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

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

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 582 out of 10,317

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VAERS ID: 1901493 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: muscle pain; Chills; Pain; Fatigue; This case was received via Regulatory Authority Reference number: GB-MHRA-ADR 26217220) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (muscle pain), CHILLS (Chills), FATIGUE (Fatigue) and PAIN (Pain) in a 48-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced CHILLS (Chills) (seriousness criterion medically significant) and PAIN (Pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (muscle pain), CHILLS (Chills), FATIGUE (Fatigue) and PAIN (Pain) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medication was not reported. It was reported that patient had all over bone and muscle pain, extreme fatigue (breathless moving) and chills (unable to stop shivering even under electric blankets). Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Report was not related to possible inflammation of the heart (myocarditis or pericarditis). Company Comment : This case concerns a 48-year-old female patient with no relevant medical history, who experienced the events of chills, myalgia, fatigue and pain. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The event fatigue occurred on the same day after the third dose of mRNA � 1273 vaccine, while the other events followed a day after. Events were reported as medically significant and at the time of report had not resolved. The rechallenge is unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 48-year-old female patient with no relevant medical history, who experienced the events of chills, myalgia, fatigue and pain. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The event fatigue occurred on the same day after the third dose of mRNA � 1273 vaccine, while the other events followed a day after. Events were reported as medically significant and at the time of report had not resolved. The rechallenge is unknown since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1901495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Rash; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26217748) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concurrent medical conditions included Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohns disease, ulcerative colitis)). On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). On 17-Nov-2021, RASH (Rash) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. The patient experienced Rash on upper arm near injection site. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Company comment: This case concerns a female patient of unknown age with medical history of taking medicines for inflammatory bowel disease who experienced the serious and unexpected event of rash. The event occurred the following day a dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since only information of one dose is disclosed and a further dose is not expected. Medical history of taking medicines for inflammatory bowel disease remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. .; Sender''s Comments: This case concerns a female patient of unknown age with medical history of taking medicines for inflammatory bowel disease who experienced the serious and unexpected event of rash. The event occurred the following day a dose of mRNA-1273 vaccine was administered. The rechallenge was not applicable since only information of one dose is disclosed and a further dose is not expected. Medical history of taking medicines for inflammatory bowel disease remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1901501 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Fatigue, Migraine, Migraine with aura, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: migraine; confusion; fatigue; Migraine aura; Migraine headache; This case was received via RA (Reference number: GB-MHRA-ADR 26220828) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), CONFUSIONAL STATE (confusion), MIGRAINE WITH AURA (Migraine aura), MIGRAINE (Migraine headache) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Patient has not had symptoms associated with COVID-19. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced MIGRAINE WITH AURA (Migraine aura) (seriousness criterion disability) and MIGRAINE (Migraine headache) (seriousness criterion disability). On an unknown date, the patient experienced MIGRAINE (migraine) (seriousness criterion disability), CONFUSIONAL STATE (confusion) (seriousness criterion disability) and FATIGUE (fatigue) (seriousness criterion disability). At the time of the report, MIGRAINE (migraine), CONFUSIONAL STATE (confusion), MIGRAINE WITH AURA (Migraine aura), MIGRAINE (Migraine headache) and FATIGUE (fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient didn''t have any side effects from first two Pfizer vaccines. No treatment medications were provided. It was reported that patient experienced very severe Migraines and Confusion after moderna. Company comment: This case concerns a 59-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Confusional state, Migraine with aura and Fatigue. The events occurred the next day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.; Sender''s Comments: This case concerns a 59-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected events of Confusional state, Migraine with aura and Fatigue. The events occurred the next day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report and retained for consistency.


VAERS ID: 1901502 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial fibrillation, SARS-CoV-2 test
SMQs:, Supraventricular tachyarrhythmias (narrow), COVID-19 (broad)

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

Write-up: Atrial fibrillation; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26220959) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of ATRIAL FIBRILLATION in a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concomitant products included RAMIPRIL for Hypertension, TOZINAMERAN PFIZER BIONTECH COVID-19 VACCINE from 24-Feb-2021 to an unknown date for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ATRIAL FIBRILLATION (seriousness criteria hospitalization and medically significant). At the time of the report, ATRIAL FIBRILLATION 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. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment Medication use information was not provided by reporter. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. This case concerns a 41-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) with relevant medical history of hypertension who experienced the serious unexpected event (AESI) of atrial fibrillation one day after the third dose of the vaccine. Rechallenge is not applicable, since no further dosing is expected. The benefit-risk relationship is not affected by this report.


VAERS ID: 1901505 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: Tired all the time; Fever; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26222032) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Tired all the time), PYREXIA (Fever) and NAUSEA (Nausea) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included NORTRIPTYLINE for an unknown indication. On 14-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Tired all the time) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 18-Nov-2021, PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, FATIGUE (Tired all the time) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. 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 Patient is not pregnant, Patient is not currently breastfeeding. Company Comment: This case concerns a 51-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pyrexia, nausea, and fatigue. The events occurred approximately 2 days after the third dose of mRNA � 1273 vaccine. Events are reported medically significant but 4-days after the received third dose the events pyrexia and nausea had resolved. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old, female patient with no relevant medical history reported, who experienced the unexpected events of pyrexia, nausea, and fatigue. The events occurred approximately 2 days after the third dose of mRNA � 1273 vaccine. Events are reported medically significant but 4-days after the received third dose the events pyrexia and nausea had resolved. The rechallenge was unknown since no information about the first two doses were disclosed. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1903144 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dry eye, Nausea, Pain in extremity, Palpitations, Peripheral coldness, SARS-CoV-2 test, Skin burning sensation
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: woke up at 7am felt a bit of a sore arm; Nausea; Heart racing; Cold hands & feet; Dry eyes; Shivering; Burning skin; Joint pain; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26210701) on 17-Nov-2021 and was forwarded to Moderna on 17-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), PERIPHERAL COLDNESS (Cold hands & feet), DRY EYE (Dry eyes), CHILLS (Shivering), SKIN BURNING SENSATION (Burning skin), ARTHRALGIA (Joint pain), PAIN IN EXTREMITY (woke up at 7am felt a bit of a sore arm) and NAUSEA (Nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 on 02-Jan-2021. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PALPITATIONS (Heart racing) (seriousness criterion medically significant), PERIPHERAL COLDNESS (Cold hands & feet) (seriousness criterion medically significant), DRY EYE (Dry eyes) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant), SKIN BURNING SENSATION (Burning skin) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (woke up at 7am felt a bit of a sore arm) (seriousness criterion medically significant). At the time of the report, PALPITATIONS (Heart racing), PERIPHERAL COLDNESS (Cold hands & feet), DRY EYE (Dry eyes), CHILLS (Shivering), SKIN BURNING SENSATION (Burning skin) and ARTHRALGIA (Joint pain) had not resolved, PAIN IN EXTREMITY (woke up at 7am felt a bit of a sore arm) was resolving and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment medications were provided. This case concerns a 37-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of pain in extremity, palpitations , peripheral coldness, dry eye, chills , skin burning sensation and arthralgia. The events occurred approximately on the next day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the third dose and no information on additional dosing is expected. 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 event.; Sender''s Comments: This case concerns a 37-year-old, female patient with no relevant medical history reported, who experienced the unexpected serious events of pain in extremity, palpitations , peripheral coldness, dry eye, chills , skin burning sensation and arthralgia. The events occurred approximately on the next day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable since the events happened after the third dose and no information on additional dosing is expected. 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 event.


VAERS ID: 1903147 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Headache, Nausea, Pain, Pyrexia, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN CALCIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chills; Headache; Tremors; felt fine after the vaccination - drank water; Shaking; Generalised joint pains; Nausea; Headache dull; Fever chills; Dizziness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26211172) on 17-Nov-2021 and was forwarded to Moderna on 17-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), TREMOR (Tremors), PAIN (felt fine after the vaccination - drank water), TREMOR (Shaking), ARTHRALGIA (Generalised joint pains), NAUSEA (Nausea), HEADACHE (Headache dull), PYREXIA (Fever chills) and DIZZINESS (Dizziness) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 from 21-Jan-2021 to 07-Feb-2021. Concomitant products included ATORVASTATIN CALCIUM for Diabetic. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ARTHRALGIA (Generalised joint pains) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), HEADACHE (Headache dull) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (Chills) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), TREMOR (Tremors) (seriousness criterion medically significant), PAIN (felt fine after the vaccination - drank water) (seriousness criterion medically significant) and TREMOR (Shaking) (seriousness criterion medically significant). On 16-Nov-2021, ARTHRALGIA (Generalised joint pains) was resolving, PYREXIA (Fever chills) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (Chills), HEADACHE (Headache), TREMOR (Tremors), PAIN (felt fine after the vaccination - drank water), TREMOR (Shaking), NAUSEA (Nausea) and HEADACHE (Headache dull) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. It was reported that patient felt fine after the vaccination. Drank water, went for long walk, mowed lawn and ate dinner. Felt groggy before bed and woke at 3am with severe chills which lasted for 45mins - uncontrollable shaking and nausea and dull headache. Took paracetamol and slept, tremors subsided. Noticed extremely sore vaccination site and aching joints. Very groggy and achy all day, slept until 2pm and shivery. Treatment medication included Paracetamol. Company Comment: This case concerns a 69-year-old patient of an unknown gender, with medical history of diabetes, who experienced serious unexpected events of CHILLS, HEADACHE (Headache and Headache dull), TREMOR (tremors and Shaking), ARTHRALGIA, PYREXIA and DIZZINESS after third dose of mRNA-1273. The events occurred the next day after third dose. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 69-year-old patient of an unknown gender, with medical history of diabetes, who experienced serious unexpected events of CHILLS, HEADACHE (Headache and Headache dull), TREMOR (tremors and Shaking), ARTHRALGIA, PYREXIA and DIZZINESS after third dose of mRNA-1273. The events occurred the next day after third dose. The re-challenge is not applicable since further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1903154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Shivers; Nausea; Diarrhea; High temperature; Vomiting; This case was received (Reference number: GB-MHRA-ADR 26211573) on 17-Nov-2021 and was forwarded to Moderna on 17-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature), VOMITING (Vomiting), CHILLS (Shivers), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No specific medical history has been reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criteria disability and medically significant) and VOMITING (Vomiting) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced CHILLS (Shivers) (seriousness criteria disability and medically significant), NAUSEA (Nausea) (seriousness criteria disability and medically significant) and DIARRHOEA (Diarrhea) (seriousness criteria disability and medically significant). At the time of the report, PYREXIA (High temperature), VOMITING (Vomiting), CHILLS (Shivers), NAUSEA (Nausea) and DIARRHOEA (Diarrhea) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. Patient was not enrolled in clinical trial company comment: This is a regulatory authority case concerning a female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Pyrexia, Vomiting, Chills, Nausea and Diarrhea. The events occurred 1 day after the third dose of mRNA-1273 vaccine. Treatment information was not provided. 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 female patient of an unknown age with no relevant medical history reported, who experienced serious, unexpected events of Pyrexia, Vomiting, Chills, Nausea and Diarrhea. The events occurred 1 day after the third dose of mRNA-1273 vaccine. Treatment information was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1903175 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: Ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26223139) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache) in a 65-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant). On 18-Nov-2021, PAIN (Ache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant information was provided No treatment information were given. 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 65-year-old male patient with no relevant medical history provided, who experienced the serious unexpected event of Pain. The event occurred one day after the administration of the third dose of mRNA-1273 vaccine. The event had resolved within two days, however, no further information regarding the clinical course of the event was provided. The action taken with the suspect product and re-challenge results were captured as unknown, as per Regulatory Authority source document, however, it could be considered as not applicable, having in mind that the event occurred after the third dose of the vaccine and no additional doses are expected at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 65-year-old male patient with no relevant medical history provided, who experienced the serious unexpected event of Pain. The event occurred one day after the administration of the third dose of mRNA-1273 vaccine. The event had resolved within two days, however, no further information regarding the clinical course of the event was provided. The action taken with the suspect product and re-challenge results were captured as unknown, as per Regulatory Authority source document, however, it could be considered as not applicable, having in mind that the event occurred after the third dose of the vaccine and no additional doses are expected at the moment. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1903342 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-11-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Malaise, Myalgia, Nausea, Pyrexia, Syncope, Tinnitus, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fever; Result Unstructured Data: Fever not measured
CDC Split Type: NLJNJFOC20211153556

Write-up: Tinnitus; Syncope; Sweating; Dizziness; Vision blurred; Myalgia; Malaise; Headache; Chills; Fever; Nausea; This spontaneous report received from a consumer via a Regulatory Authority [NL-LRB-00715227] concerned a 24 year old female of unspecified race and ethnic origin. The patient''s weight was 65 kilograms, and height was 168 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 dosage forms, 1 total, administered on 16-NOV-2021 for covid-19 immunisation. Drug start period was 9 hours. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 16-NOV-2021, the patient experienced malaise, headache, chills, fever, nausea, myalgia. On an unspecified date, the patient experienced syncope, tinnitus, sweating, dizziness, and vision blurred. Laboratory data (dates unspecified) included: Fever (NR: not provided) Fever not measured. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 17-NOV-2021, and tinnitus, nausea, sweating, dizziness, and vision blurred, was recovering from malaise, chills, and fever, and had not recovered from headache, and myalgia. This report was serious (Other Medically Important Condition).


VAERS ID: 1904612 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Cold sweat
SMQs:, Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Cold sweat; Aching joints; Shivers; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26214224) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COLD SWEAT (Cold sweat), ARTHRALGIA (Aching joints) and CHILLS (Shivers) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 24-Feb-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 14-May-2021 to an unknown date for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 12-Oct-2021 to an unknown date for Flu vaccination, LEVOTHYROXINE for Hypothyroidism. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced COLD SWEAT (Cold sweat) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and CHILLS (Shivers) (seriousness criterion medically significant). At the time of the report, COLD SWEAT (Cold sweat), ARTHRALGIA (Aching joints) and CHILLS (Shivers) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was stated that the patient felt tired 6 hours later, then aching joints by 12 hours later. Patient took paracetamol every four hours. Company Comment: This is a regulatory authority case concerning a 65-year-old female patient with no relevant medical history, who experienced serious, unexpected events of Cold sweat, Arthralgia and Chills. The events occurred 1 day after the third dose of mRNA-1273 vaccine. It was reported that patient felt tired 6 hours later, then aching joints by 12 hours later. Patient took paracetamol every four hours. Patient received COVID 19 AstraZeneca vaccine on 24-Feb-2021 and 14-May-2021. 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 65-year-old female patient with no relevant medical history, who experienced serious, unexpected events of Cold sweat, Arthralgia and Chills. The events occurred 1 day after the third dose of mRNA-1273 vaccine. It was reported that patient felt tired 6 hours later, then aching joints by 12 hours later. Patient took paracetamol every four hours. Patient received COVID 19 AstraZeneca vaccine on 24-Feb-2021 and 14-May-2021. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1904614 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211028; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Vertigo; Headache; Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26214696) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VERTIGO (Vertigo), HEADACHE (Headache) and FATIGUE (Tiredness) in a 41-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004475) for an unknown indication. Previously administered products included for Product used for unknown indication: CITALOPRAM (Patient take 40MG of citalopram a day.). Past adverse reactions to the above products included No adverse event with CITALOPRAM. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 26-Feb-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 16-Nov-2021 to an unknown date for Immunisation. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), VERTIGO (Vertigo) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), VERTIGO (Vertigo), HEADACHE (Headache) and FATIGUE (Tiredness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication details were reported. Company comment This case concerns a 41-year-old male patient, with medical history of having received flu vaccine on the same day of the administration of mRNA-1273 vaccine, and COVID-19 VACCINE ASTRAZENECA as a previous vaccine dose, who experienced the unexpected serious events of NAUSEA, VERTIGO, HEADACHE and FATIGUE. The events occurred on the following two days of the administration of the third dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of having received flu vaccine on the same day of the administration of mRNA-1273 vaccine, and COVID-19 VACCINE ASTRAZENECA as a previous vaccine dose, remains as confounders. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 41-year-old male patient, with medical history of having received flu vaccine on the same day of the administration of mRNA-1273 vaccine, and COVID-19 VACCINE ASTRAZENECA as a previous vaccine dose, who experienced the unexpected serious events of NAUSEA, VERTIGO, HEADACHE and FATIGUE. The events occurred on the following two days of the administration of the third dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of having received flu vaccine on the same day of the administration of mRNA-1273 vaccine, and COVID-19 VACCINE ASTRAZENECA as a previous vaccine dose, remains as confounders. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1904618 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Illness, Peripheral swelling, Pyrexia, Tremor
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: shaking; Exhaustion; Sickness; Swollen arm; Headache; Slight fever; Tiredness; This case was received via Regulatory Authority. Reference number: GB-MHRA-ADR 26215113) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (shaking), FATIGUE (Exhaustion), ILLNESS (Sickness), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), PYREXIA (Slight fever) and FATIGUE (Tiredness) in a 35-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 13-Mar-2021 to an unknown date for Vaccination. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Slight fever) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (shaking) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). On 17-Nov-2021, ILLNESS (Sickness) and HEADACHE (Headache) was resolving. At the time of the report, TREMOR (shaking), FATIGUE (Exhaustion) and PERIPHERAL SWELLING (Swollen arm) had not resolved and PYREXIA (Slight fever) and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment medication were provided. Patient reported of swollen arm, violent shaking, sickness, severe headache, exhaustion and sensitive to light. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not currently breastfeeding. Company comment This case concerns a 35 year-old, female patient with no relevant medical history, who experienced the serious unexpected events of Tremor, Fatigue (reported as Tiredness and exhaustion), Illness, Headache, Peripheral swelling and Pyrexia. The events Fatigue (reported as Tiredness), Illness, Headache, Peripheral swelling and Pyrexia occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the events Tremor, Fatigue (reported as exhaustion) occurred on an unknown date. The rechallenge was not applicable since the events occurred after the booster dose. The patient was vaccinated 8 months before with COVID-19 Vaccine AstraZeneca. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 35 year-old, female patient with no relevant medical history, who experienced the serious unexpected events of Tremor, Fatigue (reported as Tiredness and exhaustion), Illness, Headache, Peripheral swelling and Pyrexia. The events Fatigue (reported as Tiredness), Illness, Headache, Peripheral swelling and Pyrexia occurred approximately 1 day after the booster dose of mRNA-1273 vaccine and the events Tremor, Fatigue (reported as exhaustion) occurred on an unknown date. The rechallenge was not applicable since the events occurred after the booster dose. The patient was vaccinated 8 months before with COVID-19 Vaccine AstraZeneca. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1904621 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: nausea; Headache; Fever; This case was received (Reference number: GB-MHRA-ADR 26216400) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of (nausea), (Headache) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, NAUSEA (nausea), HEADACHE (Headache) and PYREXIA (Fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication was reported. No treatment information was reported. Company comment: This is a regulatory case concerning a 57 year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of pyrexia, nausea and headache one day after receiving the third dose of mRNA-1273 . The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting; Sender''s Comments: This is a regulatory case concerning a 57 year-old female patient, with no relevant medical history reported, who experienced the serious unexpected events of pyrexia, nausea and headache one day after receiving the third dose of mRNA-1273 . The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting


