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

Found 1,049,249 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 127 out of 10,493

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VAERS ID: 2033643 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, SARS-CoV-2 test, Vascular headache
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

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

Write-up: Diarrhea; Headache vascular; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26430624) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VASCULAR HEADACHE (Headache vascular) and DIARRHOEA (Diarrhea) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced VASCULAR HEADACHE (Headache vascular) (seriousness criteria disability and medically significant). On 31-Dec-2021, the patient experienced DIARRHOEA (Diarrhea) (seriousness criteria disability and medically significant). On 02-Jan-2022, DIARRHOEA (Diarrhea) was resolving. At the time of the report, VASCULAR HEADACHE (Headache vascular) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information was provided. Patient had constant fatigue with no energy. Patient had not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Duration of reaction/event Diarrhoea was reported as 2 days. Company comment: This case concerns a 57-year-old male patient with no medical history provided who experienced serious unexpected events of Vascular headache and Diarrhoea. The event Vascular headache occurred on the same day after the third dose of mRNA-1273 whereas the event Diarrhoea occurred two days following the vaccination. At the time of the report, both events were resolving, even though duration of the event Diarrhoea was reported as two days. It was also reported that the patient experienced constant fatigue with no energy. No further information was provided. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness 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. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 57-year-old male patient with no medical history provided who experienced serious unexpected events of Vascular headache and Diarrhoea. The event Vascular headache occurred on the same day after the third dose of mRNA-1273 whereas the event Diarrhoea occurred two days following the vaccination. At the time of the report, both events were resolving, even though duration of the event Diarrhoea was reported as two days. It was also reported that the patient experienced constant fatigue with no energy. No further information was provided. The rechallenge and action taken with the suspect product were reported as unknown as per SD and kept as such. Event terms, onset dates and outcomes captured per SD Authority reporting. Event seriousness 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. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2033679 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Weakness of arms; This case was received via Regulatory authority. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Weakness of arms) in a 46-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not Known) for an unknown indication. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Weakness of arms) (seriousness criterion medically significant). At the time of the report, MUSCULAR WEAKNESS (Weakness of arms) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication information was provided. No treatment medication were provided. 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 Company Comment: This case concerns a 46-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Muscular weakness. The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Event seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.; Sender''s Comments: This case concerns a 46-year-old female patient with no previous relevant medical history reported, who experienced the serious unexpected event of Muscular weakness. The event occurred on the day after the third dose of COVID-19 Vaccine Moderna (mRNA-1273). Event seriousness assessed as per Regulatory Authority report and retained for consistency. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 2033683 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cluster headache, Dizziness, Immunisation, Lymphadenopathy, Myalgia, Tension headache
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200019454

Write-up: Cluster headache; Tension headache; Dizzy spells; Muscle ache; Swollen glands; Primary immunisation: BNT162B2; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Regulatory number: GB-MHRA-WEBCOVID-202201051059147340-RGI8T (MHRA). Other Case identifier(s): GB-MHRA-ADR 26438231 (MHRA). A 22 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) 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: Bnt162b2 (DOSE 2, SINGLE;Lot number: Unknown; Route of administration: Unspecified), administration date: 07Sep2021, for COVID-19 immunisation, reaction(s): "Inappropriate schedule of vaccine administered"; Bnt162b2 (DOSE 1, SINGLE;Lot number: Unknown; Route of administration: Unspecified), administration date: 06Jul2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Primary immunisation: BNT162B2; Booster: COMIRNATY"; CLUSTER HEADACHE (medically significant) with onset 30Dec2021, outcome "recovered with sequelae", described as "Cluster headache"; TENSION HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Tension headache"; DIZZINESS (medically significant) with onset 30Dec2021, outcome "recovered", described as "Dizzy spells"; MYALGIA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Muscle ache"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "recovered", described as "Swollen glands". The report was not related to possible inflammation of the heart (myocarditis or pericarditis).The patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200053381 same patient/drug/different dose/ event


VAERS ID: 2033789 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-12-29
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in the a Regulatory Authority; Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: at a Regulatory Authority
CDC Split Type: HKPFIZER INC202200037068

Write-up: CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y+ T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y+ T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000015. As of 0:00 am, 31-Dec-2021, DH announced that thirteen additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 13 patients that confirmed COVID-19 after Comirnaty vaccination. A 15-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 08-Jul-2021 and 29-Jul-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 12-Dec-2021, she departed for traveling. On 28-Dec-2021, she returned from traveling. On the same day, her specimen collected upon arrival in the TSCC tested negative. The patient underwent quarantine for the first four days, during which her sample tested positive on 29-Dec-2021. On the same day, she developed a sore throat and her sample carried the N501Y and T478K mutant strains. She was confirmed as COVID-19 with mutant strain of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 01-Jan-2022. This case was split from AER 2021FOS007602 due to same reporter/product, different event/patient. Bnt162b2 (COMIRNATY) is under agreement with BioNTech SE. Follow-up closed, no further information is possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200020676 same patient/ product, different events/patients


VAERS ID: 2033792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-12-29
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202112; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200037376

Write-up: confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K; CONFIRMED CASE OF COVID-19/IMPORTED CASE WITH MUTANT STRAIN OF N501Y + T478K; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000018. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. As of 0:00 am, 25-Dec-2021, DH announced that nineteen additional confirmed cases of COVID-19 after Comirnaty vaccination. This report was split for 1 of 19 patients that confirmed COVID-19 after Comirnaty vaccination. A 32-year-old male patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 13-Jul-2021 and 13-Aug-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization while traveling. Medical history, concomitant medication(s) and past product were not reported. On 29-Dec-2021, he arrived from traveling. On the same day, the patient had symptoms. In Dec-2021, the patient tested positive. He was confirmed as COVID-19 with mutant strain of N501Y and T478K. The adverse event ''confirmed case of COVID-19/imported case with mutant strain of N501Y + T478K'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 01-Jan-2022. This case was split from AER 2021FOS007602 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. BNT162B2 (COMIRNATY) is under agreement with BioNTech SE. Causality Assessment: COVID-19, Vaccination failure Per Reporter = Possible Per Company (BioNTech SE) = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200020676 Same reporter/drug, different patient


VAERS ID: 2033805 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-12-29
   Days after vaccination:252
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202201; Test Name: Gene sequencing; Result Unstructured Data: Test Result:carried the Variant of Concern Omicron; Test Date: 20211222; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: in (country); Test Date: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: upon arrival in the Temporary Specimen Collection Centre at International Airport; Test Date: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: at Community Testing Centre; Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: HKPFIZER INC202200048296

Write-up: Confirmed case of covid-19/imported case with mutant strains of n501y and t478k/carried the variant of concern omicron; Confirmed case of covid-19/imported case with mutant strains of n501y and t478k/carried the variant of concern omicron; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from License Party and Regulatory Authority. Other Case identifier(s): HK-Fosun-2022FOS000033. This is a spontaneous report received from a non-contactable HCP received via Department of Health (DH). The regulatory authority report number is not applicable. A 28-year-old female patient started to receive two doses of Tozinameran (COMIRNATY) (lot number: unknown) on 17-Mar-2021 and 21-Apr-2021 respectively via unknown route at unspecified dosing frequency for COVID-19 immunization in (country). Medical history, concomitant medication(s) and past product were not reported. On 22-Dec-2021, the patient tested negative in (country). On 24-Dec-2021, the patient left (country) to (another country). On 27-Dec-2021, the patient returned to (country) from (another country) by flight and her specimen collected upon arrival in the Temporary Specimen Collection Centre at International Airport tested negative. The patient underwent medical surveillance and regular compulsory testing in accordance with the relevant requirements for exempted persons. On 29-Dec-2021, the patient''s sample collected at a Community Testing Centre tested negative but she developed symptoms in the evening. On 30-Dec-2021, the patient consulted a private doctor and tested positive. On 01-Jan-2022, the patient''s sample tested preliminarily positive and carried the N501Y and T478K mutant strains. The patient was confirmed as COVID-19 with mutant strains of N501Y and T478K. Whole genome sequencing analysis conducted by the Public Health Laboratory confirmed that the patient carried the Variant of Concern Omicron. After comparing the genetic sequencing, the genomes of the patient were identical to the genomes of another confirmed case of COVID-19. Additionally, two family members of the patient were confirmed as asymptomatic COVID-19, and several cases who were close contacts of one of the family members were confirmed as COVID-19 or asymptomatic COVID-19. The adverse event ''confirmed case of COVID-19/imported case with mutant strains of N501Y and T478K/carried the Variant of Concern Omicron'' was considered as Important Medical Event. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 02-Jan-2022, 03-Jan-2022, 04-Jan-2022, 05-Jan-2022, 06-Jan-2022 and 07-Jan-2022. This case was split from AER 2021FOS007582 due to same reporter/product, different event/patient. Follow-up closed, no further information is possible. Bnt162b2 (COMIRNATY) is under agreement with regulatory authority. Causality Assessment: COVID-19, Vaccination failure Per Reporter = Possible Per Company = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202200010529 same reporter/product, different event/patient


VAERS ID: 2034051 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: oedema; Oedema face; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26432276) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of FACE OEDEMA (Oedema face) and OEDEMA (oedema) in a 44-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced FACE OEDEMA (Oedema face) (seriousness criterion medically significant). On an unknown date, the patient experienced OEDEMA (oedema) (seriousness criterion medically significant). At the time of the report, FACE OEDEMA (Oedema face) had not resolved and OEDEMA (oedema) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant and treatment medications were reported It was reported that was a telephone triage over the holiday period, Reporter have not seen the patient Patient was not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test It was reported that report not related to possible blood clots or low platelet counts and report not related to possible myocarditis or pericarditis Company Comment - This regulatory authority case concerns a 44 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of face oedema and oedema. The event occurred 1 day after the third dose of mRNA-1273 vaccine, the event oedema occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 44 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected events of face oedema and oedema. The event occurred 1 day after the third dose of mRNA-1273 vaccine, the event oedema occurred on an unknown date after the third dose of mRNA-1273 vaccine. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2034788 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-25
Onset:2021-12-29
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MODERNA
Current Illness:
Preexisting Conditions: 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.MOD20224

Write-up: Fatigue; Fever; Headache; Muscle ache; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26426886) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Nausea) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was reported. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) from 31-May-2021 to an unknown date for an unknown indication. On 25-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion disability), PYREXIA (Fever) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), MYALGIA (Muscle ache) (seriousness criterion disability) and NAUSEA (Nausea) (seriousness criterion disability). On 31-Dec-2021, FATIGUE (Fatigue) had resolved with sequelae and PYREXIA (Fever), HEADACHE (Headache), MYALGIA (Muscle ache) and NAUSEA (Nausea) 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 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19 and Patient is not currently breastfeeding. Began about 6 hours after vaccine given, lasted about 48 hours. Ibuprofen taken resulted in minimal improvement in pain or fever. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial. Company Comment: This case concerns a 32-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) events of Fatigue, Pyrexia, Headache, Myalgia and Nausea. The events occurred on the same day after receiving the third dose of mRNA-1273 Vaccine which resulted in a disabling condition. At the time of the report the outcome of the events was resolved. The rechallenge is unknown as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 32-year-old female patient, with no medical history reported, who experienced the unexpected serious (medically significant) events of Fatigue, Pyrexia, Headache, Myalgia and Nausea. The events occurred on the same day after receiving the third dose of mRNA-1273 Vaccine which resulted in a disabling condition. At the time of the report the outcome of the events was resolved. The rechallenge is unknown as per SD. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2036476 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-12-29
   Days after vaccination:262
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blepharitis, Blister, Body temperature, Bone pain, Frequent bowel movements, Haemorrhage, Herpes zoster, Myalgia, Pain, Pyrexia, Swelling face, Vaccination site erythema
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Osteonecrosis (broad), Ocular infections (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: Fever of around 39C
CDC Split Type: CAMODERNATX, INC.MOD20224

Write-up: Herpes zoster inside the nose and palate; Painful; Little blisters inside the nose; Blisters inside the nose are still painful and bleeding; Swelling of the eyelids / Her eyes are still swollen; Swelling of the face; Pain in every bone; Frequent bowel movement - 18 bowel movements in 36 hours; Pain in every muscle; Fever of around 39C; Diffuse redness on the area of the injection; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Blisters inside the nose are still painful and bleeding) in a 49-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 062H21A, 3002182 and 3001654) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Apr-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Dec-2021, received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced BLEPHARITIS (Swelling of the eyelids / Her eyes are still swollen), SWELLING FACE (Swelling of the face), BONE PAIN (Pain in every bone), FREQUENT BOWEL MOVEMENTS (Frequent bowel movement - 18 bowel movements in 36 hours), MYALGIA (Pain in every muscle), PYREXIA (Fever of around 39C) and VACCINATION SITE ERYTHEMA (Diffuse redness on the area of the injection). On 01-Jan-2022, the patient experienced HAEMORRHAGE (Blisters inside the nose are still painful and bleeding) (seriousness criterion medically significant), HERPES ZOSTER (Herpes zoster inside the nose and palate), PAIN (Painful) and BLISTER (Little blisters inside the nose). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes zoster, at an unspecified dose and frequency. On 01-Jan-2022, VACCINATION SITE ERYTHEMA (Diffuse redness on the area of the injection) had resolved. At the time of the report, HAEMORRHAGE (Blisters inside the nose are still painful and bleeding), BLEPHARITIS (Swelling of the eyelids / Her eyes are still swollen), HERPES ZOSTER (Herpes zoster inside the nose and palate), PAIN (Painful) and BLISTER (Little blisters inside the nose) had not resolved and SWELLING FACE (Swelling of the face), BONE PAIN (Pain in every bone), FREQUENT BOWEL MOVEMENTS (Frequent bowel movement - 18 bowel movements in 36 hours), MYALGIA (Pain in every muscle) and PYREXIA (Fever of around 39C) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Body temperature: high (High) Fever of around 39C. No Concomitant medication information was reported. Patient reported that she had to take Valacyclovir (Valtrex) because it was so painful inside the nose with all the blisters. Despite taking anti-viral, it was still painful and bleeding. Her eyes were still swollen at the time of the call. Pictures has been provided with the follow up. This case was linked to MOD-2022-440595, MOD-2022-440637 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2022: Follow-up received on 05-Jan-2022, Pictures provided.; Sender''s Comments: This is a spontaneous case concerning a 49-year-old female patient with no medical history reported, who experienced the serious unexpected event of Haemorrhage(seriousness criterion medically significant), with other non serious events. This event occurred 3 days after the patient received their third dose of mRNA-1273 (Moderna CoviD-19 Vaccine). At the time of the report the outcome was unknown.The rechallenge was unknown since there''s no information about the first two doses. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2036478 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5109 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Immunisation, Musculoskeletal stiffness, Pain, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to animals; Arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20220102; Test Name: Nasal Swab; Result Unstructured Data: Test Result:Negative; Comments: Technique: Nasal Swab
CDC Split Type: CAPFIZER INC202200004380

