; Sender''s Comments: This is a regulatory case concerning a 51-year-old, female patient with no reported medical history, who experienced the unexpected serious event of Lymph node pain. The event occurred 1 day after the third dose of mRNA-1273 vaccine. The outcome of the event was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authoritys report due to disability.


VAERS ID: 2026596 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle spasms, Pain
SMQs:, Dystonia (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: MAEXENI; NEXPLANON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Pain; Muscle spasms; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26415222) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Pain) and MUSCLE SPASMS (Muscle spasms) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. Concomitant products included ETONOGESTREL (NEXPLANON) from 23-Mar-2021 to an unknown date for Birth control, ETHINYLESTRADIOL, LEVONORGESTREL (MAEXENI) from 15-Dec-2021 to an unknown date for Contraception. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MUSCLE SPASMS (Muscle spasms) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (Pain) (seriousness criterion medically significant). At the time of the report, PAIN (Pain) and MUSCLE SPASMS (Muscle spasms) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had vaccine at 9.50 am and by 11.30 patient''s scapula was in excruciating pain which then went to patient''s neck where patient wasn''t able to even hold head straight and had to be tilted to the left to prevent pain. Pressure against scapula also caused pain while sitting. Patient spoke to NHS 111 who advised to contact the GP. GP explained to the patient that she had a rare reaction to the Moderna and was prescribed diazepam 2mg every 6- 8 hours and 180mg of fexofenadine. relevant investigations or tests conducted: Assessment by NHS 111 and GP consultation Dosage text :Dose 3b Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test, Patient is not currently breastfeeding This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This is a regulatory authority case concerning a 28-year-old, female patient with no reported medical history, who experienced the unexpected serious events of pain and muscle spasms. The events pain and muscle spasms occurred the same day after the third dose of mRNA-1273 vaccine administration. The events were described as, patient experienced excruciating pain in the scapula and neck which caused the patient to not able to hold her head straight and had to be tilted to prevent the occurrence of pain accompanied by pain in the scapula while sitting, with pressure against the scapula. Patient sought GP consult and was prescribed with Diazepam 2 mg every 6- 8 hours and Fexofenadine 180 mg. The outcome of the events was resolving from the time of last observation. 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 28-year-old, female patient with no reported medical history, who experienced the unexpected serious events of pain and muscle spasms. The events pain and muscle spasms occurred the same day after the third dose of mRNA-1273 vaccine administration. The events were described as, patient experienced excruciating pain in the scapula and neck which caused the patient to not able to hold her head straight and had to be tilted to prevent the occurrence of pain accompanied by pain in the scapula while sitting, with pressure against the scapula. Patient sought GP consult and was prescribed with Diazepam 2 mg every 6- 8 hours and Fexofenadine 180 mg. The outcome of the events was resolving from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2026609 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Flushing, Headache, Pain
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Ache; Flushed; Shivering; Headache dull; This case was received via RA (Reference number: GB-MHRA-ADR 26416949) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), FLUSHING (Flushed), CHILLS (Shivering) and HEADACHE (Headache dull) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 29-Jun-2021 to an unknown date for Booster. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), FLUSHING (Flushed) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), FLUSHING (Flushed), CHILLS (Shivering) and HEADACHE (Headache dull) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No medical history was provided by the reporter. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Treatment medication was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Company comment: This regulatory authority case concerns a 49 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain, flushing, chills, and headache. The event occurred 1 day after the third dose of mRNA-1273 vaccine. Outcome was reported as not resolved at the time of the report. 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 49 year old female patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of pain, flushing, chills, and headache. The event occurred 1 day after the third dose of mRNA-1273 vaccine. Outcome was reported as not resolved at the time of the report. 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: 2026612 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Nausea, Presyncope, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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? 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.MOD20214

Write-up: Near fainting; Vomiting; Nausea; Dizziness; Feeling cold; This case was received (Reference number: GB-MHRA-ADR 26417467) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PRESYNCOPE (Near fainting), VOMITING (Vomiting), NAUSEA (Nausea), DIZZINESS (Dizziness) and FEELING COLD (Feeling cold) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant) and FEELING COLD (Feeling cold) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, PRESYNCOPE (Near fainting), NAUSEA (Nausea) and FEELING COLD (Feeling cold) had not resolved and VOMITING (Vomiting) and DIZZINESS (Dizziness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Patient last menstrual period date was 26-DEC-2021 Patient not had symptoms associated with COVID-19. Patient was not pregnant, Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 31-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Presyncope, Vomiting, Nausea, Dizziness and Feeling Cold. The events Dizziness and Feeling Cold occurred on the same day of the administration of the third dose of mRNA-1273. Presyncope, Vomiting and Nausea occurred the day after the vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 31-year-old female patient with no relevant medical history, who experienced the unexpected serious events of Presyncope, Vomiting, Nausea, Dizziness and Feeling Cold. The events Dizziness and Feeling Cold occurred on the same day of the administration of the third dose of mRNA-1273. Presyncope, Vomiting and Nausea occurred the day after the vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2026621 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005287 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Pain in extremity, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Comments: On no medication Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211125; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Result: Positive
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: painful arm; Blisters; This case was received (Reference number: GB-MHRA-ADR 26418261) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm) and BLISTER (Blisters) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005287) for an unknown indication. On no medication Patient is not pregnant,Patient is not currently breastfeeding. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 23-Nov-2021. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced BLISTER (Blisters) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (painful arm) and BLISTER (Blisters) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Result: Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication information provided. The patient stated that within 2 hours of the injection clear blisters starting appearing on the top section of the arm but not directly on the injections site. It was also very painful arm which was hot to touch. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 38-year-old, female patient with no relevant medical history reported who experienced the unexpected serious events of Pain in extremity and Blister. The event of Blister occurred on the same date after the third dose of COVID vaccine (mRNA-1273 Vaccine was the third dose), while the onset date of event Pain in extremity was not reported. The rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 38-year-old, female patient with no relevant medical history reported who experienced the unexpected serious events of Pain in extremity and Blister. The event of Blister occurred on the same date after the third dose of COVID vaccine (mRNA-1273 Vaccine was the third dose), while the onset date of event Pain in extremity was not reported. The rechallenge and action taken with the suspect product were kept as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2026623 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 305688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness postural, Headache, Injection site pain, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; PFIZER BIONTECH COVID-19 VACCINE; FLUCELVAX TETRA [INFLUENZA VACCINE INACT SPLIT 4V]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Feverish; Muscle ache; Headache; Nausea; Dizzy on standing; Injection site pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418416) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizzy on standing), INJECTION SITE PAIN (Injection site pain), PYREXIA (Feverish), MYALGIA (Muscle ache), HEADACHE (Headache) and NAUSEA (Nausea) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 305688) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 08-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination, INFLUENZA VACCINE INACT SPLIT 4V (FLUCELVAX TETRA [INFLUENZA VACCINE INACT SPLIT 4V]) from 16-Dec-2021 to an unknown date for Flu vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, DIZZINESS POSTURAL (Dizzy on standing), INJECTION SITE PAIN (Injection site pain), PYREXIA (Feverish), MYALGIA (Muscle ache), HEADACHE (Headache) and NAUSEA (Nausea) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient last menstrual period date: 30-DEC-2021. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant; Patient was not currently breastfeeding. Injection itself very painful, arm immediately hurting. Felt ok up until hour 6 and started to feel a bit achy and headache began. Got worse as the night progressed. Paracetamol was helpful in taking the edge off the symptoms. Has slowly got better as day after went on. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial.; Sender''s Comments: This case concerns a 18-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Dizziness Postural, Injection Site Pain, Pyrexia, Myalgia, Headache, and Nausea. The events occurred approximately 1 day after the third dose of mRNA-1273 (Moderna covid-19 vaccine). The rechallenge was not applicable as events occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.


VAERS ID: 2026628 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, SARS-CoV-2 test
SMQs:, Neuroleptic malignant 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: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Drenching sweats; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26418645) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Drenching sweats) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) 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 29-Dec-2021, the patient experienced HYPERHIDROSIS (Drenching sweats) (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS (Drenching sweats) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-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. Concomitant medications were not reported. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient received paracetamol but did not help. Company Comment : This RA case concerns a 26 year old female with no medical history reported who experienced serious ( Medically significant ) , unexpected event of hyperhidrosis which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient self-medicated with paracetamol but with no relief. The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 26 year old female with no medical history reported who experienced serious ( Medically significant ) , unexpected event of hyperhidrosis which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . This patient self-medicated with paracetamol but with no relief. The re-challenge for this case was captured as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2026631 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Peripheral swelling
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)

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: Anaphylaxis (to nuts and carried adrenaline.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Swollen lymph nodes; Swollen arm; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26418770) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and PERIPHERAL SWELLING (Swollen arm) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Anaphylaxis (to nuts and carried adrenaline.). On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) and PERIPHERAL SWELLING (Swollen arm) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were not provided. The patient was neither pregnant nor breastfeeding It was reported that nurses at the time were concerned about a reaction of injection due to dose 1 and 2 being the AstraZeneca and this being the Moderna. Patient did not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This regulatory case concerns a 37-year-old, female patient with medical history of Anaphylactic reaction, who experienced the unexpected serious events of Lymphadenopathy and Peripheral swelling. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not resolved. Patients medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.; Sender''s Comments: This regulatory case concerns a 37-year-old, female patient with medical history of Anaphylactic reaction, who experienced the unexpected serious events of Lymphadenopathy and Peripheral swelling. The events occurred on the same day after the third dose of mRNA-1273 vaccine. The outcome of the events was reported as not resolved. Patients medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority?s report due to important medical condition.


VAERS ID: 2026637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Injection site pain, Myalgia, Nausea, Night sweats, Pain in extremity, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), 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 Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: Appetite lost; Nauseous; Night sweat; Generalised muscle aches; Joint ache; Headache; Injection site pain; Pain in arm; Tingling feet/hands; Fatigue; High temperature; Fever chills; This case was received via RA (Reference number: GB-MHRA-ADR 26418906) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), PYREXIA (Fever chills), DECREASED APPETITE (Appetite lost), NAUSEA (Nauseous), NIGHT SWEATS (Night sweat), MYALGIA (Generalised muscle aches), ARTHRALGIA (Joint ache), HEADACHE (Headache), INJECTION SITE PAIN (Injection site pain), PAIN IN EXTREMITY (Pain in arm), PARAESTHESIA (Tingling feet/hands) and FATIGUE (Fatigue) 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 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), NIGHT SWEATS (Night sweat) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), PARAESTHESIA (Tingling feet/hands) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant) and NAUSEA (Nauseous) (seriousness criterion medically significant). On 30-Dec-2021, MYALGIA (Generalised muscle aches), ARTHRALGIA (Joint ache) and HEADACHE (Headache) had resolved. On 31-Dec-2021, PYREXIA (High temperature) and PYREXIA (Fever chills) had resolved. At the time of the report, DECREASED APPETITE (Appetite lost), NAUSEA (Nauseous), PAIN IN EXTREMITY (Pain in arm), PARAESTHESIA (Tingling feet/hands) and FATIGUE (Fatigue) was resolving and NIGHT SWEATS (Night sweat) and INJECTION SITE PAIN (Injection site pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-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. Patient experienced pain in arm equal to dead and aching arm on injection side. Tingling feet/hands equal to pins and needles in fingers on side of injection. Spent whole day in bed recovering as struggled just walking to the toilet. Concomitant products were not provided. Treatment medication were not reported. Company comment: This case concerns a female patient of unknown age with no medical history, who experienced the unexpected events of pyrexia(two events), night sweats, myalgia, arthralgia, headache, injection site pain, pain in extremity, paraesthesia, fatigue, decreased appetite and nausea. The events occurred on the same day or 1 day after the third dose of mRNA-1273. As reported, patient experienced pain in arm equal to dead and aching arm on injection side, tingling feet/hands equal to pins and needles in fingers on side of injection and spent whole day in bed recovering and struggled just walking to the toilet. 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 female patient of unknown age with no medical history, who experienced the unexpected events of pyrexia(two events), night sweats, myalgia, arthralgia, headache, injection site pain, pain in extremity, paraesthesia, fatigue, decreased appetite and nausea. The events occurred on the same day or 1 day after the third dose of mRNA-1273. As reported, patient experienced pain in arm equal to dead and aching arm on injection side, tingling feet/hands equal to pins and needles in fingers on side of injection and spent whole day in bed recovering and struggled just walking to the toilet. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2026638 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FK9707 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Myalgia, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20214