VAERS ID: 1904623 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

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

Write-up: Shaking; Shivering; Headache; This case was received (Reference number: GB-MHRA-ADR 26218441) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TREMOR (Shaking), CHILLS (Shivering) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 17-Nov-2021, TREMOR (Shaking) was resolving, CHILLS (Shivering) had resolved. At the time of the report, HEADACHE (Headache) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No concomitant medication details provided. No treatment medication details provided. Company Comment: This case concerns a female patient of an unknown age, with no relevant medical history reported, who experienced the serious unexpected events of TREMOR, CHILLS and HEADACHE. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a female patient of an unknown age, with no relevant medical history reported, who experienced the serious unexpected events of TREMOR, CHILLS and HEADACHE. The events occurred on the same day of the third dose of the mRNA-1273 vaccine. The rechallenge is not applicable since no information about further dosing has been disclosed. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1904760 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Contusion, Illness, Pain, Palpitations, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (broad)

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

Write-up: palpitations; Bruising; Sickness; General body pain; Abdominal pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26215097) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), ILLNESS (Sickness), PAIN (General body pain), ABDOMINAL PAIN (Abdominal pain) and CONTUSION (Bruising) in a 23-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started). Previously administered products included for Product used for unknown indication: ZONISAMIDE. Past adverse reactions to the above products included No adverse event with ZONISAMIDE. Concurrent medical conditions included Fit (in known epileptic) (Patient was epileptic and take zonisamide twice daily). On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant), PAIN (General body pain) (seriousness criterion medically significant) and ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced CONTUSION (Bruising) (seriousness criterion medically significant). On an unknown date, the patient experienced PALPITATIONS (palpitations) (seriousness criterion medically significant). On 16-Nov-2021, ILLNESS (Sickness) had resolved. At the time of the report, PALPITATIONS (palpitations) was resolving and PAIN (General body pain), ABDOMINAL PAIN (Abdominal pain) and CONTUSION (Bruising) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication were reported. Patient is not currently breastfeeding It was reported that patient received the vaccine late on the 15th, felt generally okay until late on the 16th when she started feeling nauseous, getting horrendous abdominal pain, and her body ached so badly all over she couldn''t move. She knows she had a large light red circle around where she was vaccinated which she assumes is bruising but unsure of this. Patient still have abdominal and general body pain. Patient also had heart palpitations however she believes these are caused by anxiety as she frequently experienced them before this booster too. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Company comment: This case concerns a 23-year-old female patient, with medical history of epilepsy, who experienced the unexpected serious events of PALPITATIONS, ILLNESS, PAIN, ABDOMINAL PAIN and CONTUSION. The events occurred on the following 2 days of the administration of the third dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of epilepsy, remains as a confounder. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 23-year-old female patient, with medical history of epilepsy, who experienced the unexpected serious events of PALPITATIONS, ILLNESS, PAIN, ABDOMINAL PAIN and CONTUSION. The events occurred on the following 2 days of the administration of the third dose of mRNA-1273 vaccine. The rechallenge was unknown. Patient�s medical history of epilepsy, remains as a confounder. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1904780 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-01
Onset:2021-11-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Migraine, Pain, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms stopped); Comments: Patient Not had a COVID-19 test and Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Migraine headache; Swollen lymph nodes; Ache; Vaginal bleeding; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26219279) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding), MIGRAINE (Migraine headache), LYMPHADENOPATHY (Swollen lymph nodes) and PAIN (Ache) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. Patient Not had a COVID-19 test and Patient is not currently breastfeeding. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 06-Dec-2019 and Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)). Previously administered products included for Product used for unknown indication: CITALOPRAM. Past adverse reactions to the above products included No adverse event with CITALOPRAM. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from an unknown date to 14-Mar-2021 for an unknown indication. In November 2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced MIGRAINE (Migraine headache) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) and MIGRAINE (Migraine headache) was resolving and LYMPHADENOPATHY (Swollen lymph nodes) and PAIN (Ache) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. This case concerns a 33-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of vaginal haemorrhage, migraine, lymphadenopathy and pain. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 33-year-old, female patient with relevant medical history of suspected COVID-19, who experienced the unexpected events of vaginal haemorrhage, migraine, lymphadenopathy and pain. The events occurred on an unknown number of days after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1904781 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Oropharyngeal pain, Pain, Sweating fever
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA VIRUS
Current Illness: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Ache; Shivers; Sweating fever; Throbbing headache; Chronic sore throat; Feeling unwell; This case was received via regulatory authority (Reference number:-MHRA-ADR 26219789) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (Ache), CHILLS (Shivers), SWEATING FEVER (Sweating fever), HEADACHE (Throbbing headache), OROPHARYNGEAL PAIN (Chronic sore throat) and MALAISE (Feeling unwell) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response.). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 25-Oct-2021 to an unknown date for Vaccination. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN (Ache) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant), SWEATING FEVER (Sweating fever) (seriousness criterion medically significant), HEADACHE (Throbbing headache) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Chronic sore throat) (seriousness criterion medically significant) and MALAISE (Feeling unwell) (seriousness criterion medically significant). At the time of the report, PAIN (Ache), CHILLS (Shivers), SWEATING FEVER (Sweating fever), HEADACHE (Throbbing headache), OROPHARYNGEAL PAIN (Chronic sore throat) and MALAISE (Feeling unwell) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Patient not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not enrolled in clinical trial. Company comment: This case concerns a 47-year-old female patient, with medical history of immunodeficiency, who experienced serious unexpected events of pain, chills, sweating fever, headache, oropharyngeal pain and malaise after third dose of mRNA-1273. The events occurred 1 day after vaccination. The re-challenge is not applicable since no further dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 47-year-old female patient, with medical history of immunodeficiency, who experienced serious unexpected events of pain, chills, sweating fever, headache, oropharyngeal pain and malaise after third dose of mRNA-1273. The events occurred 1 day after vaccination. The re-challenge is not applicable since no further dose is expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1904790 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Decreased appetite, Hyperhidrosis, Injection site bruising, Pain in extremity, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIHYDROCODEINE TARTRATE; MORPHINE SULFATE; OMEPRAZOLE; PREGABALIN
Current Illness: Pain
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture (Fractured pelvis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: days; intermittent; Joint pain; Sweating; Chills; Appetite lost; Pain in arm; Rigors; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26224141) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Rigors), ARTHRALGIA (Joint pain), HYPERHIDROSIS (Sweating), CHILLS (Chills), DECREASED APPETITE (Appetite lost), PAIN IN EXTREMITY (Pain in arm), PYREXIA (days) and INJECTION SITE BRUISING (intermittent) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Fracture (Fractured pelvis) in 2013. Concurrent medical conditions included Pain. Concomitant products included OMEPRAZOLE for Esophageal reflux, PREGABALIN for Nerve pain, DIHYDROCODEINE BITARTRATE (DIHYDROCODEINE TARTRATE) and MORPHINE SULFATE for Pain. On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced CHILLS (Rigors) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant), HYPERHIDROSIS (Sweating) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (days) (seriousness criterion medically significant) and INJECTION SITE BRUISING (intermittent) (seriousness criterion medically significant). At the time of the report, CHILLS (Rigors), ARTHRALGIA (Joint pain), HYPERHIDROSIS (Sweating), CHILLS (Chills), DECREASED APPETITE (Appetite lost) and PAIN IN EXTREMITY (Pain in arm) had not resolved and PYREXIA (days) and INJECTION SITE BRUISING (intermittent) outcome was unknown. Treatment medications were not reported. Patient experienced rigors, intermittent for 3 days, bad joint pain, sweats, fever, arm pain, unable to use or lift arm for 2 days. Patient was not enrolled in clinical trial. Company comment: This case concerns a 42-year-old, female patient with medical history of pain, secondary to fractured pelvis, who experienced the unexpected serious events of chills (reported as "rigors" and "chills"), arthralgia, hyperhidrosis, decreased appetite, pain in extremity, pyrexia, and injection site bruising (reported as "intermittent"). The events of arthralgia, chills, injection site bruising, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The events chills (reported as "rigors"), and pain in extremity occurred on the same day after the dose of mRNA-1273. The events arthralgia, hyperhidrosis, chills, and decreased appetite occurred 1 day after the dose of mRNA-1273. The date of onset of the events pyrexia and injection site bruising was not reported. Regulatory authority reported the rechallenge as unknown, however, no dose number was reported. Patient�s medical history of fractured pelvis could be confounder for arthralgia. The event hyperhidrosis and chills could be in association to pyrexia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events term, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.; Sender''s Comments: This case concerns a 42-year-old, female patient with medical history of pain, secondary to fractured pelvis, who experienced the unexpected serious events of chills (reported as "rigors" and "chills"), arthralgia, hyperhidrosis, decreased appetite, pain in extremity, pyrexia, and injection site bruising (reported as "intermittent"). The events of arthralgia, chills, injection site bruising, and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The events chills (reported as "rigors"), and pain in extremity occurred on the same day after the dose of mRNA-1273. The events arthralgia, hyperhidrosis, chills, and decreased appetite occurred 1 day after the dose of mRNA-1273. The date of onset of the events pyrexia and injection site bruising was not reported. Regulatory authority reported the rechallenge as unknown, however, no dose number was reported. Patient�s medical history of fractured pelvis could be confounder for arthralgia. The event hyperhidrosis and chills could be in association to pyrexia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events term, onset date, outcome and seriousness captured per source document from Regulatory Authority reporting.


VAERS ID: 1904800 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-11-16
   Days after vaccination:271
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, 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: ATORVASTATIN; BUDESONIDE; LANSOPRAZOL; SALBUTAMOL; TRAZODONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201128; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; Headache; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26229276) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination. Concomitant products included BUDESONIDE and SALBUTAMOL for Asthma, ATORVASTATIN for Cholesterol, TRAZODONE for Depression, LANSOPRAZOLE (LANSOPRAZOL) for Reflux esophagitis. On 18-Feb-2021, the patient started COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 10-May-2021, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On 18-Nov-2021, HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not reported. The patient did not have symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient did not test positive for COVID-19 since having the vaccine. Company comment: This case concerns a 69-year-old, male patient with a medical history of asthma, depression and reflux esophagitis, who experienced the events of fatigue and headache. A co-suspect product in this case is the Covid-19 AstraZeneca vaccine. The events occurred the same day after the third dose with mRNA � 1273 vaccine. Events were reported as medically significant but 2-days after the start of the events, both fatigue and headache were resolving. The rechallenge is not applicable since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 69-year-old, male patient with a medical history of asthma, depression and reflux esophagitis, who experienced the events of fatigue and headache. A co-suspect product in this case is the Covid-19 AstraZeneca vaccine. The events occurred the same day after the third dose with mRNA � 1273 vaccine. Events were reported as medically significant but 2-days after the start of the events, both fatigue and headache were resolving. The rechallenge is not applicable since the first two doses were of a different brand. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1904939 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Migraine, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Type II diabetes mellitus (taking metformin)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: following vaccination was ok then next day all of the above; Fatigue; Chills; Feverish; Generalised muscle aches; Headache dull; This case was received via regulatory authority (Reference number: -MHRA-ADR 26213538) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MIGRAINE (following vaccination was ok then next day all of the above), FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Feverish), MYALGIA (Generalised muscle aches) and HEADACHE (Headache dull) in a 68-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. Concurrent medical conditions included Type II diabetes mellitus (taking metformin) and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included METFORMIN for Type II diabetes mellitus. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), MYALGIA (Generalised muscle aches) (seriousness criterion medically significant) and HEADACHE (Headache dull) (seriousness criterion medically significant). On an unknown date, the patient experienced MIGRAINE (following vaccination was ok then next day all of the above) (seriousness criterion medically significant). On 16-Nov-2021, CHILLS (Chills) had resolved. On 17-Nov-2021, FATIGUE (Fatigue), PYREXIA (Feverish), MYALGIA (Generalised muscle aches) and HEADACHE (Headache dull) had resolved. At the time of the report, MIGRAINE (following vaccination was ok then next day all of the above) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Treatment Medication reported. Additional information added in the SD was that the patient experienced sore vaccination site and loss of appetite next day of vaccination. Company comment: This case concerns a 68-year-old, female patient with relevant medical history of Type 2 diabetes mellitus and immunodeficiency, who experienced the unexpected events of migraine, fatigue, chills, pyrexia, myalgia and headache. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.; Sender''s Comments: This case concerns a 68-year-old, female patient with relevant medical history of Type 2 diabetes mellitus and immunodeficiency, who experienced the unexpected events of migraine, fatigue, chills, pyrexia, myalgia and headache. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The Benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1904940 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Allergy to chemicals, Chest pain, Dyspnoea, Fatigue, Headache, Palpitations, 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), Hypersensitivity (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Long COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200801; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bleaches & cleansers sensitivity; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Headache NOS; Racing heart (tachycardia); This case was received via regulatory authority RA (Reference number: GB-MHRA-ADR 26215835) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache NOS), ALLERGY TO CHEMICALS (Bleaches & cleansers sensitivity), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) in a 64-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Long COVID-19. Previously administered products included for COVID-19 vaccination: SARS-COV-2 VIRUS (SARS-COV-2 VIRUS) and SARS-COV-2 VIRUS (SARS-COV-2 VIRUS). Past adverse reactions to the above products included No adverse event with SARS-COV-2 VIRUS and SARS-COV-2 VIRUS. Concurrent medical conditions included Suspected COVID-19 since 14-Mar-2020. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced HEADACHE (Headache NOS) (seriousness criterion medically significant). On an unknown date, the patient experienced ALLERGY TO CHEMICALS (Bleaches & cleansers sensitivity) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and PALPITATIONS (Heart palpitations) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache NOS) and ALLERGY TO CHEMICALS (Bleaches & cleansers sensitivity) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), 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 01-Aug-2020, SARS-CoV-2 test: inconclusive test (Inconclusive) Inconclusive test. Treatment information not provided. Concomitant medication not provided. Lab data include COVID-19 virus test was performed on 1-AUG-2020 and result was Inconclusive test. Lab data include Electrocardiogram was performed on unknown date and result was unknown. Patient reaction recur on re-administration was unknown. Patient report relate to possible inflammation of the heart (myocarditis or pericarditis). Company comment: This regulatory case concerns a 64-year-old, female patient with medical history of long term COVID-19, who experienced the unexpected, serious events of headache, allergy to chemicals, fatigue, chest pain, dyspnoea, palpitations and tachycardia. The event tachycardia occurred on the same day after third dose of mRNA-1273 vaccine. The event headache occurred two days after third dose of mRNA-1273 vaccine. Time to onset from vaccination was not reported for events allergy to chemicals, fatigue, chest pain, dyspnoea and palpitations. Regulatory authority captured rechallenge as unknown, however, no information about further dosing is disclosed. The medical history of Long term COVID-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 64-year-old, female patient with medical history of long term COVID-19, who experienced the unexpected, serious events of headache, allergy to chemicals, fatigue, chest pain, dyspnoea, palpitations and tachycardia. The event tachycardia occurred on the same day after third dose of mRNA-1273 vaccine. The event headache occurred two days after third dose of mRNA-1273 vaccine. Time to onset from vaccination was not reported for events allergy to chemicals, fatigue, chest pain, dyspnoea and palpitations. Regulatory authority captured rechallenge as unknown, however, no information about further dosing is disclosed. The medical history of Long term COVID-19 remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1904943 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis
SMQs:, Systemic lupus erythematosus (broad), Arthritis (narrow), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Arthritis; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26214473) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRITIS (Arthritis) in a 69-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. No Medical History information was reported. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ARTHRITIS (Arthritis) (seriousness criterion medically significant). At the time of the report, ARTHRITIS (Arthritis) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: This case concerns a 69-year-old female patient, with no medical history reported, who experienced serious unexpected AESI of Arthritis after a third dose of mRNA-1273. The event occurred 2 days after vaccination. The re-challenge is not applicable sin further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 69-year-old female patient, with no medical history reported, who experienced serious unexpected AESI of Arthritis after a third dose of mRNA-1273. The event occurred 2 days after vaccination. The re-challenge is not applicable sin further dose is not expected. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1904945 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Cerebral palsy; Immunodeficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Flu-like aching; Feeling sick; Headache; Sweating; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26215401) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS, PYREXIA, INFLUENZA LIKE ILLNESS, MALAISE, and HEADACHE in a 33-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Cerebral palsy and Immunodeficiency. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HYPERHIDROSIS (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (seriousness criterion medically significant), MALAISE (seriousness criterion medically significant) and HEADACHE (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced PYREXIA (seriousness criterion medically significant). At the time of the report, HYPERHIDROSIS, PYREXIA, INFLUENZA LIKE ILLNESS, and MALAISE had not resolved and HEADACHE was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 17-Nov-2021, SARS-CoV-2 test No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case concerns a 33-year-old, female patient with relevant medical history of cerebral palsy and immunodeficiency, who experienced the unexpected events of hyperhidrosis, pyrexia, influenza like illness, malaise, and headache. The events occurred 1 day after the third dose of mRNA-1273. The rechallenge was unknown as was reported by Regulatory Authority. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity or meet the criteria to be medically significant.