Write-up: extreme fatigue.; Stiff neck; chills; body aches; fever; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Dec2021 12:45 (Lot number: Ff5109) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "Pets allergy" (unspecified if ongoing). The patient''s concomitant medications were not reported. Past drug history included: Nsaid, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Fa9093, Location of injection: Arm Left), administration date: 20Jun2021, for covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Ex0438, Location of injection: Arm Left), administration date: 22Apr2021, for covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021 12:45, outcome "unknown", described as "BOOSTER"; FATIGUE (medically significant) with onset 30Dec2021, outcome "unknown", described as "extreme fatigue."; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 30Dec2021, outcome "unknown", described as "Stiff neck"; CHILLS (non-serious) with onset 30Dec2021, outcome "unknown", described as "chills"; PAIN (non-serious) with onset 30Dec2021, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 30Dec2021, outcome "unknown", described as "fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative: (02Jan2022) negative, notes: Technique: Nasal Swab. Therapeutic measures were not taken as a result of fatigue, musculoskeletal stiffness, chills, pain, pyrexia. Clinical course: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination. She has been tested positive for COVID-19 since the vaccination. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2036778 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000014A / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chills, Cough, Dizziness, Fatigue, Headache, Hypertension, Myalgia, Palpitations, Periarthritis, Vaccination site inflammation
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLIN; CELECOXIB; LEVOTHYROXINE SODIUM; PARACETAMOL; TRAMADOL; VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Becker''s muscular dystrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Abdominal pain; Frozen shoulder; Extreme tiredness; Shivering; Dry cough; Heart racing; Blood pressure high; Injection site inflammation; Headache; Woozy; Muscle ache; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424548) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26424548) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Injection site inflammation), ABDOMINAL PAIN (Abdominal pain), HEADACHE (Headache), DIZZINESS (Woozy), MYALGIA (Muscle ache), PERIARTHRITIS (Frozen shoulder), PALPITATIONS (Heart racing), FATIGUE (Extreme tiredness), HYPERTENSION (Blood pressure high), CHILLS (Shivering) and COUGH (Dry cough) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for COVID-19 vaccination. The patient''s past medical history included Becker''s muscular dystrophy. Concomitant products included AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLIN), CELECOXIB, LEVOTHYROXINE SODIUM, PARACETAMOL, TRAMADOL and VITAMIN D3 for an unknown indication. On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Parenteral) 1 dosage form. On 29-Dec-2021, the patient experienced VACCINATION SITE INFLAMMATION (Injection site inflammation) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), DIZZINESS (Woozy) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant), PALPITATIONS (Heart racing) (seriousness criterion medically significant), FATIGUE (Extreme tiredness) (seriousness criterion medically significant), HYPERTENSION (Blood pressure high) (seriousness criterion medically significant), CHILLS (Shivering) (seriousness criterion medically significant) and COUGH (Dry cough) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced PERIARTHRITIS (Frozen shoulder) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant). On 30-Dec-2021, COUGH (Dry cough) had resolved. On 31-Dec-2021, HEADACHE (Headache) and DIZZINESS (Woozy) was resolving, PALPITATIONS (Heart racing), FATIGUE (Extreme tiredness), HYPERTENSION (Blood pressure high) and CHILLS (Shivering) had resolved with sequelae. On 01-Jan-2022, MYALGIA (Muscle ache) and PERIARTHRITIS (Frozen shoulder) was resolving. At the time of the report, VACCINATION SITE INFLAMMATION (Injection site inflammation) had not resolved and ABDOMINAL PAIN (Abdominal pain) outcome was unknown. Concomitant medication include- HOLLAND AND BARRETT ULTRA WOMAN. Patient felt like she had taken an ounce of amphetamine for the first two days. Her heart was racing and pounding in the chest and blood pressure was sky high. Patient would not able to sleep, but was exhausted. Every time she dropped off her heart woke her straight up again. She also had a few sharp pains in the abdomen. It felt exactly like an awful come down off amphetamines circa late 1990''s. When she asked about her medical conditions, she specifically listed that she was a manifesting carrier for Becker''s muscular dystrophy which also carried with it dilated cardiomyopathy. It was only after the injection had been administered that the nurse told her that the spikevax vaccine has a side effect of heart swelling. And, if patient should get any heart pains patient should go to Accident and Emergency (A&E). Unfortunately, patient would not get medical help as she was awaiting the results of a PCR test having been in direct contact with the colleague who tested positive that night. Treatment information was not provided.; Sender''s Comments: This is a regulatory case concerning a 41-year-old female patient with no relevant medical history, who experienced the serious unexpected events of Vaccination site inflammation, Abdominal pain, and Palpitations(seriousness criterion medically significant). Vaccination site inflammation and Palpitations occurred on the same day the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine), with Abdominal pain occurring on an unknown date.The rechallenge was unknown since there''s only information about one dose.The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2036842 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dysmenorrhoea, Feeling cold, Headache, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, Oropharyngeal pain, Pain in extremity
SMQs:, Acute pancreatitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200000832

Write-up: very painful to move arm; Throat feels cold; feel sick; Sore throat; Appetite lost; Nausea; Period pains; Headache; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201010922406100-3NOP4 Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26423785 Regulatory Authority. A 28 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; NAUSEA (medically significant) with onset 30Dec2021, outcome "recovering", described as "Nausea"; DYSMENORRHOEA (medically significant) with onset 30Dec2021, outcome "recovered", described as "Period pains"; HEADACHE (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Sore throat"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "very painful to move arm"; DECREASED APPETITE (medically significant) with onset 30Dec2021, outcome "recovering", described as "Appetite lost"; FEELING COLD (medically significant), outcome "unknown", described as "Throat feels cold"; MALAISE (medically significant), outcome "unknown", described as "feel sick". Additional information: Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. Incredibly intense feelings of nausea and feeling like I would be about to vomit at any moment. Appetite lost with stomach only for bland foods. Intense feelings akin to period pains on morning after booster administrated, and very painful to move arm that vaccine was dosed into. Throat feels cold and almost icy whenever I feel sick which is still ongoing. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The report not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200000308

Write-up: swelling under armpit/same as jabbed arm, suspected lymph node swelling; Swelling; Booster; This is a spontaneous report received from a contactable consumer from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201011811367920-DPJRJ. A 28-year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient not had symptoms associated with COVID-19. The 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 29Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant), outcome "not recovered", described as "swelling under armpit/same as jabbed arm, suspected lymph node swelling"; SWELLING (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swelling". The patient has not tested positive for COVID-19 since having the vaccine. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036862 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FL9994 / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003747

Write-up: chest pain; booster; shivers; This is a spontaneous report received from a contactable reporter consumer or other non HCP from the Regulatory Agency (RA). Regulatory number: GB-MHRA-WEBCOVID-202201020859047260-LW4IK (RA). Other Case identifiers: GB-MHRA-ADR 26424702 (RA). A 36 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (batch/lot number: FL9994) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19, not enrolled in clinical trial. Vaccination history included: bnt162b2 (dose 1), for COVID-19 immunization; bnt162b2 (dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; CHILLS (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "shivers"; CHEST PAIN (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "chest pain". The patient underwent the following laboratory tests and procedures: COVID-19 virus test: (02Sep2021) yes - positive covid-19 test. The patient has not tested positive for COVID-19 since having the vaccine. Additional information: The reporter did not relate the report to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain upper, Dyspepsia, Flatulence, Immunisation, Interchange of vaccine products, Irritable bowel syndrome, Off label use, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM TRISILICATE;SODIUM ALGINATE;SODIUM B; MEBEVERINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200003808

Write-up: gas; stomach pain; bloating; heartburn; Irritable bowel; 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-202201021302038070-CBANL (RA). Other Case identifier(s): GB-MHRA-ADR 26424897 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 22Nov2021 (unspecified if ongoing), notes: Unsure when symptoms stopped. Concomitant medication(s) included: GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM TRISILICATE;SODIUM ALGINATE;SODIUM BICARBONATE]; INFLUENZA VIRUS, administration date 29Dec2021; MEBEVERINE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; FLATULENCE (medically significant), outcome "not recovered", described as "gas"; ABDOMINAL PAIN UPPER (medically significant), outcome "not recovered", described as "stomach pain"; ABDOMINAL DISTENSION (medically significant), outcome "not recovered", described as "bloating"; DYSPEPSIA (medically significant), outcome "not recovered", described as "heartburn"; IRRITABLE BOWEL SYNDROME (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Irritable bowel". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: yes - positive covid-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2036903 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Off label use, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200003799

Write-up: Off label use; Interchange of vaccine products; Booster; Heart pounding; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201021741278130-YWYDZ. Other Case identifier: GB-MHRA-ADR 26425107. A female patient received BNT162B2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9712) as dose 3 (booster), single for COVID-19 immunization. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Vaccination history included: COVID-19 VACCINE (DOSE 1; UNKNOWN MANUFACTURER), for COVID-19 immunization; COVID-19 VACCINE (DOSE 2; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: Off label use, interchange of vaccine products and booster, all with onset 29Dec2021 and outcome of unknown. The patient also experienced heart pounding with onset 29Dec2021 and outcome of recovered (30Dec2021). Heart pounding whether lying down or standing up and occurred a couple of hours after having the vaccine. Never previously experienced. The events were reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear pain, Eye pain, Immunisation, SARS-CoV-2 test
SMQs:, Glaucoma (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 INC202200003834

Write-up: Eye ache; Ear ache; 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-202201022309417540-J27MO. Other Case identifier(s): GB-MHRA-ADR 26425355. A 23 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9712) as dose 3 (booster), single for covid-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; EAR PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Ear ache"; EYE PAIN (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Eye ache". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2036998 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenopia, Disorientation, Eye pain, Fatigue, Headache, Pyrexia, Relapsing fever, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Corneal disorders (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: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211231; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Eye strain; Headache; Fever; Disorientation; Eye ache; Persistent headache; Fatigue; Relapsing fever; This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), EYE PAIN (Eye ache), ASTHENOPIA (Eye strain), HEADACHE (Headache), PYREXIA (Fever), DISORIENTATION (Disorientation), RELAPSING FEVER (Relapsing fever) and HEADACHE (Persistent headache) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 30-Jun-2021 to an unknown date for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and RELAPSING FEVER (Relapsing fever) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced HEADACHE (Persistent headache) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced EYE PAIN (Eye ache) (seriousness criterion medically significant) and DISORIENTATION (Disorientation) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENOPIA (Eye strain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and PYREXIA (Fever) (seriousness criterion medically significant). On 01-Jan-2022, RELAPSING FEVER (Relapsing fever) had resolved with sequelae. On 03-Jan-2022, HEADACHE (Persistent headache) had resolved with sequelae. At the time of the report, FATIGUE (Fatigue) and EYE PAIN (Eye ache) had not resolved and ASTHENOPIA (Eye strain), HEADACHE (Headache), PYREXIA (Fever) and DISORIENTATION (Disorientation) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided by the reporter. Patient received vaccination on 29 Dec 2021 at 9 am and fever started on 7 pm. On 30 Dec 2021 patient had high fever and headache. On 31 Dec 2021 fever reduced but headache and eye soreness continued. On 1 Jan 2022 fever resumed along with headache, disorientation, fatigue and eye strain. Headache, fatigue, disorientation and eye strain were reduced on 02/12 but next day fatigue, disorientation and eye strain continued. Patient had not had any symptoms associated with COVID-19 and not on any regular medication, illness or any possible inflammation of the heart. This is a regulatory case concerning a male patient of unknown age with no medical history reported, who experienced the events of fatigue, eye pain, asthenopia, pyrexia, disorientation, relapsing fever and headache. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events fatigue and relapsing fever occurred on the same day after the third dose of mRNA ? 1273 vaccine, while the events eye pain and disorientation was experienced one day after. Asthenopia, headache and pyrexia started on an unknown date. Events were reported as medically significant and at the time of report the events fatigue and eye pain have not resolved, but the rests of the events have either resolved or are resolving. 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 male patient of unknown age with no medical history reported, who experienced the events of fatigue, eye pain, asthenopia, pyrexia, disorientation, relapsing fever and headache. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The events fatigue and relapsing fever occurred on the same day after the third dose of mRNA ? 1273 vaccine, while the events eye pain and disorientation was experienced one day after. Asthenopia, headache and pyrexia started on an unknown date. Events were reported as medically significant and at the time of report the events fatigue and eye pain have not resolved, but the rests of the events have either resolved or are resolving. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2037010 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Illness, Immunisation, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (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
CDC Split Type: GBPFIZER INC202200009368

Write-up: Bruising; Booster; Sickness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) Regulatory number: GB-MHRA-WEBCOVID-202201031442041870-5ADPA. Other Case identifier(s): GB-MHRA-ADR 26428906. A 23 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) at the age of 23 years as dose 3 (booster), single for COVID-19 immunisation. Patient''s last menstrual period date was 28Dec2021. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), administration date: 18Jun2021, for COVID-19 Immunization; Bnt162b2 (Dose 2, Single), administration date: 12Aug2021, for COVID-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; ILLNESS (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Sickness"; CONTUSION (medically significant) with onset 30Dec2021, outcome "recovered" (02Jan2022), described as "Bruising". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. 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-202200024415 Same patient/Drug/Reporter, different dose number and event.


