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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)

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VAERS ID: 1907303 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004625 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder (Heart problems going back around 10 years); Hypertension; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20211004; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: headache; dizziness; feeling sick; Chronic headaches; This case was received (Reference number: GB-MHRA-ADR 26231196) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (headache), DIZZINESS (dizziness), MALAISE (feeling sick) and HEADACHE (Chronic headaches) in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004625) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 29-Sep-2021. Concurrent medical conditions included Hypertension, Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response) and Heart disorder (Heart problems going back around 10 years). On 16-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Chronic headaches) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced HEADACHE (headache) (seriousness criteria disability and medically significant), DIZZINESS (dizziness) (seriousness criteria disability and medically significant) and MALAISE (feeling sick) (seriousness criteria disability and medically significant). On 19-Nov-2021, HEADACHE (Chronic headaches) had resolved. At the time of the report, HEADACHE (headache), DIZZINESS (dizziness) and MALAISE (feeling sick) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant products included unspecified treatments or medicines known to lower the immune response. No treatment information was provided. Company Comment: This regulatory authority case concerns a 63-year-old male patient with a relevant medical history of Hypertension, Cardiac disorder and Unspecified immunosuppressive therapy , who experienced the unexpected serious (medically significant and disability) events of Headache (reported as Headache and Chronic headaches), Dizziness and Malaise after mRNA- 1273 Moderna vaccine. The event Chronic headaches occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and the rest of the events occurred at an unknown date after the third dose. Very limited information was provided. The rechallenge was reported as unknown, only information about the third dose was disclosed. Underlying hypertension, cardiac disorder and immunosuppressive therapy may be confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 63-year-old male patient with a relevant medical history of Hypertension, Cardiac disorder and Unspecified immunosuppressive therapy , who experienced the unexpected serious (medically significant and disability) events of Headache (reported as Headache and Chronic headaches), Dizziness and Malaise after mRNA- 1273 Moderna vaccine. The event Chronic headaches occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and the rest of the events occurred at an unknown date after the third dose. Very limited information was provided. The rechallenge was reported as unknown, only information about the third dose was disclosed. Underlying hypertension, cardiac disorder and immunosuppressive therapy may be confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1907325 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, 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), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210901; 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: sweating; dizzy; Passed out; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26231755) 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 LOSS OF CONSCIOUSNESS (Passed out), HYPERHIDROSIS (sweating) and DIZZINESS (dizzy) in a 39-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Patient had 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 17-Nov-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criteria hospitalization and medically significant) and DIZZINESS (dizzy) (seriousness criteria hospitalization and medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) was resolving and HYPERHIDROSIS (sweating) and DIZZINESS (dizzy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: positive (Positive) Yes-Positive COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. The day after booster patient ended up in A and E department the day after his booster. Patient collapsed at work and was unconscious for around 40 seconds after feeling dizzy, sick, chest pains, sweating. Now on 19 Nov 2021, 2 days later, had pains in left arm where the jab was given. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Patient underwent CT scan, Blood tests, ECG and Urine sample was also taken. Company Comment: This case concerns a 39-year old, male subject with no relevant medical history, who experienced the serious (seriousness criterion=hospitalization, medically significant) unexpected events of Loss of consciousness, Hyperhidrosis, and Dizziness. The events occurred one day after the booster dose of mRNA 1273 VACCINE. Patient collapsed at work and was unconscious for around 40 seconds after feeling dizzy, sick, chest pains, and sweating, which prompted visit to the emergency room. 2 days later, vaccination site pain on the left arm was still noted. At the time of the report, outcome of event Syncope was Recovering/Resolving while the outcome of all the other events was Unknown. Results for diagnostic tests done (CT scan, ECG, urine sample, unspecified blood exam) were not available; also, no treatment given was mentioned. Rechallenge is not applicable as no additional dosing is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns a 39-year old, male subject with no relevant medical history, who experienced the serious (seriousness criterion=hospitalization, medically significant) unexpected events of Loss of consciousness, Hyperhidrosis, and Dizziness. The events occurred one day after the booster dose of mRNA 1273 VACCINE. Patient collapsed at work and was unconscious for around 40 seconds after feeling dizzy, sick, chest pains, and sweating, which prompted visit to the emergency room. 2 days later, vaccination site pain on the left arm was still noted. At the time of the report, outcome of event Syncope was Recovering/Resolving while the outcome of all the other events was Unknown. Results for diagnostic tests done (CT scan, ECG, urine sample, unspecified blood exam) were not available; also, no treatment given was mentioned. Rechallenge is not applicable as no additional dosing is expected to be given. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1907342 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Fatigue, Infusion site urticaria, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PFIZER BIONTECH COVID-19 VACCINE; METFORMIN HYDROCHLORIDE
Current Illness: Asthma; Diabetes; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Infusion site hives; Swelling; High temperature; Fatigue extreme; This case was received (Reference number: GB-MHRA-ADR 26232096) 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 INFUSION SITE URTICARIA (Infusion site hives), SWELLING (Swelling), PYREXIA (High temperature) and FATIGUE (Fatigue extreme) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Asthma and Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and METFORMIN HYDROCHLORIDE for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced INFUSION SITE URTICARIA (Infusion site hives) (seriousness criterion medically significant), SWELLING (Swelling) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant) and FATIGUE (Fatigue extreme) (seriousness criterion medically significant). On 19-Nov-2021, PYREXIA (High temperature) was resolving, FATIGUE (Fatigue extreme) had resolved. At the time of the report, INFUSION SITE URTICARIA (Infusion site hives) and SWELLING (Swelling) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment information was provided. Company Comment : This is a regulatory authority case concerning a 40-year-old, female patient with concurrent medical condition of Diabetes, Asthma and Immunodeficiency, who experienced the unexpected serious events of Infusion site urticaria, swelling, pyrexia, fatigue. The events infusion site urticaria, pyrexia and swelling occurred approximately on the same day, while the event fatigue occurred 2 days after the third dose, of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The concurrent medical conditions of Diabetes, Asthma and Immunodeficiency, remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 40-year-old, female patient with concurrent medical condition of Diabetes, Asthma and Immunodeficiency, who experienced the unexpected serious events of Infusion site urticaria, swelling, pyrexia, fatigue. The events infusion site urticaria, pyrexia and swelling occurred approximately on the same day, while the event fatigue occurred 2 days after the third dose, of mRNA 1273 Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The concurrent medical conditions of Diabetes, Asthma and Immunodeficiency, remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1907345 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Diarrhoea, Dyspnoea, Fatigue, Hyperhidrosis, Off label use, Oropharyngeal pain, Palpitations, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101646324

Write-up: Watery diarrhoea; Fever; Fatigue; Palpitations; Sore throat; Breathlessness; Bloating; Breastfeeding:yes; Breastfeeding:yes; Sweating; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111221918416650-XISRK (RA). Safety Report Unique Identifier: GB-MHRA-ADR 26235376 (RA). A 29 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) at the age of 29 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). 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. The patient''s concomitant medications were not reported. The following information was reported: DYSPNOEA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Breathlessness"; ABDOMINAL DISTENSION (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Bloating"; PYREXIA (medically significant) with onset 18Nov2021, outcome "recovered" (20Nov2021), described as "Fever"; FATIGUE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Fatigue"; PALPITATIONS (medically significant) with onset 18Nov2021, outcome "recovering", described as "Palpitations"; OROPHARYNGEAL PAIN (medically significant) with onset 18Nov2021, outcome "recovering", described as "Sore throat"; DIARRHOEA (medically significant) with onset 22Nov2021, outcome "not recovered", described as "Watery diarrhoea"; HYPERHIDROSIS (medically significant) with onset 2021, outcome "recovering", described as "Sweating"; OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "Breastfeeding:yes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) no - negative COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101658812 Baby case


VAERS ID: 1907357 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-11-17
   Days after vaccination:273
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER AB0012 / 1 - / OT

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

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

Write-up: Tiredness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26222847) 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 (Tiredness) in a 67-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) 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. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 05-May-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced FATIGUE (Tiredness) (seriousness criterion medically significant). At the time of the report, FATIGUE (Tiredness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test No Treatment information was provided. Patient was not enrolled in clinical trial Company Comment : This regulatory case concerns a 67-year-old female patient, with no relevant medical history who experienced the serious unexpected event of FATIGUE. The event occurred the day after receiving a dose of mRNA-1273. This was reported as a third dose, however it was the third dose on the vaccination schedule where the first two administered doses were Chadox NCoV-19. Previous doses were considered as suspect drugs for the reported event; however, last administration date of Chadox NCoV-19 was approximately 6 months prior to the occurrence of the event. The rechallenge is considered unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as per the Regulatory Authority assessment.; Sender''s Comments: This regulatory case concerns a 67-year-old female patient, with no relevant medical history who experienced the serious unexpected event of FATIGUE. The event occurred the day after receiving a dose of mRNA-1273. This was reported as a third dose, however it was the third dose on the vaccination schedule where the first two administered doses were Chadox NCoV-19. Previous doses were considered as suspect drugs for the reported event; however, last administration date of Chadox NCoV-19 was approximately 6 months prior to the occurrence of the event. The rechallenge is considered unknown as per the Regulatory Authority assessment. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as per the Regulatory Authority assessment.


VAERS ID: 1908714 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004674 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Guillain-Barre syndrome (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: COVID-19 VACCINE ASTRAZENECA; COVID-19 VACCINE MODERNA
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: Muscle pain; Weakness; Vomiting; Tiredness; Severe headache; Leg pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26228699) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain), ASTHENIA (Weakness), VOMITING (Vomiting), FATIGUE (Tiredness), HEADACHE (Severe headache) and PAIN IN EXTREMITY (Leg pain) in a 74-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004674) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) and ELASOMERAN (COVID-19 VACCINE MODERNA) for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant), VOMITING (Vomiting) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and HEADACHE (Severe headache) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain), ASTHENIA (Weakness), VOMITING (Vomiting), FATIGUE (Tiredness), HEADACHE (Severe headache) and PAIN IN EXTREMITY (Leg pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. It was reported that patient felt really unwell, had severe headache, vomiting, muscle pain, weakness, tiredness. The patient not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No treatment medication was reported. No medical history reported. According to the provided information, the patient also received the COVID-19 VACCINE ASTRAZENECA, which is considered to be Interchange of the vaccine products. Company Comment - This case concerns a 74-year-old female patient with no medical history provided, who experienced the following serious unexpected events: Pain in extremity, Myalgia, Asthenia, Vomiting, Fatigue and Headache. The event of Pain in extremity (Leg pain) occurred during the same day after the patient had received the third dose of the mRNA-1273 vaccine, while the temporal relationship between the remaining reported events and vaccine administration cannot be determined as the start date of events was not provided. At the time of this report, all reported events were still ongoing and no additional information regarding the clinical course of the events was provided. The action taken with the suspect product and re-challenge results were retained in line with the source document (as unknown), even though the reported events occurred following the administration of the third dose and as no additional doses are not expected at the moment, the re-challenge can be assessed as 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 74-year-old female patient with no medical history provided, who experienced the following serious unexpected events: Pain in extremity, Myalgia, Asthenia, Vomiting, Fatigue and Headache. The event of Pain in extremity (Leg pain) occurred during the same day after the patient had received the third dose of the mRNA-1273 vaccine, while the temporal relationship between the remaining reported events and vaccine administration cannot be determined as the start date of events was not provided. At the time of this report, all reported events were still ongoing and no additional information regarding the clinical course of the events was provided. The action taken with the suspect product and re-challenge results were retained in line with the source document (as unknown), even though the reported events occurred following the administration of the third dose and as no additional doses are not expected at the moment, the re-challenge can be assessed as 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: 1908716 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Fatigue, Headache, Hyperhidrosis, Insomnia, Neuralgia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

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

Write-up: sweating; pain so bad; headache; Fatigue extreme; Nerve pain; Difficulty sleeping; This case was received via RA (Reference number: GB-MHRA-ADR 26231084) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), ABDOMINAL PAIN (pain so bad), HEADACHE (headache), NEURALGIA (Nerve pain), INSOMNIA (Difficulty sleeping) and FATIGUE (Fatigue extreme) in a 52-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for COVID-19 vaccination. Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (SERETIDE) for Asthma, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 05-Mar-2021 to an unknown date for COVID-19, DOXAZOSIN and IRBESARTAN for Hypertension, LORATADINE and MONTELUKAST for Multiple allergies, METFORMIN for Type 2 diabetes mellitus, FLUTICASONE FUROATE (AVAMYS) and FERROUS GLUCONATE for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criterion medically significant) and INSOMNIA (Difficulty sleeping) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced FATIGUE (Fatigue extreme) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERHIDROSIS (sweating) (seriousness criterion medically significant), ABDOMINAL PAIN (pain so bad) (seriousness criterion medically significant) and HEADACHE (headache) (seriousness criterion medically significant). On 18-Nov-2021, INSOMNIA (Difficulty sleeping) had resolved. On 19-Nov-2021, FATIGUE (Fatigue extreme) had resolved. At the time of the report, HYPERHIDROSIS (sweating), ABDOMINAL PAIN (pain so bad), HEADACHE (headache) and NEURALGIA (Nerve pain) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was reported. Jab at 11.45am. By 10/11pm evening severe nerve pain all over body, except head (although headache). Felt like nerves were on fire. Unable to sleep through the night due to pain despite co-codamol. Pain so bad, could barely move. The feeling of clothing on skin and lying in bed painful. Moments of rigidity. Pain continued the next day, began to start resolving following day after eventually sleeping and sweating. Slept mostly the following day. Occasional moments of nerve pain continue 2 days after jab. Still quite tired. Should note also had a similar reaction to the first AstraZeneca vaccine, although possibly not as painful. Patient has not tested positive for COVID-19 since having the vaccine Company comment: This is a regulatory case concerning a 52 old, female patient with no clinical history who experienced the unexpected events of HYPERHIDROSIS, ABDOMINAL PAIN, HEADACHE, NEURALGIA, INSOMNIA and FATIGUE The events occurred 1 days after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 52 old, female patient with no clinical history who experienced the unexpected events of HYPERHIDROSIS, ABDOMINAL PAIN, HEADACHE, NEURALGIA, INSOMNIA and FATIGUE The events occurred 1 days after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1908909 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-11-17
   Days after vaccination:254
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER AB0010 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza like illness, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: sore throat; swollen glands; Flu like symptoms; Muscle ache; High temperature; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26223938) on 21-Nov-2021 and was forwarded to Moderna on 21-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen glands), PYREXIA (High temperature), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle ache) in a 59-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Concomitant products included ESTRADIOL, NORETHISTERONE ACETATE (EVOREL CONTI) from 01-Jan-2015 to an unknown date for Hormone replacement therapy. On 08-Mar-2021, the patient started COVID-19 VACCINE (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) at an unspecified dose. On 17-May-2021, COVID-19 VACCINE (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to at an unspecified dose. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and MYALGIA (Muscle ache) (seriousness criterion medically significant). 18-Nov-2021, the patient experienced LYMPHADENOPATHY (swollen glands) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat), LYMPHADENOPATHY (swollen glands), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle ache) outcome was unknown and PYREXIA (High temperature) was resolving. The patient had a high temperature on evening of 17-Nov-2021, the day of the booster and through 18-Nov-2021, this developed into a mild flu-like set of symptoms, swollen glands at the nape of neck, aching muscles and a sore throat. Treatment medication was not reported. Company comment This is a regulatory authority case concerning a 59 -year-old, female patient with previous exposure to COVID 19 vaccine CHADOX1 NCOV-19 and under treatment with hormonal replacement therapy, who experienced the unexpected serious (medically significant) events of lymphadenopathy, pyrexia, influenza like illness and orophayngeal pain. The event occurred approximately 1 day after the booster dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a59 -year-old, female patient with previous exposure to COVID 19 vaccine CHADOX1 NCOV-19 and under treatment with hormonal replacement therapy, who experienced the unexpected serious (medically significant) events of lymphadenopathy, pyrexia, influenza like illness and orophayngeal pain. The event occurred approximately 1 day after the booster dose of mRNA 1273 vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.


VAERS ID: 1908911 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported. Unsure if patient has had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virusTest; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fever; Ache; Fatigue; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26226398) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), PAIN (Ache) and FATIGUE (Fatigue) in a patient of an unknown age and gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported. Unsure if patient has 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 17-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), PAIN (Ache) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 18-Nov-2021, PYREXIA (Fever), PAIN (Ache) and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. Patient is not enrolled in clinical trial Company comment:This is a regulatory case concerning an unknown years old patient with no clinical history who experienced the unexpected events of PYREXIA, PAIN and FATIGUE The events occurred 2 days after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning an unknown years old patient with no clinical history who experienced the unexpected events of PYREXIA, PAIN and FATIGUE The events occurred 2 days after the third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1908914 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-11-17
   Days after vaccination:249
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER PV46671 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dyspnoea, Fatigue, Headache, Lymphadenopathy, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: swollen gland underarm; Swollen glands; Fatigue; Swollen arm; Headache; Chills; Shortness of breath; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26231210) 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 LYMPHADENOPATHY (swollen gland underarm), LYMPHADENOPATHY (Swollen glands), FATIGUE (Fatigue), PERIPHERAL SWELLING (Swollen arm), HEADACHE (Headache), CHILLS (Chills) and DYSPNOEA (Shortness of breath) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. Concomitant products included LANSOPRAZOLE for Hiatus hernia. On 13-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On 15-May-2021, received second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced LYMPHADENOPATHY (swollen gland underarm) (seriousness criterion medically significant). On 20-Nov-2021, DYSPNOEA (Shortness of breath) had resolved. At the time of the report, LYMPHADENOPATHY (swollen gland underarm) had not resolved, LYMPHADENOPATHY (Swollen glands), FATIGUE (Fatigue) and PERIPHERAL SWELLING (Swollen arm) was resolving and HEADACHE (Headache) and CHILLS (Chills) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medication details was reported. Patient had not tested positive for COVID-19 since having the vaccine. Company comment This is a regulatory case concerning a 58-year-old female patient with no reported medical history, who experienced the serious (medically significant) events lymphadenopathy, swollen arm, headache, chills, fatigue and shortness of breath. The events occurred one day after the third dose of COVID-19 vaccination. (First dose of mRNA-1273, previous CHADOX1 NCOV-19 VACCINE ASTRAZENECA). The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 58-year-old female patient with no reported medical history, who experienced the serious (medically significant) events lymphadenopathy, swollen arm, headache, chills, fatigue and shortness of breath. The events occurred one day after the third dose of COVID-19 vaccination. (First dose of mRNA-1273, previous CHADOX1 NCOV-19 VACCINE ASTRAZENECA). The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1908917 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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, Influenza like illness
SMQs:

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

Write-up: Flu-like symptoms; Headache; This case was received via RA (Reference number: ADR 26232567) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for an unknown indication. Patient had not had symptoms associated with COVID-19. He did not have a COVID-19 test. Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 17-Nov-2021 to an unknown date for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 18-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) (seriousness criterion medically significant). On 18-Nov-2021, HEADACHE (Headache) had resolved. On 21-Nov-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved with sequelae. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient had severe headache beginning six hours after the vaccines, which were given a few minutes apart. The headache resolved after 24 hours. Flu-like symptoms began 16 hours after the vaccines and were severe enough to prevent normal activity and required frequent bed rest. Flu like symptoms lasted for 72 hours beginning 16 hours after the vaccines, and were severe enough to prevent normal activity and required frequent bed rest.Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This is a regulatory case concerning a male patient of an unknown age, with no relevant medical history reported , who experienced the serious unexpected events of INFLUENZA LIKE ILLNESS and HEADACHE one day after receiving the third dose of mRNA1273 vaccine. Concomitant vaccination against influenza remains as a confounder/co-suspect for these events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting; Sender''s Comments: This is a regulatory case concerning a male patient of an unknown age, with no relevant medical history reported , who experienced the serious unexpected events of INFLUENZA LIKE ILLNESS and HEADACHE one day after receiving the third dose of mRNA1273 vaccine. Concomitant vaccination against influenza remains as a confounder/co-suspect for these events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per regulatory reporting