VAERS ID: 1904947 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, SARS-CoV-2 test, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Trembling; Flu-like aching; Shaking; This case was received via regulatory authority (Reference number: -MHRA-ADR 26216722) on 18-Nov-2021 and was forwarded to Moderna on 18-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like aching), TREMOR (Trembling) and TREMOR (Shaking) in a 53-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced TREMOR (Shaking) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like aching) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (Trembling) (seriousness criterion medically significant). On 16-Nov-2021, TREMOR (Shaking) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like aching) had not resolved and TREMOR (Trembling) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Approximately 12 hours after receiving the booster patient felt tired and sluggish. On going to bed he had uncontrollable trembling and shaking for around 30 minutes. The next day patient was feeling aches all over the body. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial This is a regulatory case concerning a 53year-old male patient, with no relevant medical history reported, who experienced the serious unexpected events of INFLUENZA LIKE ILLNESS and TREMOR (trembling and Shaking). These events occurred Approximately 12 hours after receiving the third dose of mRNA-1273 . The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting.; Sender''s Comments: This is a regulatory case concerning a 53year-old male patient, with no relevant medical history reported, who experienced the serious unexpected events of INFLUENZA LIKE ILLNESS and TREMOR (trembling and Shaking). These events occurred Approximately 12 hours after receiving the third dose of mRNA-1273 . The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory authority reporting


VAERS ID: 1904951 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose increased, Fatigue, Periarthritis, SARS-CoV-2 test, Tinnitus
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Hearing impairment (narrow), Arthritis (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: tinnitus; fatigue; Frozen shoulder; Tinnitus aggravated; Blood sugar increased; This case was received (Reference number: GB-MHRA-ADR 26219794) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), FATIGUE (fatigue), PERIARTHRITIS (Frozen shoulder), TINNITUS (Tinnitus aggravated) and BLOOD GLUCOSE INCREASED (Blood sugar increased) in a 55-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Patient has not had symptoms associated with COVID-19. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PERIARTHRITIS (Frozen shoulder) (seriousness criterion disability), TINNITUS (Tinnitus aggravated) (seriousness criterion disability) and BLOOD GLUCOSE INCREASED (Blood sugar increased) (seriousness criterion disability). On an unknown date, the patient experienced TINNITUS (tinnitus) (seriousness criterion disability) and FATIGUE (fatigue) (seriousness criterion disability). At the time of the report, TINNITUS (tinnitus) and FATIGUE (fatigue) was resolving, PERIARTHRITIS (Frozen shoulder) and TINNITUS (Tinnitus aggravated) had not resolved and BLOOD GLUCOSE INCREASED (Blood sugar increased) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. List of concomitant medication were not given Vaccine delivered to very top of arm causing immediate discomfort to shoulder capsule which swelled and was immobile. Tinnitus in hearing ear which was loud and wiped out hearing ability. Muscles aches throughout body and increased fatigue. Blood sugar also increased to 34 for 24 hours. Company''s comment: This regulatory authority case concerns a 55-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (disability) events of Tinnitus, Fatigue, Periarthritis (AESI, reported as Frozen shoulder) and Blood glucose increased after mRNA- 1273 Moderna vaccine. The onset of the events occurred immediately after the third dose of mRNA- 1273 vaccine. Vaccine was delivered at the top of arm causing immediate discomfort to shoulder capsule which swelled and was immobile. Blood sugar increased for 24 hours. The rechallenge is not applicable, since the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 55-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (disability) events of Tinnitus, Fatigue, Periarthritis (AESI, reported as Frozen shoulder) and Blood glucose increased after mRNA- 1273 Moderna vaccine. The onset of the events occurred immediately after the third dose of mRNA- 1273 vaccine. Vaccine was delivered at the top of arm causing immediate discomfort to shoulder capsule which swelled and was immobile. Blood sugar increased for 24 hours. The rechallenge is not applicable, since the events were reported exclusively after the third dose. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1904958 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperhidrosis, Hypotension, Illness, Incontinence, Loss of consciousness, Pyrexia, SARS-CoV-2 test, Skin burning sensation, Thermal burn
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

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

Write-up: Unconsciousness; Excess sweating; Low temperature heat burn; Low BP; Fever chills; Burning skin; Incontinent; Sickness; This case was received (Reference number: GB-MHRA-ADR 26221148) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Unconsciousness), HYPERHIDROSIS (Excess sweating), THERMAL BURN (Low temperature heat burn), HYPOTENSION (Low BP), PYREXIA (Fever chills), SKIN BURNING SENSATION (Burning skin), INCONTINENCE (Incontinent) and ILLNESS (Sickness) in a 61-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criteria hospitalization and medically significant), HYPERHIDROSIS (Excess sweating) (seriousness criterion hospitalization), THERMAL BURN (Low temperature heat burn) (seriousness criterion hospitalization), HYPOTENSION (Low BP) (seriousness criterion hospitalization), PYREXIA (Fever chills) (seriousness criterion hospitalization), SKIN BURNING SENSATION (Burning skin) (seriousness criterion hospitalization), INCONTINENCE (Incontinent) (seriousness criterion hospitalization) and ILLNESS (Sickness) (seriousness criterion hospitalization). On 16-Nov-2021, HYPERHIDROSIS (Excess sweating), THERMAL BURN (Low temperature heat burn), HYPOTENSION (Low BP), PYREXIA (Fever chills) and ILLNESS (Sickness) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Unconsciousness) was resolving, SKIN BURNING SENSATION (Burning skin) had not resolved and INCONTINENCE (Incontinent) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. As per source document patient had Lost conciseness twice, rolling of eyes and heaving breathing, admitted to hospital overnight on fluids and anti sickness medication. Patient had not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial. No possible inflammation of the heart (myocarditis or pericarditis) and asked details of any relevant investigations or tests conducted: "Head scan, chest X-ray, 24 hour observation of blood pressure and stats". Treatment medication was not reported. Relevant concomitant medications were not provided by the reporter. Company comment: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected events of Loss of Consciousness, Hyperhidrosis, Thermal Burn, Hypotension, Pyrexia, Skin Burning Sensation, Incontinence, and Illness. The event occurred the same day after receiving the first dose of mRNA-1273 Vaccine with outcome of hospitalization. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected events of Loss of Consciousness, Hyperhidrosis, Thermal Burn, Hypotension, Pyrexia, Skin Burning Sensation, Incontinence, and Illness. The event occurred the same day after receiving the first dose of mRNA-1273 Vaccine with outcome of hospitalization. The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1904962 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS
Current Illness: Celiac disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211102; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: nausea; Stomach ache; Sickness; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 26221746) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache), ILLNESS (Sickness) and NAUSEA (nausea) in a 56-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concurrent medical conditions included Celiac disease. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 02-Mar-2021 to an unknown date and INFLUENZA VACCINE (INFLUENZA VIRUS) from 28-Sep-2021 to an unknown date for an unknown indication. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (nausea) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and ILLNESS (Sickness) had not resolved and NAUSEA (nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The Treatment history was not reported. Started to feel achy and headache then sickness and tummy pain. Nausea Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company''s comment: This case concerns a 56-year-old, female patient with previous relevant medical history of celiac disease, who experienced the unexpected serious events of abdominal pain upper, illness, and nausea. The event nausea is unexpected as it is retained as serious per the source document Authority reporting. The event illness occurred 1 day after the third dose (unknown dosage) of mRNA-1273. The event abdominal pain upper occurred 2 days after the third dose (unknown dosage) of mRNA-1273. The date of onset of the event nausea was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of celiac disease could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness and coding assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 56-year-old, female patient with previous relevant medical history of celiac disease, who experienced the unexpected serious events of abdominal pain upper, illness, and nausea. The event nausea is unexpected as it is retained as serious per the source document Authority reporting. The event illness occurred 1 day after the third dose (unknown dosage) of mRNA-1273. The event abdominal pain upper occurred 2 days after the third dose (unknown dosage) of mRNA-1273. The date of onset of the event nausea was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of celiac disease could be confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness and coding assessed as per Regulatory Authority reporting.


VAERS ID: 1904969 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? 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.MOD20213

Write-up: Pain in arm; Headache; Fever; This case was received via regulatory authority (Reference number: -MHRA-ADR 26222714) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), HEADACHE (Headache) and PYREXIA (Fever) in a 54-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability) and PYREXIA (Fever) (seriousness criterion disability). On 18-Nov-2021, PYREXIA (Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant drugs were reported. No treatment information were reported. It was verbally reported that, patient suffered from very high fever $g40C lasting for 48 hours. Company Comment : This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of pyrexia, headache, and pain in extremity. The events of headache and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The event headache could be in association to pyrexia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 54-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of pyrexia, headache, and pain in extremity. The events of headache and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The events occurred on the same day after the third dose (unknown dosage) of mRNA-1273. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The event headache could be in association to pyrexia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1904975 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Paraesthesia, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211114; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: pins and needles; Dizzy; Rash; This case was received via regulatory authority (Reference number: -MHRA-ADR 26224006) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles), DIZZINESS (Dizzy) and RASH (Rash) in a 21-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced DIZZINESS (Dizzy) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). On an unknown date, the patient experienced PARAESTHESIA (pins and needles) (seriousness criterion hospitalization). On 18-Nov-2021, DIZZINESS (Dizzy) and RASH (Rash) had resolved. At the time of the report, PARAESTHESIA (pins and needles) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had not tested positive for COVID-19 since having the vaccine. Patient was dizzy, rash all over the leg, swelling of throat, temperature of 39 degree, felt sick, pins and needles No concomitant medications reported. No treatment medications provided. Company comment This case concerns a 21-year-old, female patient, with no disclosed medical history, who experienced the serious, unexpected events of paresthesia, dizziness and rash. The events occurred on the same day after second dose of mRNA 1273 vaccine. The patient was dizzy, had rash all over the leg, felt swelling of throat, had pyrexia, felt sick and experienced pins and needles. The patient was said to be hospitalized, but no further details were provided. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 21-year-old, female patient, with no disclosed medical history, who experienced the serious, unexpected events of paresthesia, dizziness and rash. The events occurred on the same day after second dose of mRNA 1273 vaccine. The patient was dizzy, had rash all over the leg, felt swelling of throat, had pyrexia, felt sick and experienced pins and needles. The patient was said to be hospitalized, but no further details were provided. The rechallenge is not applicable as there is no information regarding a third dose. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1904977 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, SARS-CoV-2 test, Vaccination site hypoaesthesia
SMQs:, Arthritis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma; COPD; Difficult digestion (digestive issues); Drug allergy (allergic to tablets); Emphysema (emphysema bullea); Food allergy; Hay fever (allergic to hay); House dust mite allergy (Allergic to dust mite); Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Inflammatory reaction (random personal hygeine products(inflamatory responses)); Irritable bowel syndrome (ibs); Lung hyperinflation (Hyperinflation of lungs); Single functional kidney (1 kidney); Sinusitis
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia (dequamative pnumonitis)
Allergies:
Diagnostic Lab Data: Test Date: 20211015; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: My arm has felt like it belonged to moderna for 3 days; Injection site was chosen to be high up nr the shoulder; Joint pain; This case was received via RA (Reference number: GB-MHRA-ADR 26224761) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (My arm has felt like it belonged to moderna for 3 days), ARTHRALGIA (Injection site was chosen to be high up nr the shoulder) and ARTHRALGIA (Joint pain) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Pneumonia (dequamative pnumonitis). Concurrent medical conditions included Emphysema (emphysema bullea), Asthma, COPD, Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...), Lung hyperinflation (Hyperinflation of lungs), House dust mite allergy (Allergic to dust mite), Hay fever (allergic to hay), Food allergy, Drug allergy (allergic to tablets), Inflammatory reaction (random personal hygeine products(inflamatory responses)), Sinusitis, Single functional kidney (1 kidney), Irritable bowel syndrome (ibs) and Difficult digestion (digestive issues). On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE HYPOAESTHESIA (My arm has felt like it belonged to moderna for 3 days) (seriousness criterion medically significant) and ARTHRALGIA (Injection site was chosen to be high up nr the shoulder) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE HYPOAESTHESIA (My arm has felt like it belonged to moderna for 3 days) and ARTHRALGIA (Injection site was chosen to be high up nr the shoulder) had not resolved and ARTHRALGIA (Joint pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported. Injection site was chosen to be high up nr the shoulder, i am skinny armed ..my arm has felt like it belonged to moderna for 3 days , i could hardly move it, every movement has caused pain and stiffness in joint n random points of other body joints foot bone ,shinbone, 3 knuckles and including interupted sleep from rolling onto left shoulder .. bearable but painful and useless for at least 3 days 2 more it should resolve pain n stuffness..no pain no gain i guess ! (Triple covid jabbed sick human) Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company Comment : This case concerns a 47-year-old, female patient with relevant medical history of Immunodeficiency and Inflammatory reactions, who experienced the unexpected events of Arhtralgia and Vaccination site hypoaesthesia. The events occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The patient''s medical history of Immunodeficiency and Inflammatory reactions remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 47-year-old, female patient with relevant medical history of Immunodeficiency and Inflammatory reactions, who experienced the unexpected events of Arhtralgia and Vaccination site hypoaesthesia. The events occurred on the day of the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The patient''s medical history of Immunodeficiency and Inflammatory reactions remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1907200 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Immunisation, Interchange of vaccine products, Morning sickness, Motion sickness, Off label use
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Butrans; Hydroxychloroquine; Lansoprazole; Paracetamol; Warfarin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (oesophageal); Budd Chiari syndrome; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis).
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101604237

Write-up: received first and second dose of AstraZeneca vaccine and booster dose of COMIRNATY; received first and second dose of AstraZeneca vaccine and booster dose of COMIRNATY; received first and second dose of AstraZeneca vaccine and booster dose of COMIRNATY; mild dizziness and light headedness; Nausea gravidarum; increased nauseated feeling during any form of movement; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111161522385700-2VL2Q (RA). Other Case identifier: GB-MHRA-ADR 26209545 (RA). A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Budd Chiari syndrome" (unspecified if ongoing); "Acid reflux (oesophageal)" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing), notes: Taking regular medicines for rheumatoid arthritis or other types of arthritis except osteoarthritis. The patient was not breastfeeding. The patient last menstrual date was on 06Nov2021. The patient did not have symptoms associated with COVID-19 and did not undergo a COVID-19 test. The patient was not enrolled in the clinical trial. Concomitant medications included: INFLUENZA VIRUS taken for immunisation, administration date 10Nov2021; BUTRANS taken for rheumatoid arthritis, start date: 2016; HYDROXYCHLOROQUINE taken for rheumatoid arthritis, start date: 2007; LANSOPRAZOLE taken for gastrooesophageal reflux disease, start date: 2011; PARACETAMOL taken for rheumatoid arthritis, start date: 2011; WARFARIN taken for Budd Chiari syndrome, start date: 2011. Vaccination history included: Covid-19 vaccine AstraZeneca (DOSE 2), administration date: 30Apr2021, for COVID-19 immunisation; Covid-19 vaccine AstraZeneca (DOSE 1), administration date: 08Feb2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "received first and second dose of AstraZeneca vaccine and booster dose of COMIRNATY"; DIZZINESS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "mild dizziness and light headedness"; MORNING SICKNESS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Nausea gravidarum"; MOTION SICKNESS (medically significant) with onset 16Nov2021, outcome "unknown", described as "increased nauseated feeling during any form of movement ". The patient had not been tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1907223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Pyrexia, SARS-CoV-2 test, Skin swelling, Spinal pain
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: COVID-19; Suspected COVID-19 (unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101603823

Write-up: Slight temperature; Backache; Puffy skin; Spinal pain; Aching joints; This is a spontaneous report received from a contactable reporters (Consumer) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111162248035040-DPQHO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26212279 (MHRA). A 26 year-old female patient received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Lot number: Unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: unsure when symptoms started and stopped; "COVID-19" (unspecified if ongoing). Patient''s last menstrual period was 25Oct2021. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (MANUFACTURER UNKNOWN, Dose 1, Single), for COVID-19 immunisation. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial The following information was reported: PYREXIA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Slight temperature"; BACK PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Backache"; SKIN SWELLING (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Puffy skin"; SPINAL PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Spinal pain"; ARTHRALGIA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Aching joints". The report did not relate to relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) yes - positive COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1907241 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

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

Write-up: Swollen glands; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26221738) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, INSULIN HUMAN, INSULIN HUMAN INJECTION, ISOPHANE (HUMAN INSULINK) for Diabetes. On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant). On 18-Nov-2021, LYMPHADENOPATHY (Swollen glands) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Patient had no symptoms associated with COVID-19 Not had a COVID-19 test. Patient was not enrolled in clinical trial. Company comment: This case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected event of Lymphadenopathy. The event occurred one day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected event of Lymphadenopathy. The event occurred one day after receiving the third dose of mRNA-1273 Vaccine. The rechallenge was not applicable since only information about the third dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1907244 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hodgkin''s lymphoma (In 2000, I finished the treatment for Hodgkin''s cancer (also the reason I got the vaccination early).)
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Swelling arm; Fever; Chills; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26222563) on 19-Nov-2021 and was forwarded to Moderna on 19-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), PYREXIA (Fever) and CHILLS (Chills) in a 48-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Hodgkin''s lymphoma (In 2000, I finished the treatment for Hodgkin''s cancer (also the reason I got the vaccination early).). On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 18-Nov-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Nov-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient mentioned that her whole arm swelled up. After that she got a fever of 38.7 Celsius and she got very intense chills. The chills and fever eventually went away but her arm was still swollen a bit and her armpit was also very swollen. 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 48-year-old female patient of with relevant medical history Hodgkin''s Lymphoma, who experienced the serious unexpected events of peripheral swelling, pyrexia, chills. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable since the AEs occurred after the third dose. The medical history Hodgkin''s Lymphoma remains a confounder. 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 48-year-old female patient of with relevant medical history Hodgkin''s Lymphoma, who experienced the serious unexpected events of peripheral swelling, pyrexia, chills. The events occurred the same day after the third dose of mRNA-1273. The rechallenge was not applicable since the AEs occurred after the third dose. The medical history Hodgkin''s Lymphoma remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1907262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Illness, Myalgia, Nausea, Pyrexia, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), 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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Comments: None Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26226517) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (sickness), SYNCOPE (Fainting), PYREXIA (Fever chills), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. None Not had a COVID-19 test. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 19-Mar-2021 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). On an unknown date, the patient experienced ILLNESS (sickness) (seriousness criterion medically significant). On 18-Nov-2021, PYREXIA (Fever chills) had resolved. At the time of the report, ILLNESS (sickness) had not resolved and SYNCOPE (Fainting), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomiting) and MYALGIA (Muscle pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient was prescribed with some unknown anti sickness medication. Post vaccination patient not tested positive for COVID-19.Also patient was not enrolled in any clinical trials. This is a regulatory authority case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of Illness, Syncope, Pyrexia, Headache, Vomitting, myalgia. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, in not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of Illness, Syncope, Pyrexia, Headache, Vomitting, myalgia. The events occurred approximately on the same day after the third dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, in not affected by this report.