VAERS ID: 2037022 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Gastric pH decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness: Autoimmune disorder; Gallstones; Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211226; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: stomach acid; stomach ache; Stomach pain; Fatigue; High temperature; Aching joints; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26429743) on 04-Jan-2022 and was forwarded to Moderna on 04-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of GASTRIC PH DECREASED (stomach acid), ABDOMINAL PAIN UPPER (stomach ache), FATIGUE (Fatigue), PYREXIA (High temperature), ABDOMINAL PAIN UPPER (Stomach pain) and ARTHRALGIA (Aching joints) in a 38-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. The patient''s past medical history included COVID-19 in March 2020. Concurrent medical conditions included Gallstones, Autoimmune disorder and Immunodeficiency (Taking other treatments or medicines, not listed above, known to lower the immune response and i...). Concomitant products included LANSOPRAZOLE for Hyperacidity. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ARTHRALGIA (Aching joints) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant) and PYREXIA (High temperature) (seriousness criterion medically significant). On 02-Jan-2022, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). On an unknown date, the patient experienced GASTRIC PH DECREASED (stomach acid) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach ache) (seriousness criterion medically significant). On 31-Dec-2021, PYREXIA (High temperature) and ARTHRALGIA (Aching joints) had resolved. At the time of the report, GASTRIC PH DECREASED (stomach acid) and ABDOMINAL PAIN UPPER (stomach ache) had resolved, FATIGUE (Fatigue) was resolving and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment drug was provided by reporter. Patient last menstrual period date was19-DEC-2021. Patient had not had symptoms associated with COVID-19 Patient was not pregnant, Patient was not currently breastfeeding. Reaction was very similar to original vaccines (both Pfizer). In this instance the reactions resolved themselves more quickly but felt more severe - Patient was unable to get out of bed for two days. Patient had stomachache was only after food and again was something she experienced for a prolonged period after the Pfizer vaccine. She suspected this reaction was linked to her immune response, which was likely to be odd due to her having a severe autoimmune response to COVID-19 in March 2020. she had ongoing stomach issues since then and had been diagnosed with gallstones. However, the pain in this instance was completely different to gallstone pain and happens no matter what she eats. Please note she was taking lansoprazole for stomach acid issues. 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 38-year-old female patient, with relevant medical history of Gall stones, Autoimmune disorder, Immunodeficiency and vaccination with PFIZER BIONTECH COVID-19 VACCINE, who experienced the unexpected serious (medically significant) events of Gastric pH decreased, Abdominal pain upper, Arthralgia, Fatigue and Pyrexia. The events occurred approximately 1-4 days after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was resolving to resolved except for Abdominal pain upper which had not resolved. The rechallenge is unknown as per RA. The patient''s medical history of Gall stones, Autoimmune disorder, Immunodeficiency and vaccination with PFIZER BIONTECH COVID-19 VACCINE remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this r; Sender''s Comments: This case concerns a 38-year-old female patient, with relevant medical history of Gall stones, Autoimmune disorder, Immunodeficiency and vaccination with PFIZER BIONTECH COVID-19 VACCINE, who experienced the unexpected serious (medically significant) events of Gastric pH decreased, Abdominal pain upper, Arthralgia, Fatigue and Pyrexia. The events occurred approximately 1-4 days after receiving the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was resolving to resolved except for Abdominal pain upper which had not resolved. The rechallenge is unknown as per RA. The patient''s medical history of Gall stones, Autoimmune disorder, Immunodeficiency and vaccination with PFIZER BIONTECH COVID-19 VACCINE remain as confounders for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2037031 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Fatigue, Immunisation, Interchange of vaccine products, Off label use, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), 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: TADALAFIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Enlarged prostate (benign); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202200009299

Write-up: Off label use; Interchange of vaccine products; Booster; Diarrhea; Vomiting; Aching joints; Tiredness; 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-202201031848421080-6I6TA. Other Case identifier(s): GB-MHRA-ADR 26430070. A 55 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) at the age of 55 years as dose 3 (booster), single for COVID-19 immunisation. The patient was not enrolled in clinical trial. Relevant medical history included: "Suspected COVID-19", start date: 04Jul2021, stop date: 12Jul2021; "Enlarged prostate (benign)" (unspecified if ongoing). Concomitant medication(s) included: TADALAFIL taken for benign prostatic hyperplasia, start date: 01Mar2019. Vaccination history included: COVID-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; COVID-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; DIARRHOEA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Diarrhea"; VOMITING (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Vomiting"; ARTHRALGIA (medically significant) with onset 29Dec2021, outcome "recovered" (02Jan2022), described as "Aching joints"; FATIGUE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Tiredness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jul2021) positive. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037110 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Decreased appetite, Fatigue, Headache, Lymphadenopathy, Nausea, Pain in extremity, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: feel exhausted and tire very easily; Stomach pain; Appetite suppressed; Exhaustion; Nausea; Pain in arm; Swollen glands; Headache; Shoulder pain; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26433981) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain), DECREASED APPETITE (Appetite suppressed), FATIGUE (Exhaustion), NAUSEA (Nausea), PAIN IN EXTREMITY (Pain in arm), FATIGUE (feel exhausted and tire very easily), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and ARTHRALGIA (Shoulder pain) in a 65-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No medical history was reported. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for COVID-19 vaccination, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 12-Mar-2021 to an unknown date for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ARTHRALGIA (Shoulder pain) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant), DECREASED APPETITE (Appetite suppressed) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (feel exhausted and tire very easily) (seriousness criterion medically significant). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain), DECREASED APPETITE (Appetite suppressed), FATIGUE (Exhaustion) and NAUSEA (Nausea) had not resolved and PAIN IN EXTREMITY (Pain in arm), FATIGUE (feel exhausted and tire very easily), LYMPHADENOPATHY (Swollen glands), HEADACHE (Headache) and ARTHRALGIA (Shoulder pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient had no bruising. Patient was experienced substantial pain from shoulder to fingers 48 hours, Arm and shoulder pain remained, had remains at lesser extent. Patient was experienced hard lump under arm same side as vaccination, extremely painful radiating into shoulder and chest, worsened for couple of days now slowly reducing, mass now soft and sore. Patient was experienced nausea and suppressed appetite, very little eaten, reluctance to drink but had continued to do so to prevent dehydration. Patient felt exhausted and tire very easily, sleep when needed. Patient initial headache was resolved. Patient was experienced slight pain in chest and stomach. Paracetamol took when needed. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient took paracetamol as treatment medication. This is a regulatory case concerning a 65-year-old female patient with no reported medical history, who experienced the serious per reported severity unexpected events of abdominal pain upper, decreased appetite, fatigue, nausea, pain in extremity, fatigue, lymphadenopathy, headache and arthralgia. The events occurred within the first 2 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given 2 doses of AstraZeneca COVID-19 vaccine approximately 9 and 6 months prior to mRNA-1273 vaccination. The 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 female patient with no reported medical history, who experienced the serious per reported severity unexpected events of abdominal pain upper, decreased appetite, fatigue, nausea, pain in extremity, fatigue, lymphadenopathy, headache and arthralgia. The events occurred within the first 2 days after the third dose of mRNA-1273 vaccine administration. The events were assessed as related to the product administration. The rechallenge was reported as unknown; however, could be considered as not applicable since the events occurred after the third dose and no further dosing is expected. The patient completed primary vaccination with a different authorized or approved COVID-19 vaccine and was given 2 doses of AstraZeneca COVID-19 vaccine approximately 9 and 6 months prior to mRNA-1273 vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2037112 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000050A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Neuropathy peripheral, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

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

Write-up: back pain; pins and needles; Neuropathy; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26434142) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of BACK PAIN (back pain), PARAESTHESIA (pins and needles) and NEUROPATHY PERIPHERAL (Neuropathy) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000050A) for an unknown indication. The patient''s past medical history included Immunosuppression (No immunosuppression). Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 27-Apr-2021 to an unknown date for COVID-19 vaccination, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for Vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant). On an unknown date, the patient experienced BACK PAIN (back pain) (seriousness criterion medically significant) and PARAESTHESIA (pins and needles) (seriousness criterion medically significant). At the time of the report, BACK PAIN (back pain) and PARAESTHESIA (pins and needles) was resolving and NEUROPATHY PERIPHERAL (Neuropathy) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had pain in left deltoid within 15 minutes of injection into left deltoid. Over the remainder of the day, the patient''s pain spread to the left shoulder, down the left arm and into the left hand. Her Pins and needles and reduced strength. Patient had Cervical and axillary lymphadenopathy. She also developed chest and back pain, which are now settling. Patient not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial . Patient had no related possible blood clots or low platelet counts. Patient had normal examination, other than pain and reduced strength. Treatment information was not provided. Company comment: This regulatory case concerns a 40-year-old female patient, with no relevant medical history, who experienced the serious (medically significant) unexpected event of NEUROPATHY PERIPHERAL, BACK PAIN and PARAESTHESIA. The event of neuropathy peripheral occurred on the same day after receiving a dose of mRNA-1273 and has not recovered. No onset date was reported for other events. Previous vaccination schedule included 2 doses of Tozinameran. According to source document narrative, patient experienced pain in arm, reduced strength, paraesthesia, cervical and axillary lymphadenopathies and chest and back pain. No information regarding neuropathy was provided in the narrative. No further clinical information, including medical consultations or treatment received, was reported for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.; Sender''s Comments: This regulatory case concerns a 40-year-old female patient, with no relevant medical history, who experienced the serious (medically significant) unexpected event of NEUROPATHY PERIPHERAL, BACK PAIN and PARAESTHESIA. The event of neuropathy peripheral occurred on the same day after receiving a dose of mRNA-1273 and has not recovered. No onset date was reported for other events. Previous vaccination schedule included 2 doses of Tozinameran. According to source document narrative, patient experienced pain in arm, reduced strength, paraesthesia, cervical and axillary lymphadenopathies and chest and back pain. No information regarding neuropathy was provided in the narrative. No further clinical information, including medical consultations or treatment received, was reported for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was captured as provided by the Regulatory Authority.


VAERS ID: 2037135 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

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

Write-up: difficulty breathing; Increased shortness of breath; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26435390) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and DYSPNOEA (Increased shortness of breath) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. Concomitant products included PREDNISOLONE for Respiratory therapy, COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) from 06-Mar-2021 to an unknown date, COVID-19 VACCINE (COVID-19 VACCINE ASTRAZENECA) and INFLUENZA VACCINE (INFLUENZA VIRUS) from 13-Dec-2021 to an unknown date for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DYSPNOEA (Increased shortness of breath) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (difficulty breathing) and DYSPNOEA (Increased shortness of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient had the vaccine at 1523. At 1900 patient was started having difficulty breathing and realised airway was occluding.Called 111 and took prednisolone and 111 called to patient an ambulance. The steroids were working when the paramedic arrived and so left at home. Treatment product was not provided by the reporter; Sender''s Comments: This is an RA case concerning patient of unknown gender and age with no medical history reported, who experienced the event of dyspnea 3 hours after having the third dose of mRNA1273. Patient reports that started having difficulty breathing and realised their airway was occluding. They called EMS and took prednisolone. Patient reports that by the time the paramedics arrived, dyspnea was improving, so no hospital referral was needed. Despite not reporting any current condition, patient takes prednisolone as a concomitant medication indicated to respiratory therapy [sic], which can be a confounder. Event seriousness was captured as provided by the Regulatory Authority. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2037147 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

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

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

Write-up: Sickness; This case was received(Reference number: GB-MHRA-ADR 26435915) on 05-Jan-2022 and was forwarded to Moderna on 05-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) in a 47-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 30-Dec-2021, ILLNESS (Sickness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant Medication use information was not provided by reporter. Patient was not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not tested positive for COVID-19 since the vaccine. Patient was not enrolled in clinical trial. Treatment Medication use information was not provided by reporter. Company Comment: This RA case concerns a 47 year old female with no medical history reported, who experienced, Serious ( medically significant ) , unexpected event of Illness which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknonw by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a 47 year old female with no medical history reported, who experienced, Serious ( medically significant ) , unexpected event of Illness which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) . The re-challenge for this case was captured as unknonw by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2037177 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000040A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Candida infection, Maternal exposure during breast feeding, Oral candidiasis, Screaming
SMQs:, Severe cutaneous adverse reactions (broad), Oropharyngeal infections (narrow), Hostility/aggression (broad), Neonatal exposures via breast milk (narrow), Hypersensitivity (broad), Opportunistic infections (broad)

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

Write-up: screaming; oral thrush; blisters; Maternal exposure during breast feeding; Thrush; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26437424) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of SCREAMING (screaming), ORAL CANDIDIASIS (oral thrush), BLISTER (blisters), MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and CANDIDA INFECTION (Thrush) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000040A) for an unknown indication. Concurrent medical conditions included Breast feeding. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced CANDIDA INFECTION (Thrush) (seriousness criterion medically significant). On an unknown date, the patient experienced SCREAMING (screaming) (seriousness criterion medically significant), ORAL CANDIDIASIS (oral thrush) (seriousness criterion medically significant), BLISTER (blisters) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant). At the time of the report, SCREAMING (screaming), ORAL CANDIDIASIS (oral thrush) and BLISTER (blisters) was resolving, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and CANDIDA INFECTION (Thrush) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment medication is reported. The patient had the vaccine at 10:40am, She felt fine in herself but her baby who she breastfeed was very unsettled that evening and night. She was arching her back during feeds and screaming. Next day she noticed a few spots and blisters on her hands. Few days later she develop thrush in her nipples and had excruciating pain feeding her and suspected oral thrush for her daughter. COMPANY COMMENT: This is a Regulatory case concerning 31-years-old female patient with clinical history of breast feeding who experienced the unexpected events of SCREAMING, ORAL CANDIDIASIS, BLISTER, CANDIDA INFECTION and MATERNAL EXPOSURE DURING BREAST FEEDING The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority; Sender''s Comments: COMPANY COMMENT: This is a Regulatory case concerning 31-years-old female patient with clinical history of breast feeding who experienced the unexpected events of SCREAMING, ORAL CANDIDIASIS, BLISTER, CANDIDA INFECTION and MATERNAL EXPOSURE DURING BREAST FEEDING The events occurred 1 days after 3rd dose of mRNA-1273. The rechallenge was not applicable since only information about 3rd dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event terms, seriousness and onset dates were captured as provided by the Regulatory Authority


VAERS ID: 2037190 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anger, Dizziness, Frustration tolerance decreased, Headache, Immunisation, Interchange of vaccine products, Irritability, Maternal exposure during breast feeding, Off label use, Pain, Product use issue, SARS-CoV-2 test, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Vestibular disorders (broad), Neonatal exposures via breast milk (narrow), Hypersensitivity (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: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019173

Write-up: irritability; pain; dizzy; Temple swelling; Head pain; Angry; Frustrated; Maternal exposure during breast feeding; Drug use in unapproved population; Booster; Off label use; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201052149480360-CBWBA. Other Case identifier(s): GB-MHRA-ADR 26441411. A 40 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Breast feeding" (ongoing); "Suspected COVID-19", start date: 10Feb2020, stop date: 10Mar2020. 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. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 1, Batch/lot number: PV46678), administration date: 06May2021, for COVID-19 Immunisation, reaction(s): "Head pain", "Temple swelling", "Head pressure", "Dizziness", "Tiredness", "Diarrhoea"; Covid-19 vaccine astrazeneca (Dose 2, Batch/lot number: PV46688), administration date: 06Jul2021, for COVID-19 Immunisation, reaction(s): "Head pain", "Temple swelling". The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; MATERNAL EXPOSURE DURING BREAST FEEDING (medically significant), outcome "unknown", described as "Maternal exposure during breast feeding"; PRODUCT USE ISSUE (medically significant), outcome "unknown", described as "Drug use in unapproved population"; IRRITABILITY (medically significant), outcome "not recovered", described as "irritability"; PAIN (medically significant), outcome "not recovered", described as "pain"; DIZZINESS (medically significant), outcome "not recovered", described as "dizzy"; SWELLING FACE (medically significant), outcome "not recovered", described as "Temple swelling"; HEADACHE (medically significant), outcome "not recovered", described as "Head pain"; ANGER (medically significant), outcome "unknown", described as "Angry"; FRUSTRATION TOLERANCE DECREASED (medically significant), outcome "unknown", described as "Frustrated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of swelling face, headache. Clinical information: With all vaccines, 24 - 48hrs later the patient had one side head pulsates with pain in my temple above my ear radiating to the back of neck. Doctors tried antihistamines and antibiotics to resolve but nothing helped. Paracetamol doesn''t help the pain. With the first two vaccines it had taken around a month to clear. With this booster it''s been a week and is getting worse. It makes the patient dizzy, frustrated and angry. The patient stated that will not take the vaccine again. It also caused severe diarrhoea and irritability in my breastfeeding baby which lasted a week to two weeks both times with my first two vaccines (I am no longer breastfeeding). The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2037219 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9707 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling cold, Headache, Lower respiratory tract infection, Peripheral swelling, Pyrexia, SARS-CoV-2 test, Vaccination site erythema
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? 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 INC202200017596