Write-up: intense pain; Diarrhea; Muscle ache; This case was received via RA (Reference number: GB-MHRA-ADR 26418923) on 31-Dec-2021 and was forwarded to Moderna on 31-Dec-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (intense pain), DIARRHOEA (Diarrhea) and MYALGIA (Muscle ache) in a 24-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. FK9707) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion disability). On 30-Dec-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DIARRHOEA (Diarrhea) (seriousness criterion disability). On an unknown date, the patient experienced PAIN (intense pain) (seriousness criterion disability). At the time of the report, PAIN (intense pain) and DIARRHOEA (Diarrhea) had not resolved and MYALGIA (Muscle ache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had intense pain and trapped wind. Patient did not test positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with Covid-19. Patient was neither pregnant nor breastfeeding. Patient last menstrual period date was 7-DEC-2021. No relevant concomitant medications was reported. Treatment information was not provided. Patient was not enrolled in clinical trial. Company comment: This is a regulatory authority case concerning a 24-year-old, female patient with no reported medical history, who experienced the unexpected serious events of myalgia, diarrhea and intense pain. The event myalgia occurred the same day with the third dose of mRNA-1273 vaccine administration, the event diarrhea occurred 1 day after third dose of mRNA-1273 vaccine administration while the event intense pain occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events diarrhea and intense pain was not resolved while myalgia was resolving from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 24-year-old, female patient with no reported medical history, who experienced the unexpected serious events of myalgia, diarrhea and intense pain. The event myalgia occurred the same day with the third dose of mRNA-1273 vaccine administration, the event diarrhea occurred 1 day after third dose of mRNA-1273 vaccine administration while the event intense pain occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. No reported treatment medication. The outcome of the events diarrhea and intense pain was not resolved while myalgia was resolving from the time of last observation. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2026663 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Gingivitis, Immunisation, Influenza like illness, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Gingival disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019219

Write-up: Flu-like aching; Cold sweat; Fever; Nausea; General body pain/shooting pains in internally in various place in trunk; Gum infection; Vomited; patient received third (booster) dose of bnt162b2; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory authority. A 44 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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 was generally well. It was unsure if patient had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 2; Lot number: unknown), for COVID-19 immunisation; Bnt162b2 (DOSE 1; Lot number: unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "patient received third (booster) dose of bnt162b2"; GINGIVITIS (medically significant) with onset 01Jan2022, outcome "recovering", described as "Gum infection"; VOMITING (medically significant) with onset 01Jan2022, outcome "recovered" (Jan2022), described as "Vomited"; INFLUENZA LIKE ILLNESS (medically significant) with onset 02Jan2022, outcome "recovering", described as "Flu-like aching"; COLD SWEAT (medically significant) with onset 02Jan2022, outcome "recovering", described as "Cold sweat"; PYREXIA (medically significant) with onset 02Jan2022, outcome "recovering", described as "Fever"; NAUSEA (medically significant) with onset 02Jan2022, outcome "recovering", described as "Nausea"; PAIN (medically significant) with onset 02Jan2022, outcome "recovering", described as "General body pain/shooting pains in internally in various place in trunk". Patient didn''t think it related to myocarditis or pericarditis but had some shooting pains in internally in various place in trunk. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient did not test 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: 2026674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Immunisation, Myalgia, Nausea, Parosmia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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 INC202200019184

Write-up: the smell of meat and cheese made patient nauseous; Parosmia; muscles aching badly/Muscle ache; No appetite/Appetite lost; Lay in bed fatigued on the first day; Primary immunisation: BNT162b2; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter (Consumer, patient) from the regulatory authority The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201052208089020-CUTAD (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26441416 (regulatory authority). A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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), for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; PAROSMIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Parosmia"; MYALGIA (medically significant) with onset 01Jan2022, outcome "recovered" (02Jan2022), described as "muscles aching badly/Muscle ache"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Lay in bed fatigued on the first day"; DECREASED APPETITE (medically significant) with onset 01Jan2022, outcome "recovering", described as "No appetite/Appetite lost"; NAUSEA (medically significant), outcome "unknown", described as "the smell of meat and cheese made patient nauseous". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not pregnant and was not breastfeeding at the time of this report. 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: 2026686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Immunisation, Oropharyngeal pain, Polymerase chain reaction
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: Medical History/Concurrent Conditions: Drug allergy; Heart disorder; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202200008123

Write-up: Booster; Sore throat and positive COVID 19 test result; Sore throat and positive COVID 19 test result; Sore throat and positive COVID 19 test result; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). An elderly male patient received bnt162b2 (COMIRNATY) (Lot number: Unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart condition" (unspecified if ongoing); "stroke" (unspecified if ongoing); "drug allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported.Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), OROPHARYNGEAL PAIN (non-serious) all with onset 29Dec2021, outcome "recovering" and all described as "Sore throat and positive COVID 19 test result". The patient underwent the following laboratory tests and procedures: polymerase chain reaction: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2026860 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-19
Onset:2021-12-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Eye haemorrhage, Ocular hyperaemia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Glaucoma (broad), Retinal 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: JPPFIZER INC202200016499

Write-up: one Eye haemorrhage; one Eye haemorrhage; This is a spontaneous report received from contactable reporter(s) (Other HCP). A female patient in her 30''s received bnt162b2 (COMIRNATY), intramuscular, administration date 19Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (dose 1, single), for COVID-19 immunisation. The following information was reported: EYE HAEMORRHAGE (medically significant), OCULAR HYPERAEMIA (non-serious) all with onset 29Dec2021, outcome "unknown" and all described as "one Eye haemorrhage". The reported event onset date was on 19Dec2021 (As reported). On 29Dec2021 (10 days after vaccination), the patient experienced one Eye haemorrhage (heard from the patient herself), and the patient was worried about if the 3rd dose should be vaccinated (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the event eye hemorrhage and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 2027329 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Back pain, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; 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: Abdominal pain; Low back pain; This case was received (Reference number: GB-MHRA-ADR 26420816) 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 ABDOMINAL PAIN (Abdominal pain) and BACK PAIN (Low back pain) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant) and BACK PAIN (Low back pain) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN (Abdominal pain) and BACK PAIN (Low back pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-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. Concomitant product was not provided by the reporter Patient has not tested positive for COVID-19 since having the vaccine company comment This regulatory case concerns a 32-year-old, female patient with no relevant history, who experienced the unexpected serious events of abdominal pain and back pain (seriousness criteria- medically significant for both events) on the same day (unknown time) after the third dose of mRNA-1273 vaccine, I dosage form unknown route and site of administration, for an unknown indication. Patient did not have any symptoms associated with COVID-19. Patient was not pregnant. Patient had a lab test for covid -19 on 28 Dec 2021 and the result was negative. The events were resolving at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report, as due to important medical condition. Patient was not enrolled in clinical trial Treatment information was not provided; Sender''s Comments: This regulatory case concerns a 32-year-old, female patient with no relevant history, who experienced the unexpected serious events of abdominal pain and back pain (seriousness criteria- medically significant for both events) on the same day (unknown time) after the third dose of mRNA-1273 vaccine, I dosage form unknown route and site of administration, for an unknown indication. Patient did not have any symptoms associated with COVID-19. Patient was not pregnant. Patient had a lab test for covid -19 on 28 Dec 2021 and the result was negative. The events were resolving at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report, as due to important medical condition.


VAERS ID: 2027606 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Erythema, Fatigue, Headache, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: PFIZER BIONTECH COVID-19 VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211014; 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: exhaustion; high temperature; sore red arm; Swollen glands; Tiredness; Headache; Shivering; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26422725) 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 FATIGUE (exhaustion), PYREXIA (high temperature), ERYTHEMA (sore red arm), LYMPHADENOPATHY (Swollen glands), CHILLS (Shivering), FATIGUE (Tiredness) and HEADACHE (Headache) in a 36-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 15-May-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced CHILLS (Shivering) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (exhaustion) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant) and ERYTHEMA (sore red arm) (seriousness criterion medically significant). On 31-Dec-2021, CHILLS (Shivering) had resolved. At the time of the report, FATIGUE (exhaustion), PYREXIA (high temperature), ERYTHEMA (sore red arm) and LYMPHADENOPATHY (Swollen glands) had not resolved and FATIGUE (Tiredness) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Oct-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced flu like shivering, high temperature, exhaustion, general body pain and aching, sore red arm. She had swollen gland in the armpit of the arm that received the vaccine. Paracetamol was taken, but was not effective. Company comment: This case concerns a 36-year-old female patient with no medical history provided who experienced serious unexpected events of Chills, Lymphadenopathy, Fatigue, reported as tiredness and exhaustion, Headache, Erythema and Pyrexia. As per SD, the event Chills occurred on the same day after the third, booster dose of mRNA-1273 whereas the events Lymphadenopathy and Headache occurred one day following the vaccination. Start date of the event Fatigue was ambiguously reported as one day following vaccination and unknown date. The precise temporal relationship for the remaining events cannot be determined, having in mind that the exact start date of the reported events was not provided. It was reported that the patient experienced swollen lymph node in the armpit of the vaccinated arm. Treatment with paracetamol was not effective. At the time of the report, Erythema, Pyrexia and Lymphadenopathy were still ongoing whereas Headache was resolving and outcome of the event Fatigue was ambiguously reported as ongoing and resolving. It was also reported that the patient experienced general body pain and painful red arm. No further information was provided. The rechallenge and action taken with the suspect product were reported as unknown as per and kept as such. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received Tozinameran prior to Company product, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 36-year-old female patient with no medical history provided who experienced serious unexpected events of Chills, Lymphadenopathy, Fatigue, reported as tiredness and exhaustion, Headache, Erythema and Pyrexia. As per SD, the event Chills occurred on the same day after the third, booster dose of mRNA-1273 whereas the events Lymphadenopathy and Headache occurred one day following the vaccination. Start date of the event Fatigue was ambiguously reported as one day following vaccination and unknown date. The precise temporal relationship for the remaining events cannot be determined, having in mind that the exact start date of the reported events was not provided. It was reported that the patient experienced swollen lymph node in the armpit of the vaccinated arm. Treatment with paracetamol was not effective. At the time of the report, Erythema, Pyrexia and Lymphadenopathy were still ongoing whereas Headache was resolving and outcome of the event Fatigue was ambiguously reported as ongoing and resolving. It was also reported that the patient experienced general body pain and painful red arm. No further information was provided. The rechallenge and action taken with the suspect product were reported as unknown as per and kept as such. Event terms, onset dates and outcomes captured per Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received Tozinameran prior to Company product, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2029167 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Face oedema, Hypersensitivity, Immunisation, Obstructive airways disorder, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: body temperature; Result Unstructured Data: Test Result:40 degrees Centigrade; Comments: Fever
CDC Split Type: BRPFIZER INC202101881943