VAERS ID: 1907263 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Crohn''s; Peripheral neuropathy; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No-Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Vomiting; Shoulder soreness; This case was received via regulatory agency (Reference number: GB-MHRA-ADR 26226523) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), VOMITING (Vomiting) and ARTHRALGIA (Shoulder soreness) in a 65-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Peripheral neuropathy, Type 2 diabetes mellitus and Crohn''s. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion disability), VOMITING (Vomiting) (seriousness criterion disability) and ARTHRALGIA (Shoulder soreness) (seriousness criterion disability). At the time of the report, PYREXIA (Fever), VOMITING (Vomiting) and ARTHRALGIA (Shoulder soreness) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 test.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported. Patient not had symptoms associated with COVID-19. Patient had constant vomiting paracetamol but with being sick could not keep down been off work since vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not enrolled in clinical trial. Company Comment: This regulatory case concerns a 65-year-old, female patient with medical history of peripheral neuropathy and type 2 diabetes, who experienced the unexpected, serious events of pyrexia, vomiting and arthralgia. The events occurred on the same day after third dose of mRNA-1273 vaccine. It was not reported if the patient received previous doses of mRNA-1273 vaccine or other COVID-19 vaccine. The medical history of peripheral neuropathy and type 2 diabetes remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 65-year-old, female patient with medical history of peripheral neuropathy and type 2 diabetes, who experienced the unexpected, serious events of pyrexia, vomiting and arthralgia. The events occurred on the same day after third dose of mRNA-1273 vaccine. It was not reported if the patient received previous doses of mRNA-1273 vaccine or other COVID-19 vaccine. The medical history of peripheral neuropathy and type 2 diabetes remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907269 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Erythema, Headache, Nausea, Peripheral swelling, Pruritus, SARS-CoV-2 test, Vomiting, Wheezing
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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 Date: 20211113; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Itching; Red face; Vomited; Wheezing; Swollen arm; Diarrhoea; Headache; Nausea; Shivering; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26227011) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face), PRURITUS (Itching), WHEEZING (Wheezing), PERIPHERAL SWELLING (Swollen arm), DIARRHOEA (Diarrhoea), HEADACHE (Headache), NAUSEA (Nausea), VOMITING (Vomited) and CHILLS (Shivering) in a 59-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced WHEEZING (Wheezing) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced ERYTHEMA (Red face) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced PRURITUS (Itching) (seriousness criterion medically significant). On 17-Nov-2021, DIARRHOEA (Diarrhoea) and VOMITING (Vomited) had resolved. On 18-Nov-2021, CHILLS (Shivering) had resolved. At the time of the report, ERYTHEMA (Red face), PRURITUS (Itching) and HEADACHE (Headache) had not resolved and WHEEZING (Wheezing), PERIPHERAL SWELLING (Swollen arm) and NAUSEA (Nausea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medications were reported as paracetamol & antihistamines. Treatment information was not provided. Patient had not tested positive for COVID-19 since having the vaccine. Patient is was not enrolled in clinical trial. This regulatory authority case concerns a 59-year-old female patient with details on relevant medical history undergoing treatment with antihistamines, who experienced the unexpected serious events of Red face, Pruritus, Wheezing, Swollen arm, Diarrhoea, Nausea, Vomiting and Chills after mRNA- 1273 Moderna vaccine. The events Swollen arm, Diarrhoea, Headache, Nausea and Chills occurred on the days after the third dose of mRNA- 1273 vaccine (dosage unknown), Wheezing and Vomiting occurred approximately 1 day after the third dose, Red face 2 days after the third dose and Pruritus 3 days after the third dose. Vaccination site swelling, Nausea, Vomiting and Chills are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. Very limited information was provided regarding the clinical course of Red face and Wheezing. Concomitant treatment with antihistamines suggests the patient may have an atopic disorder, which may be a confounder. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 59-year-old female patient with details on relevant medical history undergoing treatment with antihistamines, who experienced the unexpected serious events of Red face, Pruritus, Wheezing, Swollen arm, Diarrhoea, Nausea, Vomiting and Chills after mRNA- 1273 Moderna vaccine. The events Swollen arm, Diarrhoea, Headache, Nausea and Chills occurred on the days after the third dose of mRNA- 1273 vaccine (dosage unknown), Wheezing and Vomiting occurred approximately 1 day after the third dose, Red face 2 days after the third dose and Pruritus 3 days after the third dose. Vaccination site swelling, Nausea, Vomiting and Chills are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. Very limited information was provided regarding the clinical course of Red face and Wheezing. Concomitant treatment with antihistamines suggests the patient may have an atopic disorder, which may be a confounder. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1907277 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Injection related reaction, Nausea, SARS-CoV-2 test, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: shivering; shaking; nauseous; Injection associated shivering; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26228044) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (shivering), TREMOR (shaking), NAUSEA (nauseous) and INJECTION RELATED REACTION (Injection associated shivering) in a 73-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. No Medical History information was reported. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced INJECTION RELATED REACTION (Injection associated shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (shivering) (seriousness criterion medically significant), TREMOR (shaking) (seriousness criterion medically significant) and NAUSEA (nauseous) (seriousness criterion medically significant). On 17-Nov-2021, INJECTION RELATED REACTION (Injection associated shivering) was resolving. At the time of the report, CHILLS (shivering), TREMOR (shaking) and NAUSEA (nauseous) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient reported that she took paracetamol as treatment drug. Patient also reported arm ached and seemed slightly swollen down to elbow. This case concerns a 73-year-old, female patient with no medical history reported, who experienced serious unexpected events of tremor, nausea, chills and injection related reaction after third dose of mRNA-12733. The events started 6 hours after vaccination . The re-challenge is unknown since no information regarding dose 1 and 2 was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 73-year-old, female patient with no medical history reported, who experienced serious unexpected events of tremor, nausea, chills and injection related reaction after third dose of mRNA-12733. The events started 6 hours after vaccination . The re-challenge is unknown since no information regarding dose 1 and 2 was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 1907283 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Eye swelling, Fatigue, Headache, Myalgia, Nausea, Paraesthesia, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Muscle ache; Pins and needles; Dizzy; Eyes glazed; Fatigue; Headache; Nausea; Tiredness; Fainting; Fever; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26228679) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), MYALGIA (Muscle ache), PARAESTHESIA (Pins and needles), DIZZINESS (Dizzy), EYE SWELLING (Eyes glazed), FATIGUE (Fatigue), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and FATIGUE (Tiredness) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Clinical trial participant. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On 17-Nov-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant), DIZZINESS (Dizzy) (seriousness criterion medically significant), EYE SWELLING (Eyes glazed) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 16-Nov-2021, PYREXIA (Fever) had resolved. On 17-Nov-2021, SYNCOPE (Fainting) had resolved. On 18-Nov-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, MYALGIA (Muscle ache), PARAESTHESIA (Pins and needles), DIZZINESS (Dizzy), EYE SWELLING (Eyes glazed) and FATIGUE (Fatigue) outcome was unknown and FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided. Patient had booster about 1.00pm on Tuesday 16-Nov-2021. Patient''s arm hurt and had pins and needles type feeling. All fine after that. Got up at 6.00 am following day had sudden rise in temperature, felt dizzy, headache, muscle ache. Collapsed on the floor could not speak but was conscious. Patient''s eyes glazed over and remained on the floor for about 15 mins and could not get up. Eventually got into bed and felt sick. Had Nausea, headache, fatigue, muscle ache remained throughout the day. Remained off work for 2 days. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Company comment: This is a regulatory case concerning a 54 years old, female patient with no clinical history who experienced the unexpected events of SYNCOPE, MYALGIA, PARAESTHESIA, DIZZINESS, EYE SWELLING, FATIGUE, HEADACHE, PYREXIA, NAUSEA and FATIGUE The events occurred one day after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 54 years old, female patient with no clinical history who experienced the unexpected events of SYNCOPE, MYALGIA, PARAESTHESIA, DIZZINESS, EYE SWELLING, FATIGUE, HEADACHE, PYREXIA, NAUSEA and FATIGUE The events occurred one day after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907297 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Hypersensitivity, Injection site inflammation, Pyrexia
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness: Food allergy (allergic to Ginger and have noticed this over the past 5/6 years. Mild reaction to even the smallest quantity); Lymphedema (Apart for some occasional Lymphedema,fit and well and not taking any medication.)
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction (had a severe allergic reaction to the Blue dye used during breast surgery in August 2019. This recovered quickly with treatment.); Breast cancer; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy (had radiotherapy for breast cancer 2 years ago,have been told by GP that don''t have suppressed immunity); Surgery (had a severe allergic reaction to the Blue dye used during breast surgery in August 2019. This recovered quickly with treatment)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: loose stools; high temperature; allergic reaction; Inflammation injection site; This case was received via RA (Reference number: GB-MHRA-ADR 26230814) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (loose stools), PYREXIA (high temperature), HYPERSENSITIVITY (allergic reaction) and INJECTION SITE INFLAMMATION (Inflammation injection site) in a 62-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Allergic reaction (had a severe allergic reaction to the Blue dye used during breast surgery in August 2019. This recovered quickly with treatment.), Breast cancer, Radiotherapy (had radiotherapy for breast cancer 2 years ago,have been told by GP that don''t have suppressed immunity), Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)) and Surgery (had a severe allergic reaction to the Blue dye used during breast surgery in August 2019. This recovered quickly with treatment) in August 2019. Concurrent medical conditions included Lymphedema (Apart for some occasional Lymphedema,fit and well and not taking any medication.) and Food allergy (allergic to Ginger and have noticed this over the past 5/6 years. Mild reaction to even the smallest quantity). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 26-Feb-2021 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced INJECTION SITE INFLAMMATION (Inflammation injection site) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (loose stools) (seriousness criterion medically significant), PYREXIA (high temperature) (seriousness criterion medically significant) and HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (loose stools), PYREXIA (high temperature), HYPERSENSITIVITY (allergic reaction) and INJECTION SITE INFLAMMATION (Inflammation injection site) was resolving. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. 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 The inflammation has been very severe and large with a hard core of approx 2 inches by 3 inches and heat and redness radiating from that in a 6 inch diameter. The limb is fine to use. Patient feels like this is an allergic reaction to something in the vaccine. Patients whole body has been aching and had 24 hours of high temperature and feeling ill. Now feeling weakened as if recovering from a flu like illness,have had loose stools but not runny,have had to lie down for an hour every afternoon which is unusual. Patient now on day 4 of the side effects, which seem to be slowly reducing. No treatment medication information was provided. Company comment: This is a regulatory case concerning a 62 years old, female patient with clinical history of allergy and irradiated breast cancer who experienced the unexpected events of DIARRHOEA, PYREXIA, HYPERSENSITIVITY and INJECTION SITE INFLAMMATION The events occurred one day after the third dose of mRNA-1273 vaccine The rechllenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 62 years old, female patient with clinical history of allergy and irradiated breast cancer who experienced the unexpected events of DIARRHOEA, PYREXIA, HYPERSENSITIVITY and INJECTION SITE INFLAMMATION The events occurred one day after the third dose of mRNA-1273 vaccine The rechllenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907301 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Diarrhoea, Dizziness, Dizziness postural, Hyperhidrosis, Illness, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

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

Write-up: sweating; sickness; dizziness; Excess sweating; Vomiting; Dizziness upon standing; Loose bowel; Shivering; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231193) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), ILLNESS (sickness), DIZZINESS (dizziness), HYPERHIDROSIS (Excess sweating), VOMITING (Vomiting), DIZZINESS POSTURAL (Dizziness upon standing), DIARRHOEA (Loose bowel) and CHILLS (Shivering) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for an unknown indication. No Medical History information was reported. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HYPERHIDROSIS (Excess sweating) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), DIZZINESS POSTURAL (Dizziness upon standing) (seriousness criterion medically significant), DIARRHOEA (Loose bowel) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), ILLNESS (sickness) (seriousness criterion medically significant) and DIZZINESS (dizziness) (seriousness criterion medically significant). On 16-Nov-2021, VOMITING (Vomiting) had resolved. On 17-Nov-2021, HYPERHIDROSIS (Excess sweating) was resolving, DIZZINESS POSTURAL (Dizziness upon standing), DIARRHOEA (Loose bowel) and CHILLS (Shivering) had resolved. At the time of the report, HYPERHIDROSIS (sweating), ILLNESS (sickness) and DIZZINESS (dizziness) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had dizziness shivering sweating sickness and loose bowel movements. She collapsed to floor might be fainting as she passed urine and she was unaware of it. Patient had not tested positive for COVID-19 since having the vaccine This case concerns a 72-year old, female subject with no relevant medical history, who experienced the serious (seriousness criterion=medically significant) unexpected events of Hyperhidrosis, Illness, Vomiting, Dizziness postural, Diarrhoea, and Chills. Also noted was possible Syncope described as collapsing to the floor with accompanying enuresis (unaware that she passed urine). Event illness occurred unknown number of days after the booster dose of mRNA 1273 VACCINE while all the other events occurred 1 day after the booster dose of mRNA 1273 VACCINE. At the time of the report, outcome of all the events was Recovered/Resolved except for Hyperhidrosis (outcome was Recovering/Resolving). No diagnostic tests nor treatment given was mentioned. Rechallenge is not applicable as no additional dosing is expected to be given. The patient''s age remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 72-year old, female subject with no relevant medical history, who experienced the serious (seriousness criterion=medically significant) unexpected events of Hyperhidrosis, Illness, Vomiting, Dizziness postural, Diarrhoea, and Chills. Also noted was possible Syncope described as collapsing to the floor with accompanying enuresis (unaware that she passed urine). Event illness occurred unknown number of days after the booster dose of mRNA 1273 VACCINE while all the other events occurred 1 day after the booster dose of mRNA 1273 VACCINE. At the time of the report, outcome of all the events was Recovered/Resolved except for Hyperhidrosis (outcome was Recovering/Resolving). No diagnostic tests nor treatment given was mentioned. Rechallenge is not applicable as no additional dosing is expected to be given. The patient''s age remains a confounder. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1907321 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hyperglycaemia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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: COVID-19 VACCINE ASTRAZENECA
Current Illness: Type 1 diabetes mellitus (Stable. Self manage insulin doses)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Hyperglycemia; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231625) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (Hyperglycemia) in a 63-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003675) for an unknown indication. Previously administered products included for Type 1 diabetes mellitus: Insulin. Past adverse reactions to the above products included No adverse event with Insulin. Concurrent medical conditions included Type 1 diabetes mellitus (Stable. Self manage insulin doses). Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 15-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HYPERGLYCAEMIA (Hyperglycemia) (seriousness criterion medically significant). At the time of the report, HYPERGLYCAEMIA (Hyperglycemia) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Patient had type 1 diabetes for 47 years, blood sugar was stable before booster vaccine. However still raised despite increased insulin dose. Patient had not tested positive for COVID-19 since having the vaccine. No treatment medications provided. This regulatory case concerns a 63-year-old, female patient with medical history of type I diabetes, who experienced the unexpected, serious event of Hyperglycaemia. The event occurred 1 day after third dose of mRNA-1273 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. The medical history of type I diabetes and co-suspect AstraZeneca''s COVID-19 vaccine remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 63-year-old, female patient with medical history of type I diabetes, who experienced the unexpected, serious event of Hyperglycaemia. The event occurred 1 day after third dose of mRNA-1273 vaccine. Regulatory authority captured the rechallenge as unknown, however no information about further dosing is disclosed. The medical history of type I diabetes and co-suspect AstraZeneca''s COVID-19 vaccine remain as confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1907348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (narrow)

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: LEVOTHYROXINE; SK INFLUENZA VACCINE; VITAMIN D [COLECALCIFEROL]
Current Illness: Hypothyroidism; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions: Comments: Hypothyroidism, otherwise healthy Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075132111GBR009187

Write-up: Dizziness; vertigo; Information has been received from an agency (GB-MHRA-ADR 26242570) on 24-NOV-2021. This spontaneous report was received from a physician referring to a 74 year old female patient. The patient''s pertinent medical history, concurrent conditions, previous drug allergies and reactions were not reported. Her concomitant therapies included levothyroxine, influenza vaccine(SK INFLUENZA VACCINE) and colecalciferol(VITAMIN D [COLECALCIFEROL]). On an unknown date also reported as 06-FEB-2021 and 01-MAY-2021, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) and on 11-NOV-2021 tozinameran (COVID-19 VACCINE MRNA (BNT162B2)) (lot# FH3220). Strength, dose, anatomical location, route of administration, expiration date and indication were not reported for both vaccines. The patient felt fine for 4 days after booster, and on day 5 on 16-NOV-2021, she felt very dizzy quite suddenly while out walking, got home safely, went to bed and severe vertiginous symptoms, consistent with positional vertigo, some persistent light-headedness afterwards, helped by meclizine (+) buclizine (+) cyclizine (STEMETIL). The following day had a similar episode and crashed her car. She says that she has spoken to multiple friends who have had similar severe dizziness in the days after their Pfizer booster jab. No memory loss, no numbness or weakness in the limbs. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial The outcome of vertigo was reported as resolved on an unknown date in 2021. The outcome of dizziness was reported as resolved on 23-NOV-2021. Action taken with suspect vaccines was unknown. The causal relationship between the events and suspect vaccines was not reported. According to the agency, the events were serious due to disability criteria.


VAERS ID: 1907895 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-11-16
   Days after vaccination:168
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, 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: 20211116; Test Name: PCR; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: NLPFIZER INC202101602064

Write-up: Vaccination failure; Got Covid infection; This a spontaneous report from a contactable consumer (sales representative, patient). A 38-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EJ6790 and expiry date was not reported), via an unspecified route of administration, on 01Jun2021 (age at vaccination: 38 years), as dose 2, single dose for COVID-19 immunisation at workplace clinic. The patient had no medical history. The patient''s concomitant medications were not reported. The patient previously took drug, unspecified with reaction of allergy. Historical vaccine included first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: ER7449 and expiry date was not reported), via an unspecified route of administration, on 11May2021, as dose 1, single dose for COVID-19 immunisation at workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 16Nov2021, the patient experienced vaccination failure and got covid infection. The patient underwent lab tests and procedures which included polymerase chain reaction (PCR): positive (nasal swab) on 16Nov2021. The patient did not received treatment for the event got covid infection. Outcome of the event got covid infection was not recovered and for another event, it was unknown. Awareness date was 16Nov2021.