Write-up: Headache; Tired all the time; Chest cold; Swollen arm; Injection site redness; Feeling cold; High temperature; RA YELLOW CARD VACCINE MONITOR This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA) for a sponsored program. A 16 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9707) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1(single), Batch/Lot: FE8087., Date and time of drug administration: 04Sep2021., Event onset Date: 04Sep2021., Outcome of Event: NOT RECOVERED/NOT RESOLVED.), administration date: 04Sep2021, for COVID-19 immunization, reaction(s): "Arm discomfort". The following information was reported: HEADACHE (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Headache"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovered" (30Dec2021), described as "Tired all the time"; LOWER RESPIRATORY TRACT INFECTION (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Chest cold"; PERIPHERAL SWELLING (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen arm"; VACCINATION SITE ERYTHEMA (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Injection site redness"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "High temperature"; FEELING COLD (medically significant) with onset 30Dec2021, outcome "recovered" (31Dec2021), described as "Feeling cold". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical Course: Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The reporter''s assessment of the causal relationship of the events Headache, Fatigue, Lower respiratory tract infection, Peripheral swelling, Injection site erythema, Pyrexia, feeling cold with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events headache, fatigue, lower respiratory tract infection, peripheral swelling, vaccination site erythema, pyrexia and feeling cold with the suspect drug Comirnaty cannot be excluded. The case will be reassessed once new information is available.,Linked Report(s) : GB-PFIZER INC-202101153032 same patient/same suspect/different dose/different event (Dose 1)


VAERS ID: 2037233 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200027091

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter (consumer or other non-healthcare professional) from the regulatory authority and the Product Quality Group. A 67-year-old male patient received bnt162b2 (BNT162B2) via an unspecified route of administration on 14Apr2021 (batch/lot number: ER1749) as DOSE 2, SINGLE and received bnt162b2 (BNT162B2) via an unspecified route of administration on an unspecified date (batch/lot number: unknown) as DOSE 1, SINGLE for COVID-19 immunization. The patient''s relevant medical history was not reported. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, disability, medically significant), COVID-19 (hospitalization, disability, medically significant) all with onset 29Dec2021, outcome "recovering" and all described as "SARS-CoV-2 infection." The patient underwent the following laboratory tests and procedures: COVID-19 virus test (SARS-CoV-2 test): (30Dec2021) positive, notes: Yes - Positive COVID-19 test. The Product Quality Complaints'' group reported the Investigation results and conclusion regarding Lack of efficacy complaint related to BNT162B2 (batch/lot number: ER1749). The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER1749. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Pfizer concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible; information about the batch/lot number for Dose 1 cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200009631 Same patient/product, different dose/events


VAERS ID: 2037244 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200063273

Write-up: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. A 25 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 25 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient was not breastfeeding. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Drug ineffective"; SUSPECTED COVID-19 (medically significant) with onset 29Dec2021, outcome "unknown", described as "Suspected COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. The patient had not tested positive for COVID-19 since the vaccination. 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-202101885867 Same patient, different dose/events


VAERS ID: 2038739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20220104; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Hives; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26437933) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant). On 30-Dec-2021, URTICARIA (Hives) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Reported that patient have exercise induced anaphylaxis and the reaction only occurred once patient started to walk to her car. Dosage text :Dose 3c Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial Patient has not had symptoms associated with COVID-19 Company Comment : This RA case concerns a female patient with unknown age with no medical history reported , who experienced serious ( Medically significant ) , unexpected event of urticaria which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case was reported as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.; Sender''s Comments: This RA case concerns a female patient with unknown age with no medical history reported , who experienced serious ( Medically significant ) , unexpected event of urticaria which occurred one day after vaccination with the 3rd dose of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case was reported as unknown by this RA report. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.


VAERS ID: 2038769 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-13
Onset:2021-12-29
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005686 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blindness, Giant cell arteritis, Retinal vein occlusion
SMQs:, Embolic and thrombotic events, venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (narrow), Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Loss of vision; Temporal arteritis; Central retinal vein occlusion; This case was received (Reference number: GB-MHRA-ADR 26440475) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of RETINAL VEIN OCCLUSION (Central retinal vein occlusion), BLINDNESS (Loss of vision) and GIANT CELL ARTERITIS (Temporal arteritis) in a 58-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005686) for an unknown indication. Concurrent medical conditions included Non-smoker. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication. On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RETINAL VEIN OCCLUSION (Central retinal vein occlusion) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced BLINDNESS (Loss of vision) (seriousness criteria disability and medically significant) and GIANT CELL ARTERITIS (Temporal arteritis) (seriousness criterion disability). At the time of the report, RETINAL VEIN OCCLUSION (Central retinal vein occlusion) was resolving and BLINDNESS (Loss of vision) and GIANT CELL ARTERITIS (Temporal arteritis) 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. Patient has not had symptoms associated with COVID-19 and Not had a COVID-19 test. Patient developed loss of vision overnight 2 weeks post booster dose covid vaccine found to have central retinal artery occlusion. Was checked for temporal arteritis but inflammatory markers normal, note platelets were 220 on admissions The patient report relate to possible blood clots or low platelet counts was reported as Yes. Patient was diagnosed by a scan on 29-Dec-2021 and the platelet count <150 x 109/L was reported as No. On 29-Dec-2021 patient platelet count was measured. Patient additional medical history, not already provided, that relates to previous venous, or arterial thromboses was reported as that some time ago had a raised dimer but nil else pertaining to this. Patient the last platelet count before the vaccine was on 08-Apr-2021 at 244 (usual normal range 150-450). Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial Company Comment: This case concerns a 58 year-old female patient with a history of AstraZeneca COVID-19 vaccine who experienced the unexpected serous events of retinal vein occlusion which occurred 17 days after vaccination with mRNA-1273 administered as a third dose, and the unexpected serious events of giant cell arteritis and blindness which occurred on an unknown date relative to vaccination. The medical history of AstraZeneca COVID-19 vaccine remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 58 year-old female patient with a history of AstraZeneca COVID-19 vaccine who experienced the unexpected serous events of retinal vein occlusion which occurred 17 days after vaccination with mRNA-1273 administered as a third dose, and the unexpected serious events of giant cell arteritis and blindness which occurred on an unknown date relative to vaccination. The medical history of AstraZeneca COVID-19 vaccine remains a confounder for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events'' seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2038992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Immunisation, Inflammation, Insomnia, Interchange of vaccine products, Lymphadenopathy, Off label use, Pain, 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:
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 INC202200003725

Write-up: inflammation; Swollen lymph nodes; Caused pain and discomfort; Caused pain and discomfort; unable to sleep; 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 RA. Regulatory number: GB-MHRA-WEBCOVID-202201021541592470-P2QDA. Other Case identifier: GB-MHRA-ADR 26425005. A 28-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Dec2021 (Lot number: FN5254) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER 01; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE NUMBER 02; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; INFLAMMATION (medically significant) with onset 30Dec2021, outcome "recovering", described as "inflammation"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "recovering", described as "Swollen lymph nodes"; PAIN (medically significant), DISCOMFORT (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "Caused pain and discomfort"; INSOMNIA (medically significant) with onset 30Dec2021, outcome "unknown", described as "unable to sleep". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of inflammation, lymphadenopathy, pain. Additional information: Inflammation and swelling of lymph nodes in left armpit and under left clavicle 24 hours after receiving booster jab (jab given in left arm). It caused pain and discomfort, unable to sleep. Took regular painkillers for last 3 days but inflammation still there. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The events were not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2040492 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 3 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Dizziness, Fatigue, Heart rate, Heart rate increased, Immunisation, Interchange of vaccine products, Off label use
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Vestibular disorders (broad), Medication errors (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RAMIPRIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: BP; Result Unstructured Data: Test Result:74/62; Comments: 11:00; Test Date: 20220104; Test Name: BP; Result Unstructured Data: Test Result:181/120; Test Date: 20211230; Test Name: Heart rate; Result Unstructured Data: Test Result:145 bpm; Comments: 11:00; Test Date: 20220104; Test Name: Heart rate; Result Unstructured Data: Test Result:74 bpm
CDC Split Type: CAPFIZER INC202200015481

Write-up: observed extreme BP of 181/120; Blood pressure dropped to 74/62; Heart rate suddenly increased to 145 bpm; Fatigue; dizziness; off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 29Dec2021 14:00 (Lot number: FF2595) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. No other vaccine in four weeks. The patient''s relevant medical history was not reported. Concomitant medication(s) included: RAMIPRIL in two weeks. Past drug history included: Penicillin, reaction(s): "drug Allergy"; Clyndomiyacin, reaction(s): "drug Allergy". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 042D21A, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 01Jul2021, when the patient was 62 years old, for covid-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: EY4825, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03May2021, when the patient was 62 years old, for covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021 14:00, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021 14:00, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021 14:00, outcome "unknown", described as "Booster"; BLOOD PRESSURE INCREASED (medically significant) with onset 04Jan2022, outcome "unknown", described as "observed extreme BP of 181/120"; BLOOD PRESSURE DECREASED (medically significant) with onset 30Dec2021 11:00, outcome "recovering", described as "Blood pressure dropped to 74/62"; HEART RATE INCREASED (medically significant) with onset 30Dec2021 11:00, outcome "recovering", described as "Heart rate suddenly increased to 145 bpm"; FATIGUE (non-serious) with onset 30Dec2021 11:00, outcome "recovering", described as "Fatigue"; DIZZINESS (non-serious) with onset 30Dec2021 11:00, outcome "recovering", described as "dizziness". Blood pressure dropped to 74/62, 21 hours after receiving the booster shot, Heart rate suddenly increased to 145 bpm when BP dropped. Fatigue and dizziness symptoms were experienced at this time. These symptoms lasted approximately 4 hours at which point the BP began rising and HR dropped slowly finally normalizing after 5 hours. On 04Jan2022, observed extreme BP of 181/120, HR 74 bpm, symptoms of dizziness and fatigue lasting all day. No covid prior vaccination. No covid tested post vaccination. The patient underwent the following laboratory tests and procedures: blood pressure measurement: (30Dec2021) 74/62, notes: 11:00; (04Jan2022) 181/120; heart rate: (30Dec2021) 145 bpm, notes: 11:00; (04Jan2022) 74 bpm. Therapeutic measures were not taken as a result of blood pressure decreased, heart rate increased, fatigue, dizziness.


VAERS ID: 2041012 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-12-29
   Days after vaccination:286
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes; Hypertension arterial; Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:positive L452R mutation
CDC Split Type: FRPFIZER INC202200044822

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable reporter(s) (Physician) from the RA. Regulatory number: FR-AFSSAPS-ST20220008 (RA). A 79 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 18Mar2021 (Lot number: Unknown) as dose 2, 0.3 ml single and intramuscular, administration date 25Feb2021 (Lot number: Unknown) as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Obesity" (ongoing); "Hypertension arterial" (ongoing); "Diabetes" (ongoing). The patient''s concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (hospitalization, life threatening) with onset 29Dec2021, outcome "not recovered", described as "Vaccination failure"; COVID-19 (hospitalization, life threatening) with onset 29Dec2021, outcome "not recovered", described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive l452r mutation. Clinical course: Severe COVID requiring intensive care hospitalization. No information on autopsy was provided (as reported). According to the RA based on the information currently available, the company assessed the relationship of COMIRNATY to the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-12-29
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211230; Test Name: COVID-19 test; Result Unstructured Data: Test Result:positive
CDC Split Type: FRPFIZER INC202200011902

Write-up: Positive to COVID test; Asymptomatic COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 11:00 (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Dec2021 09:30, outcome "unknown", described as "Positive to COVID test"; ASYMPTOMATIC COVID-19 (medically significant) with onset 29Dec2021, outcome "unknown", described as "Asymptomatic COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Clinical course: A consumer reported " I did my booster vaccine on 29Dec2021 at 11 am. During the same day, I learn that one of my relatives is positive to COVID-19. On 30Dec2021, at 09:30 am, my test is positive. A doubt settles in as my family in my home is tested in turn, on 03Jan2022. All are negative even the youngest of 4 years old who has difficulty with the barrier gestures. Other information: we were all asymptomatic. I think that it should be specified to avoid being tested when we are being vaccinated less than 24 hours before. It could avoid to "paralyse" many families in our stituation". The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2041050 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-06
Onset:2021-12-29
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004732 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Myositis, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Ileostomy; Inflammatory bowel disease (Take medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Suspected COVID-19; Ulcerative colitis
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Muscle pain; Myositis; This case was received via the (Reference number: GB-MHRA-ADR 26445624) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and MYOSITIS (Myositis) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004732) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 03-Jan-2021 to 12-Jan-2021, Inflammatory bowel disease (Take medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)), Crohn''s disease, Ulcerative colitis and Ileostomy. On 06-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYOSITIS (Myositis) (seriousness criterion medically significant). On an unknown date, the patient experienced MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Muscle pain) outcome was unknown and MYOSITIS (Myositis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive covid-19 test (Positive) Positive. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Concomitant medication details were provided. No treatment medication details were provided. Patient had a severe back muscle pain and was not enrolled in clinical trial. Company comment: This case concerns a male patient of an unknown age, with medical history of inflammatory bowel disease (under treatment) who experienced the serious (medically significant) unexpected events of myositis and myalgia after a dose of mRNA-1273. The events could be in association with each other. The event myositis occurred 24 days after a dose of mRNA-1273 and event outcome was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a male patient of an unknown age, with medical history of inflammatory bowel disease (under treatment) who experienced the serious (medically significant) unexpected events of myositis and myalgia after a dose of mRNA-1273. The events could be in association with each other. The event myositis occurred 24 days after a dose of mRNA-1273 and event outcome was reported as not recovered. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 2041093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Immunisation, Interchange of vaccine products, Malaise, Nausea, Off label use, Pruritus, Rash papular, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMITRIPTYLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Esophageal reflux
Allergies:
Diagnostic Lab Data: Test Date: 20220101; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009385