VAERS ID: 1908923 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   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: Abdominal pain upper, Arthralgia, Back pain, Pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad)

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

Write-up: pain; Pain stomach; Backache; Aching joints; This case was received via the RA (Reference number: GB-MHRA-ADR 26232708) on 22-Nov-2021 and was forwarded to Moderna on 22-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), ARTHRALGIA (Aching joints), BACK PAIN (Backache) and ABDOMINAL PAIN UPPER (Pain stomach) in a 67-year-old male patient 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 17-Nov-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced BACK PAIN (Backache) (seriousness criterion medically significant). On 19-Nov-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain stomach) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant). At the time of the report, PAIN (pain) and BACK PAIN (Backache) was resolving, ARTHRALGIA (Aching joints) had resolved with sequelae and ABDOMINAL PAIN UPPER (Pain stomach) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. The patient reported that, injection site became very painful on the next day restricting movement. Joints that normally experience pain in became worse. On the 3rd day after the booster, developed pain in abdomen which spread to back. It was eased with painkillers but five days on the pain was still present in lower abdomen. He stated ''I can only compare the type of pain to that of trapped wind but more intense and restricting movement''. Patient had my flu jab 5 days prior. No side effects from previous Covid jabs. At the time of my booster he was recovering from a lengthy cold and slight non Covid chest infection. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medications were not reported. Treatment medication included unspecified painkillers. Company comment: This case concerns a 67-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Arthralgia, Back pain, Abdominal pain upper and Pain. The events occurred from 1-3 days after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 67-year-old, male patient with no relevant medical history, who experienced the unexpected serious (medically significant) events of Arthralgia, Back pain, Abdominal pain upper and Pain. The events occurred from 1-3 days after the third dose of mRNA-1273 Vaccine. The rechallenge was unknown since no information about the events of the earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1910812 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-11-17
   Days after vaccination:159
Submitted: 0000-00-00
Entered: 2021-11-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: pcr test positive; Test Result: Positive ; Comments: Nasal Swab; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:UNKNOWN; Comments: Since the vaccination, has the patient been tested for COVID-19?:Yes
CDC Split Type: DEPFIZER INC202101623134

Write-up: COVID infection despite complete vaccination; COVID infection despite complete vaccination; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 49 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 11Jun2021 (Lot number: EX7823) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose Number: 1, Batch/Lot No: EX8679, Location of injection: Arm Left), administration date: 14May2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: COVID-19 (medically significant) with onset 17Nov2021, outcome "recovering", VACCINATION FAILURE (medically significant) with onset 17Nov2021, outcome "unknown" and all described as "COVID infection despite complete vaccination"; The event "covid infection despite complete vaccination" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: polymerase chain reaction positive: (18Nov2021) positive, notes: Nasal Swab; sars-cov-2 test: (unspecified date) unknown, notes: Since the vaccination, has the patient been tested for COVID-19?:Yes. Therapeutic measures were not taken as a result of covid-19, polymerase chain reaction positive. Additional information: 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 has been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events COVID-19 and Vaccination failure cannot be excluded.


VAERS ID: 1911535 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Immunisation, Interchange of vaccine products, Investigation, Off label use, Syncope, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response)
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: observations; Result Unstructured Data: Test Result:All observations remained within normal limits
CDC Split Type: GBPFIZER INC202101618960

Write-up: primary immunisation: ASTRAZENECA; Booster: COMIRNATY; primary immunisation: ASTRAZENECA; Booster: COMIRNATY; primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Fainting; Collapse vasomotor; Unresponsive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111171130023550-UIPIT (MHRA). Other Case identifier(s): GB-MHRA-ADR 26214982 (MHRA). A male patient received bnt162b2 (COMIRNATY), administered in deltoid left, administration date 17Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Taking other treatments or medicines, not listed above, known to lower the immune response. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 2, SINGLELot number: UNKNOWN Route of administration: unspecified), administration date: 22Sep2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (DOSE 1, SINGLELot number: UNKNOWN Route of administration: unspecified), administration date: 08Feb2021, for COVID-19 immunisation. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "primary immunisation: ASTRAZENECA; Booster: COMIRNATY"; SYNCOPE (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Fainting"; CIRCULATORY COLLAPSE (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Collapse vasomotor"; UNRESPONSIVE TO STIMULI (medically significant) with onset 17Nov2021, outcome "recovered" (17Nov2021), described as "Unresponsive". The events "fainting", "collapse vasomotor" and "unresponsive" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: investigation: (17Nov2021) all observations remained within normal limits. . The patient had not tested positive for COVID-19 since having the vaccine. Therapeutic measures were taken as a result of syncope, circulatory collapse, unresponsive to stimuli. It was reported 8 minutes post vaccination, patient was witnessed to tilt his head back and become unresponsive. Spontaneous recovery with oxygen. 999 called and the patient was transported to hospital. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1911552 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Chest discomfort, Electrocardiogram, Heart rate, Hypersensitivity, Immunisation, Interchange of vaccine products, Off label use, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Hypertension (broad), Hypersensitivity (narrow), Respiratory failure (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result:170/90; Test Date: 20211117; Test Name: ECG; Result Unstructured Data: Test Result:ECG did not show any ischaemia; Test Date: 20211117; Test Name: pulse rate; Result Unstructured Data: Test Result:100; Test Date: 20211117; Test Name: O2 saturation; Result Unstructured Data: Test Result:decreased; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618611

Write-up: Off-label use; Primary immunisation: Astrazeneca; Booster: COMIRNATY; The patient received the third/booster dose of BNT162b2; Tight chest; Allergy; Tight throat; O2 saturation dropped; Blood Pressure 170/90; This is a spontaneous report received from a contactable reporter(s) (Physician) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111171641383540-FSMN7 (RA). Other Case identifier(s): GB-MHRA-ADR 26216553 (RA). A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8469) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE NUMBER UNKNOWN, SINGLE; Lot number: UNKNOWN), administration date: 04Feb2021, for COVID-19 immunisation; 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 17Nov2021, outcome "unknown", described as "Off-label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Primary immunisation: Astrazeneca; Booster: COMIRNATY"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "The patient received the third/booster dose of BNT162b2"; CHEST DISCOMFORT (medically significant) with onset 17Nov2021, outcome "unknown", described as "Tight chest"; HYPERSENSITIVITY (medically significant) with onset 17Nov2021, outcome "unknown", described as "Allergy"; THROAT TIGHTNESS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Tight throat"; OXYGEN SATURATION DECREASED (medically significant) with onset 17Nov2021, outcome "unknown", described as "O2 saturation dropped"; HYPERTENSION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Blood Pressure 170/90". The events "tight chest", "allergy", "tight throat", "o2 saturation dropped" and "blood pressure 170/90" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 170/90; electrocardiogram: (17Nov2021) ecg did not show any ischaemia; heart rate: (17Nov2021) 100; oxygen saturation: (17Nov2021) decreased; sars-cov-2 test: (unspecified date) no - negative covid-19 test. Therapeutic measures were taken as a result of chest discomfort, hypersensitivity, throat tightness, oxygen saturation decreased, hypertension. Clinical course: 5 minutes after Pfizer booster, had tight chest and throat. No swelling seen. Treated with chlorphenamine maleate (PIRITON) 10mg, prednisolone 20mg, increasing tight chest and O2 sats dropped, given O2 and sent to accident and emergency (A&E) by ambulance. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. The seriousness of tight chest and allergy was reported as non-serious. The report was not related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1911573 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Injection site pain, Malaise, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA; INFLUENZA VIRUS; THYROXINE
Current Illness: Hypothyroidism
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: unwell; Fever; Headache; Generalized aching; Injection site pain; This case was received via RA (Reference number: GB-MHRA-ADR 26226483) 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 MALAISE (unwell), INJECTION SITE PAIN (Injection site pain), PYREXIA (Fever), HEADACHE (Headache) and PAIN (Generalized aching) in a 63-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hypothyroidism. 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 30-Oct-2021 to an unknown date for Vaccination, LEVOTHYROXINE SODIUM (THYROXINE) for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PAIN (Generalized aching) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criterion medically significant). At the time of the report, MALAISE (unwell) had not resolved, INJECTION SITE PAIN (Injection site pain) and HEADACHE (Headache) was resolving and PYREXIA (Fever) and PAIN (Generalized aching) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. It was verbally reported that, he had similar reactions to flu vacs in the past but not this year. No Treatment information were reported. company comment: This case concerns a 63-year-old, male patient with relevant medical history of hypothyroidism, who experienced the unexpected events of malaise, injection site pain, pyrexia, headache and pain. The events occurred between the same day and 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 63-year-old, male patient with relevant medical history of hypothyroidism, who experienced the unexpected events of malaise, injection site pain, pyrexia, headache and pain. The events occurred between the same day and 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: 1911574 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Off label use, Pain in extremity, Product use issue
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629131

Write-up: Lymph node pain/ painful lymph nodes in armpit and neck; Swollen lymph nodes/Swollen lymph nodes in armpit and neck; Maternal exposure during breast feeding; Maternal exposure during breast feeding; Painful arm; 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-202111191406452850-UOV7R. Other Case identifier(s): GB-MHRA-ADR 26227718. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLEMANUFACTURER UNKNOWN Lot Number: UNKNOWN; Route of Administration: unspecified), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "Maternal exposure during breast feeding"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Painful arm"; LYMPH NODE PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Lymph node pain/ painful lymph nodes in armpit and neck"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen lymph nodes/Swollen lymph nodes in armpit and neck". The patient had not undergone a COVID-19 test and was not pregnant at the time of this report. The patients last menstruation date was in 01Nov2021. Clinical course was reported as follows: The patient experienced swollen painful lymph nodes in armpit and neck same side as injection. Following day spread to another armpit too. The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101668594 Mother/baby case


VAERS ID: 1911589 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   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 - / -
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075132111GBR007827

Write-up: the day after my booster vaccine ( pfizer ); Swollen lymph nodes; Information has been received from health authority [GB-MHRA-WEBCOVID-202111212317386730-AIO7Y] on 22-NOV-2021. This spontaneous report has been received from a consumer regarding to herself a 47 year old non-pregnant female patient. On an unspecified date, she received a dose of hepatitis a vaccine, inactivated (HEPATITIS A VACCINE, INACTIVATED) (manufacturer unknown) (lot #, expiration date, dose, route of administration and anatomical location of vaccine were not reported) for prophylaxis. On 16-NOV-2021, she was vaccinated with a dose of Tozinameran (PFIZER BIONTECH COVID-19 VACCINE). On 17-NOV-2021, She reported that the day after her booster vaccine Tozinameran (PFIZER BIONTECH COVID-19 VACCINE), She experienced severe swelling of her armpit and surrounding area on the arm on which she had the injection. She assumed this was a reaction in her Lymph nodes. She tried to call her doctor''s surgery, hotline and Covid hotline all with unsatisfactory results and no one could confirm whether this was a known reaction or not. The swelling and soreness was severe enough for her not was able to sleep on that side. It was extremely tender and worrying. After 5 days it had started to lessen, Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial Reaction Did your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we would ask you some additional questions at the end of this report: "No" Suspect Reactions The agency considered the events as medically significant.


VAERS ID: 1911632 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-11-17
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202111; Test Name: Investigation NOS; Result Unstructured Data: Test Result:mutant strain of L452R; Test Date: 202111; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: during quarantine
CDC Split Type: HKPFIZER INC202101650023

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y; This is a spontaneous report received from non-contactable reporter(s) (Other Health Care Professional) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2021FOS005406. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 20-Nov-2021, RA announced that one additional confirmed case of COVID-19 after Comirnaty vaccination. A 62-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 29-Apr-2021 and 25-May-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On 10-Nov-2021, the patient arrived via flight. In Nov-2021, the patient tested positive during quarantine. On 17-Nov-2021, the patient had symptoms and was confirmed as COVID-19 with mutant strain of N501Y. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 21-Nov-2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Causality assessment provided by company (RA) and reporter for all reported events was Possible. Comirnaty is under agreement with RA.


VAERS ID: 1914699 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30U4675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysphonia, Erythema, Fatigue, Feeling cold, Feeling hot, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (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: SIMVASTATIN; TAMOXIFEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue extreme; Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice; Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice; Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice; Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice; Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26227527) 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 TREMOR (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice), FEELING COLD (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice), FEELING HOT (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice), ERYTHEMA (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice), DYSPHONIA (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) and FATIGUE (Fatigue extreme) in a 72-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 30U4675) for COVID-19 vaccination. Concomitant products included SIMVASTATIN and TAMOXIFEN for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced TREMOR (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) (seriousness criterion medically significant), FEELING COLD (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) (seriousness criterion medically significant), FEELING HOT (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) (seriousness criterion medically significant), ERYTHEMA (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) (seriousness criterion medically significant) and DYSPHONIA (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue extreme) (seriousness criterion medically significant). At the time of the report, TREMOR (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) had resolved, FEELING COLD (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice), FEELING HOT (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice), ERYTHEMA (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) and DYSPHONIA (Uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice) had not resolved and FATIGUE (Fatigue extreme) outcome was unknown. Patient had uncontrollable shaking for two hours. Freezing then very hot all night. Woke up to reddened face and tight croaky voice. Patient reddened face and kiss if voice together with extreme fatigue caused to call 111. They checked patient over. Was advised to speak to general practitioner (GP) who prescribed heavy antihistamine. Company Comment: This is a regulatory case concerning a 72-year-old female patient with no clinical history who experienced the unexpected events of TREMOR, FEELING COLD, FEELING HOT, ERYTHEMA, DYSPHONIA and FATIGUE The event occurred 1 day after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 72-year-old female patient with no clinical history who experienced the unexpected events of TREMOR, FEELING COLD, FEELING HOT, ERYTHEMA, DYSPHONIA and FATIGUE The event occurred 1 day after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1914705 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-11
Onset:2021-11-17
   Days after vaccination:6
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: Nausea, Tinnitus, Vertigo
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (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: CODEINE PHOSPHATE; LISINOPRIL; METFORMIN; TRAMADOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Vertigo; Nausea; Tinnitus; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26232569) 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 VERTIGO (Vertigo), NAUSEA (Nausea) and TINNITUS (Tinnitus) in a 58-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Previously administered products included for COVID-19 vaccination: SARS-COV-2 VIRUS. Past adverse reactions to the above products included No adverse event with SARS-COV-2 VIRUS. Concomitant products included CODEINE PHOSPHATE, LISINOPRIL, METFORMIN and TRAMADOL for an unknown indication. On 11-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Parenteral) 1 dosage form. On 17-Nov-2021, the patient experienced VERTIGO (Vertigo) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and TINNITUS (Tinnitus) (seriousness criterion medically significant). At the time of the report, VERTIGO (Vertigo), NAUSEA (Nausea) and TINNITUS (Tinnitus) had not resolved. Treatment medication were not reported. Patient had took Dose 3a vaccination and had experienced acute attack of vertigo, nausea and ringing in ears which was ongoing for a week at the moment. Company Comment: This is a regulatory case concerning a 65-year-old male patient with no clinical history who experienced the unexpected events of VERTIGO, NAUSEA and TINNITUS The event occurred 6 days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 65-year-old male patient with no clinical history who experienced the unexpected events of VERTIGO, NAUSEA and TINNITUS The event occurred 6 days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about the third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915006 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
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: Arthralgia, Breast pain, Chest pain, Fatigue, Myocarditis, Nausea, Pain in jaw, Palpitations, Pyrexia, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Lipodystrophy (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: aching joints; fainting; Fatigue/unusual tiredness; Chest pain; Fever; Heart palpitations; Racing heart (tachycardia); Jaw pain; Breast pain; Nausea; Myocarditis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26218141) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (aching joints), SYNCOPE (fainting), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), PAIN IN JAW (Jaw pain), BREAST PAIN (Breast pain), NAUSEA (Nausea) and MYOCARDITIS (Myocarditis) in a 61-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported. . In 2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (aching joints) (seriousness criterion medically significant), SYNCOPE (fainting) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant), TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant), PAIN IN JAW (Jaw pain) (seriousness criterion medically significant), BREAST PAIN (Breast pain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). At the time of the report, ARTHRALGIA (aching joints), SYNCOPE (fainting) and MYOCARDITIS (Myocarditis) had not resolved and FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), PYREXIA (Fever), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)), PAIN IN JAW (Jaw pain), BREAST PAIN (Breast pain) and NAUSEA (Nausea) outcome was unknown. The patient had No illnesses. Patient had no symptoms associated with COVID-19 and not had a COVID-19 test. No relevant concomitant medications were reported. It was reported that patient developed aching joints, chest pain, fainting, fatigue, fever, myocarditis, heart palpitations, tachycardia. Fast heartbeat, pains in jaw running down under breasts feeling of fainting and sickness, aching joints. Patient had not tested positive for COVID-19 since having the vaccine. Patient relevant investigations or tests conducted were reported as none and patient could not get to see doctor. No treatment information was provided. Company Comment: This is a regulatory case concerning a 61-year-old female patient with no clinical history who experienced the unexpected events of ARTHRALGIA, SYNCOPE, FATIGUE, CHEST PAIN, PYREXIA, PALPITATIONS, TACHYCARDIA, PAIN IN JAW, BREAST PAIN, NAUSEA and the expected event of MYOCARDITIS (AESI) The event occurred unknown days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 61-year-old female patient with no clinical history who experienced the unexpected events of ARTHRALGIA, SYNCOPE, FATIGUE, CHEST PAIN, PYREXIA, PALPITATIONS, TACHYCARDIA, PAIN IN JAW, BREAST PAIN, NAUSEA and the expected event of MYOCARDITIS (AESI) The event occurred unknown days after third dose of mRNA-1273 vaccine The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915022 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618523

Write-up: Allergic reaction; painful tongue; Swollen tongue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111180357448890-PPFU1 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26218796 (MHRA). A 49-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date: (2015). Vaccination history included: Covid-19 vaccine (DOSE: 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (medically significant), outcome "not recovered", described as "Allergic reaction"; SWOLLEN TONGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Swollen tongue"; GLOSSODYNIA (medically significant), outcome "unknown", described as "painful tongue". Clinical course: swollen painful tongue. It''s so swollen her top teeth were resting on it & it touched the roof of her mouth. The pain was bad, it felt like her tongue had thousands of cuts on it. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1915027 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Erythema, Fatigue, Hyperhidrosis, Immunisation, Interchange of vaccine products, Malaise, Myalgia, Nasopharyngitis, Neck pain, Off label use, Pain in extremity, Pyrexia, SARS-CoV-2 test, Swelling, Tenderness, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Ehlers-Danlos syndrome; Functional neurological symptom disorder (dissociative seizures); Comments: Have Hypermobile Ehlers Danlos, Functional Neurological Disorder (dissociative seizures) and asthma. Patient has not had symptoms associated with COVID-19 Patient is not pregnant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618557