Write-up: booster dose; allergic reaction; facial edema; airway obstruction/ respiratory pathways became obstructed; 40? fever; itchy body; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient. A female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), 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; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown," described as "booster dose;" HYPERSENSITIVITY (medically significant) with onset 29Dec2021, outcome "unknown," described as "allergic reaction;" FACE OEDEMA (medically significant) with onset 29Dec2021, outcome "unknown," described as "facial edema;" OBSTRUCTIVE AIRWAYS DISORDER (medically significant) with onset 29Dec2021, outcome "unknown," described as "airway obstruction/ respiratory pathways became obstructed;" PYREXIA (medically significant) with onset 29Dec2021, outcome "unknown," described as "40? fever;" PRURITUS (medically significant) with onset 29Dec2021, outcome "unknown," described as "itchy body." The patient underwent the following laboratory test and procedure: body temperature: (29Dec2021) 40 degrees Centigrade, notes: Fever. Therapeutic measures were taken as a result of hypersensitivity, face oedema, obstructive airways disorder, pyrexia, and pruritus. The patient ingested corticosteroids to slow down the process. The batch/lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2029191 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL3203 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Hypoaesthesia, Hypoaesthesia oral, Immunisation, Lacrimation increased, Neck pain, Paraesthesia, Paraesthesia oral, Paralysis
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Lacrimal disorders (narrow), Arthritis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202200004442

Write-up: Bell''''s palsy; lost full movement (partially paralyzed); Left eye uncontrollably tearing; neck pain; left side of face numb; left side of face /tingly; lips went numb; lips went/tingly; Dose number 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), via unspecified route of administration, administered in arm left, administration date 29Dec2021 (Lot number: FL3203) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Penicillin Allergy" (unspecified if ongoing). Concomitant medication(s) included: MIRENA. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0193, Location of injection: Arm Left), administration date: 07May2021, when the patient was 37 years old; Bnt162b2 (Dose 2, Batch/Lot No: EY0579, Location of injection: Arm Left), administration date: 09Jul2021, when the patient was 37 years old, for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Dose number 3"; BELL''S PALSY (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "Bell''''s palsy"; PARALYSIS (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "lost full movement (partially paralyzed)"; LACRIMATION INCREASED (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "Left eye uncontrollably tearing"; NECK PAIN (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "neck pain"; HYPOAESTHESIA (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "left side of face numb"; PARAESTHESIA (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "left side of face /tingly"; HYPOAESTHESIA ORAL (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "lips went numb"; PARAESTHESIA ORAL (medically significant) with onset 30Dec2021 09:00, outcome "unknown", described as "lips went/tingly". The events "bell''''s palsy", "lost full movement (partially paralyzed)", "left eye uncontrollably tearing", "neck pain", "left side of face numb", "left side of face /tingly", "lips went numb" and "lips went/tingly" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of bell''s palsy, paralysis, lacrimation increased, neck pain, hypoaesthesia, paraesthesia, hypoaesthesia oral, and paraesthesia oral which included prednisone + valacyclovir. The patient further reported that when she woke up, she couldn''t close it all the way within 24 hours of booster (3rd shot). 48 hours later, it got worse and couldn''t close eye at all.; Sender''s Comments: Linked Report(s) : CA-PFIZER INC-202200004451 same patient, same product of different dose, different event


VAERS ID: 2029521 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Muscular weakness, Musculoskeletal stiffness, Myalgia, Nausea, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: Muscle weakness; Neck stiff; Muscle ache; Joint ache; Pain joint; Nausea; Headache; Fatigue; This case was received (Reference number: GB-MHRA-ADR 26425040) on 03-Jan-2022 and was forwarded to Moderna on 03-Jan-2022. This case was received (Reference number: GB-MHRA-ADR 26425040) 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 MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Fatigue), ARTHRALGIA (Pain joint), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache), NAUSEA (Nausea), HEADACHE (Headache) and MUSCULOSKELETAL STIFFNESS (Neck stiff) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), ARTHRALGIA (Pain joint) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and MUSCULOSKELETAL STIFFNESS (Neck stiff) (seriousness criterion medically significant). On 01-Jan-2022, MUSCULOSKELETAL STIFFNESS (Neck stiff) had resolved. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), FATIGUE (Fatigue), ARTHRALGIA (Pain joint), ARTHRALGIA (Joint ache), MYALGIA (Muscle ache) and NAUSEA (Nausea) had not resolved and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drug information provided. No treatment drug information provided. Patient has not tested positive for COVID-19 since having the vaccine; Sender''s Comments: This is a regulatory case concerning a 51-year-old female patient with no medical history provided, who experienced the serious unexpected events of Muscular weakness and Musculoskeletal stiffness(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: 2029526 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypoaesthesia, Myalgia, Palpitations, Paraesthesia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (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: 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: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Fatigue; Numbness; Fever; Generalised muscle aches; Palpitations; Fatigue extreme; Tingling numbness; This case was received (Reference number: GB-RA-ADR 26420122) 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 FATIGUE (Fatigue), HYPOAESTHESIA (Numbness), PYREXIA (Fever), MYALGIA (Generalised muscle aches), PALPITATIONS (Palpitations), FATIGUE (Fatigue extreme) and PARAESTHESIA (Tingling numbness) in a 56-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 30-Nov-2021. On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant), FATIGUE (Fatigue extreme) (seriousness criterion medically significant) and PARAESTHESIA (Tingling numbness) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 31-Dec-2021, PALPITATIONS (Palpitations) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved and HYPOAESTHESIA (Numbness), PYREXIA (Fever), MYALGIA (Generalised muscle aches), FATIGUE (Fatigue extreme) and PARAESTHESIA (Tingling numbness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-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. No concomitant medications were provided. Fever started evening of day of vaccine. Continued 24 hours then started to ease. Patient had muscle ache around vaccine site which later spread to both arms and shoulders. Patient experienced heart palpitations felt strongly at times and concerning at times. As had eased, patient had not pursued medical assistance. Patient mentioned that fatigue appeared to come in waves i.e. would suddenly became overwhelmed by it and immediately fell asleep. Had tingling numbness back of hands. Waited 28 days for booster after being COVID positive as advised and had booster at approx 8:00am 29-Dec. Patient had not reacted similarly to previous COVID jabs 1 and 2 which were both AstraZeneca. Only treatment used by patient was bed rest and Paracetamol. Patient was not enrolled in clinical trial. Company comment: This case concerns a 56-year-old male patient with no relevant medical history who experienced serious unexpected events of Hypoaesthesia, Pyrexia, Myalgia, Palpitations, Fatigue, reported as Fatigue extreme and Fatigue and Paraesthesia. The events occurred on the same day after the booster dose of mRNA-1273. The patient was treated with paracetamol. At the time of the report, Palpitations had resolved whereas the remaining events were resolving. Outcome of the event Fatigue was ambiguously reported as resolved and resolving. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product, Interchange of vaccine products should have been considered in this particular case.; Sender''s Comments: This case concerns a 56-year-old male patient with no relevant medical history who experienced serious unexpected events of Hypoaesthesia, Pyrexia, Myalgia, Palpitations, Fatigue, reported as Fatigue extreme and Fatigue and Paraesthesia. The events occurred on the same day after the booster dose of mRNA-1273. The patient was treated with paracetamol. At the time of the report, Palpitations had resolved whereas the remaining events were resolving. Outcome of the event Fatigue was ambiguously reported as resolved and resolving. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness per overall case assessment by Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Having in mind that the patient received COVID-19 VACCINE ASTRAZENECA prior to Company product, Interchange of vaccine products should have been considered in this particular case.


VAERS ID: 2029528 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Discomfort, Dizziness, Fatigue, Headache, Injection site pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211125; 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: headache; dizziness; discomfort; Frontal headache; Joint ache; Faint; Injection site pain; Tiredness; This case was received (Reference number: GB-RA-ADR 26421496) 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), DIZZINESS (dizziness), DISCOMFORT (discomfort), HEADACHE (Frontal headache), FATIGUE (Tiredness), ARTHRALGIA (Joint ache), INJECTION SITE PAIN (Injection site pain) and SYNCOPE (Faint) in a 53-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 from 21-Nov-2021 to 01-Dec-2021. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant) and SYNCOPE (Faint) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criterion medically significant), DIZZINESS (dizziness) (seriousness criterion medically significant) and DISCOMFORT (discomfort) (seriousness criterion medically significant). On 31-Dec-2021, FATIGUE (Tiredness), ARTHRALGIA (Joint ache) and SYNCOPE (Faint) had resolved. At the time of the report, HEADACHE (headache), DIZZINESS (dizziness), DISCOMFORT (discomfort), HEADACHE (Frontal headache) and INJECTION SITE PAIN (Injection site pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Nov-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. No concomitant products were reported. No treatment drugs were reported -Patient is not pregnant -Patient is not currently breastfeeding patient took paracetemol taken which has reduced some of the discomfort. Rested due to tiredness and dizziness. Headache still apparent, but intermittent rather than constant. Arm sore around injection site and when rising arm. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Reaction ~Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you additional questions at the end of this report: "No" Company comment This case concerns a 53-year-old female patient, with no reported medical history, who experienced the unexpected serious events of HEADACHE, DIZZINESS, DISCOMFORT, HEADACHE, FATIGUE, ARTHRALGIA, INJECTION SITE PAIN and SYNCOPE. The events started on the same day after the administration of the third dose of mRNA-1273 vaccine. At the time of report, events had resolved or were resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 53-year-old female patient, with no reported medical history, who experienced the unexpected serious events of HEADACHE, DIZZINESS, DISCOMFORT, HEADACHE, FATIGUE, ARTHRALGIA, INJECTION SITE PAIN and SYNCOPE. The events started on the same day after the administration of the third dose of mRNA-1273 vaccine. At the time of report, events had resolved or were resolving. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2029544 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction
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: Very high tempriture, confusion, disorentation, general unwellness; This case was received via RA (Reference number: GB-MHRA-ADR 26421696) 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 ADVERSE DRUG REACTION (Very high tempriture, confusion, disorentation, general unwellness) in a 69-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 29-Dec-2021, the patient experienced ADVERSE DRUG REACTION (Very high tempriture, confusion, disorentation, general unwellness) (seriousness criterion medically significant). On 31-Dec-2021, ADVERSE DRUG REACTION (Very high tempriture, confusion, disorentation, general unwellness) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) was unknown. No concomitant medications were reported. The patient was taking Moderna booster for 3rd dose booster. Patient developed Very high temp, confusion, had left side paralysis thought patient had had a stroke. No treatment details were reported. company comment This regulatory case concerns a 61-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of adverse drug reaction (seriousness criteria- Medically significant) .The event occurred on the same day (unknown time) after the third dose of mRNA-1273 vaccine, given through parenteral route for an ill-defined disorder. Patient developed Very high temperature, confusion, had left side paralysis and the patient thought she had a stroke. It was reported that the patient was taking the third booster dose of Moderna vaccine. No concomitant medications were reported. Treatment medication was not provided by the reporter. The events were not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report.; Sender''s Comments: This regulatory case concerns a 61-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious event of adverse drug reaction(seriousness criteria- Medically significant) .The event occurred on the same day (unknown time) after the third dose of mRNA-1273 vaccine, given through parenteral route for an ill-defined disorder. Patient developed Very high temperature, confusion, had left side paralysis and the patient thought she had a stroke. It was reported that the patient was taking the third booster dose of Moderna vaccine. No concomitant medications were reported. Treatment medication was not provided by the reporter. The events were not resolved at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious per Regulatory Authority?s report.