VAERS ID: 1908733 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease (Hashimoto''s disease diagnosed in 1976. Managed since then through thyroxine.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative for COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Nausea; Tiredness; Headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26232415) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. The patient''s past medical history included Hashimoto''s disease (Hashimoto''s disease diagnosed in 1976. Managed since then through thyroxine.). Concomitant products included LEVOTHYROXINE for Hypothyroidism, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, NAUSEA (Nausea), FATIGUE (Tiredness) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative for COVID-19 test.. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. Patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient had not enrolled in clinical trial. Patient had headache about 3 hours after the vaccine and strong nausea, general tiredness which continued for around 48 hours. Patient also had pain at injection site. Patient had headache only for 48 hours. Company comment : This case concerns a 57-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of nausea, headache and fatigue. The events started approximately 3 hours after the booster dose of mRNA-1273 administration, and continued for about 48 hours, after which only headache persisted. The rechallenge was not applicable since the patient previously received vaccination with CHADOX1 NCOV-19, and no further doses are expected. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. All events are expected but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old female patient with no relevant medical history reported, who experienced the unexpected, serious (medically significant) events of nausea, headache and fatigue. The events started approximately 3 hours after the booster dose of mRNA-1273 administration, and continued for about 48 hours, after which only headache persisted. The rechallenge was not applicable since the patient previously received vaccination with CHADOX1 NCOV-19, and no further doses are expected. Seriousness assessments has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. All events are expected but considered unexpected due to seriousness assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1908760 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dizziness, Dizziness postural, Erectile dysfunction, Malaise
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Sexual dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Feeling sick; Dizziness; Getting; Loss of energy; Dizziness postural; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233075) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), DIZZINESS (Dizziness), ERECTILE DYSFUNCTION (Getting), ASTHENIA (Loss of energy) and DIZZINESS POSTURAL (Dizziness postural) in a 42-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Asthma and Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...). On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (Feeling sick) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), ERECTILE DYSFUNCTION (Getting) (seriousness criterion medically significant) and ASTHENIA (Loss of energy) (seriousness criterion medically significant). At the time of the report, MALAISE (Feeling sick), DIZZINESS (Dizziness), ERECTILE DYSFUNCTION (Getting), ASTHENIA (Loss of energy) and DIZZINESS POSTURAL (Dizziness postural) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. It was reported that the patient from since the morning on the 16th November. Dizziness when getting up, looking up and down, sudden loss of energy and feeling sick. 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.Patients relevant investigations or tests information includes that the patient will contact their doctors surgery on 22nd November. Treatment information was not provided. Company Comment: This case concerns a 42-year-old, male patient with previous relevant medical history of Asthma and Rheumatoid arthritis, who experienced the unexpected serious events of malaise, dizziness, asthenia, dizziness postural, and erectile dysfunction (reported as "getting"). The event dizziness postural occurred 1 day after the third dose (unknown dosage) of mRNA-1273. As per source document�s narrative, malaise, dizziness, and asthenia, also occurred 1 day after the third dose of mRNA-1273. The date of onset of erectile dysfunction was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of Asthma and Rheumatoid arthritis could be confounder for malaise and asthenia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 42-year-old, male patient with previous relevant medical history of Asthma and Rheumatoid arthritis, who experienced the unexpected serious events of malaise, dizziness, asthenia, dizziness postural, and erectile dysfunction (reported as "getting"). The event dizziness postural occurred 1 day after the third dose (unknown dosage) of mRNA-1273. As per source document�s narrative, malaise, dizziness, and asthenia, also occurred 1 day after the third dose of mRNA-1273. The date of onset of erectile dysfunction was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. Patient�s medical history of Asthma and Rheumatoid arthritis could be confounder for malaise and asthenia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908913 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: severe headache; nausea; Frontal headache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26228644) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (severe headache), NAUSEA (nausea) and HEADACHE (Frontal headache) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (severe headache) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). On 18-Nov-2021, HEADACHE (Frontal headache) was resolving. At the time of the report, HEADACHE (severe headache) and NAUSEA (nausea) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No Concomitant medications were reported. It was reported that patient developed Severe headache, raised temperature and nausea. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. No Treatment information was provided. Company comment: This case concerns a 74-year-old female patient with no relevant medical history, who experienced the serious unexpected events of headache (headache and frontal headache), nausea. The event frontal headache occurred on the same day after the third dose of mRNA-1273. The events headache and nausea occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 74-year-old female patient with no relevant medical history, who experienced the serious unexpected events of headache (headache and frontal headache), nausea. The event frontal headache occurred on the same day after the third dose of mRNA-1273. The events headache and nausea occurred on an unknown date after the third dose of mRNA-1273. The rechallenge is unknown, according to SD. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1908949 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN ACA5777 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20211161936

Write-up: CHILLS; FEVER; HEADACHE; GENERAL MALAISE; This spontaneous report received from a consumer via a Regulatory Authority [regulatory authority, RO-NMA-2021-SPCOV14980] concerned a 34 year old male. The patient''s weight was 72 kilograms, and height was 178 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: ACA5777 expiry: UNKNOWN) 1 dosage forms, 1 total, series 1, administered on 15-NOV-2021 for covid-19 immunisation. No concomitant medications were reported. On 16-NOV-2021, the patient experienced chills, fever, headache, general malaise and was hospitalized on an unspecified date and number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, fever, headache, and general malaise. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1911556 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618914

Write-up: The patient received third dose of COMIRNATY on 16Nov2021; The patient received third dose of COMIRNATY on 16Nov2021; The patient received third dose of COMIRNATY on 16Nov2021; Throat swelling; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111171737180350-CJNOP (RA). Other Case identifier(s): GB-MHRA-ADR 26216788 (RA). A 57 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Unknown) at the age of 57 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, single, Primary immunization series complete but manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, single, Primary immunization series complete but manufacturer unknown), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "The patient received third dose of COMIRNATY on 16Nov2021"; PHARYNGEAL SWELLING (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Throat swelling". The event "throat swelling" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) no - negative COVID-19 test. The clinical course was: Throat swelling about half an hour after having the vaccine. Went to Accident and emergency (A&E) was given antihistamine and observed for 3 hours. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Therapeutic measures were taken (antihistamine) as a result of pharyngeal swelling. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1911565 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Nausea, Off label use, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101618772

Write-up: Swollen lymph nodes; Diarrhea; Fatigue; Nausea; Swollen arm; Headache; Off label use; The patient received 2 doses COVID vaccines and comirnaty; Booster dose; This is a spontaneous report received from a contactable reporter (Consumer) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111180005123870-BXVXZ (MHRA). Other Case identifier(s): GB-MHRA-ADR 26218765 (MHRA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (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 2,SINGLE; Lot Number: UNKNOWN; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 1, SINGLE; Lot Number: UNKNOWN; Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "The patient received 2 doses COVID vaccines and comirnaty"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster dose"; LYMPHADENOPATHY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Headache"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Diarrhea"; FATIGUE (medically significant) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Fatigue"; NAUSEA (medically significant) with onset 16Nov2021, outcome "recovered" (Nov2021), described as "Nausea"; PERIPHERAL SWELLING (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Swollen arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Clinical course: The patient had no symptoms associated with COVID-19. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1911568 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Immunisation, Interchange of vaccine products, Limb discomfort, Off label use
SMQs:, Arthritis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101625631

Write-up: Chills; Pain joint; Arm discomfort; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111180947544960-BKCM4 (MHRA). Other Case identifier: GB-MHRA-ADR 26220524 (MHRA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH4751) 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 NUMBER UNKNOWN), administration date: 19May2021, for COVID-19 immunisation; COVID-19 vaccine (DOSE NUMBER UNKNOWN, MANUFACTURER UNKNOWN), for COVID-19 immunisation. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. 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 (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; CHILLS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Chills"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pain joint"; LIMB DISCOMFORT (medically significant) with onset 17Nov2021, outcome "recovering", described as "Arm discomfort". The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1911572 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Immunisation, Influenza like illness, Interchange of vaccine products, Off label use, Palpitations, Pyrexia, SARS-CoV-2 test, Vaccination site erythema, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Lymphoma (4 episodes of lymphoma over last 23 years and a 5th is on watch and wait); Shingles
Allergies:
Diagnostic Lab Data: Test Date: 20211110; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629232

Write-up: 3rd dose has been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination; 3rd dose has been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination; 3rd dose has been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination; Headache; Chills; Fever; Flu like symptoms; Heart racing; Excess sweating; Painful arm at injection site still sore and red; Painful arm at injection site still sore and red; Tiredness; sweating; This is a spontaneous report received from a contactable reporter (Consumer) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111182254553560-47VRM. Other Case identifier: GB-MHRA-ADR 26228563. A 75-year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 16Nov2021 (Lot number: fko596) (at the age of 75-years-old) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing); "Lymphoma" (unspecified if ongoing), notes: 4 episodes of lymphoma over last 23 years and a 5th is on watch and wait; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "Shingles" (unspecified if ongoing). Concomitant medication included: GABAPENTIN taken for herpes zoster, start date: 24Sep2021, stop date: 19Nov2021. Vaccination history included: COVID-19 vaccine astrazeneca (dose 1), administration date: 07Mar2021, for COVID-19 immunisation; COVID-19 vaccine astrazeneca (dose 2), administration date: 19May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "3rd dose has been administered and the patient has not previously received the full primary immunization series of BNT162b2 vaccination"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Headache"; CHILLS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Chills"; PYREXIA (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Fever"; INFLUENZA LIKE ILLNESS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Flu like symptoms"; PALPITATIONS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Heart racing"; HYPERHIDROSIS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Excess sweating"; VACCINATION SITE PAIN (medically significant), VACCINATION SITE ERYTHEMA (medically significant) all with onset 16Nov2021, outcome "not recovered" and all described as "Painful arm at injection site still sore and red"; FATIGUE (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Tiredness"; HYPERHIDROSIS (medically significant) with onset 2021, outcome "recovering", described as "sweating". Patient has not tested positive for COVID-19 since having the vaccine and is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (10Nov2021) no - negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1911576 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE; FOLIC ACID; LEVOTHYROXINE
Current Illness: Pregnancy
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Maternal exposure during pregnancy; Shoulder pain; Shoulder pain; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26230602) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority prospective pregnancy case was reported by a consumer and describes the occurrence of the first episode of ARTHRALGIA (Shoulder pain), the second episode of ARTHRALGIA (Shoulder pain) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Concurrent medical conditions included Pregnancy. Concomitant products included FLUOXETINE for Anxiety, FOLIC ACID for Folic acid supplementation, LEVOTHYROXINE for Hypothyroidism. On 13-Nov-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 16-Nov-2021, the patient experienced the first episode of ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced the second episode of ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). At the time of the report, last episode of ARTHRALGIA (Shoulder pain) had not resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. Patient has not tested positive for COVID-19 since having the vaccine and not enrolled in clinical trial Patient was exposed to the medicine Third-trimester (29-40 weeks). This case concerns a 27-year-old, female patient with no relevant medical history, who experienced Maternal exposure during pregnancy and the expected event of arthralgia (two episodes), which were assessed as serious per Regulatory authority. Last menstrual period and estimated date of delivery were not provided. The arthralgia episodes occurred approximately 3 and 6 days after the first dose of mRNA-1273. The rechallenge was not applicable as event of arthralgia 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 27-year-old, female patient with no relevant medical history, who experienced Maternal exposure during pregnancy and the expected event of arthralgia (two episodes), which were assessed as serious per Regulatory authority. Last menstrual period and estimated date of delivery were not provided. The arthralgia episodes occurred approximately 3 and 6 days after the first dose of mRNA-1273. The rechallenge was not applicable as event of arthralgia 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: 1911757 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OPDIVO; CORTRIL [HYDROCORTISONE ACETATE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101605747

Write-up: Consciousness disturbed; This is a spontaneous report received from a contactable reporter(s) (Physician). A 25 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 15Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: OPDIVO (administered every 6 weeks); CORTRIL [HYDROCORTISONE ACETATE]. On 15Nov2021 (the day of vaccination), the patient received the single dose of vaccine. On 16Nov2021 (1 day after vaccination), the patient experienced consciousness disturbed. The reporter classified the event as serious (from physician). The outcome of event was unknown. The reporter stated that the events probably related to the BNT162B2. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information in the case, the causal association between the event altered state of consciousness and the suspect drug BNT162B2 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: 1914327 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID 19 test; Result Unstructured Data: Test Result:Positive for Corona
CDC Split Type: DEPFIZER INC202101624739

Write-up: Drug ineffective; Vaccine breakthrough covid 19; This is a spontaneous report received from a contactable Consumer from License Party. The reporter is the patient. Other Case identifier(s): 99541 (Biontech). A female patient received bnt162b2 (COMIRNATY), administration date 19Jun2021 (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Drug ineffective"; COVID-19 (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Vaccine breakthrough covid 19". Despite proper vaccination (2nd vaccination was on 19Jun2021/ full vaccination protection from 04Jul2021) the patient was tested positive for Corona on 16Nov2021. The patient have had cold symptoms and strong tiredness for three days. Her big fear was getting pneumonia. BNT162B2 is under agreement with Biontech. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1914821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Low platelets
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101603901

Write-up: stomach cramps; fainting; headache; Vomiting; 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-202111161347356870-2ZWPR (RA). Other Case identifier(s): GB-MHRA-ADR 26208914 (RA). A 34 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Platelet count decreased" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunisation. The following information was reported: ABDOMINAL PAIN UPPER (medically significant) with onset 16Nov2021, outcome "not recovered", described as "stomach cramps"; SYNCOPE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "fainting"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "headache"; VOMITING (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Vomiting". Additional information: Woke at 4am with intense stomach cramps and vomiting. Fainting and then more vomiting. Extreme headache has then occurred. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient was not pregnant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. 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: 1914831 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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: Disorder gastrointestinal; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Infection (Bowels infection and Mouth infection); Infection localised
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: NEGATIVE
CDC Split Type: GBPFIZER INC202101604010

Write-up: Nothing by mouth order; 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-202111161420069680-WVWAP (RA). Other Case identifier(s): GB-MHRA-ADR 26209015 (RA). A 41 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: 1) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastrointestinal disorder" (unspecified if ongoing); "Infection" (unspecified if ongoing), notes: Bowels infection and Mouth infection; "Localised infection" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine, and it was not sure if patient was enrolled in clinical trial. The following information was reported: DYSPHAGIA (medically significant) with onset 16Nov2021, outcome "unknown", described as "Nothing by mouth order". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test, notes: NEGATIVE on an unspecified date. Reportedly, the patient has been given today, so could not speak yet. The seriousness criteria of the event was medically significant. This 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: 1914891 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Oral herpes, Pain, Pain in extremity, Peripheral swelling, Rash erythematous
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal infections (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
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: Paralysis arm; Stroke; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101604190

Write-up: Pain in arm; Swollen arm; Red rash; Fever sore; Pain; 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-202111162117075480-QG0Z8 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26211658 (MHRA). A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Stroke" (unspecified if ongoing); "arm which was paralysed after a stroke" (unspecified if ongoing); "Suspected COVID-19", start date: 10Aug2021, stop date: 16Aug2021. The patient''s concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Swollen arm"; RASH ERYTHEMATOUS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Red rash"; ORAL HERPES (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Fever sore"; PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Pain"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Pain in arm". Patient has not tested positive for COVID-19 since having the vaccine. Taking medication because of stroke Not had a COVID-19 test. Patient is not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient had really bad pain in arm which was paralysed after a stroke so don''t normally feel pain a rash and arm swollen and really cold but fever. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1914901 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Illness
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101604024

Write-up: Sickness; Tummy ache; 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-202111162328223290-DDZ0D (RA). A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 12 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 30Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported.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. Adverse reaction did not occur as a result of an exposure during pregnancy. report does not relate to possible inflammation of the heart (myocarditis or pericarditis). The following information was reported: ILLNESS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Sickness"; ABDOMINAL PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Tummy ache". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1914905 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, Headache, Hypoaesthesia, Immunisation, Interchange of vaccine products, Musculoskeletal stiffness, Myalgia, Nausea, Off label use, Pain in extremity, SARS-CoV-2 test, Vaccination site pain, Vaccination site pruritus
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Steroid inhalers as iv got asthma plus other medical conditions very weak immune system); Immune system disorder; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101604103

Write-up: Off label use; interchange of vaccine products; booster; Aching joints/Aching in knees; Aching in limb/Sore feet; Stiffness; Fatigue extreme; Muscle soreness/Muscle pain; Nausea; Numbness in hand; Headache; Injection site pain; Chills worsened; Injection site itching; Feeling of total lack of energy/Weakness; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111170211311320-XRRNF (RA). Other Case identifiers: GB-MHRA-ADR 26212331 (RA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Unknown) at the age of 36 years as dose 3 (booster), single for COVID-19 immunisation. Patient''s last menstrual period date: 10Apr2021. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Steroid inhalers as iv got asthma plus other medical conditions very weak immune system; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "very weak immune system" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 nor was currently pregnant/breastfeeding. Patient has 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. Past drug history included: Depo-medrone. Vaccination history included: COVID-19 vaccine (Dose: 1, Single, Lot number: unknown, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization; COVID-19 vaccine (Dose: 2, Single, Lot number: unknown, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (disability, medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; ARTHRALGIA (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Aching joints/Aching in knees"; PAIN IN EXTREMITY (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Aching in limb/Sore feet"; MUSCULOSKELETAL STIFFNESS (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Stiffness"; FATIGUE (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Fatigue extreme"; MYALGIA (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Muscle soreness/Muscle pain"; NAUSEA (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Nausea"; HYPOAESTHESIA (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Numbness in hand"; HEADACHE (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache"; VACCINATION SITE PAIN (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Injection site pain"; CHILLS (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Chills worsened"; VACCINATION SITE PRURITUS (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Injection site itching"; ASTHENIA (disability, medically significant) with onset 16Nov2021, outcome "not recovered", described as "Feeling of total lack of energy/Weakness". The patient further reported that she felt as if been hit by a bus like having pneumonia when it knocks u off your feet. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1914908 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0112 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Immunisation, Muscle spasms, Myalgia, Nausea, Off label use, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101604302

Write-up: extreme pain; Muscle pain; Muscle spasm; Shivering; Headache; Nausea; Off label use; 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-202111170443258480-BSUKM. Other Case identifier(s): GB-MHRA-ADR 26212463. A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FK0112) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 03Apr2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. Date of last menstrual period: 10Nov2021. The patient''s concomitant medications were not reported. Past drug history included: Sertraline, notes: Sertraline 150mg per day. Vaccination history included: Bnt162b2 (Dose 1.), for COVID-19 immunisation; Bnt162b2 (Dose 2.), for COVID-19 immunisation, reaction(s): "extreme pain". Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date was reported as 10Nov2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Muscle pain"; MUSCLE SPASMS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Muscle spasm"; CHILLS (medically significant) with onset 16Nov2021, outcome "recovering", described as "Shivering"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache"; NAUSEA (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Nausea"; PAIN (non-serious), outcome "unknown", described as "extreme pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Jun2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of myalgia, muscle spasms. Pfizer Booster side effects of muscle pain/spasm seem quite severe. Regular pain relief has no effect. No pain experienced with first dose but extreme pain experienced with second and booster. No report relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1914911 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Off label use, Oropharyngeal pain
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Comments: Asthma Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101603821