Write-up: cold; sweating; feel farigued; Fever; Painful arm; Muscle ache; Fatigue; Neck pain; Pain at jab site immediately after jab; swelling and arm tender.; swelling and arm tender.; Redness; 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 (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111180725558870-PCVYO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26219696 (MHRA). A 37 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ehlers-Danlos syndrome" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Functional Neurological Disorder" (unspecified if ongoing), notes: dissociative seizures. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 and Dose 2, Manufacturer Unknown), for COVID-19 immunisation on unspecified date. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; NASOPHARYNGITIS (medically significant), outcome "recovering", described as "cold"; HYPERHIDROSIS (medically significant), outcome "recovering", described as "sweating"; MALAISE (medically significant), outcome "recovering", described as "feel farigued"; PYREXIA (medically significant), outcome "not recovered", described as "Fever"; PAIN IN EXTREMITY (medically significant), outcome "not recovered", described as "Painful arm"; ERYTHEMA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Redness"; MYALGIA (medically significant), outcome "not recovered", described as "Muscle ache"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue"; NECK PAIN (medically significant), outcome "not recovered", described as "Neck pain"; VACCINATION SITE PAIN (medically significant) with onset 17Nov2021, outcome "unknown", described as "Pain at jab site immediately after jab"; SWELLING (medically significant), TENDERNESS (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "swelling and arm tender.". 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: 1915029 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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, Headache, Immunisation, Myalgia, Neck pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101625561

Write-up: Neck pain; Headache; Fever; Booster; Muscle pain; Fatigue; 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-202111181607004000-JTMDF. Other Case identifier(s): GB-MHRA-ADR 26222742. A 24 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 24 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Patient had no symptoms associated with COVID-19, not had a COVID-19 test, was not pregnant and was not breastfeeding at the time of report. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1; Batch/lot number: Not reported), for COVID-19 immunisation; Bnt162b2 (DOSE: 2; Batch/lot number: Not reported), for COVID-19 immunisation, reaction(s): "Fatigue", "Headache", "Muscle pain", "Neck pain", "Fever". The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Muscle pain"; FATIGUE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Fatigue"; NECK PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Neck pain"; HEADACHE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Headache"; PYREXIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Fever". The report was not related to 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: 1915035 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Body temperature, Immunisation, Interchange of vaccine products, Off label use, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: Temperature; Result Unstructured Data: Test Result:Very high
CDC Split Type: GBPFIZER INC202101629003

Write-up: Vomiting; Very High temperature; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority (RA). Regulatory number: GB-MHRA-WEBCOVID-202111191511160890-1BRRT (MHRA). Other Case identifier: GB-MHRA-ADR 26228117 (RA). A 61 year-old patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for COVID-19 immunisation. The patient had no medicines or medical problems. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Vaccination history included: COVID-19 vaccine (Dose 1, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, Single, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; VOMITING (medically significant) with onset 18Nov2021, outcome "recovered"(Nov2021), described as "Vomiting"; PYREXIA (medically significant) with onset 18Nov2021, outcome "recovered"(Nov2021), described as "Very High temperature". Clinical course: The patient experienced very high temperature and vomiting 17 hours after receiving the booster vaccination. 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: 1915072 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthritis, Eye pain, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: painful arm; by 4th day though just arm hurting; headache; high temperature; Arthritis; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26233803) 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 (painful arm), EYE PAIN (by 4th day though just arm hurting), ARTHRITIS (Arthritis), HEADACHE (headache) and PYREXIA (high temperature) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Infection. Previously administered products included for Product used for unknown indication: DEPO-MEDRONE; for Ear infection: THYROXINE (Thyroxine Optimax for ear recurring infection which is a steroid but patient took it infrequently). Past adverse reactions to the above products included No adverse event with DEPO-MEDRONE and THYROXINE. On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ARTHRITIS (Arthritis) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) (seriousness criterion medically significant), EYE PAIN (by 4th day though just arm hurting) (seriousness criterion medically significant), HEADACHE (headache) (seriousness criterion medically significant) and PYREXIA (high temperature) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (painful arm), EYE PAIN (by 4th day though just arm hurting), ARTHRITIS (Arthritis), HEADACHE (headache) and PYREXIA (high temperature) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided No Treatment Information was provided. Patient experienced numbing on side of temple opposite side to injection within 5 minutes, but this subsided after further 5 minutes (Patient had this nerve irritated by hair dye test and was opposite side as this one) drank 2 litres of water over the day. Initial ok, painful arm that evening though temperature of 101.9, high temperature continued, following day 99.9 arm any existing aches worsened (trapped nerve in shoulder, varicose vein, broken foot all much worse. Arm through to wrist hurt as if it was arthritis but she doesn''t have arthritis. Headache on 3rd day much worse. By 4th day though just arm hurting, but mostly my hand. By 6th day almost ok now, except hand still feels arthritic with bearable pain. 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 57-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of pyrexia, headache, pain in extremity, eye pain (reported as "by 4th day though just arm hurting"), and the unexpected serious AESI event arthritis. The events of headache and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The event arthritis occurred one day after the third dose (unknown dosage) of mRNA-1273. The date of onset of the events pyrexia, headache, pain in extremity, and eye pain was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 57-year-old, female patient with no reported relevant medical history, who experienced the unexpected serious events of pyrexia, headache, pain in extremity, eye pain (reported as "by 4th day though just arm hurting"), and the unexpected serious AESI event arthritis. The events of headache and pyrexia are unexpected as they are retained as serious per the source document Authority reporting. The event arthritis occurred one day after the third dose (unknown dosage) of mRNA-1273. The date of onset of the events pyrexia, headache, pain in extremity, and eye pain was not reported. Regulatory authority reported the rechallenge as unknown, however, no additional dose is expected to be given. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1915074 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Nausea, SARS-CoV-2 test, Tenderness
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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; Nausea; Tenderness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26233819) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), NAUSEA (Nausea) and TENDERNESS (Tenderness) in a 54-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and TENDERNESS (Tenderness) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant). On 19-Nov-2021, NAUSEA (Nausea) and TENDERNESS (Tenderness) had resolved. At the time of the report, FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No Treatment Medication was reported. Company Comment: This regulatory authority case concerns a 54-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Fatigue, Nausea and Tenderness after mRNA- 1273 Moderna vaccine. The events Nausea and Tenderness occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and resolved after two days. Fatigue occurred at an unknown date after the third dose. At the time of the report, it had resolved. Very limited information was provided. Fatigue and Nausea are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report; Sender''s Comments: This regulatory authority case concerns a 54-year-old female patient with no details on relevant medical history, who experienced the unexpected serious (medically significant) events of Fatigue, Nausea and Tenderness after mRNA- 1273 Moderna vaccine. The events Nausea and Tenderness occurred on the day after the third dose of mRNA- 1273 vaccine (dosage unknown) and resolved after two days. Fatigue occurred at an unknown date after the third dose. At the time of the report, it had resolved. Very limited information was provided. Fatigue and Nausea are consistent with the known safety profile of the vaccine, but since they were reported with a serious outcome they are considered unexpected. The rechallenge was reported as unknown, only information about the third dose was disclosed. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report


VAERS ID: 1915082 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Arthralgia, Body temperature, Dizziness, Fatigue, Headache, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: Fainting; Body temperature; Dizzy spells; Nausea; Fatigue; Headache; Aching joints; This case was received via RA (Reference number: GB-MHRA-ADR 26233985) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), BODY TEMPERATURE (Body temperature), DIZZINESS (Dizzy spells), NAUSEA (Nausea), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints) in a 40-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 05-Feb-2021 to an unknown date for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced DIZZINESS (Dizzy spells) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant) and BODY TEMPERATURE (Body temperature) (seriousness criterion medically significant). On 20-Nov-2021, SYNCOPE (Fainting) was resolving, BODY TEMPERATURE (Body temperature) had resolved. At the time of the report, DIZZINESS (Dizzy spells), FATIGUE (Fatigue), HEADACHE (Headache) and ARTHRALGIA (Aching joints) had not resolved and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications was not reported, Patient was not enrolled in clinical trial Company Comment: This case concerns a 40-year-old female patient with no medical history, who experienced the serious unexpected events of Syncope, Body temperature, Dizziness, Nausea, Fatigue, Headache and Arthralgia. The events of Dizziness, Nausea, Fatigue, Headache and Arthralgia occurred the same day after the third dose of mRNA-1273 vaccine while the events of Syncope and Body temperature occurred 1 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 40-year-old female patient with no medical history, who experienced the serious unexpected events of Syncope, Body temperature, Dizziness, Nausea, Fatigue, Headache and Arthralgia. The events of Dizziness, Nausea, Fatigue, Headache and Arthralgia occurred the same day after the third dose of mRNA-1273 vaccine while the events of Syncope and Body temperature occurred 1 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: 1915083 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Balance disorder, Chills, Headache, Heart rate, Peripheral swelling, SARS-CoV-2 test, Vaccination site erythema
SMQs:, Cardiac failure (broad), Angioedema (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]
Current Illness: Allergy to antibiotic (TRIMETHOPRIM); Allergy to antibiotic (Oxytetracycline); Allergy to antibiotic (Amoxicillin); Drug allergy (Terbutaline); Migraine (I take Paramax migraine tablets I have not taken any for 3 months)
Preexisting Conditions: Medical History/Concurrent Conditions: Chest infection (1 tablet of Amoxicillin for a chest infection. Due to a severe reaction.); Resuscitation (In Nov 2019 I was send to the resuscitation unit at a HCF)
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: swelling of arm evening of 17th; Headache; Chills; Unsteadiness; Heart rate; Swelling arm; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26234121) 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 BALANCE DISORDER (Unsteadiness), PERIPHERAL SWELLING (Swelling arm), HEART RATE (Heart rate), VACCINATION SITE ERYTHEMA (swelling of arm evening of 17th), HEADACHE (Headache) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004675) for an unknown indication. The patient''s past medical history included Chest infection (1 tablet of Amoxicillin for a chest infection. Due to a severe reaction.) and Resuscitation (In Nov 2019 I was send to the resuscitation unit at a HCF). Previously administered products included for Chest infection: AMOXICILLIN (1 tablet of Amoxicillin for a chest infection. Due to a severe reaction); for Drug use for unknown indication: TRIMETHOPRIM, OXYTETRACYCLINE and TERBUTALINE; for Migraine: PARAMAX. Past adverse reactions to the above products included Adverse event with AMOXICILLIN and PARAMAX; and No adverse event with OXYTETRACYCLINE, TERBUTALINE and TRIMETHOPRIM. Concurrent medical conditions included Migraine (I take Paramax migraine tablets I have not taken any for 3 months), Allergy to antibiotic (TRIMETHOPRIM), Drug allergy (Terbutaline), Allergy to antibiotic (Oxytetracycline) and Allergy to antibiotic (Amoxicillin). Concomitant products included INFLUENZA VACCINE INACT SAG 4V (FLUCELVAX TETRA [INFLUENZA VACCINE INACT SAG 4V]) from 06-Oct-2021 to an unknown date for Specific academic or work inhibition. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced BALANCE DISORDER (Unsteadiness) (seriousness criterion medically significant), HEART RATE (Heart rate) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (swelling of arm evening of 17th) (seriousness criterion medically significant). On 19-Nov-2021, HEADACHE (Headache) and CHILLS (Chills) had resolved. On 20-Nov-2021, HEART RATE (Heart rate) had resolved. On 21-Nov-2021, BALANCE DISORDER (Unsteadiness) and PERIPHERAL SWELLING (Swelling arm) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (swelling of arm evening of 17th) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Nov-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was provided as paracetamol. RA notes: As per narrative additionally event of Dysentery should also have been captured. Company comment: This case concerns a 57-year-old female patient with medical history of severe reaction to Amoxicillin, who experienced the serious unexpected events of balance disorder, headache, peripheral swelling, chills and vaccination site erythema after third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is unknown since no information regarding first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old female patient with medical history of severe reaction to Amoxicillin, who experienced the serious unexpected events of balance disorder, headache, peripheral swelling, chills and vaccination site erythema after third dose of mRNA-1273. The events occurred 2 days after vaccination. The re-challenge is unknown since no information regarding first and second dose was disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915119 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
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: High temperature; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26235390) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (High temperature) in a patient of an unknown age and gender who received mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced PYREXIA (High temperature) (seriousness criterion medically significant). On 18-Nov-2021, PYREXIA (High temperature) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna Intramuscular Injection) (Unknown) was unknown. Patient experienced Stomach cramps No relevant concomitant and treatment medications were reported Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Company comment- This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected event of pyrexia. The event pyrexia occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the serious unexpected event of pyrexia. The event pyrexia occurred on the same day after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915131 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Swelling; Erythema; This case was received via United Kingdom MHRA (Reference number: GB-MHRA-ADR 26236174) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SWELLING (Swelling) and ERYTHEMA (Erythema) in a 63-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) from an unknown date to 09-Mar-2021 and INFLUENZA VACCINE (INFLUENZA VIRUS) from 16-Nov-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) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced SWELLING (Swelling) (seriousness criterion medically significant) and ERYTHEMA (Erythema) (seriousness criterion medically significant). At the time of the report, SWELLING (Swelling) and ERYTHEMA (Erythema) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment medications was not provided by the reporter. It was reported that patient had extensive erythema and swelling of upper vaccinated arm. Loss of use of affected arm. Patient was not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 63-year-old female patient, with a relevant medical history of receiving the Influenza vaccine the same day as the 3rd dose of mRNA-1273 vaccine, who experienced the serious unexpected events of Swelling and Erythema. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The medical history of receiving the Influenza vaccine is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 63-year-old female patient, with a relevant medical history of receiving the Influenza vaccine the same day as the 3rd dose of mRNA-1273 vaccine, who experienced the serious unexpected events of Swelling and Erythema. The events occurred 1 day after the third dose of mRNA-1273 vaccine. The medical history of receiving the Influenza vaccine is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1915145 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-11-17
   Days after vaccination:108
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: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101675160

Write-up: Early miscarriage; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from a regulatory authority. Other Case identifier(s): GB-MHRA-ADR 26260306. A 27 year-old female patient (pregnant) received bnt162b2 (COMIRNATY), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Pregnancy" (not ongoing), notes: Patient no longer pregnant at the time of reporting. Patient''s last menstrual period date was on 14Oct2021. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medication included: FOLIC ACID taken for vitamin supplementation. Vaccination history included: COVID-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown ), for COVID-19 immunisation. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Early miscarriage". The pregnancy resulted in spontaneous abortion. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. Patient was exposed to the medicine before pregnancy. The reporter stated that the report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1915568 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
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 57-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 17-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 17-Nov-2021 to 19-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 was reported. No treatment information was reported. Company Comment: This is a spontaneous case concerning a 57-year-old patient of an unknown gender with no relevant medical history reported, who experienced serious, unexpected event of Vaccination complication. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine. It was not specified whether the event occurred after the first or second dose. The patient was hospitalized from 17-Nov-2021 to 19-Nov-2021 due to Vaccination complication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a spontaneous case concerning a 57-year-old patient of an unknown gender with no relevant medical history reported, who experienced serious, unexpected event of Vaccination complication. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine. It was not specified whether the event occurred after the first or second dose. The patient was hospitalized from 17-Nov-2021 to 19-Nov-2021 due to Vaccination complication. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915584 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
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 company (Reference number: MOD-2021-152) 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 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 17-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 17-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 medications were provided by reporter. No treatment medications were provided by reporter. Company Comment: This is a spontaneous case concerning a 37-year-old patient of an unknown gender with no relevant medical history reported, who experienced serious, unexpected event of Vaccination complication. The event occurred unknown days after receiving a dose of mRNA-1273 vaccine. It was not specified whether the events occurred after the first or second dose. The patient was hospitalized from 17-Nov-2021 to 18-Nov-2021 due to Vaccination complication. At the time of the report outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a spontaneous case concerning a 37-year-old patient of an unknown gender with no relevant medical history reported, who experienced serious, unexpected event of Vaccination complication. The event occurred unknown days after receiving a dose of mRNA-1273 vaccine. It was not specified whether the events occurred after the first or second dose. The patient was hospitalized from 17-Nov-2021 to 18-Nov-2021 due to Vaccination complication. At the time of the report outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1915588 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
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, 4 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 34-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 17-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use.) (seriousness criterion hospitalization). The patient was hospitalized from 17-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. Laboratory data was mentioned as the COVID-19 result was not given. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment: This case concerns a 34-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 patient was hospitalized due to the event for 3 days. The event occurred unspecified time after the unspecified dose of mRNA-1273 (Moderna COVID-19 vaccine) .No further details regarding the event 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 34-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 patient was hospitalized due to the event for 3 days. The event occurred unspecified time after the unspecified dose of mRNA-1273 (Moderna COVID-19 vaccine) .No further details regarding the event 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: 1915621 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-11-17
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; Based on the current case data, this case has been classified as invalid. 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 patient of an unknown age and 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 17-Nov-2021, the patient experienced VACCINATION COMPLICATION (COVID-19 vaccines causing adverse effects in therapeutic use) (seriousness criterion hospitalization). The patient was hospitalized from 17-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. Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter. Company Comment: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected event of Vaccination complication. The event occurred after receiving a dose of mRNA-1273 Vaccine which resulted in Hospitalization. The rechallenge was unknown since no information about the events of an earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected event of Vaccination complication. The event occurred after receiving a dose of mRNA-1273 Vaccine which resulted in Hospitalization. The rechallenge was unknown since no information about the events of an earlier dose was disclosed. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 1918158 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Fatigue, Headache, Hypoaesthesia, Nausea, Neuralgia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADCAL D3; ALENDRONIC ACID; AMLODIPINE; ASPIRINE; BISOPROLOL FUMARATE; BUMETANIDE; ISOSORBIDE MONONITRATE; LANSOPRAZOLE; LEVOTHYROXINE SODIUM; METHENAMINE HIPPURATE; ROSUVASTATIN; TRIAMCINOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic valve replacement; Depression; Heart disorder; Hypertension; Hypothyroidism (borderline hypothyroidism); Osteoarthritis; Stage 3 acute kidney injury (kidney disease - stage 3a without proteinuria)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; Headache; Nausea; Nerve pain; Numbness; Feeling of total lack of energy; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238246) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of NEURALGIA (Nerve pain), HYPOAESTHESIA (Numbness), ASTHENIA (Feeling of total lack of energy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) in an 80-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 Osteoarthritis, Heart disorder, Hypertension, Depression, Hypothyroidism (borderline hypothyroidism), Angina pectoris, Stage 3 acute kidney injury (kidney disease - stage 3a without proteinuria) and Aortic valve replacement in April 2021. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (ADCAL D3), ALENDRONIC ACID, AMLODIPINE, ACETYLSALICYLIC ACID (ASPIRINE), BISOPROLOL FUMARATE, BUMETANIDE, ISOSORBIDE MONONITRATE, LANSOPRAZOLE, LEVOTHYROXINE SODIUM, METHENAMINE HIPPURATE, ROSUVASTATIN and TRIAMCINOLONE for an unknown indication. On 17-Nov-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 ml. On 17-Nov-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced ASTHENIA (Feeling of total lack of energy) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criterion medically significant) and HYPOAESTHESIA (Numbness) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 20-Nov-2021, NEURALGIA (Nerve pain) and HYPOAESTHESIA (Numbness) had resolved, ASTHENIA (Feeling of total lack of energy) had resolved with sequelae. At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication were reported. Patient describes being incapacitated to the point of not being able to make it to A and E, which she did after having a similar reaction to the Astra Zeneca vaccination. Patient was laid up in bed with regular side effects (tiredness, headache, nausea) which then progressed into more severe symptoms. Patient was now reluctant to have further boosters, if required. Company comment: This is a regulatory authority case concerning a 80-year-old, female patient with no relevant medical history of Osteoarthritis, Heart disorder, Hypertension, Depression, Hypothyroidism (borderline hypothyroidism), Angina pectoris and Stage 3 acute kidney injury, who experienced the unexpected serious events of Neuralgia, Hypoaesthesia, Asthenia, Fatigue, Headache, Nausea. The events occurred approximately on the same day after receiving the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The medical history, of Osteoarthritis, Heart disorder, Hypertension, Depression, Hypothyroidism (borderline hypothyroidism), Angina pectoris and Stage 3 acute kidney injury remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 80-year-old, female patient with no relevant medical history of Osteoarthritis, Heart disorder, Hypertension, Depression, Hypothyroidism (borderline hypothyroidism), Angina pectoris and Stage 3 acute kidney injury, who experienced the unexpected serious events of Neuralgia, Hypoaesthesia, Asthenia, Fatigue, Headache, Nausea. The events occurred approximately on the same day after receiving the unknown dose of mRNA 1273 Covid-19 Vaccine. The rechallenge was not applicable, as the event happened after the unknown dose. The medical history, of Osteoarthritis, Heart disorder, Hypertension, Depression, Hypothyroidism (borderline hypothyroidism), Angina pectoris and Stage 3 acute kidney injury remains a confounder. The benefit-risk relationship of mRNA 1273 Covid-19 Vaccine, is not affected by this report.