VAERS ID: 2029598 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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? 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 INC202101882855

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-202112290755195600-HPRSA (RA). Other Case identifier: GB-MHRA-ADR 26406835 (RA). A 13-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, single, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SYNCOPE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Fainting". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative. Clinical course details: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029660 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Migraine, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Liver damage (in February); Migraine hemiplegic (but it is disappeared in summer)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882679

Write-up: severe migraine; Booster; Fainting; 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-202112291300320130-WGGMY (RA). Other Case identifier(s): GB-MHRA-ADR 26408727 (RA). A 21 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included some liver damage in February which caused hemiplegic migraines but it was disappeared in summer. Patient had not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. The patient''s 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 29Dec2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fainting"; MIGRAINE (medically significant), outcome "unknown", described as "severe migraine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029699 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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: SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882671

Write-up: Vomiting; This is a spontaneous report received from a contactable reporter from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112291528060900-7DCET. Other Case identifier(s): GB-MHRA-ADR 26410035. A 14-year-old male patient received bnt162b2, administration date 28Dec2021 (Batch/Lot number: unknown) as dose 1, 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. The following information was reported: vomiting with onset 29Dec2021, outcome not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report 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. Follow-up (30Dec2021): This report was incorrectly submitted to the RA with license 125742 for bnt162b2 , and is now being submitted with the correct license 027034 for bnt162b2.


VAERS ID: 2029740 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; SERTRALIN [SERTRALINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Crohn''s disease; Gastritis erosive; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohns disease, ulcerative colitis)); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882939

Write-up: off label use; interchange of vaccine products; Booster; Fainting; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112291917452000-ZNINM. Other Case identifier(s): GB-MHRA-ADR 26411097. A 35-year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 35 years as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Relevant medical history included: "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohns disease, ulcerative colitis); "Crohns disease" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing); "Gastritis erosive" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included: PANTOPRAZOLE taken for gastritis erosive, start date: 2021; SERTRALIN [SERTRALINE HYDROCHLORIDE] taken for anxiety, start date: 2021. Vaccination history included: Covid-19 vaccine (Dose 1, Lot number: Not known, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Lot number: Not known, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Fainting". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Additional information: 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: 2029741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-12-29
   Days after vaccination:229
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: Chest X-ray, Chest pain, Computerised tomogram thorax, Dyspnoea, Echocardiogram, Fatigue, Magnetic resonance imaging heart, Palpitations, Photopsia, SARS-CoV-2 test, Syncope, Tachycardia, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicitis; Clinical trial participant (Study details: Ivermectin); Ileocecal resection
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: chest X-ray; Result Unstructured Data: Test Result:unknown result; Test Name: echocardiogram; Result Unstructured Data: Test Result:unknown result; Test Name: cardiac MRI; Result Unstructured Data: Test Result:unknown result; Test Name: chest CT; Result Unstructured Data: Test Result:unknown result
CDC Split Type: GBPFIZER INC202101882709

Write-up: Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); fainting; flashing lights; Fog in front of eyes; 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-202112291919597560-PDWC2 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26411215 (MHRA). A 57 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 14May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Appendicitis", start date: Jul2020 (unknown if ongoing); "Clinical trial participant" (unspecified if ongoing), notes: Study details: Ivermectin; "Ileocecal resection" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Past drug history included: Ivermectin. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, PRIMARY IMMUNIZATION), for COVID-19 Immunization. A hospital visited and emergency Hospital for flashing lights in the left eye followed by black spots in the eye. Reported fast heartbeat to Doctor. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "fainting"; PHOTOPSIA (medically significant), outcome "unknown", described as "flashing lights"; VISION BLURRED (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Fog in front of eyes"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)". The events "fainting", "flashing lights", "fog in front of eyes", "fatigue/unusual tiredness", "chest pain", "shortness of breath", "heart palpitations" and "racing heart (tachycardia)" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test; Patient has not tested positive for COVID-19 since having the vaccine, chest x-ray: unknown result; echocardiogram: unknown result; magnetic resonance imaging heart: unknown result; computerised tomogram thorax: unknown result. Therapeutic measures were not taken as a result of syncope, photopsia, vision blurred, fatigue, chest pain, dyspnoea, palpitations, tachycardia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029743 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-11
Onset:2021-12-29
   Days after vaccination:18
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: Blood test, Diabetes mellitus, Investigation, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: WARFARINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden homozygote
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:Diabetes; Test Name: Eye pressure test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101882638

Write-up: Diabetes; 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-202112291923554030-1LNKF (MHRA). Other Case identifier(s): GB-MHRA-ADR 26411130 (MHRA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 11Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Factor V Leiden homozygote" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Concomitant medication included: WARFARINE taken for factor v leiden mutation, start date: 01Jan1991. The following information was reported: DIABETES MELLITUS (hospitalization, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Diabetes". Clinical courses: Full health check cl march 2021..all good..2:5 weeks after vaccine diagnosed sudden onset diabetes, awaiting further scans on pancreas..no previous history or predisposition to diabetes. The patient underwent the following laboratory tests and procedures: blood test: diabetes; investigation (Eye pressure test): unknown results; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)?: "No". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029753 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Heart rate, Palpitations, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: ECG; Result Unstructured Data: Test Result:normal rhythm; Comments: normal rhythm but was still high for a resting heart rate at 90bpm; Test Date: 202112; Test Name: heart rate; Result Unstructured Data: Test Result:140 beats per minute; Test Date: 202112; Test Name: heart rate; Result Unstructured Data: Test Result:90bpm; Test Name: heart rate; Result Unstructured Data: Test Result:around 60bpm at resting; Comments: usually
CDC Split Type: GBPFIZER INC202101882583

Write-up: Tachycardia/Racing heart (tachycardia); Heart palpitations; This is a spontaneous report received from a contactable Consumer from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112292016463960-SZV5H (RA). Other Case identifier(s): GB-MHRA-ADR 26411496 (RA). A 35 year-old female patient (not pregnant) received BNT162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FL9994) at the age of 35 years as dose 2, 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 and not had a COVID-19 test. Patient was not pregnant (Patient last menstrual period date: 27Dec2021). Patient was not currently breastfeeding. Vaccination history included: COVID-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunisation. The following information was reported: TACHYCARDIA (hospitalization, medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Tachycardia/Racing heart (tachycardia)"; PALPITATIONS (hospitalization, medically significant) with onset 29Dec2021, outcome "unknown", described as "Heart palpitations". Clinical course: The reaction happened a couple of minutes after receiving the vaccine. The patient stated her heart starting pounding and would not stop with breathing techniques. The medical staff monitored her heart rate at 140 beats per minute, its usually around 60 bpm at resting. The patient was advised to go for an ECG at the hospital, they said the heart had a normal rhythm but was still high for a resting heart rate at 90bpm. The patient was discharged and after 8 hours it returned to a normal rate. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient considered her report was related to possible inflammation of the heart (myocarditis or pericarditis) while the diagnosis was not made by a medical professional. No blood test, such as for certain proteins (called troponin) that signal heart muscle damage was taken. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029762 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Feeling abnormal, Immunisation, Limb discomfort, Off label use, Palmar erythema, Palpitations, Peripheral swelling, Product use issue, Pruritus, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pruritus
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy (Mild food allergies); Hay fever
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101882560

Write-up: hands felt very odd; my palms went bright red and rapidly swelled up; my palms went bright red and rapidly swelled up; injection sight went bright red and started itching; injection sight went bright red and started itching; Off label use; Drug use in unapproved population; Booster; Angioedema; itching from head to toe, particularly around her neck and ears/general itching all over; suddenly felt strange; Palpitations; 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-202112292035281330-XQGHW (RA). Other Case identifier(s): GB-MHRA-ADR 26411684 RA). A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Fk9706) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing); "Food allergy" (unspecified if ongoing), notes: Mild food allergies; "Hay fever" (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. Patient last menstrual period date 25NOV2021. Patient has not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; ANGIOEDEMA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Angioedema"; PRURITUS (non-serious) with onset 29Dec2021, outcome "not recovered", described as "itching from head to toe, particularly around her neck and ears/general itching all over "; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "unknown", described as "suddenly felt strange"; PALPITATIONS (non-serious) with onset 29Dec2021, outcome "recovered", described as "Palpitations"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "hands felt very odd"; PERIPHERAL SWELLING (non-serious), PALMAR ERYTHEMA (non-serious), outcome "unknown" and all described as "my palms went bright red and rapidly swelled up"; VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), outcome "unknown" and all described as "injection sight went bright red and started itching"; OFF LABEL USE (non-serious) with onset 29Dec2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 29Dec2021, outcome "unknown", described as "Drug use in unapproved population". 9 hours after the vaccine, she suddenly felt strange and started having mild palpitations. her hands felt very odd, her palms went bright red and rapidly swelled up. she then started itching from head to toe, particularly around her neck and ears. her injection sight went bright red and started itching. she took liquid piriton and the reaction slowed after 10 minutes. The reactions then kept flaring up and down over the next hour so she took a loratadine tablet which stopped the palpitations and angioedema, but the general itching all over continues 2 hours later. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report was unrelated to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2021) negative. Therapeutic measures were taken as a result of angioedema, pruritus, palpitations, vaccination site erythema, vaccination site pruritus. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200008383 mother baby case


VAERS ID: 2029774 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Joint range of motion decreased, Neck pain, SARS-CoV-2 test
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101882861

Write-up: shoulder pain on side that wasn''t injection site; can''t turn head or sit up; booster; neck pain; 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-202112292133151070-Y5M6P (RA). Other Case identifier: GB-MHRA-ADR 26411957 (RA). A 33 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (batch/lot number: unknown) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, 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 29Dec2021, outcome "unknown", described as "booster"; NECK PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "neck pain"; ARTHRALGIA (medically significant), outcome "unknown", described as "shoulder pain on side that wasn''t injection site"; JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "can''t turn head or sit up". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient has not tested positive for COVID-19 since having the vaccine. Additional information: The reporter 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: 2029808 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Fall, Loss of consciousness, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLOXETINE; ARIPIPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety disorder; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Post-traumatic stress disorder
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:very low
CDC Split Type: GBPFIZER INC202101882867

Write-up: felt dizzy; I felt I am going to pass out; fallen on floor; body was shaking; Faint; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112300146349420-RXLLD (MHRA). Other Case identifier: GB-MHRA-ADR 26412951 (MHRA). A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Anxiety disorder" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response and i...; "PTSD" (unspecified if ongoing). Concomitant medications included: FLOXETINE; ARIPIPRAZOLE. Past drug history included: Aripiprazole for Anxiety disorder. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunisation. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. It was unsure if patient was enrolled in clinical trial. The following information was reported: SYNCOPE (medically significant) with onset 29Dec2021, outcome "recovered with sequelae" (29Dec2021), described as "Faint"; DIZZINESS (medically significant), outcome "unknown", described as "felt dizzy"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "I felt I am going to pass out"; FALL (medically significant), outcome "unknown", described as "fallen on floor"; TREMOR (medically significant), outcome "unknown", described as "body was shaking". The patient underwent the following laboratory tests and procedures: blood pressure measurement: very low. Clinical course: Patient was not sure if she had selected correct option above. She suffered from complex mental health issues including PTSD and Anxiety disorder. Currently she was taking Fluoxetine 20mg and Aripiprazole 2.5mg, once in a day. She felt dizzy after 5 minutes of leaving the vaccination place. She started feeling more dizzy so she sat down on a shops stairs as she was in the public place. She felt she was going to pass out. The next thing she could remember when she opened her eyes was that she was fallen on floor and her body was shaking and there were people gathered around her calling ambulance. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Dyspnoea, Headache, Immunisation, Insomnia, Nausea, Pain in extremity, Palpitations, SARS-CoV-2 test, Skin warm, Vision blurred
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Arthritis (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: 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
CDC Split Type: GBPFIZER INC202101882937