Write-up: Sore throat; Tiredness; off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111170624537310-IXR8W (RA). Other Case identifier(s): GB-MHRA-ADR 26212972 (RA). A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; OROPHARYNGEAL PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Sore throat"; FATIGUE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Tiredness". Patient has not had symptoms associated with COVID-19, Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding.Patient has not tested positive for COVID-19 since having the vaccine and 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1914914 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gout, Immunisation, Injection site pain, Myalgia, Off label use, SARS-CoV-2 test, Sleep disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Extravasation events (injections, infusions and implants) (broad), Eosinophilic pneumonia (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gout; Comments: Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211115; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101604045

Write-up: muscle pain; disruptive sleep followed by acute gout attack; Secondary muscle pain at injection site; Disruptive sleep; Gout flare; off label use; 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-202111170723456090-MUA7O. A male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ALOPURINOL taken for gout, start date: 01Apr2021. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "off label use"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant), outcome "not recovered", described as "muscle pain"; GOUT (medically significant), outcome "not recovered", described as "disruptive sleep followed by acute gout attack"; GOUT (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Gout flare"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Secondary muscle pain at injection site"; SLEEP DISORDER (non-serious), outcome "unknown", described as "Disruptive sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) negative, notes: No - Negative COVID-19 test. Additional information: Unsure if patient has had symptoms associated with COVID-19. Disruptive sleep followed by acute Gout Attack, after 3rd jab. Also secondary muscle pain at injection site. No report related to possible inflammation of the heart (myocarditis or pericarditis). 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: 1914916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Interchange of vaccine products, Joint range of motion decreased, Mobility decreased, Neck pain, Off label use, Pain, Pain in extremity
SMQs:, Parkinson-like events (broad), 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: ASPIRIN [ACETYLSALICYLIC ACID]; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618569

Write-up: pain; into shoulder and neck; into shoulder and neck; Reduced mobility; unable to lift arm more than a few inches from my side; Painful arm; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111170802541290-0YEPX. Other Case identifier(s): GB-MHRA-ADR 26213716. A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing); "Neoplasm" (unspecified if ongoing), notes: Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID], start date: 01Jul2019; INFLUENZA VIRUS, administration date 01Oct2021; SIMVASTATIN taken for blood cholesterol, start date: 01Jul2019. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 2), administration date: 01May2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant), outcome "not recovered", described as "pain"; PAIN IN EXTREMITY (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Painful arm"; ARTHRALGIA (medically significant), NECK PAIN (medically significant), outcome "unknown" and all described as "into shoulder and neck"; MOBILITY DECREASED (medically significant), outcome "unknown", described as "Reduced mobility"; JOINT RANGE OF MOTION DECREASED (medically significant), outcome "unknown", described as "unable to lift arm more than a few inches from my side". Therapeutic measures were taken as a result of pain, pain in extremity, arthralgia, neck pain. Clinical course: Pain down arm from injection site to fingertips and into shoulder and neck. Reduced mobility due to pain and unable to lift arm more than a few inches from my side. No swelling or itchiness have occurred. Taken paracetamol to rase the pain. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1914920 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9413 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Influenza like illness, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211016; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101618709

Write-up: bad exhausted; flu like; Headache; Shivering; Exhaustion; 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-202111170835467490-5OSQD (RA). Other Case identifier(s): GB-MHRA-ADR 26213775 (RA). A 14 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Fk9413) at the age of 14 years as dose1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 15Oct2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The following information was reported: HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache"; CHILLS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Shivering"; FATIGUE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Exhaustion"; FATIGUE (medically significant), outcome "unknown", described as "bad exhausted "; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "flu like ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Oct2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: He was fine in the day but went to play ice hockey came home really bad exhausted, headache and flu, like he has had COVID over a month ago just so thought if it would be ok and to get it done or if it was done to soon, and asked if he should have not of played an active sport the same day. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1914925 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Electrocardiogram, Immunisation, Neck pain, Pain in jaw
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Osteonecrosis (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood tests; Result Unstructured Data: Test Result:Unknown results; Test Date: 20211116; Test Name: Mobile ECG; Result Unstructured Data: Test Result:did not show anything
CDC Split Type: GBPFIZER INC202101618665

Write-up: tight chest; Chest pain; she had pain radiating up the right side of her neck and jaw; she had pain radiating up the right side of her neck and jaw; Booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111170904373600-OHPID (regulatory authority). Other Case identifier(s): GB-MHRA-ADR 26214332 (regulatory authority). A 63 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 17:30 (Lot number: FH4751) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; CHEST DISCOMFORT (hospitalization, medically significant) with onset 16Nov2021 17:55, outcome "unknown", described as "tight chest"; CHEST PAIN (hospitalization, medically significant) with onset 16Nov2021 17:55, outcome "unknown", described as "Chest pain"; NECK PAIN (hospitalization, medically significant), PAIN IN JAW (hospitalization, medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "she had pain radiating up the right side of her neck and jaw". The patient was hospitalized for immunisation, chest discomfort, chest pain, neck pain, pain in jaw (start date: 16Nov2021). Clinical course: patient was administered booster covid vaccine at 17:30. Patient waited about 20 minutes before leaving the pharmacy, and returned about 5 minutes later complaining of tight chest pains. Within a couple of minutes she had pain radiating up the right side of her neck and jaw. The paramedics were called. Mobile ECG did not show anything but she was admitted for blood tests. Patient was admitted to hospital for blood tests. The patient underwent the following laboratory tests and procedures: blood test: (16Nov2021) unknown results; electrocardiogram: (16Nov2021) did not show anything. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1914934 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-11-16
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Comments: Positive lateral flow test
CDC Split Type: GBPFIZER INC202101618533

Write-up: Patient tested positive for COVID-19 on 16Nov2021; SARS-CoV-2 infection; Loss of smell; Loss of taste; Cold symptoms; 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-202111171025100020-HNYT8 (RA). Other Case identifier(s): GB-MHRA-ADR 26214535 (RA). A 22 year-old female patient received bnt162b2 (BNT162B2), administration date 21Jul2021 (Lot number: FD8813) as dose 2, single and administration date 23Jun2021 (Lot number: EW3143) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Patient tested positive for COVID-19 on 16Nov2021"; COVID-19 (medically significant) with onset 16Nov2021, outcome "not recovered", described as "SARS-CoV-2 infection"; ANOSMIA (medically significant) with onset 2021, outcome "not recovered", described as "Loss of smell"; AGEUSIA (medically significant) with onset 2021, outcome "unknown", described as "Loss of taste"; NASOPHARYNGITIS (medically significant) with onset 2021, outcome "unknown", described as "Cold symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) yes - positive covid-19 test, notes: Positive lateral flow test. Clinical course: Patient was not enrolled in clinical trial. Patient had suspect COVID-19 from 14Nov2021 and ongoing. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1914935 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FVC0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Illness, Immunisation, Interchange of vaccine products, Myalgia, Nausea, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: MERCAPTOPURIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Flu (Had flu jab end of October); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618559

Write-up: Nausea; Chills; Generalised muscle aches; Headache; Joint pain; Sickness; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111171028293970-F5ZUT. Other Case identifier(s): GB-MHRA-ADR 26214552. A 48-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FVC0596) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Flu" (unspecified if ongoing), notes: Had flu jab end of October; "Inflammatory bowel disease" (unspecified if ongoing), notes: Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis); "Crohn''s disease" (unspecified if ongoing); "Ulcerative colitis" (unspecified if ongoing). Unsure if patient has had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included: MERCAPTOPURIN taken for colitis ulcerative. Past drug history included: Microgynon; Sertraline; Balsalazide. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Nausea"; CHILLS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Chills"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Generalised muscle aches"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Joint pain"; ILLNESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Sickness". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (17Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: 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: 1914967 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0114 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Illness, Immunisation, SARS-CoV-2 test, Sleep disorder, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201227; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101618705

Write-up: fell asleep but broken sleep.; Booster; Shaking; Sick; Vomited; This is a spontaneous report received from a contactable consumer from the products Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111171507184820-XEWY7 (MHRA). Other Case identifiers: GB-MHRA-ADR 26216161 (MHRA). A 72-year-old male patient received BNT162B2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH0114) at the age of 72 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: ''''Suspected COVID-19", start date: 26Dec2020 (not ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Past drug history included: Levothyroxine; Sertraline. Vaccination history included: BNT162B2 (Dose 1) for COVID-19 immunisation; BNT162B2 (Dose 2), for COVID-19 immunisation. The patient previously received the full primary immunization series of BNT162B2. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; TREMOR (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Shaking"; ILLNESS (non-serious) with onset 16Nov2021, outcome "unknown", described as "Sick"; VOMITING (non-serious) with onset 16Nov2021, outcome "unknown", described as "Vomited"; SLEEP DISORDER (non-serious), outcome "unknown", described as "fell asleep but broken sleep." The course of the events was as follows: around 4 hours after the booster, in bed, started shaking uncontrollably and also had to go to the bathroom as felt as if going to be sick. Vomited twice and returned to bed, still shaking. Shaking seemed to stop after another 4-5 hours. Finally fell asleep but broken sleep. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (27Dec2020) positive, notes: Yes - Positive COVID-19 test. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1914971 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Heart rate increased, Immunisation, Influenza, Influenza like illness, Interchange of vaccine products, Off label use, Pain in extremity
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
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 INC202101618498

Write-up: stomach cramps; flu like symptoms; Painful arm/Painful arm - same as injection site; Flu symptoms; Diarrhoea; Heart rate high/Resting heart rate raised by 20%; Off label use; Interchange of vaccine products; BOOSTER; This is a spontaneous report from a contactable consumer. received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202111171541453910-PBG0Q. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 26216302 A 56-year-old male patient received bnt162b2 (COMIRNATY), administered in arm, administration date 16Nov2021 (Lot number: FK0596) (at the age of 56-years-old) 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. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 20Feb2021, for COVID-19 immunisation and Covid-19 vaccine astrazeneca (DOSE 2), administration date: 10May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "BOOSTER"; ABDOMINAL PAIN UPPER (medically significant), outcome "not recovered", described as "stomach cramps"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Painful arm/Painful arm - same as injection site"; INFLUENZA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Flu symptoms"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Diarrhoea"; HEART RATE INCREASED (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Heart rate high/Resting heart rate raised by 20%"; and INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "flu like symptoms". Clinical course: Resting heart rate raised by 20%, Painful arm - same as injection site, Flu like symptoms, Stomach cramps and diarrhoea. The patient has not tested positive for COVID-19 since having the vaccine. It was also reported that the report does not relate to possible inflammation of the heart (myocarditis or pericariditis). No follow-up attempts are Needed. No further information is expected.


VAERS ID: 1914973 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Immunisation
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618506

Write-up: Booster; Facial droop; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111171549304220-SBU0K (MHRA). Other Case identifier: GB-MHRA-ADR 26216309 (MHRA). A 32-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 32 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1) and Bnt162b2 (Dose 2), both for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; and FACIAL PARALYSIS (medically significant) with onset 16Nov2021, outcome "recovering", described as "Facial droop". Left eyelid and surrounding drooped. 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 and has not had a COVID-19 test. Patient is not pregnant. Patient last menstrual period date was on 01Jan2017. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1914981 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cold sweat, Immunisation, Interchange of vaccine products, Loss of consciousness, Off label use, Presyncope, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101618641

Write-up: passed out; clammy; Near fainting; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP, patient) from the Regulatory Agency. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111171645599080-XDJWI. Other Case identifier(s): GB-MHRA-ADR 26216601. A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: Fh3220) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Past drug history included: Citalopram, notes: daily. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "passed out"; COLD SWEAT (non-serious), outcome "unknown", described as "clammy"; PRESYNCOPE (non-serious) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Near fainting". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Passed out on the bathroom floor.. had severe fizzing noise in ears.. very clammy and wet skin. 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 possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are needed. No further information is expected.


VAERS ID: 1914984 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysgeusia, Ear disorder, Fatigue, Immunisation, Interchange of vaccine products, Muscle fatigue, Off label use, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Taste and smell disorders (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ATORVASTATIN; LEVOTHYROXINE; PARACETAMOL; RISEDRONATE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; High cholesterol; Hypothyroidism; Osteopenia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618570

Write-up: hot ear; odd metallic taste in my mouth; Fatigue; Muscle fatigue; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111171707086640-KJVLE (RA). Other Case identifier: GB-MHRA-ADR 26216769 (RA). A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FKO596) at the age of 69 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing). Concomitant medications included: AMLODIPINE taken for hypertension; ATORVASTATIN taken for blood cholesterol increased; INFLUENZA VIRUS taken for immunisation, administration date 27Oct2021; LEVOTHYROXINE taken for hypothyroidism; PARACETAMOL; RISEDRONATE SODIUM taken for osteopenia, start date: 2019. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), administration date: 14Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 2), administration date: 27Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Fatigue"; MUSCLE FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Muscle fatigue"; EAR DISORDER (medically significant), outcome "unknown", described as "hot ear"; DYSGEUSIA (medically significant), outcome "unknown", described as "odd metallic taste in my mouth". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient has an odd metallic taste in her mouth, and a recurring ''hot ear'' for some reason. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1914985 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3320 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate increased, Immunisation, Interchange of vaccine products, Off label use, Palpitations, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (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: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211006; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618694

Write-up: High temperature; Palpitations; High pulse rate; 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-202111171708246070-RN9FL (RA). Other Case identifier(s): GB-MHRA-ADR 26216712 (RA). A 65 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FH3320) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 16Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca, administration date: 26Feb2021, for COVID-19 vaccination; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "booster"; PYREXIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "High temperature"; PALPITATIONS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Palpitations"; HEART RATE INCREASED (medically significant) with onset 17Nov2021, outcome "not recovered", described as "High pulse rate". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Oct2021) negative, notes: No - Negative COVID-19 test. Clinical course: patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. ECG monitoring device to be fitted on 18Nov2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1915000 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Hyperhidrosis, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101618731

Write-up: 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-202111172022419670-B5JFA (MHRA). Other Case identifier(s): GB-MHRA-ADR 26217770 (MHRA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FK0596) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for Covid-19 immunization; Covid-19 vaccine astrazeneca (Dose 2), for Covid-19 immunization. Patient has 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 (medically significant) with onset 16Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; VISION BLURRED (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Blurred vision"; CHILLS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Shivers"; HYPERHIDROSIS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Sweating". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1915001 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, Pain, Rhinorrhoea
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: Medical History/Concurrent Conditions: Clinical trial participant (Study details:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618688

Write-up: Runny nose; Headache temporal; Booster; Pain; 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-202111172029299800-TPKWS. Other Case identifier(s): GB-MHRA-ADR 26217783. A female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), administration date: 15May2021, for COVID-19 immunisation; Bnt162b2 (Dose 1), administration date: Feb2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; PAIN (medically significant) with onset 16Nov2021, outcome "recovering", described as "Pain"; RHINORRHOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Runny nose"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache temporal". The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient had not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1915016 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Dizziness, Headache, Immunisation, Interchange of vaccine products, Off label use, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular 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: CITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618646

Write-up: pain under arm; Swelling arm; Dizzy; Headache; Off-label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable consumer from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111172319036610-GSNWF. Other Case identifier: GB-MHRA-ADR 26218740. A 50-year-old female patient received BNT162B2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history was not reported. Patient is not enrolled in clinical trial and has not had symptoms associated with COVID-19. She had not had a COVID-19 test. Concomitant medications included: citalopram. Vaccination history included: COVID-19 vaccine astrazeneca (DOSE 1), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; PERIPHERAL SWELLING (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Swelling arm"; DIZZINESS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Dizzy"; HEADACHE (medically significant) with onset 16Nov2021, outcome "recovering", described as "Headache"; AXILLARY PAIN (medically significant), outcome "unknown", described as "pain under arm ". Patient has not tested positive for COVID-19 since having the vaccine No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1915021 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Headache, Immunisation, Interchange of vaccine products, Musculoskeletal chest pain, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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: CERELLE; LERCANIDIPINE; PROPRANOLOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenomyosis; Anxiety; Depression; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618530

Write-up: Interchange of vaccines products; Booster; Generalised muscle aches; Abdominal pain; Headache; Rib pain; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202111180346424310-2ZXJZ and Safety Report Unique Identifier GB-MHRA-ADR 26218797. A female patient of an unspecified age received third dose (booster) of BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Nov2021 as single dose for COVID-19 immunisation. She previously received the first dose of COVID-19 VACCINE ASTRAZENECA on 03Mar2021 and second dose of COVID-19 VACCINE ASTRAZENECA on 30Apr2021, both for COVID-19 immunisation. Medical history included adenomyosis, hypertension, anxiety, and depression. She has not had symptoms associated with COVID-19. She was not enrolled in clinical trial. Concomitant medications included desogestrel (CERELLE) taken for adenomyosis from 01Sep2021; influenza vaccine (INFLUENZA VIRUS) taken for immunization from 17Nov2021; lercanidipine taken for hypertension from 01May2019; propranolol taken for anxiety from 01May2019; and sertraline taken for depression from 06Sep2021. The patient experienced generalised muscle aches, abdominal pain, headache, and rib pain, all on 16Nov2021 with outcome of not recovered. Events were reported as medically significant by health authority. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on unknown date. No follow-up attempts are needed; information about lot/batch number cannot be obtained.