VAERS ID: 1918209 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, SARS-CoV-2 test, White blood cell count
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); White blood cell count low
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: white blood cell count; Result Unstructured Data: Test Result:Low
CDC Split Type: GBPFIZER INC202101618831

Write-up: Numbness in hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111171604271860-XGHKV (MHRA). Other Case identifier(s): GB-MHRA-ADR 26216373 (MHRA). A 23 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...; "low white blood cell count" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for Covid-19 immunization. The following information was reported: HYPOAESTHESIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Numbness in hand". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test; white blood cell count: low. Clinical Course: There were no reports related to possible inflammation of the heart (myocarditis or pericarditis). The patient had One kidney. Patient has not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918226 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Immunisation, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: LEVETIRACETAM
Current Illness: Generalized tonic-clonic seizure (Usually controlled well with medication)
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac ablation; Ventricular tachycardia (treated with 2x radio frequency ablation surgery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101618521

Write-up: booster; Epileptic seizure/breakthrough seizure; This is a spontaneous report received from a contactable reporter: Consumer from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111172029476900-8MS06 (RA). Other Case identifier: GB-MHRA-ADR 26217874 (RA). A 37-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Right ventricular outflow tract tachycardia" (unspecified if ongoing), notes: treated with 2x radio frequency ablation surgery; "Primary generalised epilepsy (tonic clonic seizures)" (ongoing), notes: Usually controlled well with medication; "radio frequency ablation surgery" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding and was not enrolled in clinical trial. The patient''s last menstrual date was on 14Nov2021. Concomitant medication included: LEVETIRACETAM taken for epilepsy, start date: 01Nov2006. Vaccination history included: Bnt162b2 (Dose: 2), administration date: 01Mar2021, for COVID-19 immunisation; Bnt162b2 (Dose: 1), for Covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; SEIZURE (medically significant) with onset 17Nov2021, outcome "recovering", described as "Epileptic seizure/breakthrough seizure". The patient has primary generalised epilepsy (tonic clonic seizures) which was usually controlled well with medication and so this breakthrough seizure was unusual for the patient. The outcome of epileptic seizure was recovering however it was also reported that the stop date of the event was on 17Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918239 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101618516

Write-up: pain; Muscle ache; Arm became sore a couple of hours after receiving the vaccine; 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-202111180707564620-KBGLC (RA). Other Case identifier(s): GB-MHRA-ADR 26219543 (RA). A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) at the age of 12 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 26Sep2021, stop date: 29Sep2021. The patient''s concomitant medications were not reported. The following information was reported: PAIN (medically significant), outcome "recovering", described as "pain"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Muscle ache"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Arm became sore a couple of hours after receiving the vaccine". The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Sep2021) yes - positive covid-19 test. Clinical course: Arm became sore a couple of hours after receiving the vaccine. Woke this morning with significantly more pain than was initially felt. No follow-up attempts are needed; No further information is expected.


VAERS ID: 1918240 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Immunisation, Insomnia, Interchange of vaccine products, Muscle spasms, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Dystonia (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: Asthma; Bundle branch block; Joint pain; Multiple sclerosis (Taking medicines for multiple sclerosis); Relapsing-remitting multiple sclerosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101618861

Write-up: Off label use; Interchange of vaccine products; Booster; Foot cramps/Foot cramp/severe foot cramp both feet and ankles; hardly slept; sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111180718587660-QLDRA (MHRA). Other Case identifier(s): GB-MHRA-ADR 26219629 (MHRA). A 47-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Joint pain" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Multiple sclerosis" (unspecified if ongoing), notes: Taking medicines for multiple sclerosis; "RRMS" (unspecified if ongoing); "branch block bundle" (unspecified if ongoing). Concomitant medications were not reported. Past drug history included: Gabapentin for joint pain; Prednisolone (reported as "predisilone"), notes: week ago and antibiotics too (unspecified). Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Last menstrual period: 09Jun2010. 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 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; MUSCLE SPASMS (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Foot cramps/Foot cramp/severe foot cramp both feet and ankles"; INSOMNIA (medically significant) with onset 17Nov2021, outcome "unknown", described as "hardly slept"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "unknown", described as "sore arm". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. Clinical course: she got vaccines yesterday afternoon and since last night (17Nov2021), had severe foot cramp both feet and ankles, hardly slept, sore arm that it. 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; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918251 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Psychomotor hyperactivity, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (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: ELVANSE; MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD; ADHD, combined type; Autism; Dyspraxia; Poor sleep; Comments: Autism ADHD Dyspraxia Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211110; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625659

Write-up: Hyperactive; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111180832329700-B0GJQ (RA). Other Case identifier(s): GB-MHRA-ADR 26220069 (RA). A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 16Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "Dyspraxia" (unspecified if ongoing); "ADHD, combined type", start date: 18Nov2021 (unspecified if ongoing); "Poor sleep", start date: 17Nov2021 (unspecified if ongoing). Concomitant medication(s) included: ELVANSE taken for attention deficit hyperactivity disorder, start date: 18Nov2021; MELATONIN taken for poor quality sleep, start date: 17Nov2021. The following information was reported: PSYCHOMOTOR HYPERACTIVITY (medically significant) with onset 17Nov2021, outcome "recovering", described as "Hyperactive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient not had symptoms associated with COVID-19. Patient had autism and ADHD once he had the vaccine, patient was ok the next morning and throughout the day, patient was extremely hyper as if had eaten lots of skittles and full fat coke, Patient had not tested positive for COVID-19 since having the vaccine, Patient was not enrolled in clinical trial. It was reported that reaction the report was not related to possible blood clots or low platelet counts. The report was not related to possible myocarditis or pericarditis. It was reported that Suspect Reactions, requested to provide details of any relevant investigations or tests conducted "observations". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918256 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Off label use, Pain in extremity, Vaccination site pain
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101625565

Write-up: Off-label use; Booster; Painful arm now the same from booster in the other arm; very painful arms at injection site, now the same from booster in the other arm; 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-202111180905339510 (RA). Other Case identifier(s): GB-RA-ADR 26220277 (RA). A 56-year-old female patient received bnt162b2 (COMIRNATY; Solution for injection; Lot number: FK0596), administration date 17Nov2021 at the age of 56 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 2), administration date: 11May2021, for covid-19 immunization, reaction(s): "Painful arm", "very painful arms at injection site"; Bnt162b2 (Dose 1), for covid-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. The following information was reported: OFF LABEL USE (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Off-label use"; IMMUNISATION (disability, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (disability, medically significant) with onset 2021, outcome "recovering", described as "very painful arms at injection site, now the same from booster in the other arm"; PAIN IN EXTREMITY (disability, medically significant) with onset 17Nov2021, outcome "not recovered", described as "Painful arm now the same from booster in the other arm". Patient had very painful arms at injection site, still suffering from 2nd jab and now the same from booster in the other arm. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101644822 Same patient/drug, different dose/event (Dose 2)


VAERS ID: 1918259 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FL1939 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hyperhidrosis, Hypoaesthesia, Immunisation, Interchange of vaccine products, Myalgia, Nasopharyngitis, Off label use, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101625658

Write-up: Booster; Interchange of vaccine products; Off label use; Sweating; Vomited; Joint pain; Muscle pain; Cold; Numbness of fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111180936084200-RCXES. Other Case identifier(s): GB-MHRA-ADR 26220388. A 67 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FL1939) at the age of 67 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 (dose1, 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. 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 and was not enrolled in clinical trial. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; HYPERHIDROSIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Sweating"; VOMITING (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Vomited"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Joint pain"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Muscle pain"; NASOPHARYNGITIS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Cold"; HYPOAESTHESIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Numbness of fingers". No follow up attempts are needed. No further information is expected.


VAERS ID: 1918268 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Dizziness, Dizziness postural, Immunisation, Movement disorder, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; COPD (early stages); Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: GBPFIZER INC202101625724

Write-up: dizziness; nausea; dead arm unable to lift or drive; Dizziness postural; Booster; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111181011212790-JTB0B (MHRA). Other Case identifier: GB-MHRA-ADR 26220598 (MHRA). A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COPD" (unspecified if ongoing), notes: early stages; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally); "high blood pressure" (unspecified if ongoing). Patient not had symptoms associated with COVID-19. Patient last menstrual period date was 06Apr2009. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for covid-19 immunization; Bnt162b2 (Dose 2), for covid-19 immunization. The patient was not pregnant at the time of vaccination and was not currently breastfeeding. The following information was reported: IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; DIZZINESS (disability), outcome "unknown", described as "dizziness"; NAUSEA (disability), outcome "unknown", described as "nausea"; DIZZINESS POSTURAL (disability) with onset 18Nov2021, outcome "not recovered", described as "Dizziness postural"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "dead arm unable to lift or drive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient was not tested positive for COVID-19 since the vaccination. Patient was not enrolled in clinical trial. This report does not relate to possible blood clots or low platelet counts and possible myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918274 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 ACO596 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625984

Write-up: booster; Joint pain; This is a spontaneous report received from a contactable reporter, Consumer, from the Regulatory Authority (RA). Regulatory number: GB-RA-WEBCOVID-202111181040460790 (RA). Other Case identifier(s): GB-RA-ADR 26220771 (RA). A 72-year-old patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: ACO596) at the age of 72 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. Patient was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 Immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; ARTHRALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Joint pain". Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: COVID-19 virus test: negative, notes: No - Negative COVID-19 test. This 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: 1918306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-10
Onset:2021-11-17
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Illness, Nausea, Pyrexia, SARS-CoV-2 test, Sputum increased
SMQs:, Anaphylactic reaction (broad), 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: Comments: Patient has not had symptoms associated with COVID-19.
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 INC202101625770

Write-up: 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-202111181255168070-AE4KA (RA). Other Case identifier(s): GB-MHRA-ADR 26221500 (RA). A 20 year-old male patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (Lot number: FH4751) 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: NAUSEA (medically significant), outcome "unknown", described as "nauseous"; PYREXIA (medically significant), outcome "unknown", described as "extremely high fever"; COUGH (medically significant), outcome "unknown", described as "coughing"; ILLNESS (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Sickness"; SPUTUM INCREASED (medically significant), outcome "unknown", described as "producing a lot of mucus". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (17Nov2021) no - negative covid-19 test. Clinical course: He had extremely high fever, nauseous, coughing, producing a lot of mucus. He did not have symptoms associated with COVID-19. He has not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Visual field defect
SMQs:, Noninfectious encephalitis (broad), Optic nerve disorders (broad), Retinal disorders (broad), Medication errors (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: DULOXETINE; EVACAL D3; NEBIDO [TESTOSTERONE UNDECANOATE]; QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic anxiety; Major depression; Secondary hypogonadism
Allergies:
Diagnostic Lab Data: Test Date: 20211110; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625905

Write-up: Scotoma; 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-202111181844235860-NWM8C (RA). Other Case identifier: GB-MHRA-ADR 26223675 (RA). A 51 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Major depression" (unspecified if ongoing); "Secondary hypogonadism" (unspecified if ongoing); "Chronic anxiety" (unspecified if ongoing). Concomitant medications included: DULOXETINE taken for major depression; EVACAL D3 taken for vitamin D; NEBIDO [TESTOSTERONE UNDECANOATE] taken for secondary hypogonadism; QUETIAPINE taken for chronic anxiety. Vaccination history included: Covid-19 vaccine ASTRAZENECA (Dose 1, Lot number: Not known), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer, Lot number: Not known), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; VISUAL FIELD DEFECT (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Scotoma". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (10Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Scotoma in right eye. Initially near-central, then peripheral left quarter, then vertical left third of visual field. Symptoms lasted approximately four hours. 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 possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918367 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dehydration, Feeling cold, Headache, Immunisation, Injection related reaction, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Skin burning sensation, Tremor
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Medication errors (broad), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INFLUENZA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Idiopathic pulmonary fibrosis; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunode))
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 INC202101625828

Write-up: headaches; feet; shaking; shivers; Injection associated shivering; Burning in both arms; Shaking on feet; Body Cold all over having Booster Covid and Flu vaccine; 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-202111181946218360-4XUOU (RA). Other Case identifier(s): GB-MHRA-ADR 26223898 (RA). A male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8469) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Idiopathic pulmonary fibrosis" (unspecified if ongoing); "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunode). Concomitant medication(s) included: INFLUENZA taken for immunisation. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1), for COVID-19 Immunization; Covid-19 vaccine astrazeneca (dose 2), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HEADACHE (medically significant), outcome "unknown", described as "headaches"; DEHYDRATION (medically significant), outcome "unknown", described as "feet"; TREMOR (medically significant), outcome "unknown", described as "shaking"; CHILLS (medically significant), outcome "unknown", described as "shivers"; INJECTION RELATED REACTION (medically significant), outcome "not recovered", described as "Injection associated shivering"; SKIN BURNING SENSATION (medically significant), outcome "unknown", described as "Burning in both arms"; TREMOR (medically significant), outcome "unknown", described as "Shaking on feet"; FEELING COLD (medically significant), outcome "unknown", described as "Body Cold all over having Booster Covid and Flu vaccine". It was reported that headaches, shivers, burning in both arms, shaking on feet, body cold all over having booster covid and Ffu vaccine. Patient is not enrolled in clinical trial. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) negative, notes: No - Negative COVID-19 test. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918378 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Malaise, Off label use, SARS-CoV-2 test
SMQs:, 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: Multiple sclerosis (Taking unpecified medicines for multiple sclerosis)
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 INC202101625568

Write-up: Swollen lymph nodes; Generally unwell; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (RA). Regulatory number: -MHRA-WEBCOVID-202111182146174130-WPBED (MHRA). Other Case identifier(s): -MHRA-ADR 26224348 (MHRA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK9413) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (ongoing), notes: Taking unpecified medicines for multiple sclerosis. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; MALAISE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Generally unwell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Report did not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1918379 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Immunisation, Interchange of vaccine products, Lymph node pain, Off label use, SARS-CoV-2 test, Vaccination site pain
SMQs:, 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: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625578

Write-up: Significant pain in the under arm/arm pit area on the side of the vaccination site.; Lymph node pain; Off label Use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202111182158108460-WLU7C (MHRA). Other Case identifier(s): GB-MHRA-ADR 26224357 (MHRA). A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Fh4751) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Date of last menstrual period: 01Nov2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label Use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; LYMPH NODE PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Lymph node pain"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "Significant pain in the under arm/arm pit area on the side of the vaccination site.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. It was reported that the Patient not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible myocarditis or pericarditis. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918398 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FR9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Headache, Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Myalgia, Nausea, Off label use, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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: AMLODIP; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101625642

Write-up: heavy; had no reaction whatsoever for my 2 x vaccinations; Chills; Joint pain; Nausea; Off label use; interchange of vaccine products; booster; Pain in arm; Headache; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111190407161060-6TAKN (RA). Other Case identifier(s): GB-MHRA-ADR 26224814 (RA). A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FR9413) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: AMLODIP taken for hypertension; RAMIPRIL taken for hypertension. Vaccination history included: Covid-19 vaccine astrazeneca (Dose: 1, single), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (Dose: 2, single), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; HEAVY MENSTRUAL BLEEDING (medically significant), outcome "not recovered", described as "heavy"; VOMITING (medically significant), outcome "not recovered", described as "had no reaction whatsoever for my 2 x vaccinations"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Pain in arm"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Muscle pain"; CHILLS (medically significant) with onset 18Nov2021, outcome "recovering", described as "Chills"; ARTHRALGIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Joint pain"; NAUSEA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Nausea". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient reported Heavy, numb, painful arm. Had NO reaction whatsoever for my 2 x Vaccinations. so why am I getting the full side effects after a booster. 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. 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: 1918400 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-15
Onset:2021-11-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20201223; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101625626

Write-up: Swollen glands; 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-202111190449280690-ZLPUT (RA). Other Case identifier(s): GB-MHRA-ADR 26224820 (RA). A 12-year-old male patient received bnt162b2 (BNT162B2), administration date 15Nov2021 (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: LYMPHADENOPATHY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Swollen glands"; The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2020) positive, notes: Yes - Positive COVID-19 test. Additional information: The patients Arm pit is swollen and sore. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The 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: 1918408 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Chills, Feeling cold, Headache, Immunisation, Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20211026; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628954

Write-up: Shivering; Headache; Painful arm; Off label use; Interchange of vaccine products; Booster; Feeling cold; This is a spontaneous report received from a contactable reporter Consumer or other non HCP from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111190750300410-H1QFC. Other Case identifier(s): GB-MHRA-ADR 26225543. A 22 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) at the age of 22 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1.), administration date: 07Mar2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (dose 2.), administration date: 15May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; FEELING COLD (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Feeling cold"; CHILLS (medically significant) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Shivering"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (19Nov2021), described as "Headache"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "recovering", described as "Painful arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (26Oct2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Patient last menstrual period date 19Nov2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1918413 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Hypoaesthesia, Immunisation, Interchange of vaccine products, Neuralgia, Neurological examination, Off label use, Paraesthesia oral, Sciatica
SMQs:, Peripheral neuropathy (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Medication errors (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chronic fatigue syndrome
Allergies:
Diagnostic Lab Data: Test Name: Neurological; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101629100

Write-up: Off label use; Interchange of vaccine products; Booster; numbness; Nerve pain; tingling nerves on the left hand side of my mouth; sciatic pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111190933028770-CSGDS. Other Case identifier(s): GB-MHRA-ADR 26226165. A 38 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic fatigue syndrome" (unspecified if ongoing); "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 Immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; HYPOAESTHESIA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "numbness"; NEURALGIA (medically significant) with onset 17Nov2021, outcome "recovering", described as "Nerve pain"; PARAESTHESIA ORAL (medically significant) with onset 17Nov2021, outcome "unknown", described as "tingling nerves on the left hand side of my mouth"; SCIATICA (medically significant) with onset 17Nov2021, outcome "recovering", described as "sciatic pain". The events "numbness", "nerve pain", "tingling nerves on the left hand side of my mouth" and "sciatic pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: neurological examination: unknown results. Clinical course: after 10 mins strong shooting nerve pain from elbow into fingers on the same arm as injection. Half hour later tingling nerves on the left hand side of mouth and up over lip. Both these resolved within half an hour but ached for a couple hours after. Two hours after vaccine she had tingling and sciatic pain (she did not suffer from this condition) in her left leg from above her gluteal, down the back of leg into foot. There was a degree of numbness. The patient called Emergency who had GP call back and confirmed as likely vaccine reaction. She was then seen in person by GP next day. The leg issue after 24 hours has started improving. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Neurological exam by GP. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918414 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Blood pressure measurement, Feeling cold, Headache, Immunisation, Insomnia, SARS-CoV-2 test, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:120/80; Test Date: 20211115; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628901