Write-up: Headache; Shivering; Nausea; Heart pounding; Insomnia; Aching joints; Shortness of breath; Blurred vision; Painful L arm; Skin warm; Booster; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the Regulatory Agency. The Regulatory number: GB-MHRA-WEBCOVID-202112300441135570-6SKKL (MHRA) and the Other Case identifier is GB-MHRA-ADR 26412990 (MHRA). A 20-year-old male patient received the third dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 29Dec2021 (Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Relevant medical history included: "Suspected COVID-19," start date: 29Dec2021. Patient is not enrolled in clinical trial. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (first dose (batch/lot number: unknown) as DOSE 1, SINGLE) for COVID-19 immunization; Bnt162b2 (second dose (batch/lot number: unknown) as DOSE 2, SINGLE) for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown" described as "Booster"; HEADACHE (medically significant), outcome "not recovered" described as "Headache"; CHILLS (medically significant), outcome "not recovered" described as "Shivering"; NAUSEA (medically significant), outcome "not recovered" described as "Nausea"; PALPITATIONS (medically significant), outcome "not recovered" described as "Heart pounding"; INSOMNIA (medically significant), outcome "not recovered" described as "Insomnia"; ARTHRALGIA (medically significant), outcome "not recovered" described as "Aching joints"; DYSPNOEA (medically significant), outcome "not recovered" described as "Shortness of breath"; VISION BLURRED (medically significant), outcome "not recovered" described as "Blurred vision"; PAIN IN EXTREMITY (medically significant), outcome "not recovered" described as "Painful L arm"; and SKIN WARM (medically significant), outcome "not recovered" described as "Skin warm." The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about the batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 2029819 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Immunisation, Insomnia, Interchange of vaccine products, Off label use, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101882550

Write-up: zero sleep; Nosebleed; Pins and needles; 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 RA. Regulatory number: GB-MHRA-WEBCOVID-202112300749593490-A1ZFS. Other Case identifier(s): GB-MHRA-ADR 26413922. A 26-year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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. The following information was reported: OFF LABEL USE (disability, medically significant), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant), outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (disability, medically significant), outcome "unknown", described as "Booster"; EPISTAXIS (disability, medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nosebleed"; PARAESTHESIA (disability, medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pins and needles"; INSOMNIA (disability, medically significant), outcome "unknown", described as "zero sleep". Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029823 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Lethargy, Lymphadenopathy, Off label use, Pain, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: FEXOFENADINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885786

Write-up: Headache; Ache; Swollen lymph nodes; Off label use; Interchange of vaccine products; Booster; Lethargy; 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-202112300831101710-VGMLC (RA). Other Case identifier(s): GB-MHRA-ADR 26414166 (RA). A 44 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 44 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Allergic rhinitis" (unspecified if ongoing). Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding and had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication(s) included: FEXOFENADINE HYDROCHLORIDE taken for rhinitis allergic. Vaccination history included: COVID-19 vaccine astrazeneca (Dose 1), administration date: 30Apr2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose 2), administration date: 25Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; LETHARGY (medically significant) with onset 29Dec2021, outcome "unknown", described as "Lethargy"; HEADACHE (medically significant) with onset 30Dec2021, outcome "unknown", described as "Headache"; PAIN (medically significant) with onset 30Dec2021, outcome "unknown", described as "Ache"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "unknown", described as "Swollen lymph nodes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test and result showed no - negative COVID-19 test. Report did no 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: 2029828 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Pain in jaw, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Osteonecrosis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Fibromyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101886031

Write-up: Jaw pain; Fever; booster; Headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112300845379720-QVLRW. Other Case identifier: GB-MHRA-ADR 26414191. A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 30 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunisation; Bnt162b2 (DOSE 2), for COVID-19 immunisation. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache"; PAIN IN JAW (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Jaw pain"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029843 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
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: Arthralgia, Decreased appetite, Fatigue, Headache, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AVAMYS; LORATADINE; NEBIVOLOL HYDROCHLORIDE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic sinusitis; Blood pressure high; Frequent headaches; Sinusitis; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885913

Write-up: Generalized joint pain; Localised muscle pain; Nausea; Appetite lost; Tiredness; Headache dull; 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-202112300942118400-LECTJ. Other Case identifier(s): GB-MHRA-ADR 26414522. A 49-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Allergic sinusitis" (unspecified if ongoing); "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "Sinusitis" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Frequent headaches" (unspecified if ongoing). Concomitant medication(s) included: AVAMYS taken for sinusitis; LORATADINE taken for sinusitis; NEBIVOLOL HYDROCHLORIDE taken for hypertension, start date: 1992; PARACETAMOL taken for headache. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19; patient had not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. The following information was reported: HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache dull"; ARTHRALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Generalized joint pain"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Localised muscle pain"; NAUSEA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Nausea"; DECREASED APPETITE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Appetite lost"; FATIGUE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Tiredness". Patient has not tested positive for COVID-19 since having the vaccine. The report of the consumer 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: 2029848 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Arthralgia, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity
SMQs:, Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101886018

Write-up: Headache; Joint pain; Pain in arm; off label use; interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter( (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112300955159340-5MFQA. Other Case identifier(s): GB-MHRA-ADR 26414548. A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr... 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 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; ARTHRALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Joint pain"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Pain in arm". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029864 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Immunisation, Lymphadenopathy, Nausea, Pyrexia, SARS-CoV-2 test
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), 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 INC202101885654

Write-up: Nauseous; Diarrhea; Dizziness; Fever; Booster; Swollen lymph nodes; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112301100316080-RAO4U. Other Case identifier(s): GB-MHRA-ADR 26415068. A 27-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) 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 (1st single dose), administration date: 16Jun2021, for COVID-19 IMMUNISATION; Comirnaty (2nd single dose), administration date: 13Aug2021, for COVID-19 IMMUNISATION, reaction: "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Nauseous"; DIARRHOEA (medically significant) with onset 30Dec2021, outcome "recovered", described as "Diarrhea"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Fever"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Dizziness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Additional information: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200011942 Same patient same product different event time gap from Dose 1


VAERS ID: 2029919 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
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: Anaphylactic reaction, Immunisation, Interchange of vaccine products, Lip swelling, Off label use, Paraesthesia, Pharyngeal swelling, Rash, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101885600

Write-up: Off label use; Interchange of vaccine products; Booster; tingling sensation; Swelling of tongue; Swelling of lips; Swelling of throat; Rash on face and arms; Anaphylactic reaction; This is a spontaneous report received from a contactable consumer from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112301440429140-CVAJF (RA). Other Case identifier: GB-MHRA-ADR 26416567 (RA). A female patient received bnt162b2 (COMIRNATY) (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), 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"; ANAPHYLACTIC REACTION (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Anaphylactic reaction"; PARAESTHESIA (medically significant), outcome "unknown", described as "tingling sensation"; SWOLLEN TONGUE (medically significant), outcome "recovering", described as "Swelling of tongue"; LIP SWELLING (medically significant), outcome "recovering", described as "Swelling of lips"; PHARYNGEAL SWELLING (medically significant), outcome "recovering", described as "Swelling of throat"; RASH (medically significant), outcome "unknown", described as "Rash on face and arms". Therapeutic measures were taken as a result of anaphylactic reaction, paraesthesia, swollen tongue, lip swelling, pharyngeal swelling, rash. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19 Not had a COVID-19 test. Clinical course: "Initial tingling sensation after vaccine and approx 20mins post vaccine: Swelling of tongue, lips and throat mainly on left side where vaccine was administered. Rash on face and arms. I took antihistamines within 5 mins of swelling starting. Approx 8 hours post vaccine the swelling started to go down significantly." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Interchange of vaccine products, Off label use, Photophobia, SARS-CoV-2 test
SMQs:, Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885810

Write-up: Shivers; Headache; Light sensitivity to eye/Been sensitive to light since the morning; 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 Agency Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112301507009750-KKHAM Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26416836 Regulatory Authority. A 46 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3, (booster) single 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 patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine AstraZeneca (Dose 1, Single), administration date: 21Mar2021, for COVID-19 immunisation; COVID-19 vaccine AstraZeneca (Dose 2, Single), administration date: 14Jun2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Shivers"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; PHOTOPHOBIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Light sensitivity to eye/Been sensitive to light since the morning". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Clinical Course: Been sensitive to light since the morning after receiving the booster. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029928 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101885553

Write-up: Nausea; Fatigue; Off label use; Interchange of vaccine products; Booster; Painful arm; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112301510139640-O4523. Other Case identifier: GB-MHRA-ADR 26416700. A 35 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 09Sep2021 (unspecified if ongoing). Patient has not tested positive for COVID-19 since having the booster vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, non-Pfizer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, non-Pfizer), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Painful arm"; NAUSEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Sep2021) positive. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029929 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Arthralgia, Hallucination, Headache, Hypoaesthesia, Muscular weakness, Neck pain, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Arthritis (broad), Tendinopathies and ligament disorders (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: AMLODIPINE; ASPIRIN [ACETYLSALICYLIC ACID]; BISOPROLOL; LANSOPRAZOLE; THYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Atypical angina; Hypothyroidism; Oesophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885752

Write-up: Hallucinating/ strange dreams; Numbness to left arm including hand; strange dreams; Pain from neck to shoulder and left arm; Pain from neck to shoulder and left arm; Pain from neck to shoulder and left arm; Headache; Weakness of arms/Weakness to left arm from above shoulder to wrist; 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-202112301512054090-4DOMB (RA). Other Case identifier(s): GB-MHRA-ADR 26416855 (RA). A 64 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254, expiration date unknown) at the age of 64 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Atypical angina" (unspecified if ongoing); "Angina pectoris" (unspecified if ongoing); "Oesophageal reflux" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for angina pectoris; ASPIRIN [ACETYLSALICYLIC ACID] taken for angina pectoris; BISOPROLOL taken for angina pectoris; LANSOPRAZOLE taken for gastrooesophageal reflux disease; THYROXINE taken for hypothyroidism. The following information was reported: MUSCULAR WEAKNESS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Weakness of arms/Weakness to left arm from above shoulder to wrist"; PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Pain"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; HALLUCINATION (medically significant), outcome "unknown", described as "Hallucinating/ strange dreams"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness to left arm including hand"; ABNORMAL DREAMS (non-serious), outcome "unknown", described as "strange dreams"; NECK PAIN (non-serious), ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "Pain from neck to shoulder and left arm". Clinical course: Weakness to left arm from above shoulder to wrist. Pain from neck to shoulder and left arm. Numbness to left arm including hand. Hallucinating/ strange dreams. Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. Not had a COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
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: Axillary pain, Immunisation, Oropharyngeal pain, Pain in extremity
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885736

Write-up: Painful arm; Booster; Sore throat; Armpit 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-202112301530505080-7RK9O (RA). Other Case identifier(s): GB-MHRA-ADR 26416892 (RA). A 38 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 29Dec2021 (ongoing). Patient was not had a COVID-19 test and was not currently breastfeeding. 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 (medically significant) with onset 2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Sore throat"; AXILLARY PAIN (medically significant) with onset 2021, outcome "not recovered", described as "Armpit pain"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Painful arm". Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This 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: 2029943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dehydration, Fatigue, Feeling abnormal, Immunisation, Myalgia, Night sweats, SARS-CoV-2 test, Tension headache
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Dehydration (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: NEBIDO [TESTOSTERONE UNDECANOATE]; VENTOLIN [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Transgender
Allergies:
Diagnostic Lab Data: Test Date: 20211207; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885899

Write-up: Tension headache; Fuzzy head; Night sweats; Fatigue extreme; Shivers; Muscle pain; Dehydration; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301558351760-OGI88 (RA). Other Case identifier: GB-MHRA-ADR 26417120 (RA). A 28 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Transgender" (unspecified if ongoing). Patient had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. It was unsure if patient has had symptoms associated with COVID-19. Concomitant medications included: INFLUENZA VIRUS taken for antiviral prophylaxis, administration date 10Oct2021; NEBIDO [TESTOSTERONE UNDECANOATE] taken for trans-sexualism, start date: 28Nov2016; VENTOLIN [SALBUTAMOL SULFATE] taken for asthma. 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 29Dec2021, outcome "unknown", described as "Booster"; TENSION HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tension headache"; FEELING ABNORMAL (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fuzzy head"; NIGHT SWEATS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Night sweats"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue extreme"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Shivers"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle pain"; DEHYDRATION (medically significant) with onset 30Dec2021, outcome "recovering", described as "Dehydration". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Dec2021) no - negative COVID-19 test. The report was not related 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: 2029952 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Immunisation, Off label use, Pain in extremity, Product use issue, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
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 INC202101886005