Write-up: raised rash/raised rash covering large sections of my body, arms and legs; itchy; Hives; Feeling unwell/generally unwell; Feeling of total lack of energy; Nausea/nauseous; Tired; Off label use; Interchange of vaccine products; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201030903479000-VZHVJ (RA). Other Case identifier(s): GB-MHRA-ADR 26426464 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Esophageal reflux" (unspecified if ongoing). Concomitant medication(s) included: AMITRIPTYLINE taken for gastrooesophageal reflux disease, start date: 01Jul2013. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; RASH PAPULAR (medically significant) with onset 31Dec2021, outcome "recovering", described as "raised rash/raised rash covering large sections of my body, arms and legs"; PRURITUS (medically significant) with onset 31Dec2021, outcome "recovering", described as "itchy"; URTICARIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Hives"; MALAISE (medically significant) with onset 31Dec2021, outcome "recovering", described as "Feeling unwell/generally unwell"; ASTHENIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Feeling of total lack of energy"; NAUSEA (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Nausea/nauseous"; FATIGUE (medically significant) with onset 31Dec2021, outcome "unknown", described as "Tired". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) negative, notes: No - Negative COVID-19 test. The clinical course was reported as the patient has not had symptoms associated with COVID-19. On 31Dec2021, the patient woke to find an itchy, raised rash covering large sections of body, arms, and legs. The patient was also nauseous, tired, and felt generally unwell. Patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient rang NHS 111 and had consultation with GP. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041113 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness, Blood pressure decreased, Blood pressure measurement, Chills, Cough, Dizziness, Heat illness, Immunisation, Influenza, Influenza like illness, Loss of consciousness, Migraine, Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Somnolence, Vomiting, Water intoxication
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (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: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:dropped; Test Name: Temperature; Result Unstructured Data: Test Result:38.6 C; Comments: High temperature; Test Name: Temperature; Result Unstructured Data: Test Result:37.2 C; Comments: In 3 hour; Test Name: Temperature; Result Unstructured Data: Test Result:37.5; Test Date: 20220102; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009471

Write-up: runny nose; dizziness; shivering; fell asleep; my head was hot and everything around me went black; my head was hot and everything around me went black; everything around me went black. I didn''t see anything; I drunk 3 cups of water and went back to sleep; Flu-like symptoms; Cough; Vomiting; High temperature; sore throat; Flu; Migraine; Booster; Blood pressure dropped; 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-202201031131257380-CDLR9. Other Case identifier(s): GB-MHRA-ADR 26427597. A 35-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL] taken for oral contraception, start date: 2017. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 25May2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: 24Jul2021, for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; RHINORRHOEA (medically significant), outcome "recovering", described as "runny nose"; OROPHARYNGEAL PAIN (medically significant) with onset 01Jan2022, outcome "recovering", described as "sore throat"; DIZZINESS (medically significant), outcome "recovering", described as "dizziness"; CHILLS (medically significant), outcome "recovering", described as "shivering"; BLOOD PRESSURE DECREASED (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Blood pressure dropped"; MIGRAINE (medically significant) with onset 31Dec2021, outcome "recovered" (02Jan2022), described as "Migraine"; INFLUENZA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Flu"; VOMITING (medically significant) with onset 02Jan2022, outcome "recovering", described as "Vomiting"; PYREXIA (medically significant) with onset 02Jan2022, outcome "recovering", described as "High temperature"; SOMNOLENCE (medically significant), outcome "unknown", described as "fell asleep"; HEAT ILLNESS (medically significant), LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown" and all described as "my head was hot and everything around me went black"; BLINDNESS (medically significant), outcome "unknown", described as "everything around me went black. I didn''t see anything"; WATER INTOXICATION (medically significant), outcome "unknown", described as "I drunk 3 cups of water and went back to sleep"; INFLUENZA LIKE ILLNESS (medically significant), outcome "unknown", described as "Flu-like symptoms", COUGH (medically significant), outcome "unknown", described as "Cough".The patient underwent the following laboratory tests and procedures: blood pressure measurement: (unspecified date) dropped; pyrexia: (unspecified date) 38.6 c, notes: High temperature; (unspecified date) 37.2 c, notes: In 3 hour; (unspecified date) 37.5; sars-cov-2 test: (02Jan2022) negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of chills, pyrexia. Clinical course: Patient last menstrual period date: 30Dec2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. After she had the vaccine she came home and fell asleep. Few hours later she woke up and made her way to the bathroom. At the bathroom door she felt extremely dizzy, her head was hot and everything around her went black. She didn''t see anything. She had to lie down on the floor. Then when she was fine to get up she drunk 3 cups of water and went back to sleep. She woke up fine the next day but she still was a bit dizzy. On the 31st December she had a migrain at night. A few days after on the 1st of January 2022 she woke up with a sore throat and started to develope flu-like symptoms (runny nose, dizziness, sore throat, cough) and the migrain slowly dissapeared. She started to take day nurse on that day.Then at night she had a high temperature about 38.6 C when she was shivering and she had to take 2 ibuprofen and her partner sponged her down with warm water to help the temperature go down and she took 2 ibuprofen. Managed to put it down to 37.2 C in 3 hrs. She took a night nurse dose. The next day today she woke up with 37.5 and very dizzy when she called 111 for advice they said she should report this cause it may all the side effects of the booster vaccine. And got advice to take cold and flu medicines and call the GP next day if she is still not doing fine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Report does not relate to possible inflammation of the heart. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200029350 Same patient, Different dose/event


VAERS ID: 2041125 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009573

Write-up: Difficulty sleeping; 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-202201031329205020-IUXXD. Other Case identifier(s): GB-MHRA-ADR 26428009. A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; INSOMNIA (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Difficulty sleeping". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041138 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FNS95Y / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Interchange of vaccine products, Investigation, Malaise, Off label use, Parosmia, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain; Dyslexia; Dyspraxia; Hypersensitivity; Comments: Chronic pain syndrome. Dyspraxia and Dyslexia. Hypersensitivity Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: lateral flow tests; Test Result: Negative ; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009403

Write-up: feel sick and unwell; Off label use; Interchange of vaccine products; Booster; Phantosmia; 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-202201031546582290-SRYZO. Other Case identifier(s): GB-MHRA-ADR 26429238. A 33 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FNS95Y) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic pain" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing); "Dyspraxia" (unspecified if ongoing); "Dyslexia" (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2 MANUFACTUERER UNKNOWN), for Covid-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PAROSMIA (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Phantosmia"; MALAISE (medically significant), outcome "unknown", described as "feel sick and unwell". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test; investigation: negative. Clinical course: 3 hours after the booster jab, he started smelling a strong smell of smoke, after investing the house he has confirmed that it was not her home environment, and it was a constant smell of smoke at all times, that at times makes me feel sick and unwell. After conferring with a family member, only she was experiencing this smell of smoke. The lateral flow test he has taken have all been negative. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This report was not relate to possible inflammation of the heart (myocarditis or pericarditis). Lateral flow test, searched for source of oder and conferred with family member about scent. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041161 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Interchange of vaccine products, Menstrual disorder, Menstruation irregular, Off label use
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200009570

Write-up: menstrual clotting; Menstrual cramp; Irregular menstrual cycle; Off label use; Interchange of vaccine products; Booster; heavy bleeding/period; 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-202201032048038720-KLMEX. Other Case identifier(s): GB-MHRA-ADR 26430316. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. Patient is not enrolled in clinical trial. Vaccination history included: Covid-19 vaccine astrazeneca (dose 1, never had any issues with them), for COVID-19 immunisation; Covid-19 vaccine astrazeneca (dose 2, never had any issues with them), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 29Dec2021, outcome "recovering", described as "heavy bleeding/period"; MENSTRUATION IRREGULAR (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Irregular menstrual cycle"; DYSMENORRHOEA (medically significant) with onset 03Jan2022, outcome "not recovered", described as "Menstrual cramp"; MENSTRUAL DISORDER (medically significant), outcome "unknown", described as "menstrual clotting". Patient has not tested positive for COVID-19 since having the vaccine. Clinical course: Within 24 hours of receiving the vaccination, I unexpectedly started having a period. I am not due my period for over 2 weeks. I have had heavy bleeding. I have been clotting. I have had constant substantial abdominal cramps. This is very unusual for me. I have regular periods that are always on time. I do not bleed heavily. I definitely do not have blood clots during my period and I have never suffered with abdominal cramps since starting my periods as a teenager. All of this has started since having the Pfizer booster vaccine. I will be contacting my GP for further advice. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211222; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009463

Write-up: Ear pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201032149427460-JPPMX (MHRA). Other Case identifier(s): GB-MHRA-ADR 26430392 (MHRA). A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: Not known) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; EAR PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Ear pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) no - negative covid-19 test. Clinical course included sharp and shooting pain in the right ear which is intermittent. Pain is severe and probably 9 if 10 is the most. 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: 2041183 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-26
Onset:2021-12-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210829; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200009550

Write-up: Migraine type headaches; 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-202201032244267570-A2HKD. Other Case identifier(s): GB-MHRA-ADR 26430448. A female patient received bnt162b2 (COMIRNATY), administration date 26Dec2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started and stopped. The patient''s concomitant medications were not reported. The following information was reported: MIGRAINE (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Migraine type headaches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Aug2021) yes - positive covid-19 test. Clinical information: Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The reporter was asked questions if report was related to possible inflammation of the heart (myocarditis or pericarditis) to which answer was given as no. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2041184 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Headache, Immunisation, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200009578

Write-up: Cough/tickly cough; Headache unilateral; Booster; Throat pain; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from the Regulatory Authority (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201032245047340-JLESL (MHRA). Other Case identifier(s): GB-MHRA-ADR 26430453 (MHRA). A 34-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FK9706) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; OROPHARYNGEAL PAIN (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Throat pain"; COUGH (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Cough/tickly cough"; HEADACHE (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Headache unilateral". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Therapeutic measures were taken as a result of headache. Additional information: Medical history: Patient last menstrual period date: 22Dec2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Clinical course: Paracetamol did not resolve headache despite taking two full day-worth of maximum dose. Painful throat getting worse and accompanied by a tickly cough. Reaction report was not related to possible inflammation of the heart (myocarditis or pericarditis). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2041246 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Headache, Immunisation, Pain in extremity, Pruritus, SARS-CoV-2 test, Vaccination site swelling
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200019132

Write-up: Redness; Itching; Swelling at site of injection around the size of the circumference of a cup; Headache; Very painful arm on day two; Primary immunisation: BNT162b2; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201051723485520-7QGBZ. Other Case identifier(s): GB-MHRA-ADR 26440293. A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2), for COVID-19 immunisation; Bnt162b2 (DOSE 1), for COVID-19 immunisation. The patient did not have symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; ERYTHEMA (medically significant), outcome "recovering", described as "Redness"; PRURITUS (medically significant), outcome "recovered", described as "Itching"; VACCINATION SITE SWELLING (medically significant), outcome "unknown", described as "Swelling at site of injection around the size of the circumference of a cup"; Raised skin with redness and intense itching; Also itching all over; HEADACHE (medically significant), outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (medically significant) with onset 31Dec2021, outcome "unknown", described as "Very painful arm on day two". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative covid-19 test. Therapeutic measures were taken as a result of pain in extremity, had to take pain relief. The patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 2041336 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Inflammatory pain, Pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder (had heart problems before 2012 and had a operation); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: pain; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Fainting; Chest pain; Inflammatory pain; Felt faint; Light-headed; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26445164) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PAIN (pain), DIZZINESS (Felt faint), DIZZINESS (Light-headed), the first episode of CHEST PAIN (Chest pain), INFLAMMATORY PAIN (Inflammatory pain), FATIGUE (Fatigue/unusual tiredness), the second episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and SYNCOPE (Fainting) in a 36-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000014A) for an unknown indication. The patient''s past medical history included Heart disorder (had heart problems before 2012 and had a operation) and Surgery. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced DIZZINESS (Felt faint) (seriousness criterion medically significant) and DIZZINESS (Light-headed) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced the first episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant) and INFLAMMATORY PAIN (Inflammatory pain) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN (pain) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), the second episode of CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and SYNCOPE (Fainting) (seriousness criterion medically significant). On 30-Dec-2021, DIZZINESS (Felt faint) had resolved. At the time of the report, PAIN (pain), FATIGUE (Fatigue/unusual tiredness), the last episode of CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath) and SYNCOPE (Fainting) outcome was unknown, DIZZINESS (Light-headed) was resolving and INFLAMMATORY PAIN (Inflammatory pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product usage were not provided. Patient had visited hospital on Thursday night and had X-rays , blood tests and ECG. He had informed that he have a inflammatory and co-codamol was given to help the pain. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient had no symptoms associated with COVID-19 . Blood test for Troponin was carried out and results were unknown. Company comment: This regulatory case concerns a 36-year-old, male patient, with medical history of heart disorder, who experienced the unexpected, serious (Medically significant) events ofpain, dizziness (reported as "felt faint" and "light-headed"), chest pain, inflammatory pain, fatigue, chest pain, dyspnoea and syncope. The patient developed dizziness 1 day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved the next day with chest pain and inflammatory pain. After being evaluated at the hospital, where radiography, blood tests and electrocardiogram were done, he was told it was inflammatory and was given co-codamol to help the pain. It was not reported if the patient was admitted or not. Exact time to onset was not disclosed for events fatigue, dyspnoea and syncope. The medical history of heart disorder remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 36-year-old, male patient, with medical history of heart disorder, who experienced the unexpected, serious (Medically significant) events ofpain, dizziness (reported as "felt faint" and "light-headed"), chest pain, inflammatory pain, fatigue, chest pain, dyspnoea and syncope. The patient developed dizziness 1 day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. Evolved the next day with chest pain and inflammatory pain. After being evaluated at the hospital, where radiography, blood tests and electrocardiogram were done, he was told it was inflammatory and was given co-codamol to help the pain. It was not reported if the patient was admitted or not. Exact time to onset was not disclosed for events fatigue, dyspnoea and syncope. The medical history of heart disorder remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2041350 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