Write-up: faint; headache; very cold; Could not sleep; Shaking; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: -MHRA-WEBCOVID-202111190941446770-2LCPO (MHRA). Other Case identifier(s): -MHRA-ADR 26226285 (RA). A male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Diabetes type 2" (unspecified if ongoing); "High Blood pressure" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Manufacturer Unknown), for COVID-19 vaccination; Covid-19 vaccine (dose 2, Manufacturer Unknown), for COVID-19 vaccination. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; SYNCOPE (medically significant), outcome "recovering", described as "faint"; HEADACHE (medically significant), outcome "recovering", described as "headache"; FEELING COLD (medically significant), outcome "recovering", described as "very cold"; TREMOR (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Shaking"; INSOMNIA (medically significant), outcome "recovering", described as "Could not sleep". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) 120/80; sars-cov-2 test: (15Nov2021) negative, notes: No - Negative COVID-19 test. Clinical course: Woke up in night shaking. Very cold, headache. Could not sleep. In the morning I stood up and started to faint but managed to hit the bed. Spent rest of the day resting felt better by the evening. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918415 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Asthenia, Blood test, Computerised tomogram head, Headache, Immunisation, Lumbar puncture, Nausea, Photophobia, Prothrombin time prolonged, SARS-CoV-2 test, Vascular headache, Venogram, Vomiting
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiopulmonary resuscitation (Bystander commenced CPR, unclear.); Pulmonary embolism (PE in context of COVID.); Subarachnoid haemorrhage (Pending LP to rule out SAH.)
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:normal; Test Name: CT-head; Result Unstructured Data: Test Result:Normal; Test Name: lp; Result Unstructured Data: Test Result:Pending; Comments: Pending LP to rule out SAH.; Test Name: Pt; Result Unstructured Data: Test Result:sudden onset 10/10; Comments: Pt c/o sudden onset 10/10.; Test Name: Pt; Result Unstructured Data: Test Result:Pt came round; Comments: Pt came round after 1min.; Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: CT venogram; Result Unstructured Data: Test Result:Pending
CDC Split Type: GBPFIZER INC202101628879

Write-up: photophobia; nausea; vomiting; headache; generalised weakness; Booster; Headache vascular; This is a spontaneous report received from a contactable Physician from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111191006091390-VFTVC (MHRA). Other Case identifier(s): GB-MHRA-ADR 26226350 (MHRA). A 26 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PE", start date: 2020 (unspecified if ongoing), notes: PE in context of COVID.; "CPR" (unspecified if ongoing), notes: Bystander commenced CPR, unclear.; "SAH" (unspecified if ongoing), notes: Pending LP to rule out SAH. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 05Feb2021, for COVID-19 immunisation; Bnt162b2 (Dose 2), administration date: 14Apr2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (hospitalization) with onset 17Nov2021, outcome "unknown", described as "Booster"; PHOTOPHOBIA (hospitalization), outcome "unknown", described as "photophobia"; NAUSEA (hospitalization), outcome "unknown", described as "nausea"; VOMITING (hospitalization), outcome "unknown", described as "vomiting"; HEADACHE (hospitalization), outcome "unknown", described as "headache"; VASCULAR HEADACHE (hospitalization) with onset 17Nov2021, outcome "recovering", described as "Headache vascular"; ASTHENIA (hospitalization), outcome "unknown", described as "generalised weakness". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) normal; computerised tomogram head: (unspecified date) normal; lumbar puncture: (unspecified date) pending, notes: Pending LP to rule out SAH; prothrombin time prolonged: (unspecified date) sudden onset 10/10, notes: Pt c/o sudden onset 10/10; (unspecified date) pt came round, notes: Pt came round after 1min; sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test; venogram: (unspecified date) pending. The clinical course was :Pt c/o sudden onset 10/10 headache 5 mins after receiving booster dose accompanied by nausea and vomiting. Later in the day, experienced an unwitnessed collapse. Bystander commenced CPR, unclear if had arrest. Pt came round after 1min. Pt c/o ongoing headache with photophobia and generalised weakness. 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: 1918422 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Dizziness postural, Headache, Immunisation, Influenza, Interchange of vaccine products, Off label use, Pain, SARS-CoV-2 test
SMQs:, Retroperitoneal fibrosis (broad), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628930

Write-up: painful to move; Back pain; Head pain; Flu symptoms; Dizziness upon standing; 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-202111191118407050-QTNL0. Other Case identifier(s): GB-MHRA-ADR 26226891. A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH3220) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Concomitant medication(s) included: INFLUENZA VIRUS taken for influenza, administration date 15Oct2021. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacture unknown., Dose 1); Covid-19 vaccine (Primary immunization series completed but manufacture unknown., Dose 2). The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; BACK PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Back pain"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Head pain"; INFLUENZA (medically significant) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Flu symptoms"; DIZZINESS POSTURAL (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Dizziness upon standing"; PAIN (medically significant), outcome "unknown", described as "painful to move ". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of back pain. Clinical course: Very painful to move and feel very unsteady on my feet. Back pain not responding to pain killers. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918428 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT
HEPA: HEP A (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Pain during injection; i have restricted mobility in my arm; Shoulder pain; This case was initially received via Regulatory Authority (Reference number: GB-MHRA-ADR 26227330) on 21-Nov-2021. The most recent information was received on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA (Shoulder pain) and INJECTION SITE PAIN (Pain during injection) in a 47-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product HEPATITIS A VACCINE for Pain. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient received dose of HEPATITIS A VACCINE (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ARTHRALGIA (Shoulder pain) (seriousness criterion disability). On an unknown date, the patient experienced INJECTION SITE PAIN (Pain during injection) (seriousness criterion disability) and PAIN IN EXTREMITY (i have restricted mobility in my arm). At the time of the report, ARTHRALGIA (Shoulder pain) had not resolved, INJECTION SITE PAIN (Pain during injection) outcome was unknown and PAIN IN EXTREMITY (i have restricted mobility in my arm) was resolving. No concomitant medication details was provided. No treatment medication details was provided. Patient reported that since receiving the booster vaccine , had severe pain in shoulder in which the vaccine was administered. This started about 4 hours after receiving the vaccine and was also more painful on administration than other vaccines received. unable to raise arm and very painful movement. This was persisting over 48 hours after the vaccination. company comment: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the serious unexpected events of arthralgia and injection site pain and a non-serious event. The event arthralgia occurred on the same day after the third dose of mRNA-1273. The event injection site pain 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. Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow-up received on 24-Nov-2021; case upgraded to serious, new events added, action taken updated; Sender''s Comments: This case concerns a 47-year-old female patient with no relevant medical history, who experienced the serious unexpected events of arthralgia and injection site pain and a non-serious event. The event arthralgia occurred on the same day after the third dose of mRNA-1273. The event injection site pain 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: 1918432 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Immunisation, Interchange of vaccine products, Muscle spasms, Off label use, SARS-CoV-2 test
SMQs:, Dystonia (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629150

Write-up: Leg cramps; Off label use; Booster; interchange of vaccine products; 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-202111191412182020-1YMRD (MHRA). Other Case identifier(s): GB-MHRA-ADR 26227794 (MHRA). A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Clinical trial participant" (unspecified if ongoing), notes: Study details: PRIVACY. Concomitant medication included: INFLUENZA VIRUS taken for immunisation, administration date 10Sep2021. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1; lot unknown), administration date: 21Feb2021, for COVID-19 immunisation; Covid-19 vaccine astrazeneca (dose 2; lot unknown), administration date: 06May2021, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; MUSCLE SPASMS (medically significant) with onset 19Nov2021, outcome "recovered" (19Nov2021), described as "Leg cramps". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) no - negative covid-19 test. Therapeutic measures were taken as a result of muscle spasms. Clinical course details: Awoke with the worst leg cramps have ever experienced (in both legs). Supported herself on door frames & furniture, lay on another bed & began raising her legs above and waist until she could attempt cycling movements upside down. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918435 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Infection, Off label use, Pain, Pain in extremity, SARS-CoV-2 test, Skin mass, Swelling, Tenderness, Vaccination site erythema
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infection
Allergies:
Diagnostic Lab Data: Test Date: 20211118; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629087

Write-up: Hard lump under the skin; Redness at injection site; very painful and tender; very painful and tender; Pain when moving arm; Swollen; off label use; Booster; Infection; 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-202111191504288840-4TCU6 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26228184 (MHRA). A 42 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH8469) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Infection" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Pregabalin; Cerelle; Zopiclone; Risperidone; Folic acid; Bisoprolol; Duloxetine; Lansoprazole. 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 (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; IMMUNISATION (hospitalization, medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; INFECTION (hospitalization, medically significant) with onset 17Nov2021, outcome "recovering", described as "Infection"; SKIN MASS (hospitalization, medically significant), outcome "unknown", described as "Hard lump under the skin"; VACCINATION SITE ERYTHEMA (hospitalization, medically significant), outcome "unknown", described as "Redness at injection site"; TENDERNESS (hospitalization, medically significant), PAIN (hospitalization, medically significant), outcome "unknown" and all described as "very painful and tender"; PAIN IN EXTREMITY (hospitalization, medically significant), outcome "unknown", described as "Pain when moving arm"; SWELLING (hospitalization, medically significant), outcome "unknown", described as "Swollen". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Nov2021) no - negative covid-19 test. The event infection was treated with flucloxacillin. Clinical course: hard lump under the skin. Redness at injection site. Very painful and tender. Swollen. Pain when moving arm. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918436 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Arthralgia, Blood pressure increased, Blood pressure measurement, Body temperature, Dry mouth, Feeling hot, Flushing, Headache, Heart rate, Heart rate increased, Hyperhidrosis, Immunisation, Malaise, Nasopharyngitis, Nausea, Oropharyngeal pain, Pruritus, Red ear syndrome, SARS-CoV-2 test, Tremor, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVOREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ear operation (Multiple operations to both ears, since childhood into adulthood); HRT (continue to titrate dose); Hysterectomy; Menopause; Perimenopausal symptoms (Perimenopausal symptoms prior yo Hysterectomy); Surgical menopause
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:normal limits; Test Name: BP; Result Unstructured Data: Test Result:raised blood pressure; Test Name: temperature; Result Unstructured Data: Test Result:37.6; Test Name: pulse; Result Unstructured Data: Test Result:normal limits; Test Name: pulse; Result Unstructured Data: Test Result:rapid; Test Date: 20211118; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628951

Write-up: 21 hives; urticaria; 00hrs legs hot; dry mouth; flushing; shaking; sore throat; nausea; itchy; unwell; sweating palms and sole of feet; Achy joints; ear lobes hot; increased heart rate; raised blood pressure; Cold; Giant hives; Urticaria acute; Headache; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111191510549290-JAFDL. Other Case identifier(s): GB-MHRA-ADR 26228214. A 46 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hysterectomy", start date: Mar2021 (unspecified if ongoing); "Surgical menopause", start date: Mar2021 (unspecified if ongoing); "Perimenopausal symptoms" (unspecified if ongoing), notes: Perimenopausal symptoms prior yo Hysterectomy; "Multiple operations to both ears" (unspecified if ongoing), notes: Multiple operations to both ears, since childhood into adulthood; "Menopause" (unspecified if ongoing); "HRT", start date: Apr2021 (unspecified if ongoing), notes: continue to titrate dose. Concomitant medication(s) included: EVOREL taken for menopause, start date: 12Apr2021; INFLUENZA VIRUS, administration date 12Nov2021. Vaccination history included: Covid-19 mrna vaccine biontech (Dose 1), administration date: 17Dec2020, for COVID-19 vaccination; Covid-19 mrna vaccine biontech (Dose 2), administration date: 21Feb2021, for COVID-19 vaccination, reaction(s): "Inappropriate schedule of vaccine administered", "Headache", "Joint ache", "Shaking", "Hot flush". The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; URTICARIA (medically significant), outcome "not recovered", described as "21 hives"; URTICARIA (medically significant), outcome "not recovered", described as "urticaria"; FEELING HOT (medically significant), outcome "not recovered", described as "00hrs legs hot"; DRY MOUTH (medically significant), outcome "not recovered", described as "dry mouth"; FLUSHING (medically significant), outcome "not recovered", described as "flushing"; TREMOR (medically significant), outcome "not recovered", described as "shaking"; OROPHARYNGEAL PAIN (medically significant), outcome "not recovered", described as "sore throat"; NAUSEA (medically significant), outcome "not recovered", described as "nausea"; PRURITUS (medically significant), outcome "not recovered", described as "itchy"; MALAISE (medically significant), outcome "not recovered", described as "unwell"; ANGIOEDEMA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Giant hives"; URTICARIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Urticaria acute"; HEADACHE (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Headache"; NASOPHARYNGITIS (medically significant) with onset 18Nov2021, outcome "recovering", described as "Cold"; HYPERHIDROSIS (medically significant), outcome "unknown", described as "sweating palms and sole of feet"; ARTHRALGIA (medically significant), outcome "unknown", described as "Achy joints"; RED EAR SYNDROME (medically significant), outcome "unknown", described as "ear lobes hot"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "increased heart rate"; BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "raised blood pressure". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) normal limits; (unspecified date) raised blood pressure; body temperature: (unspecified date) 37.6; heart rate: (unspecified date) normal limits; (unspecified date) rapid; sars-cov-2 test: (18Nov2021) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of urticaria, urticaria, feeling hot, dry mouth, flushing, tremor, oropharyngeal pain, nausea, pruritus, malaise, angioedema, urticaria, headache, nasopharyngitis, hyperhidrosis, arthralgia, red ear syndrome. Clinical course: Patient has not had symptoms associated with COVID-19. Patient is not pregnant. On have 2nd covid vaccination 48 hrs after vaccination hot flushing to neck and face body shaking managed with ice pack, between having vaccination and this episode achy joints and headache, need paracetamol and bed rest. Unwell on the morning of 18.11.21 continuing symptoms throughout the day of: Headache, Nausea, Cold, Achy joints, Sore throat, Hands and feet especially cold, Left work early, showered warmed up and then flushing. Went to bed at 21.00hrs legs hot, ear lobes hot and itchy at this point nothing else raised alarm. 22.00hrs itching shins and back, dry mouth, sweating palms and sole of feet, increased heart rate and raised blood pressure. Checking in mirror, multiple hives/urticaria on back,under armpits and shins. Larotidine taken, seeked out of hours support by partner, as I was unwell with shaking and rapid breathing, no availability from out of hours doctors, ambulance service. Breathing not effected. Attended MIU BP and pulse came back within normal limits, temperature 37.6. Seen by out of hours doctor who prescribed Piriton 4 hourly, stay of work, watch and wait with awareness if red flag symptoms. 19.11.21 hives remain, itchy, headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Reaction:~Does your report relate to possible inflammation of the heart (myocarditis or pericarditis)? If yes, we will ask you some additional questions at the end of this report: "No". Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Seen by out of hours Doctor, medication and advise given. To discuss with GP in regards to future vaccinations". No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101638953 Same patient/Drug/Reporter, different dose number and event.


VAERS ID: 1918460 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FH3220 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Immunisation, Interchange of vaccine products, Malaise, Muscle rigidity, Muscle spasms, Muscle tightness, Off label use, Peripheral swelling, SARS-CoV-2 test, Tremor
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (narrow), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Medical History/Concurrent Conditions: Behcet''s syndrome; Clinical trial participant; 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 INC202101629102

Write-up: shaking; muscle spasms; Her hands twisted in on themselves and her fingers clenched; Muscular rigour; swelling in her legs; feeling of being terribly unwell; feeling quite tired and washed out; 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-202111200744248870-WGOYL (RA). Other Case identifier(s): GB-MHRA-ADR 26231991 (RA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 09:30 (Lot number: FH3220) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 25Feb2020 (unspecified if ongoing), notes: Unsure when symptoms stopped; "Clinical trial participant" (unspecified if ongoing); "Behcets syndrome" (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 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; TREMOR (medically significant), outcome "recovered", described as "shaking"; MUSCLE SPASMS (medically significant), outcome "recovered", described as "muscle spasms"; MUSCLE RIGIDITY (medically significant) with onset 18Nov2021, outcome "recovered" (19Nov2021), described as "Muscular rigour"; PERIPHERAL SWELLING (medically significant) with onset 17Nov2021, outcome "unknown", described as "swelling in her legs"; MALAISE (medically significant) with onset 17Nov2021, outcome "unknown", described as "feeling of being terribly unwell"; FATIGUE (medically significant) with onset 17Nov2021, outcome "unknown", described as "feeling quite tired and washed out"; MUSCLE TIGHTNESS (medically significant), outcome "unknown", described as "Her hands twisted in on themselves and her fingers clenched". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: booster was 9.30am. Worked four hours as waitress. The patient got swelling and sensation of wobbling flesh (as reported) in her legs under my knees after lunch. Continued day which included dog walking and at evening pottery class had on sudden, short feeling of being terribly unwell. It passed in about a minute and she continued doing my pottery. Drove for an hour home, ate a healthy meal at 9pm and went to bed feeling quite tired and washed out. During the early hours of the morning she woke up shaking uncontrollably - arms, legs and her torso jumping about involuntarily. She told herself to go back to sleep to sleep it off and the fitting/muscle spasms episodes woke her up about another three times. She thought it was a relatively short period of time but her daughter in the room below kept been woken up. Her hands twisted in on themselves and her fingers clenched. Her legs were jumping about from my hips down. Patient has not tested positive for COVID-19 since having the vaccine. Clinical trial participant. Study details: Access through Regulatory Authority. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1918462 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Axillary mass, Axillary pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use, SARS-CoV-2 test
SMQs:, 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? Yes
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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629029

Write-up: pain in armpit; Swollen lymph nodes; lump felt in armpit; 3rd dose has been administered (bnt162b2) and the patient has previously received the full primary immunization series of another vaccine; 3rd dose has been administered (bnt162b2) and the patient has previously received the full primary immunization series of another vaccine; 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-202111200900468070-6C7RR (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231095 (MHRA). A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 53 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication(s) included: INFLUENZA VIRUS taken for immunisation, administration date 23Oct2021. 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), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "3rd dose has been administered (bnt162b2) and the patient has previously received the full primary immunization series of another vaccine"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; AXILLARY PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "pain in armpit"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; AXILLARY MASS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "lump felt in armpit". The events "pain in armpit" and "lump felt in armpit" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Nov2021) no - negative covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine Clinical course: Pain in armpit 24 hours after vaccine, lump felt. General practitioner GP telephone consult said wait 5 days before follow up. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1918493 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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: Fatigue, Immunisation, Interchange of vaccine products, Myalgia, Off label use, Pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211013; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101628979

Write-up: pain; Muscle pain; Exhaustion; Off label use; Interchange of vaccine products; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111201926495780-L3IFF (RA). Other Case identifier(s): GB-MHRA-ADR 26231834 (RA). A 43 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 12:00 (Batch/Lot number: unknown) at the age of 43 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Unsure if patient had had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. 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 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; PAIN (medically significant) with onset 17Nov2021 19:00, outcome "recovering", described as "pain"; MYALGIA (medically significant) with onset 17Nov2021 19:00, outcome "not recovered", described as "Muscle pain"; FATIGUE (medically significant) with onset 17Nov2021 19:00, outcome "not recovered", described as "Exhaustion". Clinical course: reaction started around 7pm following 12pm appointment. Really bad night 1, day 2 was mixed but really bad reaction of muscle pain and exhaustion after doing some light housework. Day 3 and in pain all day and exhausted. The report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Oct2021) negative. 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: 1918500 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FK9413 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Fatigue, Immunisation, Interchange of vaccine products, Lethargy, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211119; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101628860