Write-up: Headache; Tiredness; Off label use; breast feeding; Painful arm; Booster; 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-202112301629464510-MFJDI (MHRA). Other Case identifier(s): GB-MHRA-ADR 26417208 (MHRA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). Patient last menstrual period date: 27Nov2021. Patient has not had symptoms associated with COVID-19. 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 (disability) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEADACHE (disability) with onset 30Dec2021, outcome "recovering", described as "Headache"; PAIN IN EXTREMITY (disability) with onset 29Dec2021, outcome "recovering", described as "Painful arm"; FATIGUE (disability) with onset 30Dec2021, outcome "recovering", described as "Tiredness"; OFF LABEL USE (non-serious) with onset 29Dec2021, outcome "unknown", described as "Off label use"; PRODUCT USE ISSUE (non-serious) with onset 29Dec2021, outcome "unknown", described as "breast feeding". Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to 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. 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-202200017334 Baby case


VAERS ID: 2029953 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Eye pain, Headache, Immunisation, Interchange of vaccine products, Muscular weakness, Myalgia, Neck pain, Off label use, Pain in extremity, SARS-CoV-2 test, Sleep disorder due to general medical condition, insomnia type
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Eosinophilic pneumonia (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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Menopausal; Overweight
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885648

Write-up: Chills; Generalised muscle aches; Sore eyes; Neck pain; Joint pain; Hands weakness of; terrible headache; She struggled to sleep due to soreness in her arms and legs; Weakness generalized/generally feeling weak; sore arm on the injection side/soreness in her arms and legs/sore hands; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112301631501220-CDJP5. Other Case identifier: GB-MHRA-ADR 26417326. A 49-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 13:30 (Batch/Lot number: unknown) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "peri-menopausal" (unspecified if ongoing); "over-weight" (unspecified if ongoing). Date of last menstrual period: 21Dec2021. Concomitant medication included: citalopram taken for depression, start date: 01Jun2019. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021 13:30, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021 13:30, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021 13:30, outcome "unknown", described as "Booster"; CHILLS (medically significant), outcome "not recovered", described as "Chills"; MYALGIA (medically significant), outcome "not recovered", described as "Generalised muscle aches"; EYE PAIN (medically significant), outcome "not recovered", described as "Sore eyes"; NECK PAIN (medically significant), outcome "not recovered", described as "Neck pain"; ARTHRALGIA (medically significant), outcome "not recovered", described as "Joint pain"; MUSCULAR WEAKNESS (medically significant), outcome "not recovered", described as "Hands weakness of"; ASTHENIA (medically significant) with onset 29Dec2021 23:00, outcome "not recovered", described as "Weakness generalized/generally feeling weak"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021 23:00, outcome "unknown", described as "sore arm on the injection side/soreness in her arms and legs/sore hands"; HEADACHE (medically significant), outcome "unknown", described as "terrible headache"; SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (medically significant), outcome "unknown", described as "She struggled to sleep due to soreness in her arms and legs". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative. Clinical course: Patient had the booster yesterday around 13:30 and the side effects began around 23:00, starting with a sore arm on the injection side and generally feeling weak. She struggled to sleep due to soreness in her arms and legs. When she woke this morning, she had a terrible headache, a sore neck, very sore hands and flu-like chills. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. 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: 2029958 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
SMQs:, 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 INC202101885628

Write-up: Off label use; Interchange of vaccine products; Booster; Swollen glands; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202112301645307100-5KDVF. Other Case identifier(s): GB-MHRA-ADR 26417336. A 30 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (dose 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "recovering", described as "Swollen glands". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Fatigue, Hot flush, Immunisation, Interchange of vaccine products, Malaise, Migraine, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Steroid inhaler for asthma); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101885932

Write-up: Migraine; Fatigue; Nausea; Dizziness; Hot flush; Chest pain; Generally unwell; 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 (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301646075430-QUH1D (RA). Other Case identifier(s): GB-MHRA-ADR 26417353 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Steroid inhaler for asthma; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER 1; UNKNOWN MANUFACTURER), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER 2; UNKNOWN MANUFACTURER), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MIGRAINE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Migraine"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Nausea"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "recovering", described as "Dizziness"; HOT FLUSH (medically significant) with onset 30Dec2021, outcome "recovered", described as "Hot flush"; CHEST PAIN (medically significant) with onset 30Dec2021, outcome "recovered", described as "Chest pain"; MALAISE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Generally unwell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative. Patient has not tested positive for COVID-19 since having the vaccine. The report of the consumer 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: 2029967 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9707 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Immunisation, Pain
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: GBPFIZER INC202101885682

Write-up: pain; Earache; patient received third (booster) dose of BNT162b2; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112301705391470-MRHZX (RA). Other Case identifier(s): GB-MHRA-ADR 26417451 (RA). A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9707) at the age of 34 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: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "patient received third (booster) dose of BNT162b2"; PAIN (medically significant), outcome "recovering", described as "pain"; EAR PAIN (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Earache". Therapeutic measures were taken as a result of pain, ear pain. Clinical course: Patient had very painful earache around 5hrs post vaccine. Used paracetamol and ibuprofen to eventually ease pain. Still some residual pain the next day. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient had not tested positive for COVID-19 since having the vaccine. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. 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: 2029974 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Chest discomfort, Chills, Headache, Immunisation, Influenza like illness, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREGABALIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885551

Write-up: Flu like symptoms; Tight chest; Headache; Nausea; Shivers; 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-202112301732530720-VTVBJ. Other Case identifier(s): GB-MHRA-ADR 26417689. A 56 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia syndrome" (unspecified if ongoing). Concomitant medication(s) included: PREGABALIN taken for fibromyalgia. 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 29Dec2021, outcome "unknown", described as "Booster"; INFLUENZA LIKE ILLNESS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Flu like symptoms"; CHEST DISCOMFORT (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tight chest"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; NAUSEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; CHILLS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Shivers". Clinical course: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test.Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Reaction. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis): If yes, we will ask you some additional questions at the end of this report: "No" No follow-up attempts are possible. No further information is expected.


VAERS ID: 2029978 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Interchange of vaccine products, Off label use, Pain, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Medication errors (broad), 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885890

Write-up: Off label use; Interchange of vaccine products; Booster; Headache; Ache; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202112301806206400-KGP1W. Other Case identifier(s): GB-MHRA-ADR 26417767. A 39 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Fk9706) at the age of 39 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient 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: 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 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache"; PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Ache"; SUSPECTED COVID-19 (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Suspected COVID-19". 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. No further information is expected.


VAERS ID: 2029980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Fatigue, Immunisation, Migraine, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), 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 Date: 20201009; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101885587

Write-up: Fever; Joint pain; Chest pain; Fatigue; Nausea; Muscle pain; Migraine; 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-202112301818110090-7UQQR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26417791 (MHRA). A 27 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fever"; ARTHRALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Joint pain"; CHEST PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Chest pain"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue"; NAUSEA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Nausea"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle pain"; MIGRAINE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Migraine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Oct2020) yes - positive covid-19 test. Therapeutic measures were taken as a result of pyrexia, arthralgia, chest pain, fatigue, nausea, myalgia, migraine. Clinical course:Totally incapacitated- can barely stand up. Have been taking paracetamol. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction. Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No". Text for relevant medical history and concurrent conditions. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2029981 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Lymph node pain, Myalgia, Off label use, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: ATORVASTATIN; CLOPIDOGREL; CODEINE SULFATE; PAROXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Menopause; TIA
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885980

Write-up: armpit pain; the area around the site started to feel hot; area around injection site felt swollen; Off label use; Interchange of vaccine products; Booster; Lymph node pain; Injection site pain; Muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory authority. A 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Transient ischaemic attack" (unspecified if ongoing); "Menopause" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN taken for transient ischaemic attack; CLOPIDOGREL taken for transient ischaemic attack; CODEINE SULFATE taken for arthritis; PAROXETINE taken for menopause. Past drug history included: Codeine sulphate. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine astrazeneca (DOSE 2), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant), outcome "recovering", described as "armpit pain"; LYMPH NODE PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Lymph node pain"; VACCINATION SITE PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Injection site pain"; MYALGIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Muscle ache"; VACCINATION SITE WARMTH (medically significant), outcome "unknown", described as "the area around the site started to feel hot"; VACCINATION SITE SWELLING (medically significant), outcome "unknown", described as "area around injection site felt swollen". Clinical course: Clopidogrel and Atorvastatin following a TIA a few years back. Taking codeine sulphate for arthritis pain and paroxetine to alleviate menopause symptoms. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Reactions started almost immediately upon injection (no reaction to previous Astra Zeneca doses). Experienced more pain upon receiving injection than is usual, like a sharp pinch and then the area around the site started to feel hot and hurt. After a couple of hours the patient experienced muscle ache all along her arm and thought she could feel some pain from armpit on same side as injection. The armpit pain has increased overnight, arm was feeling very heavy and area around injection site was hot and felt swollen (but the patient was told that it did not look swollen by her partner). GP was not seeing any patients in person and she has been unable to arrange a telephone appointment, she will try again the day after. 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: 2029994 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Illness, Immunisation, 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 INC202101885664

Write-up: Sickness; Booster; Shivers; Headache; 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-202112301947500380-NSKP7 Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26418178 Regulatory Authority. A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 25 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. Unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. Patient last menstrual period date 01Dec2020. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Shivers"; HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache"; ILLNESS (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Sickness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. 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". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030000 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Heart rate, Heart rate increased, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Medication errors (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 Name: heart rate; Result Unstructured Data: Test Result:69-72; Comments: Resting heart rate; Test Name: heart rate; Result Unstructured Data: Test Result:100-120; Comments: for the night; Test Date: 20211229; Test Name: heart rate; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885987

Write-up: Off label use; Interchange of vaccine products; Booster; Heart rate; heart rate was consistently high compared to normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112302015432240-1IANB Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26418271 Regulatory Authority. A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Fn3543) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose: Unknown), for Vaccination; Covid-19 vaccine (DOSE Unknown; MANUFACTUERER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEART RATE (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Heart rate"; HEART RATE INCREASED (medically significant) with onset 29Dec2021, outcome "recovered", described as "heart rate was consistently high compared to normal". The patient underwent the following laboratory tests and procedures: heart rate: (unspecified date) 69-72, notes: Resting heart rate; (unspecified date) 100-120, notes: for the night; (29Dec2021) high; sars-cov-2 test: (unspecified date) negative, notes: No - Negative COVID-19 test. Clinical course: last menstrual period date was 29Dec2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. From the evening after her booster, her heart rate was consistently high compared to normal. This lasted approximately 16h. Resting heart rate was around 69-72. Her watch tracked her heart rate of 100-120 for the night. 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: 2030009 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Dizziness, Hyperhidrosis, Immunisation, Paraesthesia, Presyncope, Seizure
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (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: QUETIAPINE; SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101885908

Write-up: Sweating; Light-headed; Tingling feet/hands; Near fainting; Convulsive seizure; Vasovagal attack; Booster; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202112302059565780-MOQKE. Other Case identifier: GB-MHRA-ADR 26418384. A 34 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication included: QUETIAPINE; SERTRALINE. 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. Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (disability) with onset 29Dec2021, outcome "unknown", described as "Booster"; SEIZURE (disability), outcome "recovered", described as "Convulsive seizure"; PRESYNCOPE (disability) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Vasovagal attack"; HYPERHIDROSIS (disability), outcome "recovered", described as "Sweating"; DIZZINESS (disability), outcome "recovered", described as "Light-headed"; PARAESTHESIA (disability), outcome "recovered", described as "Tingling feet/hands"; PRESYNCOPE (disability), outcome "recovered", described as "Near fainting". No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
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: Asthma, Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: Medical History/Concurrent Conditions: Allergy; Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885945