VAERS ID: 1915043 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chest pain, Chills, Facial pain, Fatigue, Glossodynia, Headache, Incorrect dose administered, Memory impairment, Metastasis, Pain in extremity, Palpitations, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: Medical history was not reported.
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: blood clotting test - elevated.; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Heart palpitations; Incorrect dose administered; Chest pain; Facial pain; Metastasis; Shivering; Swollen arm; Painful L arm; Fatigue extreme; Headache; Tongue sore; Memory impaired; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231257) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of METASTASIS (Metastasis), PYREXIA (Fever), PALPITATIONS (Heart palpitations), CHILLS (Shivering), PERIPHERAL SWELLING (Swollen arm), PAIN IN EXTREMITY (Painful L arm), FATIGUE (Fatigue extreme), HEADACHE, GLOSSODYNIA (Tongue sore), MEMORY IMPAIRMENT, CHEST PAIN, FACIAL PAIN and INCORRECT DOSE ADMINISTERED in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Medical history was not reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 16-Mar-2021 to 17-May-2021 and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced METASTASIS (Metastasis) (seriousness criterion hospitalization), CHILLS (Shivering) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Painful L arm) (seriousness criterion hospitalization), FATIGUE (Fatigue extreme) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), GLOSSODYNIA (Tongue sore) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Memory impaired) (seriousness criterion hospitalization) and FACIAL PAIN (Facial pain) (seriousness criterion hospitalization). On 17-Nov-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization), PALPITATIONS (Heart palpitations) (seriousness criterion hospitalization) and INCORRECT DOSE ADMINISTERED (Incorrect dose administered) (seriousness criterion hospitalization). On 16-Nov-2021, CHILLS (Shivering) was resolving. On 17-Nov-2021, CHEST PAIN (Chest pain) had resolved. On 18-Nov-2021, HEADACHE (Headache), GLOSSODYNIA (Tongue sore) and FACIAL PAIN (Facial pain) had resolved. On 20-Nov-2021, PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Painful L arm) was resolving, FATIGUE (Fatigue extreme) and MEMORY IMPAIRMENT (Memory impaired) had resolved. At the time of the report, METASTASIS (Metastasis) had not resolved and PYREXIA (Fever), PALPITATIONS (Heart palpitations) and INCORRECT DOSE ADMINISTERED (Incorrect dose administered) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: high (High) blood clotting test - elevated.. On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments. Treatment information was not provided. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Lab data included ECG. Patient had an error given a double dose of the moderna vaccine on 18-11-2021 at midday that 0.5 dose instead of 0.25. 6 people doubled dosed. Patient had really very ill from 2pm on 16-11-2021 to 18/11. She had chest pain on the 17/11 evening. The patient was double dosed. She went to hospital. In hospital that the patient had some blood tests included ECG and full check. Patient vitals were normal. Patient had gone back for further clotting tests in a weeks time. 6 persons were double dosed on the morning of 16/11/2021. HCP took about 3 min to sort out the injection, was in and out of the vial several times and constantly flicking the syringe. The second person didn''t even check it before it was injected. Patient had an incorrect date on her vaccine card. The patient had indicated that she was a bad reactor and it was never queried whereas on the first two vaccinations they had referred me to the in house doctor first for discussions and advice. There was no monitoring of people resting for 15mins afterwards either which was a shambolic set up. Patient was very worried about long term effects and her bloods. Company Comment: This case concerns a 54-year-old female patient with no relevant medical history provided, who experienced the following serious unexpected events: Metastasis, Chills, Pain in extremity, Peripheral swelling (Swollen arm), Fatigue, Headache, Glossodynia, Memory impairment and Facial pain which occurred during the same day when the patient had received the mRNA-1273 vaccine. In addition, the unexpected serious events of Chest pain occurred the days after the administration of the vaccine, while the start date for the unexpected serious events of Palpitations and Pyrexia was not provided. Except that blood clotting test was slightly elevated, no further information regarding clinical course of the events and laboratory investigations has been provided at this time. At the time of this report, the event of Metastasis was reported as not resolved, while the outcome of the events of Pyrexia and Palpitations was unknown. The remaining events were reported as resolving or resolved at the time of the report. The rechallenge was reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. It was also stated that the patient had Incorrect dose administered and as per source document, the patient received "a double dose of the mRNA-1273 vaccine (0.5 dose instead of 0.25)". It should be noted that the patient received two doses of COVID-19 vaccine Astrazeneca followed by the third dose of mRNA-1273. It was reported that the patient experienced Metastasis and no information regarding the underlying disease and patient''s primary cancer was provided, however, based on nature of the event it can be concluded that Metastasis are unrelated to the mRNA-1273 and related to the patient''s underlying disease. The company causality for the event of Incorrect dose administered is not applicable. 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 54-year-old female patient with no relevant medical history provided, who experienced the following serious unexpected events: Metastasis, Chills, Pain in extremity, Peripheral swelling (Swollen arm), Fatigue, Headache, Glossodynia, Memory impairment and Facial pain which occurred during the same day when the patient had received the mRNA-1273 vaccine. In addition, the unexpected serious events of Chest pain occurred the days after the administration of the vaccine, while the start date for the unexpected serious events of Palpitations and Pyrexia was not provided. Except that blood clotting test was slightly elevated, no further information regarding clinical course of the events and laboratory investigations has been provided at this time. At the time of this report, the event of Metastasis was reported as not resolved, while the outcome of the events of Pyrexia and Palpitations was unknown. The remaining events were reported as resolving or resolved at the time of the report. The rechallenge was reported as unknown as per SD and kept as such, however, it could have been considered as not applicable as the patient experienced the events following the third dose of the vaccine. It was also stated that the patient had Incorrect dose administered and as per source document, the patient received "a double dose of the mRNA-1273 vaccine (0.5 dose instead of 0.25)". It should be noted that the patient received two doses of COVID-19 vaccine Astrazeneca followed by the third dose of mRNA-1273. It was reported that the patient experienced Metastasis and no information regarding the underlying disease and patient''s primary cancer was provided, however, based on nature of the event it can be concluded that Metastasis are unrelated to the mRNA-1273 and related to the patient''s underlying disease. The company causality for the event of Incorrect dose administered is not applicable. 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: 1915080 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Musculoskeletal stiffness, Pain in extremity
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: INFLUENZA VIRUS
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: throbbing pain in vaccinated bicep; Stiffness; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233974) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (throbbing pain in vaccinated bicep) and MUSCULOSKELETAL STIFFNESS (Stiffness) in a 66-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 08-Nov-2021 to an unknown date for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (throbbing pain in vaccinated bicep) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (throbbing pain in vaccinated bicep) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiffness) 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. Not had a COVID-19 test. Treatment medication not provided Patient experienced limited mobility in raising arm (could not raise above shoulder height or extend fully 90 degrees from body. Patient was not enrolled in clinical trial. Company Comment: This is a regulatory authority case concerning a 66-year-old male patient with no relevant medical history, who experienced unexpected events of Musculoskeletal Stiffness and Pain in extremity. The events occurred the same day after the third dose of mRNA-1273 vaccine. It was reported that patient experienced limited mobility in raising arm (could not raise it above shoulder height or extend it fully 90 degrees from body). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 66-year-old male patient with no relevant medical history, who experienced unexpected events of Musculoskeletal Stiffness and Pain in extremity. The events occurred the same day after the third dose of mRNA-1273 vaccine. It was reported that patient experienced limited mobility in raising arm (could not raise it above shoulder height or extend it fully 90 degrees from body). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915124 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-30
Onset:2021-11-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Menstrual flooding; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26235539) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Menstrual flooding) in a 43-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Oct-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Menstrual flooding) (seriousness criterion medically significant). At the time of the report, HEAVY MENSTRUAL BLEEDING (Menstrual flooding) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 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. This happened after patient had the second dose march 2021 and flooded out for a month. The patient not had symptoms associated with COVID-19 and was not pregnant. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient�s last menstrual date: 18-OCT-2021 Patient states that this happened after she had the second dose march 2021. She had her period and flooded out for a month Company comment: This case concerns a 43-year-old female subject, with no medical history reported, who experienced the unexpected and serious event of Heavy menstrual bleeding. The event occurred 17 days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 43-year-old female subject, with no medical history reported, who experienced the unexpected and serious event of Heavy menstrual bleeding. The event occurred 17 days after the third dose of mRNA-1273 vaccine. The rechallenge is unknown, as reported in SD. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915384 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ1763 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Epilepsy, Feeling abnormal, Hypersensitivity, Loss of consciousness, Oropharyngeal discomfort, Oxygen saturation, Pruritus, Seizure, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Developmental delay; Epileptic seizure
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: blood pressure; Result Unstructured Data: Test Result:no decreased; Test Date: 20211116; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20211116; Test Name: SpO2; Result Unstructured Data: Test Result:94-96 %; Comments: After resting; Test Date: 20211116; Test Name: tachycardia; Result Unstructured Data: Test Result:no tachycardia
CDC Split Type: JPPFIZER INC202101605945

Write-up: partial epilepsy/systemic epileptic seizure; loss of consciousness; 30 minutes after the vaccination, Pharynx strange sensation of presented; feels poorly; giddiness; itching feeling occurred on the left side of body.; Convulsion; allergic reaction; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21131049. A 42-year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 16:00 (Lot number: FJ1763, Expiration Date: 30Apr2022) at the age of 42-years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Disorder of development" (unspecified if ongoing); "Epileptic seizure" (unspecified if ongoing). Body temperature before vaccination was 36.7 degrees Centigrade. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown, first dose.), for COVID-19 immunisation. The following information was reported: EPILEPSY (hospitalization) with onset 16Nov2021 18:00, outcome "unknown", described as "partial epilepsy/systemic epileptic seizure"; SEIZURE (hospitalization) with onset 16Nov2021 16:00, outcome "unknown", described as "Convulsion"; LOSS OF CONSCIOUSNESS (hospitalization) with onset 16Nov2021 18:00, outcome "unknown", described as "loss of consciousness"; PRURITUS (hospitalization) with onset 16Nov2021 16:15, outcome "unknown", described as "itching feeling occurred on the left side of body."; OROPHARYNGEAL DISCOMFORT (hospitalization) with onset 16Nov2021 16:30, outcome "unknown", described as "30 minutes after the vaccination, Pharynx strange sensation of presented"; FEELING ABNORMAL (hospitalization) with onset 16Nov2021 16:30, outcome "unknown", described as "feels poorly"; DIZZINESS (hospitalization) with onset 16Nov2021 16:30, outcome "unknown", described as "giddiness"; HYPERSENSITIVITY (hospitalization) with onset 16Nov2021, outcome "unknown", described as "allergic reaction". The patient was hospitalized for epilepsy, seizure, loss of consciousness, pruritus, oropharyngeal discomfort, feeling abnormal, dizziness, hypersensitivity (start date: 17Nov2021). The events "partial epilepsy/systemic epileptic seizure", "convulsion", "loss of consciousness", "itching feeling occurred on the left side of body.", "30 minutes after the vaccination, pharynx strange sensation of presented", "feels poorly", "giddiness" and "allergic reaction" were evaluated at the physician office visit. On 16Nov2021 at 16:00 (the day of vaccination) the patient experienced convulsion. On 17Nov2021 (1 day after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: Around 15 minutes after the vaccination, an itching feeling occurred on the left side of body. 30 minutes after the vaccination, pharynx strange sensation of presented and the itching feeling increased. Therefore, dexchlorpheniramine maleate (POLARAMINE "1A") was used via intramuscular route. After resting, the patient complained of feels poorly and giddiness. SpO2 94 ~ 96%. After the vaccination, 0.3 ml of adrenaline was intramuscularly injected. At the patient request, the patient lay in bed to rest. (Due to the animosity of the allergic reaction, adrenaline was administered although the patient had no decreased blood pressure or no tachycardia.) 2 hours after the vaccination, partial epilepsy occurred. The reporter called an ambulance for the patient. Partial epilepsy proceeded to systemic epileptic seizure, and loss of consciousness occurred. The patient was emergency transported. On17Nov2021 (1 day after the vaccination), the outcome of the event was unknown. The reporting physician classified the event as serious (Hospitalized: from 17Nov2021) and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was Epileptic seizure. The reporting physician commented as follows: the reporter think that the patient symptoms of epileptic seizure occurred from the COMIRNATY vaccination. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1915557 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20213

Write-up: COVID-19 vaccines causing adverse effects in therapeutic use.; This case was received via a regulatory authority (Reference number: MOD-2021-104) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use.) in a 27-year-old patient of an unknown gender who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use.) (seriousness criterion hospitalization). The patient was hospitalized from 16-Nov-2021 to 17-Nov-2021 due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use.) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. Patient had Covid-19 test and result was not reported. No concomitant medication was reported. No treatment information was provided. Company comment: This case concerns a 27-years-old patient of an unknown gender, with no relevant medical history reported, who experienced the serious unexpected event of VACCINATION COMPLICATION. The event occurred after an unknown time interval after the dose of the mRNA-1273. The rechallenge is not applicable, as there is no information that states vaccination dose number and there is only one dose reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 27-years-old patient of an unknown gender, with no relevant medical history reported, who experienced the serious unexpected event of VACCINATION COMPLICATION. The event occurred after an unknown time interval after the dose of the mRNA-1273. The rechallenge is not applicable, as there is no information that states vaccination dose number and there is only one dose reported. The benefit-risk relationship of the mRNA-1273 is not affected by this report.


VAERS ID: 1915586 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20213

Write-up: COVID-19 vaccines causing adverse effects in therapeutic use; This case was received via a regulatory authority (Reference number: MOD-2021-156) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) in a 48-year-old patient of an unknown gender who received mRNA-1273 (COVID-19 Vaccine Moderna) for an unknown indication. Previously administered products included for Product used for unknown indication: Lorazepam. Past adverse reactions to the above products included No adverse event with Lorazepam. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 16-Nov-2021 to 18-Nov-2021 due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information provided. No treatment medication information provided. Company Comment: This case concerns a 48-year-old patient with no relevant medical history who experienced serious unexpected event of vaccination complication, reported as COVID-19 vaccines causing adverse effects in therapeutic use. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . The patient was hospitalized for 2 days due to the event. No further details regarding clinical course were provided. Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This case concerns a 48-year-old patient with no relevant medical history who experienced serious unexpected event of vaccination complication, reported as COVID-19 vaccines causing adverse effects in therapeutic use. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . The patient was hospitalized for 2 days due to the event. No further details regarding clinical course were provided. Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1915595 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20213

Write-up: COVID-19 vaccines causing adverse effects in therapeutic use; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) in a 21-year-old patient of an unknown gender who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 16-Nov-2021 to 18-Nov-2021 due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No relevant concomitant medications were reported by the reporter. Lab data included COVID-19, HbA1C, HbSag, HCV, LFT which results were not provided. Treatment information was not provided Company comment: This case concerns a 21-year-old patient of unknown gender with no relevant medical history who experienced serious unexpected event of vaccination complication, reported as COVID-19 vaccines causing adverse effects in therapeutic use. The patient was hospitalized due to the event. The event occurred unspecified time after the unspecified dose of mRNA-1273 (Moderna COVID-19 vaccine) .Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This case concerns a 21-year-old patient of unknown gender with no relevant medical history who experienced serious unexpected event of vaccination complication, reported as COVID-19 vaccines causing adverse effects in therapeutic use. The patient was hospitalized due to the event. The event occurred unspecified time after the unspecified dose of mRNA-1273 (Moderna COVID-19 vaccine) .Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1915602 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20213

Write-up: COVID-19 vaccines causing adverse effects in therapeutic use; This case was received via a regulatory authority (Reference number: MOD-2021-141) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) in a 37-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 18-Nov-2021 to 20-Nov-2021 due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Company comment: This case concerns a 37-year-old male patient with no relevant medical history who experienced serious unexpected event of vaccination complication, reported as COVID-19 vaccines causing adverse effects in therapeutic use. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . The patient was hospitalized for 2 days due to the event. No further details regarding clinical course were provided. Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender''s Comments: This case concerns a 37-year-old male patient with no relevant medical history who experienced serious unexpected event of vaccination complication, reported as COVID-19 vaccines causing adverse effects in therapeutic use. The event occurred unspecified time after the unspecified dose of the Moderna COVID-19 vaccine . The patient was hospitalized for 2 days due to the event. No further details regarding clinical course were provided. Rechallenge was not applicable since due to unknown outcome and lack of information on the number of doses administered, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.


VAERS ID: 1915612 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20213

Write-up: COVID-19 vaccines causing adverse effects in therapeutic use; This case was received via a regulatory authority (Reference number: MOD-2021-098) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) in a 62-year-old patient of an unknown gender who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Enalapril and Amlodipine. Past adverse reactions to the above products included No adverse event with Amlodipine and Enalapril. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 16-Nov-2021 to 17-Nov-2021 due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. On an unspecified date lab tests FT3, FT4, TSH were performed, results were not provided. No concomitant medications information was reported. No treatment medications were provided. Company comment: This is a spontaneous case concerning a 62-year-old patient of an unknown gender, with no relevant medical history reported, who experienced serious, unexpected event of Vaccination complication. The patient received a dose of mRNA-1273 on an unknown date. The patient was hospitalized from 16-Nov-2021 to 17-Nov-2021 due to Vaccination complication. Very limited information regarding this event has been provided at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a spontaneous case concerning a 62-year-old patient of an unknown gender, with no relevant medical history reported, who experienced serious, unexpected event of Vaccination complication. The patient received a dose of mRNA-1273 on an unknown date. The patient was hospitalized from 16-Nov-2021 to 17-Nov-2021 due to Vaccination complication. Very limited information regarding this event has been provided at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915613 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination complication
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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: THMODERNATX, INC.MOD20213

Write-up: COVID-19 vaccines causing adverse effects in therapeutic use; This case was received via a regulatory authority (Reference number: MOD-2021-163) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) in a 31-year-old patient of an unknown gender who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 16-Nov-2021 to 17-Nov-2021 due to VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. The patient''s lab test include COVID-19 tests, no result provided No concomitant medication was reported. No treatment information was reported. Company comment: This case concerns a 31 year-old patient of unknown gender, with no relevant medical history, who experienced the serious (due to hospitalization) unexpected event of Vaccination complication. The event occurred after the mRNA-1273 vaccine, date and dose number not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 31 year-old patient of unknown gender, with no relevant medical history, who experienced the serious (due to hospitalization) unexpected event of Vaccination complication. The event occurred after the mRNA-1273 vaccine, date and dose number not provided. The rechallenge was not applicable since dose number was not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918147 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Cold sweat, Dizziness postural, Feeling abnormal, Feeling cold, Feeling hot, Headache, Immunisation, Loss of consciousness, 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), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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: ANAESTHETIC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101628899