Write-up: slight upset stomach; extreme tiredness; loss of appetite; total loss of energy; sore arm; Lethargy; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter, consumer, from a regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111202150092750-P4YLK. Other Case identifier: GB-MHRA-ADR 26231956. A 62-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK9413) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included: INFLUENZA VIRUS taken for immunisation, administration date Oct2021. Past drug history included: Esomeprazole for reflux. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-2), administration date: 16May2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose-1), administration date: Feb2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; ABDOMINAL DISCOMFORT (medically significant), outcome "not recovered", described as "slight upset stomach"; FATIGUE (medically significant), outcome "not recovered", described as "extreme tiredness"; LETHARGY (medically significant) with onset 18Nov2021, outcome "recovering", described as "Lethargy"; DECREASED APPETITE (medically significant), outcome "unknown", described as "loss of appetite"; ASTHENIA (medically significant), outcome "unknown", described as "total loss of energy"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "sore arm". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (19Nov2021) negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. This 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: 1918508 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue/unusual tiredness; Fever; Headache; Breathlessness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26232047) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathlessness), HEADACHE (Headache), FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) in a 60-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004675) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 30-Mar-2020. Concomitant products included BISOPROLOL for High weight. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DYSPNOEA (Breathlessness) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Breathlessness) had not resolved, HEADACHE (Headache) was resolving and FATIGUE (Fatigue/unusual tiredness) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. No concomitant medications were reported. Treatment included Co-codomal and rest. 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 60-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of Dyspnoea, Headache, Fatigue and Pyrexia. The events of Fatigue and Pyrexia occurred on an unknown day after the third dose of mRNA-1273 vaccine, the event of Dyspnoea occurred the same day after the third dose of mRNA-1273 vaccine and the event of Headache occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a 60-year-old male patient, with no relevant medical history, who experienced the serious unexpected events of Dyspnoea, Headache, Fatigue and Pyrexia. The events of Fatigue and Pyrexia occurred on an unknown day after the third dose of mRNA-1273 vaccine, the event of Dyspnoea occurred the same day after the third dose of mRNA-1273 vaccine and the event of Headache occurred one day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1918535 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Heavy menstrual bleeding, Menstrual disorder, 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: BACLOFEN; INFLUENZA VIRUS; KLIOVANCE; TRAMADOL.
Current Illness: Postmenopausal syndrome (I have not had a period for 3.5 years!)
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26234541) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation abnormal) and HEAVY MENSTRUAL BLEEDING (menstrual bleed) in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included Postmenopausal syndrome (I have not had a period for 3.5 years!). Concomitant products included INFLUENZA VACCINE (INFLUENZA VIRUS) from 17-Nov-2021 to 17-Nov-2021 for Flu vaccination, ESTRADIOL, NORETHISTERONE ACETATE (KLIOVANCE) from 02-Aug-2019 to an unknown date for HRT, BACLOFEN from 01-Mar-2020 to an unknown date for Muscle pain, TRAMADOL from 11-Sep-2019 to an unknown date for Pain. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Nov-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HEAVY MENSTRUAL BLEEDING (menstrual bleed) (seriousness criterion medically significant). On an unknown date, the patient experienced MENSTRUAL DISORDER (Menstruation abnormal) (seriousness criterion medically significant). At the time of the report, MENSTRUAL DISORDER (Menstruation abnormal) had not resolved and HEAVY MENSTRUAL BLEEDING (menstrual bleed) 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. It was reported that post menopausal after vaccine patient had a bad menstrual bleed which was still continuing but lightly now. Patient not had a period for 3.5 years. She had a throbbing headache and spent 4 days in bed. Patient was not tested positive for COVID-19 since having the vaccine. This is a regulatory authority case concerning a 54-year-old, female patient with concurrent medical condition of postmenopausal (not had a period for 3.5 years), who experienced the unexpected serious events of headache, menstrual bleed and menstrual disorder. The event headache occurred the same day with the third dose of mRNA-1273 vaccine administration, the event menstrual bleed occurred 1 day after the third dose of mRNA-1273 vaccine administration while the event menstrual disorder occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Patient was not enrolled in clinical trial. No treatment medication provided. Sender''s Comments: This is a regulatory authority case concerning a 54-year-old, female patient with concurrent medical condition of postmenopausal (not had a period for 3.5 years), who experienced the unexpected serious events of headache, menstrual bleed and menstrual disorder. The event headache occurred the same day with the third dose of mRNA-1273 vaccine administration, the event menstrual bleed occurred 1 day after the third dose of mRNA-1273 vaccine administration while the event menstrual disorder occurrence unknown with respect to the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1918591 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Dizziness postural, 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? 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: Dizzy on standing; Headache; Nausea; Shivering; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26238532) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizzy on standing), HEADACHE (Headache), NAUSEA (Nausea) and CHILLS (Shivering) in a 55-year-old male 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 17-Nov-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (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, CHILLS (Shivering) had resolved. On 18-Nov-2021, DIZZINESS POSTURAL (Dizzy on standing) had resolved. On 22-Nov-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 55-year-old male patient, with no medical history, who experienced the serious unexpected events of Dizziness postural, Headache, Nausea, and Chills. The events occurred one day after the third dose / Booster 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 55-year-old male patient, with no medical history, who experienced the serious unexpected events of Dizziness postural, Headache, Nausea, and Chills. The events occurred one day after the third dose / Booster 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: 1918634 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache
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: Frontal headache; This case was received via Regulatory Authority. (Reference number: GB-MHRA-ADR 26240701) on 24-Nov-2021 and was forwarded to Moderna on 24-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Frontal headache) in a 70-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for COVID-19 vaccination. No Medical History information was reported. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced HEADACHE (Frontal headache) (seriousness criterion medically significant). On 19-Nov-2021, HEADACHE (Frontal headache) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided by the reporter. Treatment information was not provided. Paracetamol was the medication provided. Company comment; This is a regulatory case concerning a 70-year-old female patient with no relevant medical history reported, who experienced the expected event of headache. The event occurred on the same day after the third dose of mRNA � 1273 vaccine. Headache was reported as medically significant but two days later the event 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 is a regulatory case concerning a 70-year-old female patient with no relevant medical history reported, who experienced the expected event of headache. The event occurred on the same day after the third dose of mRNA � 1273 vaccine. Headache was reported as medically significant but two days later the event 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: 1918823 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   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 FK6302 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Cold sweat, Depressed level of consciousness, Heart rate, Hyperventilation, Hypotension, Nausea, Oxygen saturation, Pallor, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: BP; Result Unstructured Data: Test Result:71/39 mmHg; Test Date: 20211117; Test Name: BT; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20211117; Test Name: BT; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20211117; Test Name: HR; Result Unstructured Data: Test Result:56/min; Test Date: 20211117; Test Name: SpO2; Test Result: 98 %; Comments: (RA)
CDC Split Type: JPPFIZER INC202101606179

Write-up: Shock; Consciousness clouding; Pallor facial; Hyperventilation syndrome; Hypotension/BP=71/39 mmHg; Cold sweat; Nausea; Anaphylaxis; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21131081 (PMDA). A 23 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 14:15 (Lot number: FK6302, Expiration Date: 30Apr2022) at the age of 23 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The following information was reported: SHOCK (hospitalization, medically significant) with onset 17Nov2021 14:30, outcome "unknown", described as "Shock"; DEPRESSED LEVEL OF CONSCIOUSNESS (hospitalization, medically significant) with onset 17Nov2021 14:30, outcome "unknown", described as "Consciousness clouding"; PALLOR (hospitalization) with onset 17Nov2021 14:30, outcome "unknown", described as "Pallor facial"; HYPERVENTILATION (hospitalization) with onset 17Nov2021 14:30, outcome "unknown", described as "Hyperventilation syndrome"; HYPOTENSION (hospitalization) with onset 17Nov2021 14:30, outcome "unknown", described as "Hypotension/BP=71/39 mmHg"; COLD SWEAT (hospitalization) with onset 17Nov2021 14:30, outcome "unknown", described as "Cold sweat"; NAUSEA (hospitalization) with onset 17Nov2021 14:30, outcome "unknown", described as "Nausea"; ANAPHYLACTIC REACTION (hospitalization, medically significant) with onset 17Nov2021 14:30, outcome "unknown", described as "Anaphylaxis". The patient was hospitalized for shock, depressed level of consciousness, pallor, hyperventilation, hypotension, cold sweat, nausea, anaphylactic reaction (start date: 17Nov2021). The patient underwent the following laboratory tests and procedures: blood pressure measurement: (17Nov2021) 71/39 mmHg; body temperature: (17Nov2021) 36.6 Centigrade, notes: Before vaccination; (17Nov2021) 36.2 Centigrade; heart rate: (17Nov2021) 56/min; oxygen saturation: (17Nov2021) 98 %, notes: (RA). Therapeutic measures were taken as a result of shock, depressed level of consciousness, pallor, hyperventilation, hypotension, cold sweat, nausea, anaphylactic reaction. The course of the event was as follows: On 17Nov2021 after 14:00 (at 14:15) (the day of vaccination), the first dose of vaccination was administrated at the outpatient department of the clinic. 15 minutes after the vaccination, the patient experienced anaphylaxis. Few minutes after the vaccination (on 17Nov2021), the patient experienced pallor facial, cold sweat, BP=71/39 mmHg, HR=56/min, SpO2=98% (RA), BT=36.2 centigrade, and it became a shock vital. Intramuscular injection of adrenaline 0.5mg and administration of LACTEC 500mL via iv drip started (therapeutic measure). The blood pressure increased gradually, and the consciousness also recovered. For detailed examination and follow-up, the patient was transported to the hospital by ambulance (Symptoms were consciousness clouding, nausea, hyperventilation syndrome, hypotension). The reporting physician classified the event as serious (hospitalized from 17Nov2021 (the day of vaccination)) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1919125 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-11-17
   Days after vaccination:97
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Erythema, Rash
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: TWMODERNATX, INC.MOD20213

Write-up: Asthma; Skin rash (non-injection site); Erythema, extensive erythema (erythema all over the body), asthma; This regulatory authority case was reported by an other health care professional and describes the occurrence of ASTHMA (Asthma), RASH (Skin rash (non-injection site)) and ERYTHEMA (Erythema, extensive erythema (erythema all over the body), asthma) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced ASTHMA (Asthma) (seriousness criterion medically significant), RASH (Skin rash (non-injection site)) (seriousness criterion medically significant) and ERYTHEMA (Erythema, extensive erythema (erythema all over the body), asthma) (seriousness criterion medically significant). At the time of the report, ASTHMA (Asthma), RASH (Skin rash (non-injection site)) and ERYTHEMA (Erythema, extensive erythema (erythema all over the body), asthma) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 11/17/2021 Healthcare person called the patient on 17-Nov-2021for care and were told that the rash had subsided after consulting the doctor. On 16-Nov-2021 patient went to a large vaccination station to receive the second dose of Moderna, and the doctor assessed that it was not suitable and asked the patient to go back to the original vaccination site for reporting. He was told that a doctor should assess whether a different manufacturer for the second dose of vaccine would be needed. If he is suggested to receive different vaccines, he can present the medical certificate or adverse reaction report for mixed vaccination, and the patient indicated that he would contact the health center again and have no needs for other care Treatment information not provided. Concomitant medication not provided. On 15-Aug-2021 Systemic redness, swelling and dyspnea. Company comment: This case concerns a 54-year-old male patient with no previous relevant medical history reported, who experienced the serious unexpected events of Asthma, Rash and Erythema. The events occurred 3 days after the dose of COVID-19 Vaccine Moderna (mRNA-1273) and reported with the follow-up date 3 months later. 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 54-year-old male patient with no previous relevant medical history reported, who experienced the serious unexpected events of Asthma, Rash and Erythema. The events occurred 3 days after the dose of COVID-19 Vaccine Moderna (mRNA-1273) and reported with the follow-up date 3 months later. 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: 1919169 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-10-27
Onset:2021-11-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Myocarditis; This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medication includes Benamine 30mg IVD stat, Ketorolac 30mg IVD ST, Lasix 20mg IVD ST and Hydrocortisone 100mg IVD ST. It was reported that the patient received first dose of COVID-19 vaccine (Moderna) on 16 Jul 2021 at school and received the first dose of COVID-19 vaccine (Moderna) on 27 Oct 2021at the activity center. She had fever, chills, dizziness and dyspnea on 17 Nov and sought medical emergency treatment. Patient''s vital signs includes Body temperature: 39.6 ?, respiratory rate: 20 breaths/min, heartbeat: 135 beats/min, blood pressure: 122/58 mmHg and SpO2: 96% with N/C 3L/min. Patient performed various diagnostic tests like GCS E4V5M6, FDP-D Dime: 1643.47 ng/mL, CRP:15.76 mg/dL, PCT: 0.74 ng/mL, troponin I: 1140.6-$g5852.2 ng/L, Influ A+B Ag showed negative,COVID-19 display undetected on 17 Nov, U/A showed pyuria, ECG showed sinus tachycardia , VPC. CXR showed RLL pneumonia, KUB showed abdominal distention, CT for r/o IAI due to elevated CRP, PCT and TnI 1140 ng/L and data showed RLL pneumonia with pleural effusion. Bed-side echo displayed mild pericardial effusion, poor left ventricular systolic function. The doctor''s diagnosis was reported as myopericarditis, RLL pneumonia with pleural effusion and UTI hence admitted to ICU for treatment. On 18 Nov 2021 as a part of follow up husband of the patient indicated that he received the second dose of Moderna and is now at ICU because of chest tightness. Company comment: This case concerns a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious expected event (AESI) of myocarditis 21 days after the first dose of the vaccine. Rechallenge is not applicable, since no further dosing was expected. However, second dose was given several months later per RA report. The benefit-risk relationship is not affected by this report.; Sender''s Comments: This case concerns a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) with no relevant medical history who experienced the serious expected event (AESI) of myocarditis 21 days after the first dose of the vaccine. Rechallenge is not applicable, since no further dosing was expected. However, second dose was given several months later per RA report. The benefit-risk relationship is not affected by this report


VAERS ID: 1919174 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-22
Onset:2021-11-17
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Muscular weakness, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis (Erythematous gastritis); Reflux esophagitis (Reflux esophagitis LA grade A)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Limb pain; Weakness of limbs; Muscle soreness; Headache; This regulatory authority case was reported by another health care professional and describes the occurrence of PAIN IN EXTREMITY (Limb pain), MUSCULAR WEAKNESS (Weakness of limbs), MYALGIA (Muscle soreness) and HEADACHE (Headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Reflux esophagitis (Reflux esophagitis LA grade A) and Gastritis (Erythematous gastritis). On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced PAIN IN EXTREMITY (Limb pain) (seriousness criterion medically significant), MUSCULAR WEAKNESS (Weakness of limbs) (seriousness criterion medically significant), MYALGIA (Muscle soreness) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Limb pain), MUSCULAR WEAKNESS (Weakness of limbs), MYALGIA (Muscle soreness) and HEADACHE (Headache) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. On 17-Nov-2021, 08:56, the patient came to the emergency clinic. The patient said that he suffered from back pain, headache, general soreness, hand, and feet numbness three days after vaccination, without limp weakness ormild sobwas. He received PirOXICam(20mg/ml) shot 20mg stat. After observation, he was discharged and made an appointment for a visit to the Department of Neurology on November 22nd, 2021. The following is a follow up care 18-Nov-2021 He didn''t answer the phone call. On 18-Nov-2021 14:15 Called the patient. The patient lived alone and had a stent in his heart. He said that after receiving the second dose of Moderna on 22-Oct-2021, he started to suffer from back pain since 25-Oct-2021. He was prescribed medication and returned home to recuperate Company comment: This case concerns a 69-year-old male patient, with no relevant medical history, who experienced the unexpected serious events of PAIN IN EXTREMITY, MUSCULAR WEAKNESS, MYALGIA and HEADACHE. The events occurred approximately 27 days after the administration of the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 69-year-old male patient, with no relevant medical history, who experienced the unexpected serious events of PAIN IN EXTREMITY, MUSCULAR WEAKNESS, MYALGIA and HEADACHE. The events occurred approximately 27 days after the administration of the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1919778 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-16
Onset:2021-11-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004675 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Lethargy, Malaise, SARS-CoV-2 test
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Arthritis (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: feeling unwell; tiredness; lethargy; Aching joints; This case was received via RA (Reference number: GB-MHRA-ADR 26244860) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of in a 64-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 28-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) (unknown route) 1 dosage form. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment information was not provided. The patient not had symptoms associated with COVID-19.The patient was not tested positive for COVID-19 since having the vaccine The patient was not enrolled in clinical trial Company comment: This is a regulatory authority case concerning a 64-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as previous dose, who experienced the unexpected serious events of arthralgia, malaise, fatigue and lethargy. The event arthralgia occurred 1 day after the third dose of mRNA-1273 vaccine administration while the events malaise, fatigue and lethargy exact occurrence unknown but stated that the events occurred after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 64-year-old, female patient with vaccine history of receiving another brand of Covid-19 vaccine (Covid-19 vaccine AstraZeneca) as previous dose, who experienced the unexpected serious events of arthralgia, malaise, fatigue and lethargy. The event arthralgia occurred 1 day after the third dose of mRNA-1273 vaccine administration while the events malaise, fatigue and lethargy exact occurrence unknown but stated that the events occurred after the third dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1919799 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0561021A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

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

Write-up: CHEST PAIN; This regulatory authority case was reported by a pharmacist and describes the occurrence of CHEST PAIN (CHEST PAIN) in an 18-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 0561021A) for an unknown indication. No Medical History information was reported. On 17-Nov-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Nov-2021 at 2:00 AM, the patient experienced CHEST PAIN (CHEST PAIN) (seriousness criterion hospitalization prolonged). At the time of the report, CHEST PAIN (CHEST PAIN) outcome was unknown. Not Provided The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication was provided. Company Comment : This case concerns an 18-year female subject with no relevant medical history, who experienced the serious unexpected event of Chest pain. The event, which resulted in hospitalization, occurred on the same day after a dose of mRNA 1273 VACCINE, dose number unknown. No diagnostic tests done nor treatment medication given were mentioned. At the time of the report, outcome of the events was Unknown. Rechallenge is not applicable as dose number is unknown. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.; Sender''s Comments: This case concerns an 18-year female subject with no relevant medical history, who experienced the serious unexpected event of Chest pain. The event, which resulted in hospitalization, occurred on the same day after a dose of mRNA 1273 VACCINE, dose number unknown. No diagnostic tests done nor treatment medication given were mentioned. At the time of the report, outcome of the events was Unknown. Rechallenge is not applicable as dose number is unknown. The benefit-risk relationship of mRNA 1273 VACCINE is not affected by this report.