Write-up: Asthma; SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable Consumer or other non HCP from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112302102045740-ZTAG8. Other Case identifier(s): GB-MHRA-ADR 26418397. A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypersensitivity" (unspecified if ongoing); "Depression" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Venlafaxine for depression; Salbutamol for dog allergy; Epi pen for dog allergy. The following information was reported: DRUG INEFFECTIVE (life threatening), SUSPECTED COVID-19 (life threatening) all with onset 29Dec2021, outcome "not recovered" and all described as "SARS-CoV-2 infection"; ASTHMA (life threatening), outcome "not recovered", described as "Asthma". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient received second dose a few months ago and have had asthma symptoms of varying severity ever since. I do not have asthma otherwise, but carry a salbutamol inhaler and epi-pen due to a dog allergy. On two occasions the patient used my epi-pen as has been completely unable to breathe. The patient was using inhaler daily. The patient was able to do most daily tasks but find it is easily exacerbated. Patient is not enrolled in clinical trial. The report is 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: 2030025 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Immunisation, Lymphadenopathy, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101885789

Write-up: Muscle ache; Swollen lymph nodes; Loss of energy; Decreased appetite; 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-202112302152262500-KO01C (RA). Other Case identifier(s): GB-MHRA-ADR 26418467 (RA). A 33 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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. Patient had not had 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. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle ache"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph nodes"; ASTHENIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Loss of energy"; DECREASED APPETITE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Decreased appetite". 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: 2030029 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-29
   Days after vaccination:2
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: Back pain, Chest pain, Chills, Diarrhoea, Dyspnoea, Eye pain, Fatigue, Headache, Heart rate, Hyperhidrosis, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Nausea, Off label use, Pain in extremity, Palpitations, Peripheral swelling, Pyrexia, Rash erythematous, SARS-CoV-2 test, Tachycardia
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue syndrome
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 INC202101885944

Write-up: off label use; interchange of vaccine products; Booster; Fatigue/unusual tiredness; Chest pain; Fever; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Headache; Exhaustion; Drenching sweats; Heart rate; Aching in limb; Stiff neck; Backache; Eye pain; Chills; Red rash; Swollen arm; Chest pain; Shortness of breath; Nausea; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112302222017980-NFYOF (RA). Other Case identifier(s): GB-MHRA-ADR 26418549 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "CFS" (unspecified if ongoing). The patient''s 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), outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache"; FATIGUE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Exhaustion"; HYPERHIDROSIS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Drenching sweats"; HEART RATE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Heart rate"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Aching in limb"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Stiff neck"; BACK PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Backache"; EYE PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Eye pain"; CHILLS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Chills"; RASH ERYTHEMATOUS (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Red rash"; PERIPHERAL SWELLING (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Swollen arm"; CHEST PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", DYSPNOEA (medically significant) with onset 29Dec2021, outcome "not recovered" and all described as "Shortness of breath"; NAUSEA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Nausea"; DIARRHOEA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Diarrhea"; FATIGUE (medically significant), outcome "unknown", described as "Fatigue/unusual tiredness"; CHEST PAIN (medically significant), outcome "unknown", described as "Chest pain"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; DYSPNOEA (medically significant), outcome "unknown", described as "Shortness of breath"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) no - negative covid-19 test. Clinical course: the patient had CFS. Unsure if patient has 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. This report relates to possible inflammation of the heart (myocarditis or pericarditis), as reported. The symptoms did not led to a hospital stay. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030032 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Chills, Fatigue, Headache, Heart rate, Heart rate increased, Immunisation, Interchange of vaccine products, Nausea, Off label use, Pain, Pain in extremity, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Study details:); Osteoarthritis; Psoriasis; Suspected COVID-19 (Had Covid Mar2020)
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202101886021

Write-up: arm pain; Chills in the night - body shaking; Headache; Nausea; Fatigue; Pain; elevated resting heart rate through the day/elevated resting heart rate on waking/Heart rate high; Chills in the night - body shaking; 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-202112302226326320-XGC5L (RA). Other Case identifier(s): GB-MHRA-ADR 26418572 (RA). A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Mild Osteoarthritis" (unspecified if ongoing); "Psoriasis" (unspecified if ongoing); "Suspected COVID-19", start date: 24Mar2020, stop date: 06Apr2020, notes: Had Covid Mar2020; "Clinical trial participant" (unspecified if ongoing), notes: Study details: Zoe. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 22Mar2021, for Vaccination; Covid-19 vaccine astrazeneca (Dose 2), administration date: 28May2021, for Vaccination; Influenza virus, administration date: 13Nov2021, for Vaccination. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "arm pain"; CHILLS (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), TREMOR (medically significant), outcome "unknown" and all described as "Chills in the night - body shaking"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Nausea"; FATIGUE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Fatigue"; PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pain"; HEART RATE INCREASED (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "elevated resting heart rate through the day/elevated resting heart rate on waking/Heart rate high". The patient underwent the following laboratory tests and procedures: heart rate: high. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030034 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9706 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101886017

Write-up: Fever; Fatigue; Muscle ache; Booster; Headache; Itching; 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-202112302228419740-PJD24 (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26418570 (regulatory authority). A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient last menstrual period date was 12Dec2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. 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 29Dec2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Headache"; PRURITUS (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Itching"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Fever"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Fatigue"; MYALGIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Muscle ache". Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The reporter 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: (29Dec2021) no - negative covid-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2030043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FN1664 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Immunisation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (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; Test Result: Negative
CDC Split Type: GBPFIZER INC202101886037

Write-up: Shortness of breath; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202112302303564660-SJD5I. Other Case identifier(s): GB-MHRA-ADR 26418610. A 40 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN1664) 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 29Dec2021, outcome "unknown", described as "Booster"; DYSPNOEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Shortness of breath". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030047 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Facial paralysis, Immunisation, Interchange of vaccine products, Magnetic resonance imaging, Off label use
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: Test Name: CT; Result Unstructured Data: Test Result:proved inconclusive; Comments: after first vaccine; Test Name: MRI; Result Unstructured Data: Test Result:proved inconclusive; Comments: after first vaccine
CDC Split Type: GBPFIZER INC202101885915

Write-up: Off label use; interchange of vaccine products; booster; Facial palsy/ facial droop; 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-202112302336170230-KUSPF. Other Case identifier(s): GB-MHRA-ADR 26418680. A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for covid-19 immunization, reaction(s): "facial droop"; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for covid-19 immunization, reaction(s): "facial droop". The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; FACIAL PARALYSIS (medically significant) with onset 29Dec2021, outcome "recovering", described as "Facial palsy/ facial droop". The patient underwent the following laboratory tests and procedures: computerised tomogram: proved inconclusive, notes: after first vaccine; magnetic resonance imaging: proved inconclusive, notes: after first vaccine. Clinical course: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Onset of facial droop 3 hours after vaccine. Right side of face showing droop of eyelid and mouth. Internal sensation radiating down side of head behind ear and across jaw and cheekbone. Same experience with both first and second vaccines. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reporter did not consider the report 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: 2030050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Glossodynia, Immunisation, Pyrexia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20211229; Test Name: Fever; Result Unstructured Data: Test Result:Fever; Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885633

Write-up: Rash; Pain tongue; Booster; Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202112302351325080-W4LMA (RA). Other Case identifier(s): GB-MHRA-ADR 26418695 (RA). A female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Vaccination history included: Bnt162b2 (DOSE 1), administration date: 28Jul2021, for COVID-19 immunization; Bnt162b2 (DOSE 2), administration date: 24Sep2021, for COVID-19 immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Fever"; RASH (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Rash"; GLOSSODYNIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Pain tongue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: No - Negative COVID-19 test; body temperature: (29Dec2021) fever. Clinical course: Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2030073 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FM3802 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Fatigue, Headache, Immunisation, Insomnia, Interchange of vaccine products, Myalgia, Off label use, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), 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: IBUPROFEN; LUCETTE; PARACETAMOL
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211126; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101885572

Write-up: fatigue; Headache; Muscle ache; Fever chills; Armpit pain; Injection site pain; Insomnia; 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). Regulatory number: GB-MHRA-WEBCOVID-202112310350196970-JDSUP (RA). Other Case identifier(s): GB-MHRA-ADR 26418916 (RA). A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FM3802) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 24Nov2021 (ongoing). Patient last menstrual period date: 26Dec2021. Patient was not pregnant. Patient is not currently breastfeeding. Concomitant medication(s) included: IBUPROFEN taken for covid-19 treatment, start date: 26Nov2021, stop date: Dec2021; LUCETTE taken for oral contraception, start date: 2015; PARACETAMOL taken for covid-19 treatment, start date: 26Nov2021, stop date: Dec2021. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), administration date: 03May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), administration date: 27Jun2021, for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; FATIGUE (medically significant), outcome "recovering", described as "fatigue"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Headache"; INSOMNIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Insomnia"; MYALGIA (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Muscle ache"; PYREXIA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Fever chills"; AXILLARY PAIN (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Armpit pain"; VACCINATION SITE PAIN (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Injection site pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Nov2021) positive, notes: Yes - Positive COVID-19 test. Clinical course reported as: Insomnia started on date of booster vaccination, followed by all other symptoms at the same time. Most painful and difficult to manage is armpit pain. Managed at home with paracetamol and ibuprofen. Previously tested positive for Covid-19 on 26Nov2021 and currently experiencing symptoms of long covid, specifically extreme fatigue. No reactions to vaccination 1 or 2 AZ. 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: 2030079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Maternal exposure during pregnancy, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101885880

Write-up: Vomited; I am 16 weeks pregnant; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202112310558360730-USUMA (regulatory authority). Other Case identifier: GB-MHRA-ADR 26419450 (regulatory authority). A female patient (pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 22Nov2021, stop date: 27Nov2021; "COVID-19", start date: 22Dec2021 (unspecified if ongoing). The patient was 16 weeks pregnant at the time of exposure to bnt162b2. The patient was 16 weeks pregnant at the event onset. Patient had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 29Dec2021, outcome "unknown", described as "I am 16 weeks pregnant"; VOMITING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Vomited". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) yes - positive COVID-19 test. 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: 2030086 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Abnormal dreams, Anxiety, Fatigue, Immunisation, Nasopharyngitis, Panic reaction
SMQs:, 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 INC202101885712

Write-up: cold like symptoms/Common cold; Booster; Anxiety; Panic reaction; fatigue; Lucid dreams; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202112310711563730-WD2O8. Other Case identifier(s): GB-MHRA-ADR 26419653. A 39 year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), administration date 29Dec2021 (Lot number: Fn3543) at the age of 39 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; ANXIETY (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Anxiety"; PANIC REACTION (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Panic reaction"; FATIGUE (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "fatigue"; ABNORMAL DREAMS (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Lucid dreams"; NASOPHARYNGITIS (medically significant) with onset 31Dec2021, outcome "not recovered", described as "cold like symptoms/Common cold". Panic and anxiety straight after (did not experience with the 1st or 2nd jab). Lasted 24hrs along with fatigue and very lucid dreams. 48 hrs later cold like symptoms. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2030087 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101885866