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

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

Write-up: chills; Fever; This case was received via Agency Regulatory Authority (Reference number: GB-MHRA-ADR 26445798) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (Fever) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 11-May-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). On 30-Dec-2021, PYREXIA (Fever) had resolved. At the time of the report, CHILLS (chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had Fever chills and sweats started at 8pm followed vaccine at 11.45am. Lasted all night. So the patient took paracetamol. Patient has not had symptoms associated with COVID-19. This report does not relate to possible inflammation of the heart (myocarditis or pericarditis) Patient was not currently breastfeeding. Patient last menstrual period date was reported as 23-DEC-2021. 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 34-year-old female patient, with no relevant medical history reported in this case, who experience the serious unexpected events of Chills and Pyrexia. The event Chills occurred in an unknown date after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The event Pyrexia occurred the same day of the administration of the vaccine and the outcome was Recovered/Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 34-year-old female patient, with no relevant medical history reported in this case, who experience the serious unexpected events of Chills and Pyrexia. The event Chills occurred in an unknown date after the administration of the 3rd dose of the mRNA-1273 vaccine and the outcome at the time of the report was Recovering/Resolving. The event Pyrexia occurred the same day of the administration of the vaccine and the outcome was Recovered/Resolved. The rechallenge could be considered not applicable since the events occurred after the 3rd dose and no additional dosing will be given. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2041378 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Palpitations, SARS-CoV-2 test, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210110; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: dizziness; Fatigue/unusual tiredness; Chest pain; Shortness of breath; Heart palpitations; Racing heart (tachycardia); Palpitations; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 26446235) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations), TACHYCARDIA (Racing heart (tachycardia)) and PALPITATIONS (Palpitations) in a 41-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant), FATIGUE (Fatigue/unusual tiredness) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations) (seriousness criterion medically significant) and TACHYCARDIA (Racing heart (tachycardia)) (seriousness criterion medically significant). At the time of the report, DIZZINESS (dizziness), FATIGUE (Fatigue/unusual tiredness), CHEST PAIN (Chest pain), DYSPNOEA (Shortness of breath), PALPITATIONS (Heart palpitations) and TACHYCARDIA (Racing heart (tachycardia)) outcome was unknown and PALPITATIONS (Palpitations) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Company comment: This is a regulatory case concerning a 41-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected events dizziness, fatigue, chest pain, dyspnoea, palpitations and tachycardia. The events started on the same day after receiving the third dose of mRNA-1273. After 7 days of symptoms was prescribed beta blockers and further medical evaluation. The benefit-risk relationship of mRNA-1273 is not affected by this report. Patient has Heart palpitations, dizziness and migraines increasing in intensity from the first day after the booster. After 7 days of symptoms doctor has prescribed beta blockers to stabilise symptoms and is reviewing in a week. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Concomitant product was not provided by the reporter Treatment information was not provided reports relate to possible inflammation of the heart relevant investigations or tests conducted: Blood pressure,blood work; Sender''s Comments: Company comment: This is a regulatory case concerning a 41-year-old female patient with no reported medical history, who experienced the serious (medically significant) unexpected events dizziness, fatigue, chest pain, dyspnoea, palpitations and tachycardia. The events started on the same day after receiving the third dose of mRNA-1273. After 7 days of symptoms was prescribed beta blockers and further medical evaluation. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2041695 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-01
Onset:2021-12-29
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023F2IA / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Amnesia, Arthralgia, Axillary pain, Blindness, Blood pressure measurement, Body temperature, Bone pain, Chest discomfort, Chest pain, Chills, Contusion, Delirium, Delusion, Dyspnoea, Electrocardiogram, Fatigue, Feeling abnormal, Feeling cold, Head discomfort, Headache, Heart rate, Hyperhidrosis, Hypertension, Micturition disorder, Myalgia, Pain, Peripheral swelling, Pyrexia, Serology test, Speech disorder, Spinal pain, Spirometry, Tachycardia, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Osteonecrosis (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breathing difficult (had breathing difficulties he supposed to have COVID-19); Gastric disorder; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: Blood pressure; Result Unstructured Data: abnormal (The pressure rose to systolic 180 mmHg and diastolic 60 mmHg); Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: High (temperature continued to rise over 38 Celsius); Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: High (Fever rose to 40.5 degree Celsius); Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: temperature (37.5 degree Celsius).; Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: temperature gradually increased to 39.5 degree Celsius. (after taking vitamin); Test Date: 20211230; Test Name: Body temperature; Result Unstructured Data: normal (temperature dropped to 37 degree Celsius); Test Date: 20211230; Test Name: Body temperature; Result Unstructured Data: High (temperature returned to 38.5/39 degree Celsius); Test Date: 20211230; Test Name: Body temperature; Result Unstructured Data: temperature was 40 degree Celsius; Test Date: 20211231; Test Name: Body temperature; Result Unstructured Data: normal (temperature dropped to 37 degree Celsius); Test Date: 20211231; Test Name: Body temperature; Result Unstructured Data: normal (temperature normalized without any medication); Test Name: ECG; Result Unstructured Data: normal; Test Date: 20211229; Test Name: Heart rate; Result Unstructured Data: High (above 100 beats per minute at rest); Test Date: 2021; Test Name: Serological test; Result Unstructured Data: COVID-19 experience of (33.87-33.81 IgG); Test Name: Spirometry; Result Unstructured Data: normal
CDC Split Type: ITMODERNATX, INC.MOD20214

Write-up: large swollen and painful underarm; froze to death; severe chest pain to the left of the heart; Pains throughout his body; He had a bruise; Distress in the cerebellum; A pain like a stiff neck that it goes down on the normal vertebrae on his back; He cannot focus on the letters in the normal reading position,sees everything blurry up close; He is sweating a lot now; vision loss; He urinated at least 50 times; Pain in the armpit on the side of the inoculation; Fatigue; His skull hurts/he does not have a normal headache/Big headache/Headache/severe headache; Very high feverTemperature; Shoulder pain; had muscle pain; Many chills of cold/ Chills; He was delirious; He could not breathe normally/shortness of breath; He had delusions; He was absolutely not in himself; at rest it seemed that the heart rate went above 100 beats per minute; Pressure rose to sistolic 180 mmHg and diastolic 60 mmHg; Pain like he had broken bones, his pelvis in excruciating pain/ severe pain in the femur at the junction of the quadriceps/cervical, dorsal,lumbar vertebrae pain,painful pelvis as broken; he felt needles in his chest; he could not say more than three words at the same time; Patient don''t remember anything from those moments; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (vision loss) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 0P6G2IA and 023F2IA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 on 16-Apr-2020, Gastric disorder and Breathing difficult (had breathing difficulties he supposed to have COVID-19). On 01-Dec-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Dec-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 29-Dec-2021, the patient experienced DELIRIUM (He was delirious), DYSPNOEA (He could not breathe normally/shortness of breath), DELUSION (He had delusions), FEELING ABNORMAL (He was absolutely not in himself), TACHYCARDIA (at rest it seemed that the heart rate went above 100 beats per minute), HYPERTENSION (Pressure rose to sistolic 180 mmHg and diastolic 60 mmHg), BONE PAIN (Pain like he had broken bones, his pelvis in excruciating pain/ severe pain in the femur at the junction of the quadriceps/cervical, dorsal,lumbar vertebrae pain,painful pelvis as broken), CHEST DISCOMFORT (he felt needles in his chest), SPEECH DISORDER (he could not say more than three words at the same time), AMNESIA (Patient don''t remember anything from those moments), CHILLS (Many chills of cold/ Chills), FATIGUE (Fatigue), HEADACHE (His skull hurts/he does not have a normal headache/Big headache/Headache/severe headache), PYREXIA (Very high feverTemperature), ARTHRALGIA (Shoulder pain) and MYALGIA (had muscle pain). On 30-Dec-2021, the patient experienced BLINDNESS (vision loss) (seriousness criterion medically significant), MICTURITION DISORDER (He urinated at least 50 times), HYPERHIDROSIS (He is sweating a lot now), CONTUSION (He had a bruise), HEAD DISCOMFORT (Distress in the cerebellum), SPINAL PAIN (A pain like a stiff neck that it goes down on the normal vertebrae on his back), VISION BLURRED (He cannot focus on the letters in the normal reading position,sees everything blurry up close) and AXILLARY PAIN (Pain in the armpit on the side of the inoculation). On 31-Dec-2021, the patient experienced PAIN (Pains throughout his body). On 07-Jan-2022, the patient experienced CHEST PAIN (severe chest pain to the left of the heart). On an unknown date, the patient experienced PERIPHERAL SWELLING (large swollen and painful underarm) and FEELING COLD (froze to death). The patient was treated with ACETYLSALICYLIC ACID, ASCORBIC ACID (VIVIN-C) on 29-Dec-2021 at an unspecified dose and frequency; IBUPROFEN on 29-Dec-2021 for Headache, Pain, Chest pain and Body temperature, at a dose of when needed; IBUPROFEN on 30-Dec-2021 for Headache, Pain, Chest pain and Body temperature, at an unspecified dose and frequency; IBUPROFEN on 31-Dec-2021 for Headache, Pain, Chest pain and Body temperature, at an unspecified dose and frequency; IBUPROFEN on 07-Jan-2022 for Headache, Pain, Chest pain and Body temperature, at an unspecified dose and frequency; PARACETAMOL (TACHIPIRIN) in December 2021 at an unspecified dose and frequency; CEFIXIME (CEFIXORAL) on 30-Dec-2021 at an unspecified dose and frequency and CEFIXIME (CEFIXORAL) on 31-Jan-2021 at an unspecified dose and frequency. At the time of the report, BLINDNESS (vision loss), DELIRIUM (He was delirious), DYSPNOEA (He could not breathe normally/shortness of breath), DELUSION (He had delusions), MICTURITION DISORDER (He urinated at least 50 times), PERIPHERAL SWELLING (large swollen and painful underarm), HYPERHIDROSIS (He is sweating a lot now), FEELING ABNORMAL (He was absolutely not in himself), TACHYCARDIA (at rest it seemed that the heart rate went above 100 beats per minute), HYPERTENSION (Pressure rose to sistolic 180 mmHg and diastolic 60 mmHg), CONTUSION (He had a bruise), HEAD DISCOMFORT (Distress in the cerebellum), SPINAL PAIN (A pain like a stiff neck that it goes down on the normal vertebrae on his back), VISION BLURRED (He cannot focus on the letters in the normal reading position,sees everything blurry up close), BONE PAIN (Pain like he had broken bones, his pelvis in excruciating pain/ severe pain in the femur at the junction of the quadriceps/cervical, dorsal,lumbar vertebrae pain,painful pelvis as broken), PAIN (Pains throughout his body), CHEST DISCOMFORT (he felt needles in his chest), SPEECH DISORDER (he could not say more than three words at the same time), CHEST PAIN (severe chest pain to the left of the heart), AMNESIA (Patient don''t remember anything from those moments), FEELING COLD (froze to death), CHILLS (Many chills of cold/ Chills), AXILLARY PAIN (Pain in the armpit on the side of the inoculation), FATIGUE (Fatigue), PYREXIA (Very high feverTemperature), ARTHRALGIA (Shoulder pain) and MYALGIA (had muscle pain) outcome was unknown and HEADACHE (His skull hurts/he does not have a normal headache/Big headache/Headache/severe headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Serology test: abnormal (abnormal) COVID-19 experience of (33.87-33.81 IgG). On 29-Dec-2021, Blood pressure measurement: abnormal (abnormal) abnormal (The pressure rose to systolic 180 mmHg and diastolic 60 mmHg). On 29-Dec-2021, Body temperature: high (High) High (temperature continued to rise over 38 Celsius), 40.5 (High) High (Fever rose to 40.5 degree Celsius), 37.5 (normal) temperature (37.5 degree Celsius). and 39.5 (High) temperature gradually increased to 39.5 degree Celsius. (after taking vitamin). On 29-Dec-2021, Heart rate: high (High) High (above 100 beats per minute at rest). On 30-Dec-2021, Body temperature: 37 (normal) normal (temperature dropped to 37 degree Celsius), 38.5/39 (High) High (temperature returned to 38.5/39 degree Celsius) and 40 (High) temperature was 40 degree Celsius. On 31-Dec-2021, Body temperature: 37 (normal) normal (temperature dropped to 37 degree Celsius) and normal (normal) normal (temperature normalized without any medication). On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Spirometry: normal (normal) normal. No concomitant medications were reported. Patient had blurry vision:had 10 tenths the oculist check on November 5th for work suitability. Patient could hardly move due to severe pain (muscle and bones). On 30th and 31st, patient temperature dropped to 37?C only after taking Brufen 600 and Cefixoral 400 antibiotic, as advised by the private doctor. Patient finished Brufen 600, and temperature returned to 38.5/39?C. On the night of the 31/12/21, after around 11:30 p.m., his temperature normalized without any medication. To date 12/02/22, he had stopped the antibiotics, taken with Brufen 600 for physical pain. On Friday 07/01/22, during the night, he started to get severe chest pain to the left of the heart and began taking Brufen again which offered relief. I have been continuing the therapy for 3 days. Company comment: This case concerns a 44-year-old male patient with no relevant medical history who experienced serious unexpected event of blindness, reported as vision loss, that occurred approximately 1 day after the 2nd dose of the mRNA-1273 . Reportedly the patient noticed vision loss along with swollen and painful underarm. The patient also complained of inability to focus on the letters and blurry vision up close. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-435126 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 08-Jan-2022: Follow-up information received includes text requires translation. On 08-Jan-2022: Translated document received on 12-Jan-2022 contains significant information and events, treatment drug and lab data has been updated.; Sender''s Comments: This case concerns a 44-year-old male patient with no relevant medical history who experienced serious unexpected event of blindness, reported as vision loss, that occurred approximately 1 day after the 2nd dose of the mRNA-1273 . Reportedly the patient noticed vision loss along with swollen and painful underarm. The patient also complained of inability to focus on the letters and blurry vision up close. The rechallenge was not applicable due to occurrence after the 2nd dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2041819 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1032A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:140/90 mmHg; Comments: pre-vaccination; Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:169/105 mmHg; Comments: post vaccination
CDC Split Type: PHPFIZER INC202200020553