VAERS ID: 1921366 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-14
Onset:2021-11-17
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Pain in extremity, Vision blurred
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), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101628043

Write-up: collapsed; pains in my leg; blurred vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) received via COVAES. The reporter is the patient. A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 14Nov2021 10:15 (Batch/Lot number: unknown) at the age of 25 years as dose 1, single for covid-19 immunization. The patient''s relevant medical history was not reported. The patient took concomitant medications. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 17Nov2021 02:00, outcome "unknown", described as "collapsed"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021 02:00, outcome "unknown", described as "pains in my leg"; VISION BLURRED (non-serious) with onset 17Nov2021 02:00, outcome "unknown", described as "blurred vision". Therapeutic measures were not taken as a result of loss of consciousness, pain in extremity, vision blurred. Additional information: It was reported that on the 17th woke up with pains in her leg then went outside to get some fresh air and had blurred vision and collapsed. Other vaccine same date details [{other vaccine same date vaccine date=14/Nov/2021, other vaccine same date dose number=1, other vaccine same date vaccine location=PRIVACY}]. The patient did not receive other vaccines in four weeks and received other medication the pill in two weeks. The patient had no Covid prior vaccination and not tested for Covid post vaccination. The patient had no other medical history and no known allergies. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Veterans Administration facility. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 1921591 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-23
Onset:2021-11-17
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Crohn's disease, Dehydration, Malaise, Urticaria, Weight
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Gastrointestinal premalignant disorders (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow), Immune-mediated/autoimmune disorders (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: INFLECTRA [INFLIXIMAB]; PREDNISONE
Current Illness: Crohn''s disease (Treated with Infliximab)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: a regulatory authority; Result Unstructured Data: Test Result:1; Comments: Patient''s previous a regulatory authority score was 1 on 16Sep2021; Test Date: 20211118; Test Name: a regulatory authority; Result Unstructured Data: Test Result:7; Comments: Legend Remission = <5 Mild Disease = 5-7 Moderate Disease = 8-16 Severe Disease = $g 16 1. General well-being (17Nov2021): 1 Legend Very Well = 0 Slightly below par = 1 Poor = 2 Very Poor = 3 Terrible = 4 2. Abdominal Pain (17Nov2021): 1 Legend None = 0 Mild = 1 Moderate = 2 Severe = 3 3. Number of liquid or soft stools per day (17Nov2021): 4 4. Complications: 1 (arthralgia) Patient''s previous HBI score was 1 on 16Sep2021 Associated infusion date: 18Nov2021 Product Lot #: FG6750995 Expiry: 30Nov2023 Associated infusion date: 16Sep2021 Product Lot #: ER2661 Expiry: 31Aug2025; Test Date: 20211118; Test Name: weight; Test Result: 69 kg
CDC Split Type: CAPFIZER INC202101572097

Write-up: excessive hives; patient was extremely dehydrated; sick from the vaccine; a regulatory authority score from 1 to 7; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 19Nov2021, this case now contains serious adverse reactions. Information processed together This is a spontaneous report received from contactable reporter(Consumer or other non HCP and Other HCP - the patient) and from a contactable nurse for a Pfizer sponsored program. A 27 year-old male patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date 23Oct2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Crohn''s disease" (ongoing), notes: Treated with Infliximab. Concomitant medications included: INFLECTRA [INFLIXIMAB] taken for Crohn''s disease, start date: 16Sep2021; PREDNISONE, start date: 02Sep2020 (ongoing). Vaccination history included: Covid vaccine (Dose 1), for Covid-19 immunisation. The following information was reported: URTICARIA (medically significant), outcome "unknown", described as "excessive hives"; DEHYDRATION (medically significant), outcome "unknown", described as "patient was extremely dehydrated"; CROHN''S DISEASE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Harvey-Bradshaw Index score from 1 to 7"; MALAISE (non-serious), outcome "unknown", described as "sick from the vaccine". The patient underwent the following laboratory tests and procedures: a regulatory authority (Crohn''s disease): (16Sep2021) 1, notes: Patient''s previous regulatory authority score was 1 on 16Sep2021; (18Nov2021) 7, notes: Legend Remission = <5 Mild Disease = 5-7 Moderate Disease = 8-16 Severe Disease = $g 16 1. General well-being (17Nov2021): 1 2. Abdominal Pain (17Nov2021): 1 3. Number of liquid or soft stools per day (17Nov2021): 4 4. Complications: 1 (arthralgia) Therapeutic measures were taken as a result of urticaria including antihistamines. Course of the event. Nurse reported that the patient received their infusion on 18Nov2021 , 9 weeks after last infusion (which took place on 16Sep2021). Patients prescribed infusions are every 4 weeks. Nurse reported that the patient reported he had knee surgery in October, but is healing quite well. Patient also reported that he received his second Covid vaccine 23Oct2021 and has been experiencing excessive hives since. He currently is taking antihistamines to control the hives. Nurse reported that during pre-infusion blood draw the patient was extremely dehydrated and needle-phobic and the nurse was unable to draw blood. 500ml bolus of Normal Saline (N/S) was initiated to infuse and the bolus absorbed. Nurse reported that the patient had a regulatory authority score of 7 The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information, a possible contributory role of vaccination with BNT162B2 to the reported events Hives, Dehydration, Crohn''s aggravated and Malaise cannot be excluded considering the plausible drug-event temporal association. 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: 1921595 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthritis, Hypoaesthesia, Movement disorder, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211116; Test Name: Antigen testing; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: CAPFIZER INC202101625360

Write-up: entires body was in extreme pain; arthritis was in every part of her body; she couldn''t move to roll over in bed; pain and numbness in her arms and hands; pain and numbness in her arms and hands/Her hands wouldn''t not work properly for approx 8 hours/they felt like they were numb and asleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 36 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 14:30 (Lot number: FD0810) at the age of 36 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no other medications the patient received within 2 weeks of vaccination. The following information was reported: PAIN (medically significant) with onset 17Nov2021 15:00, outcome "not recovered", described as "entires body was in extreme pain"; ARTHRITIS (medically significant) with onset 17Nov2021 15:00, outcome "not recovered", described as "arthritis was in every part of her body"; MOVEMENT DISORDER (medically significant) with onset 17Nov2021 15:00, outcome "not recovered", described as "she couldn''t move to roll over in bed"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021 15:00, outcome "not recovered", described as "pain and numbness in her arms and hands"; HYPOAESTHESIA (medically significant) with onset 17Nov2021 15:00, outcome "not recovered", described as "pain and numbness in her arms and hands/Her hands wouldn''t not work properly for approx 8 hours/they felt like they were numb and asleep". The events "entires body was in extreme pain", "arthritis was in every part of her body", "she couldn''t move to roll over in bed", "pain and numbness in her arms and hands" and "pain and numbness in her arms and hands/her hands wouldn''t not work properly for approx 8 hours/they felt like they were numb and asleep" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Nov2021) negative, notes: Nasal Swab. Therapeutic measures were not taken as a result of pain, arthritis, movement disorder, pain in extremity, hypoaesthesia. Her entires body was in extreme pain. Her muscles and joints. It felt like arthritis was in every part of her body, to the point where she couldn''t move to roll over in bed. The most worrisome part, though, was the pain and numbness in her arms and hands. Her hands wouldn''t not work properly for approx 8 hours, they felt like they were numb and asleep. Even after they came back a little, the pain lasted for days in her arms. She couldn''t make a ball with her fingers/fist in either hand and it was hard to hold or carry anything in her hands. Today her left forearm and hand in particular are in a lot of pain, and still unable to squeeze her hand. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.


VAERS ID: 1922065 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hyperleukocytosis, Immunisation, Myelocytosis, Neutrophil count, Neutrophil count increased, White blood cell count
SMQs:, Malignancy related conditions (narrow), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rituximab; Doxorubicin HCl; Vincristine Sulfate; CYCLOPHOSPHAMIDE; PREDNISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: B-cell lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20211120; Test Name: MYELEMIA; Result Unstructured Data: Test Result:2300; Test Date: 20211115; Test Name: neutrophils; Result Unstructured Data: Test Result:2700; Test Date: 20211118; Test Name: neutrophils; Result Unstructured Data: Test Result:15000; Test Date: 20211115; Test Name: leucocytes; Result Unstructured Data: Test Result:3300; Test Date: 20211118; Test Name: leucocytes; Result Unstructured Data: Test Result:19000
CDC Split Type: FRPFIZER INC202101642611

Write-up: Mylemia at 2300; Hyperleukocytosis at 19000 with neutrophils at 15000; Hyperleukocytosis at 19000 with neutrophils at 15000; COMIRNATY on 17Nov2021 (3rd dose); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: UNKNOWN) as dose 3 (booster), single for covid-19 immunisation; rituximab (RITUXIMAB) (Batch/Lot number: unknown) for b-cell lymphoma; doxorubicin hcl (DOXORUBICIN HCL) (Batch/Lot number: unknown) for b-cell lymphoma; vincristine sulfate (VINCRISTINE SULFATE) (Batch/Lot number: unknown) for b-cell lymphoma; cyclophosphamide (CYCLOPHOSPHAMIDE) (Batch/Lot number: unknown) for b-cell lymphoma; prednisone (PREDNISONE) (Batch/Lot number: unknown) for b-cell lymphoma. Relevant medical history included: "B-cell lymphoma" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Second dose, Manufacturer unknown), for Covid-19 immunization. The following information was reported: HYPERLEUKOCYTOSIS (medically significant), NEUTROPHIL COUNT INCREASED (non-serious) all with onset 18Nov2021, outcome "unknown" and all described as "Hyperleukocytosis at 19000 with neutrophils at 15000"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "COMIRNATY on 17Nov2021 (3rd dose)"; MYELOCYTOSIS (non-serious) with onset 20Nov2021, outcome "unknown", described as "Mylemia at 2300". The patient underwent the following laboratory tests and procedures: myelocytosis: (20Nov2021) 2300; neutrophil count: (15Nov2021) 2700; (18Nov2021) 15000; white blood cell count: (15Nov2021) 3300; (18Nov2021) 19000. The action taken for rituximab, doxorubicin hcl, vincristine sulfate, cyclophosphamide and prednisone was unknown. Therapeutic measures were taken as a result of hyperleukocytosis, neutrophil count increased. Clinical information: Treated for B-cell lymphoma by R-CHOP protocol, 2nd cure on 08Nov2021, growth factor from 15Nov2021 to 19Nov2021, COMIRNATY on 17Nov2021 (3rd dose), the next day 18Nov2021 (already 3 injections of nivestim) hyperleukocytosis at 19 000 including 15000 neutrophils (3300 including 2700 3 days before on 15Nov2021. Then myelemia at 2300 on 20Nov2021. The lot number for bnt162b2, rituximab, doxorubicin hcl, vincristine sulfate was not provided and will be requested during follow up.


VAERS ID: 1922115 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-13
Onset:2021-11-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Computerised tomogram, Electrocardiogram, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:no clotting which is at deadly elevation; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no clotting which is at deadly elevation; Test Name: CT scan; Result Unstructured Data: Test Result:no clotting which is at deadly elevation; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:no clotting which is at deadly elevation; Test Date: 20211010; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101629464

Write-up: Heart palpitations; Racing heart (tachycardia); Chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202111180910294590-CMO9L (RA). Other Case identifier(s): GB-MHRA-ADR 26220271 (RA). A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 13Nov2021 (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: CHEST PAIN (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Chest pain"; PALPITATIONS (medically significant), outcome "unknown", described as "Heart palpitations"; TACHYCARDIA (medically significant), outcome "unknown", described as "Racing heart (tachycardia)". The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) no clotting which is at deadly elevation; chest x-ray: (unspecified date) no clotting which is at deadly elevation; computerised tomogram: (unspecified date) no clotting which is at deadly elevation; electrocardiogram: (unspecified date) no clotting which is at deadly elevation; sars-cov-2 test: (10Oct2021) positive, notes: Yes - Positive COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. It was reported that Consistently having chest pains through out the day as a side effect of this ''safe'' vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report was related to possible inflammation of the heart (myocarditis or pericarditis). Was any treatment given because of your symptoms. Please provide details of any medication prescribed reported as no, it falls into the ''annoying'' category. Has there been any other recent or ongoing illness that you haven''t already. mentioned. If so please provide details of this reported as no. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922128 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Hypoaesthesia, Immunisation, Interchange of vaccine products, Pain in extremity, Paraesthesia, Peripheral swelling, SARS-CoV-2 test, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Jugular vein thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20211115; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: NEGATIVE
CDC Split Type: GBPFIZER INC202101629363

Write-up: Armpit pain; Swollen left side of neck/shoulder; Swollen arm; Pins and needles/Tingling in left hand; Numbness in hand; Interchange of vaccine products; Booster; painful arm; 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-202111190743368270-QIPBY. Other Case identifier(s): GB-MHRA-ADR 26225498. A 41 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Jugular vein thrombosis", start date: Sep2020 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1. BACTH/LOT NUMBER: UNKNOWN, ), administration date: 13Mar2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (DOSE 2. BACTH/LOT NUMBER: UNKNOWN), administration date: 22May2021, for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date was reported as 18Nov2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (medically significant) with onset 2021, outcome "not recovered", described as "painful arm"; AXILLARY PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Armpit pain"; SWELLING (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen left side of neck/shoulder"; PERIPHERAL SWELLING (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen arm"; PARAESTHESIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Pins and needles/Tingling in left hand"; HYPOAESTHESIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Numbness in hand". It was further reported that swollen and painful armpit. swollen left side of neck/shoulder. painful arm. tingling in left hand. No report was not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (15Nov2021) no - negative covid-19 test, notes: NEGATIVE. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922131 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Immunisation, Influenza, Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test, Sinus headache
SMQs:, Anaphylactic reaction (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; IBUPROFEN
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)); Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20211010; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101629186

Write-up: Flu symptoms; Headache sinus; Coughing; patient received third dose of BNT162b2 on 17Nov2021; patient received third dose of BNT162b2 on 17Nov2021; patient received third dose of BNT162b2 on 17Nov2021; Painful arm; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory number: GB-MHRA-WEBCOVID-202111190844548250-T8BLV (MHRA). Other Case identifiers: GB-MHRA-ADR 26226051 (MHRA). A 60 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) at the age of 60 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started, Unsure when symptoms stopped; "Immunodeficiency" (unspecified if ongoing), notes: Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodeficiency); "Type 2 diabetes" (unspecified if ongoing). Concomitant medications included: INFLUENZA VACCINE vaccine, administration date 13Sep2021 taken for immunisation; PARACETAMOL; IBUPROFEN. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1, SINGLE, Batch/Lot no. - unknown), administration date: 04Mar2021, for covid-19 immunisation; COVID-19 vaccine astrazeneca (DOSE 2, SINGLE, Batch/Lot no. - unknown), administration date: 18May2021, for COVID-19 immunisation. 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), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "patient received third dose of BNT162b2 on 17Nov2021"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Painful arm"; INFLUENZA (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Flu symptoms"; SINUS HEADACHE (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Headache sinus"; COUGH (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Coughing". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Oct2021) negative. No follow up attempts are possible. No further information is expected.


VAERS ID: 1922134 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Immunisation, Interchange of vaccine products, Myalgia, Off label use, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), 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
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Raised blood pressure
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629128

Write-up: Muscle ache; Off label use; interchange of vaccine products; booster; Pain injection site; Chills; Diarrhoea; Headache; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111190901084000-1X52V (MHRA). Other Case identifiers: GB-MHRA-ADR 26226022 (RA). A 63 year-old patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "raised blood pressure" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Concomitant medication included: AMLODIPINE taken for blood pressure increased. Vaccination history included: COVID-19 vaccine astrazeneca (Dose: 1, Single, Lot number: unknown, Primary immunization series complete, Manufacturer: AstraZeneca), for COVID-19 immunisation; COVID-19 vaccine astrazeneca (Dose: 2, Single, Lot number: unknown, Primary immunization series complete, Manufacturer: AstraZeneca), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (medically significant) with onset 17Nov2021, outcome "recovering", described as "Pain injection site"; CHILLS (medically significant) with onset 17Nov2021, outcome "recovering", described as "Chills"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Diarrhoea"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Headache"; MYALGIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Muscle ache". Clinical course reported by the patient: Most symptoms started late in the day the patient had the vaccination and continued throughout the night. Last night (the second night) was better. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. No follow up attempts are possible. No further information is expected.


VAERS ID: 1922135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Headache, Immunisation, Interchange of vaccine products, Lethargy, Lymph node palpable, Lymphadenitis, Lymphadenopathy, Off label use, Pain, Pyrexia, SARS-CoV-2 test, Toothache
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20211118; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever; Test Date: 20211114; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101628977

Write-up: lymphadenopathy; Lymph node palpable; Lower mandible-theeth pain; Armpit lymph node inflammation; Body aches; Chills; Temperature; Lethargy; headache; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202111190903250280-NWC9T, Safety Report Unique Identifier GB-MHRA-ADR 26226397. A 42-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on 17Nov2021 as dose 3 (booster), single (lot# FK0596), for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose and second dose of COVID-19 vaccine (Primary Immunization series complete but unknown manufacturer) on an unspecified date for COVID-19 immunisation. The patient''s last menstrual period date was on 26May2021, the patient had not had symptoms associated with COVID-19, was not pregnant, nor breastfeeding, had not tested positive for COVID-19 since having the vaccine, and was not enrolled in clinical trial. A COVID-19 test on 14Nov2021 was negative. The clinical course was the following: After 24 hours the patient had body aches, chills, headache, temperature, and lethargy. After 48 hours the patient had lower mandible-teeth pain, armpit lymph node inflammation (the arm where the vaccine was administered), and headache. The events reported by the regulatory authority were headache and lymph node palpable on 19Nov2021. The case was assessed as serious due to medically important condition. The patient had not recovered from headache and lymph node palpable. The outcome of the remaining symptoms was not specified. No follow up attempts are needed. No further information is expected


VAERS ID: 1922136 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629157

Write-up: Swollen lymph nodes; Patient received third dose of Comirnaty; Patient received third dose of Comirnaty; Patient received third dose of Comirnaty; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202111190915299870-14KDK (MHRA). Other Case identifier(s): GB-MHRA-ADR 26226044 (MHRA). A 51 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: fk0596) as dose 3 (booster), single for COVID-19 immunisation. Patient was not enrolled in clinical trial. Patient had no symptoms associated with COVID-19, and not had a COVID-19 since having the vaccine. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (DOSE 1, Lot number: Unknown, Primary Immunization series complete, Manufacturer unknown), for COVID-19 immunization; COVID-19 vaccine (DOSE 2, Batch/Lot number: Unknown, Primary Immunization series complete, Manufacturer unknown), for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "Patient received third dose of Comirnaty"; LYMPHADENOPATHY (medically significant) with onset 19Nov2021, outcome "not recovered", described as "Swollen lymph nodes". No follow up attempts are possible. No further information is expected.