Write-up: Passed out; Temporary vision loss; Feeling hot; Dizzy on standing; Feeling abnormal/ started funny; Feeling cold; Clammy; Headache; Shaking; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: GB-MHRA-EYC 00266680. Other Case identifier(s): GB-MHRA-ADR 26216178. A 50 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 16:10 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: ANAESTHETIC. Vaccination history included: Covid-19 vaccine (Dose 1 . Primary Immunization series complete but unknown manufacturer), for covid-19 immunization; Covid-19 vaccine (Dose 2. Primary Immunization series complete but unknown manufacturer), for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; DIZZINESS POSTURAL (medically significant) with onset 16Nov2021 22:45, outcome "not recovered", described as "Dizzy on standing"; COLD SWEAT (medically significant) with onset 16Nov2021 11:06, outcome "unknown", described as "Clammy"; FEELING ABNORMAL (medically significant) with onset 16Nov2021 22:40, outcome "unknown", described as "Feeling abnormal/ started funny"; FEELING COLD (medically significant) with onset 16Nov2021 11:06, outcome "unknown", described as "Feeling cold"; FEELING HOT (medically significant) with onset 16Nov2021 22:45, outcome "unknown", described as "Feeling hot"; HEADACHE (medically significant) with onset 16Nov2021 11:06, outcome "unknown", described as "Headache"; LOSS OF CONSCIOUSNESS (medically significant) with onset 16Nov2021 22:50, outcome "unknown", described as "Passed out"; TREMOR (medically significant) with onset 16Nov2021 11:06, outcome "unknown", described as "Shaking"; BLINDNESS TRANSIENT (medically significant) with onset 16Nov2021 22:50, outcome "unknown", described as "Temporary vision loss". Clinical course: On 16Nov2021 at 16.10 COVID booster, at 22.40 started funny. 22.45 feeling hot dizzy. 22.50-22.55 couldn''t see/vision went on way back from bathroom to bedroom/must have passed out in bedroom doorway on rising diving for bed before passing out again. At 11.06 freezing but clammy and shaky - headache. After 4.30 slept. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918148 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adverse drug reaction, Chills, Eye pain, Eye pruritus, Fatigue, Immunisation, Lethargy, Off label use, Rhinorrhoea, Sneezing
SMQs:, Anaphylactic reaction (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101625834

Write-up: Runny nose, feeling very tired, lethargic, sneezing, slight cough, chills.; chills; lethargic; tired; runny nose; very sore itchy eyes; very sore itchy eyes; sneezing quite a lot; off label use; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-EYC 00266817 (RA). Other Case identifier(s): GB-MHRA-ADR 26224150 (RA). A 50 year-old female patient received bnt162b2 (COMIRNATY), parenteral, administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "off label use"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; ADVERSE DRUG REACTION (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Runny nose, feeling very tired, lethargic, sneezing, slight cough, chills."; CHILLS (medically significant) with onset 17Nov2021, outcome "recovering", described as "chills"; LETHARGY (medically significant) with onset 17Nov2021, outcome "recovering", described as "lethargic"; FATIGUE (medically significant) with onset 17Nov2021, outcome "recovering", described as "tired "; RHINORRHOEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "runny nose "; EYE PRURITUS (medically significant), EYE PAIN (medically significant) all with onset 17Nov2021, outcome "recovering" and all described as "very sore itchy eyes"; SNEEZING (medically significant) with onset 17Nov2021, outcome "recovering", described as "sneezing quite a lot". Clinical course: Patient felt ill the next day after having Pfizer booster vaccine. She had chills, felt very lethargic and tired and had a runny nose and very sore itchy eyes. She was also sneezing, quite a lot but the next day felt a lot better although not 100 percent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918151 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA BN3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Dizziness, Erythema, Feeling hot, Headache, Nausea, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; AMITRIPTYLINE; INDAPAMIDE
Current Illness:
Preexisting Conditions: Comments: The medical history was not provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: red and hot aching arm. nausea, dizziness. headache. confused.; red and hot aching arm. nausea, dizziness. headache. confused.; red and hot aching arm. nausea, dizziness. headache. confused.; red and hot aching arm. nausea, dizziness. headache. confused.; red and hot aching arm. nausea, dizziness. headache. confused.; red and hot aching arm. nausea, dizziness. headache. confused.; red and hot aching arm. nausea, dizziness. headache. confused.; This case was received via regulatory authority (Reference number: -MHRA-ADR 26225905) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (red and hot aching arm. nausea, dizziness. headache. confused.), DIZZINESS (red and hot aching arm. nausea, dizziness. headache. confused.), HEADACHE (red and hot aching arm. nausea, dizziness. headache. confused.), CONFUSIONAL STATE (red and hot aching arm. nausea, dizziness. headache. confused.), ERYTHEMA (red and hot aching arm. nausea, dizziness. headache. confused.), FEELING HOT (red and hot aching arm. nausea, dizziness. headache. confused.) and PAIN IN EXTREMITY (red and hot aching arm. nausea, dizziness. headache. confused.) in a 78-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. BN3004675) for Booster. The medical history was not provided by the reporter. Concomitant products included FOLIC ACID, AMITRIPTYLINE and INDAPAMIDE for an unknown indication. On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 16-Nov-2021, the patient experienced NAUSEA (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant), DIZZINESS (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant), HEADACHE (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant), CONFUSIONAL STATE (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant), ERYTHEMA (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant), FEELING HOT (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant) and PAIN IN EXTREMITY (red and hot aching arm. nausea, dizziness. headache. confused.) (seriousness criterion medically significant). At the time of the report, NAUSEA (red and hot aching arm. nausea, dizziness. headache. confused.), DIZZINESS (red and hot aching arm. nausea, dizziness. headache. confused.), HEADACHE (red and hot aching arm. nausea, dizziness. headache. confused.), CONFUSIONAL STATE (red and hot aching arm. nausea, dizziness. headache. confused.), ERYTHEMA (red and hot aching arm. nausea, dizziness. headache. confused.), FEELING HOT (red and hot aching arm. nausea, dizziness. headache. confused.) and PAIN IN EXTREMITY (red and hot aching arm. nausea, dizziness. headache. confused.) had not resolved. No treatment medications provided by the reporter. Patient experienced Red and hot aching arm, Nausea, dizziness, Headache and Confused. Company Comment : This case concerns a 78-year-old female patient, with no medical history, who experienced the serious unexpected events of Nausea, Dizziness, Headache, Confusional state, Erythema, Feeling Hot and Pain in extremity. The events occurred the same day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 78-year-old female patient, with no medical history, who experienced the serious unexpected events of Nausea, Dizziness, Headache, Confusional state, Erythema, Feeling Hot and Pain in extremity. The events occurred the same day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1918181 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESTRADOT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Menopause; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101604055

Write-up: urticaria; Booster; Off label use; Interchange of vaccine products; Giant hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from the Regulatory Authority (RA). Regulatory number: GB-RA-WEBCOVID-202111162341526690-PSATV (RA). Other Case identifier(s): GB-RA-ADR 26212305 (RA). A 55 year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 55 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Suspected COVID-19", start date: 15Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Menopause" (unspecified if ongoing). Concomitant medication included: ESTRADOT taken for menopause, start date: 11Jan2021. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose 1 and Dose 2), for COVID-19 immunization. Patient was not pregnant; Patient was not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; ANGIOEDEMA (medically significant) with onset 16Nov2021, outcome "recovered" (16Nov2021), described as "Giant hives"; URTICARIA (medically significant), outcome "not recovered", described as "urticaria". After having the booster vaccination in the morning, a few hours after this she noticed a rash on her legs body, this was a urticaria rash. She had previously many years ago suffered with this type of rash and had not had this rash for many years until today. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: 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. Amendment: This follow-up report is being submitted to allow appropriate reporting to health authorities.


VAERS ID: 1918223 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-06
Onset:2021-11-16
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0546 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism (Diagnosed with autism); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211004; Test Name: inflammation of the heart; Result Unstructured Data: Test Result:UNKNOWN; Test Date: 20211004; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101625831

Write-up: Pain chest; Palpitations; 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-202111171955578880-ZAJIG. Other Case identifier(s): GB-MHRA-ADR 26217697. A 13 year-old female patient received bnt162b2 (COMIRNATY), administration date 06Nov2021 (Lot number: FK0546) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism spectrum disorder" (unspecified if ongoing), notes: Diagnosed with autism; "Suspected COVID-19", start date: 03Oct2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The following information was reported: CHEST PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Pain chest"; PALPITATIONS (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Palpitations". The patient underwent the following laboratory tests and procedures: myocarditis: (04Oct2021) unknown; sars-cov-2 test: (04Oct2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: It was reported that suffering from sharp stabbing pain in chest which has been coming and going for last 24 hours. Can feel heart beating in chest. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. It was reported that adverse reaction did not occur as a result of an exposure during pregnancy. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Symptoms lead to a hospital stay reported as: "no". Diagnosis made by a medical professional reported: as "no". Are you happy for us to contact your GP or treating physician reported as yes. Were any blood tests, such as for certain proteins (called troponin) that signal heart muscle damage taken reported as "no". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F145475 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Lymphadenopathy, Mobility decreased, Vaccination site pain
SMQs:, Parkinson-like events (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: INSULIN LISPRO; INSULIN DEGLUDEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Type 1 diabetes mellitus (For over 15 years.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618605

Write-up: Armpit pain/ Pain and soreness in my left armpit; Booster; also very sore to raise my arm out above 45 degrees, so above my chest; the underarm was swollen, with an expanded ball (presume lymph node from looking online); Also very sore to raise my arm out above 45 degrees, so above my chest, as armpit then feels strained (like a chest muscle the day or two after a gym workout); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111180605449170-TMQCJ. Other Case identifiers: GB-MHRA-ADR 26219242. A male patient received BNT162B2 (COMIRNATY), administered in arm left, administration date 16Nov2021 (Lot number: F145475) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Type 1 diabetic" (unspecified if ongoing), notes: For over 15 years.; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response. Patient has not had symptoms associated with COVID-19 nor had a COVID-19 test also not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medications included: INSULIN LISPRO taken for type 1 diabetes mellitus, start date: 01Jan2005; INSULIN DEGLUDEC taken for type 1 diabetes mellitus, start date: 06May2006. Vaccination history included: BNT162B2 (Dose 1, single, Lot number: Unknown), for COVID-19 immunisation; BNT162B2 (Dose 2, single, Lot number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Armpit pain/Pain and soreness in my left armpit"; VACCINATION SITE PAIN (medically significant) with onset 2021, outcome "not recovered", described as "also very sore to raise my arm out above 45 degrees, so above my chest"; LYMPHADENOPATHY (medically significant) with onset 2021, outcome "unknown", described as "the underarm was swollen, with an expanded ball (presume lymph node from looking online)", MOBILITY DECREASED (medically significant) with onset 2021, outcome "unknown", described as "Also very sore to raise my arm out above 45 degrees, so above my chest, as armpit then feels strained (like a chest muscle the day or two after a gym workout)". No follow up attempts are possible. No further information is expected.


VAERS ID: 1918238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-16
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LAMOTRIGINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; SARS-CoV-2 infection
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101618564

Write-up: Stomach ache; Headache; Shivers; Drenching sweats; 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-202111180614585770-FT6RE. Other Case identifier(s): GB-MHRA-ADR 26219268. A 40-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "COVID-19 infection", start date: 08Jan2021 (unspecified if ongoing); "Epilepsy" (unspecified if ongoing). Patient''s last menstrual date is 18Nov2021. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 21Oct2021; LAMOTRIGINE taken for epilepsy. The following information was reported: HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache"; CHILLS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Shivers"; HYPERHIDROSIS (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Drenching sweats"; ABDOMINAL PAIN UPPER (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Stomach ache". The events were reported as serious (medically significant). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2021) yes - positive 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: 1918245 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, Product use issue, SARS-CoV-2 test, Sluggishness, Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: BUDESONIDE; DESOGESTREL; FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]; SALBUTAMOL; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (taking budesonide, though I often forget to); Mental disorder; Premenstrual tension
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625920

Write-up: Injection site warmth; Injection site redness; injection site lump/ injection site mass; Sluggishness; quite out of it the day after; FLUCELVAX TETRA on 16Nov2021; FLUCELVAX TETRA on 16Nov2021; Off label use; Interchange of vaccine products; Booster; my arm hurts when it moves; Injection site pain; 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-202111180813118850-HPXUB. Other Case identifier: GB-MHRA-ADR 26220019. A 21 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) at the age of 21 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: taking budesonide, though I often forget to; "Premenstrual tension" (unspecified if ongoing); "Mental disorder" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Concomitant medication(s) included: BUDESONIDE taken for asthma; DESOGESTREL taken for premenstrual syndrome; FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V] taken for immunisation, administration date 16Nov2021; SALBUTAMOL; SERTRALINE taken for mental disorder. Vaccination history included: Covid-19 vaccine Astrazeneca (Dose 1) and Covid-19 vaccine Astrazeneca (Dose 2), both for COVID-19 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 16Nov2021, outcome "not recovered", described as "my arm hurts when it moves"; VACCINATION SITE PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Injection site pain"; VACCINATION SITE WARMTH (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Injection site warmth"; VACCINATION SITE ERYTHEMA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Injection site redness"; VACCINATION SITE MASS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "injection site lump/ injection site mass"; SLUGGISHNESS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Sluggishness"; FEELING ABNORMAL (medically significant) with onset 17Nov2021, outcome "unknown", described as "quite out of it the day after"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 16Nov2021, outcome "unknown" and all described as "FLUCELVAX TETRA on 16Nov2021". The patient underwent the following laboratory test: COVID-19 virus test: no - negative covid-19 test. Clinical course: My arm hurts when it moves, I noticed this within hours of receiving the injection. The lump/mass (couldn''t figure out how to describe it) looks and acts like a large bug bite, or a small horsefly bite, though it isn''t itchy. It started out smaller but then spread, I''m very slightly worried about it. I also was quite out of it the day after, though a good night''s sleep has helped a bit with that. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918255 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Chills, Decreased appetite, Feeling hot, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Malaise, Myalgia, Nausea, Off label use, Pain, Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (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: ACRIVASTINE; CLENIL MODULITE; VENTOLINE [SALBUTAMOL SULFATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Multiple allergies; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101625901

Write-up: shivering; swollen armpit; Vomited; My whole body was aching; Armpit pain; muscle pain; very hot; whole body was aching; swollen armpit; Swollen lymph nodes; Joint pain; Nausea; Off label use; Interchange of vaccine products; Booster; Injection site pain; Headache/my head was so painful; Fever; Appetite lost; Feeling unwell/ made me a little unsteady; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: -MHRA-WEBCOVID-202111180859168190-BQIWL (RA). Other Case identifier(s): -MHRA-ADR 26220290 (MHRA). A 38 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 14:00 (Lot number: FH4751) at the age of 38 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 01Dec2020, stop date: 23Jan2021; "Multiple allergies" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medications included: ACRIVASTINE taken for multiple allergies; CLENIL MODULITE taken for asthma; VENTOLINE [SALBUTAMOL SULFATE] taken for asthma. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose 2), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; CHILLS (medically significant), outcome "recovering", described as "shivering"; SWELLING (medically significant), outcome "recovering", described as "swollen armpit"; VACCINATION SITE PAIN (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Injection site pain"; HEADACHE (medically significant) with onset 16Nov2021, outcome "not recovered", described as "Headache/my head was so painful"; PYREXIA (medically significant) with onset 16Nov2021, outcome "recovered" (18Nov2021), described as "Fever"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Joint pain"; NAUSEA (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Nausea"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; DECREASED APPETITE (medically significant) with onset 16Nov2021, outcome "recovering", described as "Appetite lost"; MALAISE (medically significant) with onset 16Nov2021, outcome "recovering", described as "Feeling unwell/ made me a little unsteady"; VOMITING (medically significant), outcome "unknown", described as "Vomited"; PAIN (medically significant), outcome "unknown", described as "My whole body was aching"; AXILLARY PAIN (medically significant), outcome "unknown", described as "Armpit pain"; MYALGIA (medically significant), outcome "unknown", described as "muscle pain"; FEELING HOT (medically significant), outcome "unknown", described as "very hot"; PAIN (medically significant), outcome "unknown", described as "whole body was aching"; SWELLING (medically significant), outcome "unknown", described as "swollen armpit ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive, notes: Yes - Positive COVID-19 test. Therapeutic measures were taken as a result of chills, swelling, vaccination site pain, headache, pyrexia, arthralgia, nausea, lymphadenopathy, decreased appetite, malaise, vomiting, pain, axillary pain, pain that included paracetamol. Clinical course: Injection around 2pm. Felt OK for a few hours but as evening went on started feeling more and more unwell with the fever starting and started feeling nauseous. That night was constantly shivering for a few hours in bed, slept for an hour, then was awake and vomited. An hour or so later slept again for about an hour before waking up very very hot. In the morning my head was so painful it made me a little unsteady, but I was no longer feeling nauseous. Patient''s whole body was aching (possibly because of all the shivering the night before), joints ached, and my fever was up and down all day. I was taking paracetamol every 4 hours. Last night I actually slept OK but have woken this morning with a swollen armpit which is a little painful and prevents my arm going fully flat down my side. The fever appears to have broken, and I still have a headache, muscle ache and joint ache. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918257 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Decreased appetite, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Pain, Poor quality sleep, SARS-CoV-2 test, Somnolence
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211112; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625651

Write-up: Ache; Appetite lost; Groggy; Tiredness; Poor sleep; Stomachache; Third dose administrated COVID-19 MRNA VACCINE BIONTECH; previously administrated COVID-19 VACCINE ASTRAZENECA then COVID-19 MRNA VACCINE BIONTECH; Third dose administrated COVID-19 MRNA VACCINE BIONTECH; 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-202111180931018180-AEKCQ (RA). Other Case identifier(s): GB-MHRA-ADR 26220393 (RA). A 34 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) 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: Covid-19 vaccine astrazeneca (Primary Immunization series complete but ASTRAZENECA manufacturer), administration date: 15May2021, for Vaccination; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 16Nov2021, outcome "unknown" and all described as "Third dose administrated COVID-19 MRNA VACCINE BIONTECH"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "previously administrated COVID-19 VACCINE ASTRAZENECA then COVID-19 MRNA VACCINE BIONTECH"; PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Ache"; DECREASED APPETITE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Appetite lost"; SOMNOLENCE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Groggy"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Tiredness"; POOR QUALITY SLEEP (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Poor sleep"; ABDOMINAL PAIN UPPER (medically significant) with onset 17Nov2021, outcome "recovering", described as "Stomachache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient had not symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. His 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: 1918260 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FKO596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Immunisation, Injection related reaction, Interchange of vaccine products, Nausea, Off label use, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101625645

Write-up: vomiting; nausea; headache; stomach cramps; Injection associated shivering; 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-202111180936202860-W5DZG (RA). Other Case identifier(s): GB-MHRA-ADR 26220464 (RA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Lot number: FKO596) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 21Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE), administration date: 05Feb2021, for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 16Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 16Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant), outcome "unknown", described as "vomiting"; NAUSEA (medically significant), outcome "unknown", described as "nausea"; HEADACHE (medically significant), outcome "unknown", described as "headache"; ABDOMINAL PAIN UPPER (medically significant), outcome "unknown", described as "stomach cramps"; INJECTION RELATED REACTION (medically significant) with onset 16Nov2021, outcome "recovered" (17Nov2021), described as "Injection associated shivering". Clinical Course: Patient did not have a COVID-19 test. Patient not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed; No further information is expected.


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