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300130099. A 53 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Dec2021 (Lot number: 1F1032A) at the age of 53 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (29Dec2021) 140/90 mmHg, notes: pre-vaccination; (29Dec2021) 169/105 mmHg, notes: post vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2042196 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM; EVOREL; FOSTAIR; PROCHLORPERAZINE; SALAMOL [SALBUTAMOL SULFATE]; SERTRALINE
Current Illness: Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Finger dislocation; Salpingo-oophorectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Asthma aggravated; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26445604) on 07-Jan-2022 and was forwarded to Moderna on 07-Jan-2022. This regulatory authority case was reported by a physician and describes the occurrence of ASTHMA (Asthma aggravated) in a 48-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. The patient''s past medical history included Finger dislocation and Salpingo-oophorectomy. Concurrent medical conditions included Asthma. Concomitant products included CITALOPRAM from 02-Nov-2021 to an unknown date, ESTRADIOL (EVOREL) from 01-Mar-2021 to an unknown date, BECLOMETASONE DIPROPIONATE, FORMOTEROL FUMARATE (FOSTAIR) from 06-Apr-2021 to an unknown date, PROCHLORPERAZINE from 04-Nov-2021 to an unknown date, SALBUTAMOL SULFATE (SALAMOL [SALBUTAMOL SULFATE]) from 12-Nov-2019 to an unknown date and SERTRALINE from 15-Oct-2021 to an unknown date for Ill-defined disorder. On 29-Dec-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ASTHMA (Asthma aggravated) (seriousness criterion medically significant). At the time of the report, ASTHMA (Asthma aggravated) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment medications were provided. Company comment:This Regulatory Authority case is concerning a female patient of 48- year-old with concurrent medical history of Asthma, experienced the unexpected serious events of Asthma (seriousness criterion medically significant) which events occurred on same day after the unknown dose of mRNA-1273 vaccine. The event outcome was reported unknown. Patients'' medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reporter''s Comments: Exacerbation of asthma wihtin an hour of having Moderna Covid booster; Sender''s Comments: This Regulatory Authority case is concerning a female patient of 48- year-old with concurrent medical history of Asthma, experienced the unexpected serious events of Asthma (seriousness criterion medically significant) which events occurred on same day after the unknown dose of mRNA-1273 vaccine. The event outcome was reported unknown. Patients'' medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2042500 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose increased, Chills, Decreased appetite, Dyspepsia, Fatigue, Headache, Pain, Peripheral coldness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal nonspecific dysfunction (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Blood pressure high (I have high blood pressure, for which take Telmisartan.); Diabetes; Fibromyalgia; Myalgic encephalomyelitis (I had ME.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Shivers; Headache; Cold feet; Appetite lost; Generalised aching; Indigestion; Teeth chattering; Tiredness; Blood sugar increased; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26452483) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (Shivers), HEADACHE (Headache), PERIPHERAL COLDNESS (Cold feet), DECREASED APPETITE (Appetite lost), PAIN (Generalised aching), DYSPEPSIA (Indigestion), CHILLS (Teeth chattering), FATIGUE (Tiredness) and BLOOD GLUCOSE INCREASED (Blood sugar increased) in a 62-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. Previously administered products included for Blood pressure high: TELMISARTAN. Past adverse reactions to the above products included No adverse event with TELMISARTAN. Concurrent medical conditions included Fibromyalgia, Diabetes, Myalgic encephalomyelitis (I had ME.) and Blood pressure high (I have high blood pressure, for which take Telmisartan.). On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced CHILLS (Shivers) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PERIPHERAL COLDNESS (Cold feet) (seriousness criterion medically significant), DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), PAIN (Generalised aching) (seriousness criterion medically significant), DYSPEPSIA (Indigestion) (seriousness criterion medically significant), CHILLS (Teeth chattering) (seriousness criterion medically significant), FATIGUE (Tiredness) (seriousness criterion medically significant) and BLOOD GLUCOSE INCREASED (Blood sugar increased) (seriousness criterion medically significant). On 02-Jan-2022, CHILLS (Teeth chattering) had resolved. On 05-Jan-2022, CHILLS (Shivers), DECREASED APPETITE (Appetite lost) and PAIN (Generalised aching) had resolved. At the time of the report, HEADACHE (Headache), PERIPHERAL COLDNESS (Cold feet), DYSPEPSIA (Indigestion), FATIGUE (Tiredness) and BLOOD GLUCOSE INCREASED (Blood sugar increased) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The report stated that the booster dose increased the patient''s blood sugars significantly from an average of 6.0 to 19.00. The same happened with her previous jabs. Paracetamol helped with the cold feet and teeth chattering. She had the same reactions but for longer, with her Pfizer jabs. The patient has not tested positive for COVID-19 since having the vaccine. No concomitant medication use was reported. Company Comment: This regulatory case concerns a 62-year-old, female patient with relevant medical history of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Fibromyalgia, who experienced the unexpected, serious events of chills (LLT: shivers), headache, peripheral coldness, decreased appetite, pain, dyspepsia, chills (LLT: teeth chattering), fatigue and blood glucose increased. The events occurred on the same day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The patient took paracetamol (unspecified dosage, frequency and duration) which helped with the events peripheral coldness (cold feet) and chills (teeth chattering). The events chills (LLT: shivers), decreased appetite, pain and chills (LLT: teeth chattering) had resolved at the time of the report. The other events were resolving at the time of the report. The medical history of ME/CFS and Fibromyalgia, which typically presents with fatigue and pain, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory case concerns a 62-year-old, female patient with relevant medical history of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Fibromyalgia, who experienced the unexpected, serious events of chills (LLT: shivers), headache, peripheral coldness, decreased appetite, pain, dyspepsia, chills (LLT: teeth chattering), fatigue and blood glucose increased. The events occurred on the same day after administration of the booster dose of the Moderna mRNA-1273 vaccine. The patient took paracetamol (unspecified dosage, frequency and duration) which helped with the events peripheral coldness (cold feet) and chills (teeth chattering). The events chills (LLT: shivers), decreased appetite, pain and chills (LLT: teeth chattering) had resolved at the time of the report. The other events were resolving at the time of the report. The medical history of ME/CFS and Fibromyalgia, which typically presents with fatigue and pain, remain as confounders. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2042503 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-15
Onset:2021-12-29
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2022-01-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation delayed, Muscle spasms, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility 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: 20210827; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: cramps; Heavy periods; Late period; This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (cramps), MENSTRUATION DELAYED (Late period) and HEAVY MENSTRUAL BLEEDING (Heavy periods) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. The patient''s past medical history included Suspected COVID-19 from 24-Aug-2021 to 02-Sep-2021. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MENSTRUATION DELAYED (Late period) (seriousness criterion medically significant). On 05-Jan-2022, the patient experienced HEAVY MENSTRUAL BLEEDING (Heavy periods) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCLE SPASMS (cramps) (seriousness criterion medically significant). On 05-Jan-2022, MENSTRUATION DELAYED (Late period) was resolving. At the time of the report, MUSCLE SPASMS (cramps) and HEAVY MENSTRUAL BLEEDING (Heavy periods) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Aug-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment medications was not reported. Patient stated that her periods run like clockwork the same time every month with the same reactions.She was weak and normally they last 4 days.She was on day 3 and having a really heavy period for 3 straight days and bad cramp. This is a regulatory authority case concerning a 34-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Muscle spasms, Menstruation delayed, Heavy menstrual bleeding. The events occurred approximately 2 weeks day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as not resolved. 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 34-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Muscle spasms, Menstruation delayed, Heavy menstrual bleeding. The events occurred approximately 2 weeks day after the third dose of mRNA-1273 COVID 19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events were reported as not resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.


VAERS ID: 2044852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Constipation, Immunisation, Myalgia, Neck pain, Poor quality sleep, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200015500

Write-up: Back pain; Shoulder pain; Neck pain; Sleep restless/cannot sleep at night; Muscle ache; Constipation; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201041131476510-WW4LI (RA). Other Case identifier(s): GB-MHRA-ADR 26432938 (RA). A 29 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; CONSTIPATION (medically significant) with onset 30Dec2021, outcome "recovering", described as "Constipation"; POOR QUALITY SLEEP (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Sleep restless/cannot sleep at night"; MYALGIA (medically significant) with onset 02Jan2022, outcome "not recovered", described as "Muscle ache"; BACK PAIN (medically significant), outcome "not recovered", described as "Back pain"; ARTHRALGIA (medically significant), outcome "unknown", described as "Shoulder pain"; NECK PAIN (medically significant), outcome "unknown", described as "Neck pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative COVID-19 test. Clinical course: Patient could not sleep at night, he was not sure if it was because of the booster or not but it was been ever since, and when he do eventually fall asleep he awake with shoulder, neck and back pain. 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: 2044913 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN5254 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Immunisation, Initial insomnia, Interchange of vaccine products, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (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 Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200015783

Write-up: Trouble falling asleep; Tiredness; Shortness of breath; Foot 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 (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201042100288760-QVM4X (MHRA). Other Case identifier(s): GB-MHRA-ADR 26435977 (MHRA). A 36 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN5254) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 and DISE 2; MANUFACTUERER UNKNOWN) for Covid-19 immunisation. Patient last menstrual period date: 21Dec2021. 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. Concomitant drugs were unknown. The patient underwent sars-cov-2 test: negative. It was reported set pain for 10 after two hours, and was on the top of the foot just below the three middle toes. Breathing was difficult for the first two days due to only being able to take shallow breaths, this is improving but not result. Not being able to sleep began two days ago, and feels like her brain was fully functional even though she was very tired. Additionally sleep was only happening for several hours at a time which was unusual. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event trouble falling asleep was not recovered and the outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2044936 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3006325 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dermatitis acneiform, Fatigue, Headache, Hyperaesthesia, Migraine, Nausea, Pyrexia, Sensitive skin
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 MRNA VACCINE BNT162B2
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Nauseated; Headache; Skin sensitivity; Pimple-like rash; Nauseous; Migraine; Increased skin sensitivity; Feverish; Fatigue; This case was received via the regulatory authority RA (Reference number: GB-MHRA-ADR 26441220) on 06-Jan-2022 and was forwarded to Moderna on 06-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated), HEADACHE (Headache), SENSITIVE SKIN (Skin sensitivity), NAUSEA (Nauseous), MIGRAINE (Migraine), HYPERAESTHESIA (Increased skin sensitivity), PYREXIA (Feverish), FATIGUE (Fatigue) and DERMATITIS ACNEIFORM (Pimple-like rash) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3006325) for an unknown indication. Concomitant products included TOZINAMERAN (COVID-19 MRNA VACCINE BNT162B2) for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced NAUSEA (Nauseous) (seriousness criterion medically significant), MIGRAINE (Migraine) (seriousness criterion medically significant), HYPERAESTHESIA (Increased skin sensitivity) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On 04-Jan-2022, the patient experienced DERMATITIS ACNEIFORM (Pimple-like rash) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nauseated) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and SENSITIVE SKIN (Skin sensitivity) (seriousness criterion medically significant). On 30-Dec-2021, HYPERAESTHESIA (Increased skin sensitivity) and PYREXIA (Feverish) had resolved. On 31-Dec-2021, NAUSEA (Nauseous), MIGRAINE (Migraine) and FATIGUE (Fatigue) had resolved. At the time of the report, NAUSEA (Nauseated), HEADACHE (Headache), SENSITIVE SKIN (Skin sensitivity) and DERMATITIS ACNEIFORM (Pimple-like rash) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. She was not currently breastfeeding. No treatment medication details were provided. It was reported that approx. 2hrs after the vaccine she started to get a headache which got progressively worse as time went by and by the evening was accompanied with extreme fatigue, feeling nauseated and finally skin sensitivity on my arms, back, stomach and thighs. The sensitivity felt like having a burn and something brushes the burn and causes a painful sensation. The skin sensitivity was more prominent the day after the vaccine and the other symptoms remained difficult to manage so she slept for almost 2 whole days to recover. All symptoms had considerably eased by the evening of 31-Dec-2021 and she was able to do some minor housework by the evening of 31st. Then late at night on 04-Jan-2022, she thought she had a heat rash developing on her arm (non vaccinated arm). But heat rash normally displays very different to this and was not sore like this was. Small pimple like spots were appearing which were very itchy and sore. This has continued to 05-Jan-2022, 24hrs later. After 24hrs the spot like rash has just become a little sore if aggravated by rough fabric or something and was not as itchy as before. Patient was not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: This regulatory authority case concerns a 25-year-old female patient with no reported medical history and previous administration of COVID-19 Vaccine Pfizer BioNTech, who experienced serious unexpected event of nausea, headache, sensitive skin, nausea, migraine, hyperaesthesia, pyrexia, fatigue and dermatitis acneiform, that occurred on the same day and 6 days after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.; Sender''s Comments: This regulatory authority case concerns a 25-year-old female patient with no reported medical history and previous administration of COVID-19 Vaccine Pfizer BioNTech, who experienced serious unexpected event of nausea, headache, sensitive skin, nausea, migraine, hyperaesthesia, pyrexia, fatigue and dermatitis acneiform, that occurred on the same day and 6 days after the 3rd dose of the mRNA-1273 . The rechallenge was not applicable due to occurrence after the 3rd dose. The regulatory authority assessed the rechallenge as unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Seriousness as per regulatory authority.


VAERS ID: 2044990 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005688 / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Ear pain, Illness, Nausea, SARS-CoV-2 test, Tinnitus
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (broad), COVID-19 (broad)