VAERS ID: 1922137 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Diarrhoea, Fatigue, Glossodynia, Headache, Heart rate, Immunisation, Interchange of vaccine products, Microsleep, Musculoskeletal stiffness, Myalgia, Off label use, Palpitations, Rash, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE
Current Illness: Poor quality sleep
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart rate; Result Unstructured Data: Test Result:67-122; Comments: my heart resting rate is around 67 BM - this went up to 122; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629341

Write-up: Rash; Headache; Generalised muscle aches; Microsleep; Tiredness; Loss of energy; Stiff neck; Stinging tongue; Diarrhea; Off label use; booster; interchange of vaccine products; Palpitations; 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-202111190917599180-Y2NRV. Other Case identifier: GB-MHRA-ADR 26226121. A 51 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Poor quality sleep" (ongoing). Concomitant medication included: AMITRIPTYLINE taken for poor quality sleep. 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 17Nov2021, outcome "unknown", described as "Off label use"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; RASH (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Rash"; HEADACHE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Headache"; MYALGIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Generalised muscle aches"; MICROSLEEP (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Microsleep"; FATIGUE (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Tiredness"; PALPITATIONS (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Palpitations"; ASTHENIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Loss of energy"; DIARRHOEA (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Diarrhea"; MUSCULOSKELETAL STIFFNESS (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Stiff neck"; GLOSSODYNIA (medically significant) with onset 18Nov2021, outcome "recovering", described as "Stinging tongue". The patient underwent the following laboratory tests and procedures: heart rate: 67-122, notes: my heart resting rate is around 67 BM - this went up to 122; sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: It was stated that within 1 hour of the injection, a started observe Palpitations. Thereafter, he started with above symptoms -some were still ongoing. The patient still suffering issue and in general feel that spent 2 hours in spin dryer. It was stated that the patient feeling slightly better. Patient was not tested positive for COVID-19 since the vaccination. Patient not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The reporter did not consider this report relate to possible inflammation of the heart myocarditis or pericarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922148 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Immunisation, SARS-CoV-2 test, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; ATORVASTATIN; PROPRANOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign essential tremor; Blood pressure high; Cholesterol
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101629225

Write-up: Blurry vision; Headache/Headache temporal; Patient received third dose of Comirnaty; This is a spontaneous report received from a contactable reporter (Consumer) from the Regulatory Authority (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111191110185030-L9DSI (MHRA). Other Case identifier(s): GB-MHRA-ADR 26226795 (MHRA). A 70 year-old male patient received BNT162B2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) at the age of 70 years as dose 3 (booster), single for COVID-19 immunisation. Unsure if patient has had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Relevant medical history included: "Benign essential tremor" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; ATORVASTATIN taken for blood cholesterol; INFLUENZA VIRUS, administration date Oct2021; PROPRANOLOL taken for essential tremor. Vaccination history included: Bnt162b2 (Lot Number: Unknown), administration date: 09Feb2021, for COVID-19 immunisation; BNT162B2 (Lot Number: Unknown), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Patient received third dose of Comirnaty"; VISION BLURRED (medically significant) with onset 17Nov2021, outcome "recovered" (Nov2021), described as "Blurry vision"; HEADACHE (medically significant) with onset 17Nov2021, outcome "recovered" (18Nov2021), described as "Headache/Headache temporal". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative. Therapeutic measures were taken as a result of headache. Clinical course: The eye sight of patient went blurred at 8:30pm on the 17Nov2021 then he had a light headache that night then the next morning he woke with a light headache that disappeared. Then at 12:45 am the patient started to get a headache that turned into the worst one he ever had and had to go to bed and it lasted three hours, Paracetamol didn''t work. No follow-up attempts are possible; information about Lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922169 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F1T0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Back pain, Groin pain, Immunisation, Interchange of vaccine products, Lethargy, Myalgia, Off label use, Pain, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Asthma: symbicot and ventilin inhalers.); Hypertension; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629338

Write-up: fever; pain; Armpit pain; Lethargy; Muscle ache; Fever chills; Low back pain; Groin pain; Off label use; Interchange of vaccine products; Booster; Painful L arm; 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-202111191328539770-KDDB8 (RA). Other Case identifier(s): GB-MHRA-ADR 26227542 (RA). A 58 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: F1T0596) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing), notes: Asthma: symbicot and ventilin inhalers.; "Steroid therapy" (unspecified if ongoing), notes: Taking regular steroid treatment (e.g. orally or rectally). The patient''s concomitant medications were not reported. Past drug history included: Indapamide for Hypertension, notes: Hypertension: Indapamide; Omperazapole. 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 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; PYREXIA (medically significant), outcome "recovering", described as "fever"; AXILLARY PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Armpit pain"; LETHARGY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Lethargy"; MYALGIA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Muscle ache"; PYREXIA (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Fever chills"; PAIN IN EXTREMITY (medically significant) with onset 17Nov2021, outcome "not recovered", described as "Painful L arm"; BACK PAIN (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Low back pain"; GROIN PAIN (medically significant) with onset 18Nov2021, outcome "recovered" (2021), described as "Groin pain"; PAIN (medically significant), outcome "unknown", described as "pain". Therapeutic measures were taken as a result of pyrexia, pyrexia, pain in extremity. The patient took 2 paracetamols at night to help with sore arm. Reportedly, she took 2 paracetamols at night to help with the fever and chills. Clinical Information: It was reported that the patient had a sore arm at injection site approx 2 hours after vaccine. Next morning felt very lethargic and developed aches, pains, fever and chills during the day, sore armpit on the vaccination arm. She had no chills or fever the next morning but lethargy and aches and pains and sore armpit. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). Reportedly, no relevant investigations or tests conducted. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922227 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Immunisation, Interchange of vaccine products, Lymphadenopathy, Off label use
SMQs:, Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephritis interstitial (Had instertitial nephritis 5 years ago brought on by a virus, cured by steroids.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629216

Write-up: Swollen painful nodes under left armpit, same side as injection; Swollen painful nodes under left armpit, same side as injection; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111192154077030-JOLDR. Other Case identifiers: GB-MHRA-ADR 26230276. A 52 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Unknown) as dose 3 (booster) , single for COVID-19 immunisation. Relevant medical history included: "instertitial nephritis" (unspecified if ongoing), notes: Had instertitial nephritis 5 years ago brought on by a virus, cured by steroids. Patient has not had symptoms associated with COVID-19 nor had a COVID-19 test. Patient was currently not pregnant/breastfeeding and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1, Single, Lot number: unknown, Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation; COVID-19 vaccine (Dose 2, 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 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant), AXILLARY PAIN (medically significant) all with onset 18Nov2021, outcome "not recovered" and all described as "Swollen painful nodes under left armpit, same side as injection". No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1922231 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vaccination site erythema, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 INC202101629382

Write-up: abdominal pain; Vaccination site erythema; Vomiting; diarrhea - bile color and just water; Booster; 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-202111192217395290-1D8BS (RA). Other Case identifier(s): GB-MHRA-ADR 26230341 (RA). A 45 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Date of last menstrual period: 11Jul2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; ABDOMINAL PAIN (medically significant), outcome "not recovered", described as "abdominal pain"; VACCINATION SITE ERYTHEMA (medically significant), outcome "not recovered", described as "Vaccination site erythema"; VOMITING (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Vomiting"; DIARRHOEA (medically significant) with onset 18Nov2021, outcome "not recovered", described as "diarrhea - bile color and just water". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient reported that she experienced severe vomiting and diarrhea - bile color and just water and unable to keep water down. Report does not relate to possible inflammation of the heart (myocarditis or pericarditis). Patient''s last menstrual period date was 11Jul2021. Patient did not have symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1922255 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Breast reconstruction, Headache, Immunisation, Interchange of vaccine products, Lymphadenopathy, Lymphoedema, Nausea, Off label use, Pain, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Breast malignant tumours (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer (reconstruction for breast cancer); Mastectomy (double mastectomy)
Allergies:
Diagnostic Lab Data: Test Name: Temp 38.7; Result Unstructured Data: Test Result:38.7
CDC Split Type: GBPFIZER INC202101629324

Write-up: lymphoedema; nausea; body ache; headache; pain around injection site; breast reconstruction; Swollen lymph nodes; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202111201028437430-QHVPY; Other Case identifier(s): GB-MHRA-ADR 26231191. A 63-year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FH4751) as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Breast cancer" (unspecified if ongoing), notes: reconstruction for breast cancer; "Mastectomy" (unspecified if ongoing), notes: double mastectomy. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine ((MANUFACTURER UNKNOWN)), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; LYMPHOEDEMA (medically significant), outcome "not recovered", described as "lymphoedema"; NAUSEA (medically significant), outcome "not recovered", described as "nausea"; LYMPHADENOPATHY (medically significant) with onset 18Nov2021, outcome "not recovered", described as "Swollen lymph nodes"; PAIN (medically significant), outcome "unknown", described as "body ache"; HEADACHE (medically significant), outcome "unknown", described as "headache"; VACCINATION SITE PAIN (medically significant), outcome "unknown", described as "pain around injection site"; BREAST RECONSTRUCTION (medically significant), outcome "unknown", described as "breast reconstruction". Temp 38.7 plus body aches headaches nausea pain around injection site right arm spreading to axilla and my breast reconstruction. Now very swollen and painful third day post vaccine worried about lymphoedema. 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. Reporter report was not included with information related to possible inflammation of the heart (myocarditis or pericarditis). The patient underwent the following laboratory tests and procedures: body temperature: 38.7. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922259 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Fatigue, Headache, Illness, Immunisation, Interchange of vaccine products, Off label use, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEINE; PHENOXYMETHYLPENICILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pain; Prophylaxis; Splenectomy (through trauma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101629505

Write-up: Diarrhoea/Diarrhea; Sickness; Fever; Headache; Tiredness; the patient received a third/booster dose; the patient received a third/booster dose; the patient received a third/booster dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202111201147155350-XBLOH (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231297 (MHRA). A 48 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: Not known) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Splenectomy", start date: 1987 (unspecified if ongoing), notes: through trauma; "Pain" (unspecified if ongoing); "Prophylaxis" (unspecified if ongoing). Concomitant medication(s) included: CODEINE taken for pain, start date: 01Jan2018; INFLUENZA VIRUS taken for immunisation, administration date 17Nov2021; PHENOXYMETHYLPENICILLIN taken for prophylaxis, start date: 01Jan2018. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1. Batch/Lot number: Unknown), administration date: 05Feb2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (DOSE 2. Batch/Lot number: Unknown), administration date: 30Apr2021, for COVID-19 immunization. The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant) all with onset 17Nov2021, outcome "unknown" and all described as "the patient received a third/booster dose"; DIARRHOEA (medically significant) with onset 19Nov2021, outcome "recovering", described as "Diarrhoea/Diarrhea"; ILLNESS (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Sickness"; PYREXIA (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Fever"; HEADACHE (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Headache"; FATIGUE (medically significant) with onset 19Nov2021, outcome "recovered" (20Nov2021), described as "Tiredness". It started with a headache at 2pm on 19Nov21 then a fever and tiredness began around 6pm. she went to bed at 10pm and that''s when sickness began almost straight away with diarrhoea starting shortly afterwards. Symptoms began to ease around 7am 20Nov21. There were no report related to possible inflammation of the heart (myocarditis or pericarditis). 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. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1922284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Headache, Immunisation, Interchange of vaccine products, Nausea, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20201213; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101629304

Write-up: vomiting; nausea; no energy; no appetite; Headache; Interchange of vaccine products; Booster; off label use; 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-202111201807530640-MJGG4 (RA). Other Case identifier(s): GB-MHRA-ADR 26231758 (RA). A 66 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 10Dec2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine astrazeneca (Dose-1), administration date: 06Feb2021, for COVID-19 immunization; Covid-19 vaccine astrazeneca (Dose-2), administration date: 06May2021, for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "off label use"; VOMITING (medically significant), outcome "unknown", described as "vomiting"; NAUSEA (medically significant), outcome "unknown", described as "nausea"; HEADACHE (medically significant) with onset 18Nov2021, outcome "recovering", described as "Headache"; ASTHENIA (medically significant), outcome "unknown", described as "no energy"; DECREASED APPETITE (medically significant), outcome "unknown", described as "no appetite". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2020) positive, notes: Yes - Positive COVID-19 test. Clinical course: Unsure if patient was 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: 1922286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK0596 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Electrocardiogram, Immunisation, Interchange of vaccine products, Investigation, Nausea, Off label use, Oxygen consumption, SARS-CoV-2 test, Syncope
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), 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: blood pressure; Result Unstructured Data: Test Result:Results:Unknown; Test Name: ECG; Result Unstructured Data: Test Result:Results:Unknown; Test Name: blood sugar; Result Unstructured Data: Test Result:Results:Unknown; Test Name: oxygen levels; Result Unstructured Data: Test Result:Results:Unknown; Test Date: 20211026; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629272

Write-up: Syncope; Nauseous; Off label use; interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202111201817290920-969CE (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231778 (MHRA). A 63 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: FK0596) as dose 3 (booster) single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VIRUS VACCINE INACTIVATED, administration date 17Nov2021. Vaccination history included: Covid-19 vaccine ((MANUFACTURER UNKNOWN)), for Covid-19 immunisation. The following information was reported: SYNCOPE (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Syncope"; OFF LABEL USE (medically significant) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 17Nov2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 17Nov2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 18Nov2021, outcome "recovered" (18Nov2021), described as "Nauseous". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) results:unknown; electrocardiogram: (unspecified date) results:unknown; investigation: (unspecified date) results:unknown; oxygen consumption: (unspecified date) results:unknown; sars-cov-2 test: (26Oct2021) no - negative covid-19 test. Clinical Course: After blacking out he was attended by paramedics. All their tests were satisfactory. The reporte does not relate to possible inflammation of heart. Patient has 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: 1922296 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4751 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Adverse reaction, Condition aggravated, Cough, Diarrhoea, Dizziness, Freezing phenomenon, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...)
Allergies:
Diagnostic Lab Data: Test Date: 20211031; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101629362

Write-up: ill; Condition worsened; dizzy head; cough; nausea; vomiting; Loose bowels; freezing cold; sore stomach; dreadful cough; Off label use; Interchange of vaccine products; Booster; Adverse reaction to product; 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-202111201909224920-RQHLO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26231821 (MHRA). A 67 year-old female patient received bnt162b2 (COMIRNATY), administration date 17Nov2021 (Lot number: Fh4751) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic obstructive pulmonary disease" (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. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 2), administration date: 12Feb2021, for Covid-19 immunisation; Covid-19 vaccine astrazeneca (Dose 1), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (disability) with onset 17Nov2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (disability) with onset 17Nov2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (disability) with onset 17Nov2021, outcome "unknown", described as "Booster"; ADVERSE REACTION (disability) with onset 17Nov2021, outcome "not recovered", described as "Adverse reaction to product"; MALAISE (disability), outcome "unknown", described as "ill"; CONDITION AGGRAVATED (disability), outcome "unknown", described as "Condition worsened"; DIZZINESS (disability), outcome "unknown", described as "dizzy head"; COUGH (disability), outcome "unknown", described as "cough"; NAUSEA (disability), outcome "unknown", described as "nausea"; VOMITING (disability), outcome "unknown", described as "vomiting"; DIARRHOEA (disability), outcome "unknown", described as "Loose bowels"; FREEZING PHENOMENON (disability), outcome "recovered", described as "freezing cold"; ABDOMINAL PAIN UPPER (disability), outcome "unknown", described as "sore stomach"; COUGH (disability), outcome "unknown", described as "dreadful cough". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Oct2021) negative, notes: No - Negative COVID-19 test. Clinical Course: She Had the booster on Wednesday 17Nov2021 she felt really ill that night worse the next day with dizzy head cough nausea vomiting loose bowels sweating and then freezing cold this has continued for 4 days She have a very sore stomach and a dreadful cough. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart No follow-up attempts are needed. No further information is expected.


VAERS ID: 1922349 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Fatigue, Headache, Malaise, Nasal congestion, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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; PFIZER BIONTECH COVID-19 VACCINE; FLUTICASONE; INFLUENZA VIRUS; LEVOTHYROXINE; OMALIZUMAB; RAMIPRIL; TIOTROPIUM
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: unwell; Cough; Nose congestion; Headache dull; Chills; Fatigue; This case was received via RA (Reference number: GB-MHRA-ADR 26246065) on 25-Nov-2021 and was forwarded to Moderna on 25-Nov-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (unwell), FATIGUE (Fatigue), NASAL CONGESTION (Nose congestion), COUGH (Cough), HEADACHE (Headache dull) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004732) for COVID-19 vaccination. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) and INFLUENZA VACCINE (INFLUENZA VIRUS) for Vaccination, AMLODIPINE, FLUTICASONE, LEVOTHYROXINE, OMALIZUMAB, RAMIPRIL and TIOTROPIUM for an unknown indication. On 17-Nov-2021, the patient received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). On 18-Nov-2021, the patient experienced HEADACHE (Headache dull) (seriousness criterion medically significant). On 21-Nov-2021, the patient experienced NASAL CONGESTION (Nose congestion) (seriousness criterion medically significant). On an unknown date, the patient experienced MALAISE (unwell) (seriousness criterion medically significant) and COUGH (Cough) (seriousness criterion medically significant). On 23-Nov-2021, HEADACHE (Headache dull) had resolved. On 24-Nov-2021, CHILLS (Chills) had resolved. At the time of the report, MALAISE (unwell) and FATIGUE (Fatigue) had not resolved and NASAL CONGESTION (Nose congestion) and COUGH (Cough) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Treatment product was not provided by the reporter. Patient was unwell enough to be taking paracetamol regularly and cancel planned activities. Patient has not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a female patient of an unknown age with a relevant medical history of Ramipril use, who experienced the serious unexpected events of Malaise, Fatigue, Nasal congestion, Cough, Headache and Chills. The events of Malaise and Cough occurred on an unknown date after the third dose of mRNA-1273 vaccine, the events of Fatigue and Chills occurred the same day after the third dose of mRNA-1273 vaccine, the event of Headache occurred 1 day after the third dose of mRNA-1273 vaccine and Nasal congestion occurred 4 days after the third dose of mRNA-1273 vaccine. The medical history of Ramipril use is a confounder for the event of cough. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.; Sender''s Comments: This case concerns a female patient of an unknown age with a relevant medical history of Ramipril use, who experienced the serious unexpected events of Malaise, Fatigue, Nasal congestion, Cough, Headache and Chills. The events of Malaise and Cough occurred on an unknown date after the third dose of mRNA-1273 vaccine, the events of Fatigue and Chills occurred the same day after the third dose of mRNA-1273 vaccine, the event of Headache occurred 1 day after the third dose of mRNA-1273 vaccine and Nasal congestion occurred 4 days after the third dose of mRNA-1273 vaccine. The medical history of Ramipril use is a confounder for the event of cough. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting and retained for consistency with the RA report.


VAERS ID: 1922620 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-11-17
Onset:2021-11-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK6302 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Hyperhidrosis, Loss of consciousness, Oxygen saturation, Presyncope, Syncope
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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211117; Test Name: Blood pressure; Result Unstructured Data: Test Result: 118/76 mmHg; Test Date: 20211117; Test Name: body temperature; Result Unstructured Data: Test Result: 36.2 Centigrade; Comments: before the vaccination; Test Date: 20211117; Test Name: P; Result Unstructured Data: Test Result: 61; Test Date: 20211117; Test Name: SPO; Test Result: 99%.
CDC Split Type: JPPFIZER INC202101620064

Write-up: Neurally mediated syncope; Loss of consciousness; Vasovagal reflex; Feels poorly; Sweaty; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from the Regulatory Authority. The Regulatory Authority number v21131533. This patient was a 31-year and 9-month-old male (age at vaccination). Body temperature before vaccination was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire. On 17Nov2021 at 12:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FK6302, Expiration date 30Apr2022) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 17Nov2021 at 12:40 (10 minutes after the vaccination), the patient experienced Vasovagal reflex. On 17Nov2021 (same day of the vaccination), the outcome of the event was recovered. The event course was reported as after receiving the vaccination, at around 12:40, the patient experienced Feels poorly, Loss of consciousness, and Sweaty. 118/76mmHg, P:61, SPO: 99%. The patient was lying down, the consciousness was clear soon. The patient was a type of experiencing loss of posture when receiving injection and collecting blood before. Intravenous drip was suggested, but the patient refused to receive injection. The patient did not want to receive the second dose of corona vaccine. The reporter classified the event as non-serious and the causality between the event and bn162b2 as related. There was no other possible cause of the event such as any other diseases. The reporter''s comment was it was considered as Neurally mediated syncope. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1922807 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-04
Onset:2021-11-17
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-12-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

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

Write-up: Pulmonary embolism; This regulatory authority case was reported by an other health care professional and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 68-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 17-Nov-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. 11/17/2021 The patient''s past medical history: rhinorrhea with sneezing for 10+ years, L4~L5 HIVD s/p in 2000 at a Hospital. 07/13/2021 Received the first dose of COVID-19 vaccine (Moderna) in a Hospital, only with low fever. 10/04/2021 Received the second dose of moderna vaccine. 11/17/2021 Came to our emergency department due to breathing and coughing. Body temperature 35.8C; 177/125mmHg; HR 109 (beats/min); RR: 20 (breaths/min). The blood examination showed elevated D-dimer, CRP and pro- BNP, mild high cardio enzyme. CXR: no active lung lesion and no mediastinal widening. Chest-abdomen CT was prescribed for high D-dimer, favor pulmonary embolism. The CT revealed bilateral pulmonary trunk embolism. Admitted to ICU for treatment. Company comment: This case concerns a 68-year-old male patient with no medical history reported, who experienced the serious unexpected AESI of pulmonary embolism after second dose of mRNA-1273. The event occurred 45 days after second dose. The re-challenge is unknown since event outcome was recovering and occurred after second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old male patient with no medical history reported, who experienced the serious unexpected AESI of pulmonary embolism after second dose of mRNA-1273. The event occurred 45 days after second dose. The re-challenge is unknown since event outcome was recovering and occurred after second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


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