Write-up: Off label use; Interchange of vaccine products; Booster; Armpit pain; Headache; Fever; Fever chills; Lethargic; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory authority. A 32 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (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: COVID-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (Dose 2, Manufacturer unknown), for COVID-19 immunization. Patient had no symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (disability, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Armpit pain"; HEADACHE (disability, medically significant) with onset 29Dec2021, outcome "not recovered", described as "Headache"; PYREXIA (disability, medically significant) with onset 29Dec2021, outcome "recovered" (Dec2021), described as "Fever"; PYREXIA (disability, medically significant) with onset 29Dec2021, outcome "recovering", described as "Fever chills"; LETHARGY (disability, medically significant) with onset 29Dec2021, outcome "recovering", described as "Lethargic". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) 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: 2030096 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
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: Arthralgia, Dizziness, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dizziness; Fever; Headache; Joint pain; This case was received via RA (Reference number: GB-MHRA-ADR 26420121) 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 ARTHRALGIA (Joint pain), DIZZINESS (Dizziness), PYREXIA (Fever) and HEADACHE (Headache) in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (Joint pain) and DIZZINESS (Dizziness) had not resolved and PYREXIA (Fever) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-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. No concomitant and treatment medications were not provided. Patient has not had symptoms associated with COVID-19. Patient experienced sore arm which progressively worsened over night. By the morning all of his joints were sore and through the day he developed dizziness, a headache and fever with his joints becoming very painful. Over the second night, the fever, headache and dizziness became very bad. On the third morning, the symptoms were still present but were much less severe. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment:This RA case concerns a male patient of 41-year-old with no medical history, who experienced the unexpected serious events of Arthralgia, Pyrexia, Dizziness and Fatigue (Medically significant). The event Arthralgia occurred same day after the third dose of mRNA-1273 vaccine and events Dizziness, Pyrexia and Headache occurred one day after the third dose of mRNA-1273 vaccine. The outcome was reported resolving for Headache and Pyrexia whereas not resolved for Arthralgia and Dizziness. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority ?s report due to important medical condition.; Sender''s Comments: This RA case concerns a male patient of 41-year-old with no medical history, who experienced the unexpected serious events of Arthralgia, Pyrexia, Dizziness and Fatigue (Medically significant). The event Arthralgia occurred same day after the third dose of mRNA-1273 vaccine and events Dizziness, Pyrexia and Headache occurred one day after the third dose of mRNA-1273 vaccine. The outcome was reported resolving for Headache and Pyrexia whereas not resolved for Arthralgia and Dizziness. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. The case was assessed as serious as per Regulatory Authority ?s report due to important medical condition.


VAERS ID: 2030104 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

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

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

Write-up: High temperature; Shivers; Vomited; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420338) 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 PYREXIA (High temperature), CHILLS (Shivers) and VOMITING (Vomited) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On 29-Dec-2021, CHILLS (Shivers) and VOMITING (Vomited) had resolved. On 30-Dec-2021, PYREXIA (High temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. 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 is a regulatory case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected, according to CCDS, events of PYREXIA, CHILLS and VOMITING. The events occurred on the same day after the third dose of mRNA-1273 and recovered. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a patient of an unknown age and gender with no medical history reported, who experienced the serious unexpected, according to CCDS, events of PYREXIA, CHILLS and VOMITING. The events occurred on the same day after the third dose of mRNA-1273 and recovered. The rechallenge was assessed as unknown according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030107 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Back pain, Decreased appetite, Headache, Hot flush, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (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: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; Hot flush; Back pain aggravated; Sleepy; Appetite impaired; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420425) 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 PYREXIA (Fever), HEADACHE (Headache), HOT FLUSH (Hot flush), BACK PAIN (Back pain aggravated), SOMNOLENCE (Sleepy) and DECREASED APPETITE (Appetite impaired) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 30-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), HOT FLUSH (Hot flush) (seriousness criterion medically significant), BACK PAIN (Back pain aggravated) (seriousness criterion medically significant), SOMNOLENCE (Sleepy) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite impaired) (seriousness criterion medically significant). On 30-Dec-2021, HEADACHE (Headache) had resolved. On 31-Dec-2021, BACK PAIN (Back pain aggravated) and SOMNOLENCE (Sleepy) had resolved. At the time of the report, PYREXIA (Fever), HOT FLUSH (Hot flush) and DECREASED APPETITE (Appetite impaired) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment medication information was not provided by the reporter. It was reported that it was a painful headache most painful she ever had and it was worse than a migraine. She also experienced hot and cold sweats lasted 24 hours. Loss of appetite for 24 hours. She felt feverish for 2 days. Company comment: This case concerns a 34-year-old female patient with no medical history provided, who experienced serious unexpected events of Pyrexia, Decreased appetite, Somnolence, Hot flush, Back pain and Headache. The event of Pyrexia occurred during the same day after the patient had received the mRNA-1273 (as third dose)., while the remaining events occurred the day after this vaccination. According to the case description, the patient had sore arm, painful headache, hot and cold sweats, loss of appetite and felt feverish. As per data in the structured fields of the source document, the events of Decreased appetite, Hot flush and Pyrexia had not resolved, however, as per case description, decreased appetite and Hot flush lasted fr 24 hours, and the patient felt feverish for two days. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 34-year-old female patient with no medical history provided, who experienced serious unexpected events of Pyrexia, Decreased appetite, Somnolence, Hot flush, Back pain and Headache. The event of Pyrexia occurred during the same day after the patient had received the mRNA-1273 (as third dose)., while the remaining events occurred the day after this vaccination. According to the case description, the patient had sore arm, painful headache, hot and cold sweats, loss of appetite and felt feverish. As per data in the structured fields of the source document, the events of Decreased appetite, Hot flush and Pyrexia had not resolved, however, as per case description, decreased appetite and Hot flush lasted fr 24 hours, and the patient felt feverish for two days. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such, however, could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030111 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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 postural, Nausea, Paraesthesia, Peripheral swelling, Pruritus, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: Anxiety (Amitriptyline & Fluoxetine); Depression (Amitriptyline & Fluoxetine); Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...); Irritable bowel syndrome (Mebeveribe)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Itchy skin; Dizzy on standing; Nausea; Swollen arm; Tingling; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26420601) 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 PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy skin), DIZZINESS POSTURAL (Dizzy on standing), PARAESTHESIA (Tingling) and NAUSEA (Nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Previously administered products included for Anxiety: Amitriptyline; for Depression: FLUOXETINE; for Urinary incontinence: TOLTERODINE; for Reflux gastritis: DESOGESTREL and OMEPRAZOLE. Past adverse reactions to the above products included No adverse reaction with Amitriptyline, DESOGESTREL, FLUOXETINE, OMEPRAZOLE and TOLTERODINE. Concurrent medical conditions included Depression (Amitriptyline & Fluoxetine), Anxiety (Amitriptyline & Fluoxetine), Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...) and Irritable bowel syndrome (Mebeveribe). On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and PARAESTHESIA (Tingling) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Swollen arm), PRURITUS (Itchy skin), DIZZINESS POSTURAL (Dizzy on standing) and PARAESTHESIA (Tingling) had not resolved and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not currently breastfeeding Patient is not enrolled in clinical trial No concomitant medications were provided by reporter No treatment medications were provided by reporter Company comment: This regulatory case concerns a 38-year-old female patient, with medical history of anxiety and reflux gastritis, who experienced the serious unexpected events of PERIPHERAL SWELLING, PRURITUS, DIZZINESS POSTURAL, PARAESTHESIA and NAUSEA. The events PERIPHERAL SWELLING and PARAESTHESIA occurred on the same day of the third dose of mRNA-1273. The events DIZZINESS POSTURAL and NAUSEA occurred on the following day of the third dose of mRNA-1273. The event PRURITUS occurred two days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on the following day of the third dose of mRNA-1273. The history of anxiety and reflux gastritis and the use of concomitant FLUOXETINE and OMEPRAZOLE remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.; Sender''s Comments: This regulatory case concerns a 38-year-old female patient, with medical history of anxiety and reflux gastritis, who experienced the serious unexpected events of PERIPHERAL SWELLING, PRURITUS, DIZZINESS POSTURAL, PARAESTHESIA and NAUSEA. The events PERIPHERAL SWELLING and PARAESTHESIA occurred on the same day of the third dose of mRNA-1273. The events DIZZINESS POSTURAL and NAUSEA occurred on the following day of the third dose of mRNA-1273. The event PRURITUS occurred two days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, but it could be considered not applicable as no information about further dosing has been disclosed. A SARS-CoV-2 test: negative was performed on the following day of the third dose of mRNA-1273. The history of anxiety and reflux gastritis and the use of concomitant FLUOXETINE and OMEPRAZOLE remain as confounders. The benefit-risk relationship of the mRNA-1273 is not affected by this report. The seriousness was assessed as per regulatory authority report.


VAERS ID: 2030119 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   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 postural, 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; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Dizziness postural; This case was received via RA (Reference number: GB-MHRA-ADR 26420872) 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 DIZZINESS POSTURAL (Dizziness postural) in a 61-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022a) 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 29-Dec-2021, the patient experienced DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion medically significant). At the time of the report, DIZZINESS POSTURAL (Dizziness postural) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication list was not provided. Treatment medication information was not provided by the reporter. It was reported that patient won''t up on the 29th and could smell his own breath which smells like the day after he had tooth out. It smelt like his breath or mouth was septic. Not had this before, been dizzy now since 29th. Patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company comment: This case concerns a 61-year-old, male patient with no medical history reported, who experienced the unexpected event of dizziness postural. The event occurred approximately 1 day after the third dose of mRNA-1273. As reported, 1 days after third dose the patient could smell his own breath which smelled like the day after he had tooth out. It smelt like his breath or mouth was septic, as reported. Patient had been dizzy since the 1 days after vaccination. Event was ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 61-year-old, male patient with no medical history reported, who experienced the unexpected event of dizziness postural. The event occurred approximately 1 day after the third dose of mRNA-1273. As reported, 1 days after third dose the patient could smell his own breath which smelled like the day after he had tooth out. It smelt like his breath or mouth was septic, as reported. Patient had been dizzy since the 1 days after vaccination. Event was ongoing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2030123 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   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: Axillary pain, Chest discomfort, Cold sweat, Dizziness postural, Irregular breathing, Vision blurred
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Respiratory failure (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: THYROXINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Irregular breathing; Tight chest; Dizzy on standing; Blurring of eyes; Cold sweat; Armpit pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26420929) 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 IRREGULAR BREATHING (Irregular breathing), CHEST DISCOMFORT (Tight chest), COLD SWEAT (Cold sweat), AXILLARY PAIN (Armpit pain), DIZZINESS POSTURAL (Dizzy on standing) and VISION BLURRED (Blurring of eyes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced AXILLARY PAIN (Armpit pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced COLD SWEAT (Cold sweat) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced IRREGULAR BREATHING (Irregular breathing) (seriousness criterion medically significant), CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant) and VISION BLURRED (Blurring of eyes) (seriousness criterion medically significant). At the time of the report, IRREGULAR BREATHING (Irregular breathing), CHEST DISCOMFORT (Tight chest), COLD SWEAT (Cold sweat), AXILLARY PAIN (Armpit pain), DIZZINESS POSTURAL (Dizzy on standing) and VISION BLURRED (Blurring of eyes) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Treatment medication was not provided by the reporter. Company comment: This Regulatory Authority case concerns a patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of irregular breathing, chest discomfort, cold sweat, axillary pain, dizziness postural and vision blurred. The patient developed axillary pain on the same day of receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved the next day with cold sweat and 2 days later with irregular breathing, chest discomfort, dizziness postural and vision blurred. It was not reported if the previous two doses of the patient COVID-19 vaccination schedule were mRNA-1273 vaccines as well. 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 patient of unknown age and gender, with no reported medical history, who experienced the unexpected, serious (Medically significant) events of irregular breathing, chest discomfort, cold sweat, axillary pain, dizziness postural and vision blurred. The patient developed axillary pain on the same day of receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved the next day with cold sweat and 2 days later with irregular breathing, chest discomfort, dizziness postural and vision blurred. It was not reported if the previous two doses of the patient COVID-19 vaccination schedule were mRNA-1273 vaccines as well. 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.


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