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

Write-up: tinnitus; feel nauseous slightly every day but not terrible; ear ringing and loss of hearing in right ear and ear ache in both comes and comes; Ear ache; Ear ringing; Dizziness; Sickness; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 26448934) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus), NAUSEA (feel nauseous slightly every day but not terrible), EAR PAIN (ear ringing and loss of hearing in right ear and ear ache in both comes and comes), DIZZINESS (Dizziness), ILLNESS (Sickness), TINNITUS (Ear ringing) and EAR PAIN (Ear ache) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005688) for an unknown indication. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced ILLNESS (Sickness) (seriousness criterion medically significant). On 30-Dec-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criterion medically significant). On 03-Jan-2022, the patient experienced TINNITUS (Ear ringing) (seriousness criterion medically significant). On 04-Jan-2022, the patient experienced EAR PAIN (Ear ache) (seriousness criterion medically significant). On an unknown date, the patient experienced TINNITUS (tinnitus) (seriousness criterion medically significant), NAUSEA (feel nauseous slightly every day but not terrible) (seriousness criterion medically significant) and EAR PAIN (ear ringing and loss of hearing in right ear and ear ache in both comes and comes) (seriousness criterion medically significant). At the time of the report, TINNITUS (tinnitus), NAUSEA (feel nauseous slightly every day but not terrible), EAR PAIN (ear ringing and loss of hearing in right ear and ear ache in both comes and comes), DIZZINESS (Dizziness), ILLNESS (Sickness), TINNITUS (Ear ringing) and EAR PAIN (Ear ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. She slightly felt nauseous every day but not terrible, loss of appetite came and went. Ear ringing and loss of hearing in right ear and earache in both came, mainly when she stood up but sometimes randomly when sitting. Tinnitus occasionally occurred, she suffered from migraines normally so these things were causing headaches which could then turn into migraines. She has not tested positive for COVID-19 since having the vaccine. She was not enrolled in clinical trial. It was reported that, her reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). No treatment drugs were reported. Company comment: This case concerns a 28-year-old female patient with medical history of migraines, who experienced the unexpected, serious (medically significant) events of tinnitus, dizziness, and ear pain. The events started the same day after the booster dose of mRNA-1273. The medical history of migraines is a confounder. The patient experienced nausea, intermittent loss of appetite, as well as tinnitus and hearing loss in the right ear. She also experiences ear pain in both ears. The patient reports that these events caused her to have headaches which then developed into migraines. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This case concerns a 28-year-old female patient with medical history of migraines, who experienced the unexpected, serious (medically significant) events of tinnitus, dizziness, and ear pain. The events started the same day after the booster dose of mRNA-1273. The medical history of migraines is a confounder. The patient experienced nausea, intermittent loss of appetite, as well as tinnitus and hearing loss in the right ear. She also experiences ear pain in both ears. The patient reports that these events caused her to have headaches which then developed into migraines. Seriousness assessment has been retained as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a medically significant condition. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 2044992 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-18
Onset:2021-12-29
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA LOT000014A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CINNARIZINE;
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Pulmonary embolism; This case was received via Regulatory Authority(Reference number: GB-RA-ADR 26449283) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in a 57-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. LOT000014A) for an unknown indication. Concomitant products included CINNARIZINE for Meniere''s disease, COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 14-Mar-2021 to an unknown date and COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for Vaccination. On 18-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion life threatening). At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient felt fully fit prior to the booster, felt generally unwell shortly after the vaccine. Then the following day or two became aware of pain in his left calf, that had gone hard and was quite warm or hot to the touch. He felt very tired from then but pain in leg went away. On 29-Dec-2021 he was on a walk late afternoon, that would not normally have affected him but on this occasion, he became short of breath. He had great difficulty getting back to the car but on return to home, went to bed to rest. The next morning, he was still struggling to breath so rang 111, a paramedic came out and requested an ambulance as he was admitted to hospital. He remained there until discharge on 02-Jan-2021. He was diagnosed as having a large blood clot extending into both lungs. Relevant investigations or tests conducted: A chest x-ray on admission. Discharge notes read: FBC NAD -D-dimer 3666, trop 668 - CRP 25 CTPA There is right heart strain and dilatation associated with large volume proximal pulmonary emboli bilaterally with marked extension through the lower lobes. 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 C?mpany comment: This is a regulatory case concerning a 57-year-old male patient with no relevant medical history reported, who experienced the serious unexpected, according CCDS, event of PULMONARY EMBOLISM (AESI). The event occurred approximately 11 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as life threatening. Sender''s Comments: This is a regulatory case concerning a 57-year-old male patient with no relevant medical history reported, who experienced the serious unexpected, according CCDS, event of PULMONARY EMBOLISM (AESI). The event occurred approximately 11 days after the third dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting as life threatening.


VAERS ID: 2045003 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 000022A / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Injection site pain, Lethargy, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: 20211227; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Myalgia; Headache; Fever; Fever chills; Nausea; Joint pain; Lethargy; Injection site pain; This case was received via RA (Reference number: GB-MHRA-ADR 26450103) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MYALGIA (Myalgia), HEADACHE (Headache), PYREXIA (Fever), PYREXIA (Fever chills), NAUSEA (Nausea), ARTHRALGIA (Joint pain), LETHARGY (Lethargy) and INJECTION SITE PAIN (Injection site pain) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 000022A) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MYALGIA (Myalgia) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), ARTHRALGIA (Joint pain) (seriousness criterion medically significant), LETHARGY (Lethargy) (seriousness criterion medically significant) and INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 02-Jan-2022, MYALGIA (Myalgia), PYREXIA (Fever), PYREXIA (Fever chills) and NAUSEA (Nausea) had resolved. On 03-Jan-2022, ARTHRALGIA (Joint pain) had resolved. On 04-Jan-2022, LETHARGY (Lethargy) had resolved. On 05-Jan-2022, HEADACHE (Headache) was resolving. At the time of the report, INJECTION SITE PAIN (Injection site pain) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment medication were reported. Patient was in bed for 3 days and had to have time off work for 6 days due to severe headache. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial Company comment: This regulatory case concerns a 28-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) events of myalgia, headache, pyrexia (reported as "fever" and "fever chills"), nausea, arthralgia, lethargy and injection site pain. The events occurred on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria was maintained for the events for consistency with the RA report.; Sender''s Comments: This regulatory case concerns a 28-year-old, female patient with no reported medical history, who experienced the unexpected, serious (Medically significant) events of myalgia, headache, pyrexia (reported as "fever" and "fever chills"), nausea, arthralgia, lethargy and injection site pain. The events occurred on the same day after receiving a dose of mRNA-1273 vaccine, considered as the third dose of the patient''s COVID-19 vaccination schedule. It was not reported if the previous two doses of her COVID-19 vaccination schedule were mRNA-1273 vaccines as well. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria was maintained for the events for consistency with the RA report.


VAERS ID: 2045004 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Visual disturbances; This case was received (Reference number: GB-MHRA-ADR 26450184) on 09-Jan-2022 and was forwarded to Moderna on 09-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Visual disturbances) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 27-Mar-2021 to an unknown date for Vaccination, LANSOPRAZOLE and SERTRALINE for an unknown indication. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced VISUAL IMPAIRMENT (Visual disturbances) (seriousness criterion medically significant). At the time of the report, VISUAL IMPAIRMENT (Visual disturbances) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient had inconsistent visual disturbances, sudden dizzy episodes where everything had slides. It Lasted only a moment, but then had nausea and vision felt a bit precarious for a few hours afterwards Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial The patients report was not related to possible myocarditis or pericarditis This is a regulatory case concerning a 42-year-old female patient with no medical history reported, who experienced the expected event of visual impairment. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The event occurred on the same day after the third dose of mRNA ? 1273 vaccine. Visual impairment was reported as medically significant and at the time of report had not resolved. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. No treatment medication information was mentioned by reporter; Sender''s Comments: This is a regulatory case concerning a 42-year-old female patient with no medical history reported, who experienced the expected event of visual impairment. A concomitant product in this case is the Covid-19 AstraZeneca vaccine. The event occurred on the same day after the third dose of mRNA ? 1273 vaccine. Visual impairment was reported as medically significant and at the time of report had not resolved. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 2045146 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FN3543 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Immunisation, SARS-CoV-2 test
SMQs:, Guillain-Barre 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: 20211210; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200035681

Write-up: Weakness; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority. Regulatory number: GB-MHRA-WEBCOVID-202201091416464040-1NBMP. Other Case identifier(s): GB-MHRA-ADR 26453586. A 25 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Lot number: FN3543) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, Lot number: UNKNOWN Route of administration: Unspecified), for COVID-19 immunisation; Bnt162b2 (DOSE 1, Lot number: UNKNOWN Route of administration: Unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster: COMIRNATY"; ASTHENIA (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Weakness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Dec2021) yes - positive covid-19 test. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200070044 Same pt, different events/doses


VAERS ID: 2045153 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-12-29
   Days after vaccination:276
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005889 / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20220103; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Headache; This case was received (Reference number: GB-MHRA-ADR 26453724) on 10-Jan-2022 and was forwarded to Moderna on 10-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 43-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005889) for an unknown indication. No Medical History information was reported. On 28-Mar-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Patient has not had symptoms associated with COVID-19. Patient experienced severe headache since having booster, and was ongoing. No painkillers got rid of headache. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient''s relevant investigations or tests included patient''s bloods taken. Treatment information was not provided. Company Comment - This regulatory authority case concerns a 43 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of headache. The event occurred 1 day after the third dose of mRNA-1273 vaccine, and had not resolved at the time if the report. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This regulatory authority case concerns a 43 year old male patient with no relevant medical history, who experienced the serious (medically significant) unexpected event of headache. The event occurred 1 day after the third dose of mRNA-1273 vaccine, and had not resolved at the time if the report. The rechallenge was not applicable as there are no plans for future dosing. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2045157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Immunisation, Pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200035606

Write-up: pain; Pain menstrual/painful period; Primary immunisation: BNT162b2; Booster: COMIRNATY; heavy period; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201091755572890-ZLZUK (RA). Other Case identifier(s): GB-MHRA-ADR 26453782 (RA). A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation, reaction(s): "Pain menstrual", "Heavy periods"; Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown, Route of administration: unspecified), for COVID-19 immunisation, reaction(s): "Pain menstrual", "Heavy periods". The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; PAIN (medically significant), outcome "not recovered", described as "pain"; DYSMENORRHOEA (medically significant) with onset 09Jan2022, outcome "not recovered", described as "Pain menstrual/painful period"; HEAVY MENSTRUAL BLEEDING (medically significant) with onset 2021, outcome "unknown", described as "heavy period". It was reported that as with other Pfizer vaccines, the patient experienced extremely painful and heavy period circa 10 days or so after vaccine. The patient had not tested positive for COVID-19 since having the vaccine.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200069830 Same patient/different dose/different events


VAERS ID: 2045200 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Immunisation, Joint range of motion decreased, Product administered at inappropriate site, SARS-CoV-2 test
SMQs:, Drug abuse and dependence (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20211123; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200055060

Write-up: shoulder joint on the jabbed arm was very sore and within 1 day could not move it; Shoulder pain; Booster dose 3; Vaccine having been administered in the wrong place; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202201111428412570-7Z8Y0, Safety Report Unique Identifier GB-MHRA-ADR 26462188. A 43-year-old female patient received third (Booster) dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) in arm via an unspecified route of administration on 29Dec2021 as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. On 23Nov2021, the patient underwent COVID-19 virus test and the result was positive. The patient previously received two doses of BNT162b2 (COMIRNATY; Lot number: UNKNOWN), via unspecified route of administration in an unspecified anatomical site as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On 31Dec2021, 2 days after vaccination, the patient experienced shoulder pain; reported as serious for being medically significant. On an unknown date, in Jan2022, within 1 day, she could not move shoulder joint. Clinical course was reported as follows: Two days after the vaccine her shoulder joint on the jabbed arm was very sore and within 1 day she could not move it. The patient still could not move it on 11Jan2022 and it was painful, sore and lacking strength. There was no trauma or other injury involved so she thought this to the vaccine been administered in the wrong place, higher up in her arm and into the shoulder joint. The patient was not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events shoulder pain and she could not move shoulder joint was not recovered at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200077070 same patient/drug/different dose/ event


VAERS ID: 2045251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-12-29
   Days after vaccination:152
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200068892

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; MHRA YELLOW CARD VACCINE MONITOR This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from a Regulatory Authority for a sponsored program. A 31 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FC9001) as dose 2, single and administration date 26May2021 (Lot number: ET8885) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history was not reported. The patient was 12 weeks pregnant at the time of exposure to bnt162b2. The patient is expected to deliver a baby(s) on 03Feb2022. Concomitant medication(s) included: FOLIC ACID taken for vitamin supplementation. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.


VAERS ID: 2045743 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1032A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:160/80 mmHg; Comments: pre-vaccination; Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:200/115 mmHg; Comments: post-vaccination
CDC Split Type: PHPFIZER INC202200020543

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300130126 (PHFDA). A 57 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY), intramuscular, administration date 29Dec2021 (Lot number: 1F1032A) at the age of 57 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 29Dec2021, outcome "recovered" (31Dec2021), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (29Dec2021) 160/80 mmHg, notes: pre-vaccination; (29Dec2021) 200/115 mmHg, notes: post-vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2045747 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F1032A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:150/90 mmHg; Comments: pre-vaccination; Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:173/103 mmHg; Comments: post-vaccination
CDC Split Type: PHPFIZER INC202200020579

Write-up: Elevated BP, 173/103 mmHg; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300130192. A 38 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Dec2021 (Lot number: 1F1032A) at the age of 38 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Elevated BP, 173/103 mmHg". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (29Dec2021) 150/90 mmHg, notes: pre-vaccination; (29Dec2021) 173/103 mmHg, notes: post-vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2045748 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH IFI032A / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (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: Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:153/90 mmHg; Comments: pre-vaccination; Test Date: 20211229; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:178/109 mmHg; Comments: post vaccination
CDC Split Type: PHPFIZER INC202200020586

Write-up: Elevated BP; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: PH-PHFDA-300130204. A 57 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Dec2021 (Lot number: IFI032A) at the age of 57 years as dose number unknown, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD PRESSURE INCREASED (medically significant) with onset 29Dec2021, outcome "recovered" (29Dec2021), described as "Elevated BP". The patient underwent the following laboratory tests and procedures: blood pressure measurement: (29Dec2021) 153/90 mmHg, notes: pre-vaccination; (29Dec2021) 178/109 mmHg, notes: post vaccination. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2045750 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 123001 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Immunisation, Nasopharyngitis, Product use issue, Throat irritation
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202200021144

Write-up: COVID-positive; COVID-positive; Scratchy throat; cough; colds; Less than 6 months from the 2nd dose; Less than 6 months from the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 32 year-old patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Lot number: 123001) as dose number unknown (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-positive"; THROAT IRRITATION (non-serious), outcome "unknown", described as "Scratchy throat"; COUGH (non-serious), outcome "unknown", described as "cough"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "colds"; PRODUCT USE ISSUE (non-serious), outcome "unknown", described as "Less than 6 months from the 2nd dose". No follow-up attempts are required. No further information is expected; Sender''s Comments: Linked Report(s) : PH-PFIZER_INC-202200021143 same reporter and product, different patietn and event


VAERS ID: 2045842 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044G21A / 3 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Chills, Dizziness, Dry mouth, Dysgeusia, Feeling cold, Headache, Hypoaesthesia, Laboratory test, Malaise, Nausea, Pain, Paraesthesia, Paraesthesia oral, Peripheral swelling, Presyncope, SARS-CoV-2 test, Sepsis, Tremor, Urine analysis
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (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: FILOTEMPO; SEEBRI; GIBITER
Current Illness: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: no altered parameters; Test Name: Laboratory test; Result Unstructured Data: Blood infection; Test Date: 202201; Test Name: COVID-19 test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Urine analysis; Result Unstructured Data: no altered parameters
CDC Split Type: PTMODERNATX, INC.MOD20224

Write-up: Dry mouth; Pain; Unwell state; Chills; Blood infection; Tingling in the body/tingling in feet; Tongue tingling/ Tingling in mouth; Feet got numb; Woke up dizzy; She has felt a lot of nausea; Headaches; Almost fainting (never did though); Trembling body/body was trembling/tremble all over her body/trembling in her legs; Swollen hands/feet got swollen; Salty mouth; She was cold; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Blood infection) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044G21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: ASTRAZENECA COVID-19 VACCINE (First dose, Lot number: ABU5441) on 03-Mar-2021, ASTRAZENECA COVID-19 VACCINE (Second dose and Lot number: ABW4801) on 26-May-2021. Past adverse reactions to the above products included No adverse event with ASTRAZENECA COVID-19 VACCINE and ASTRAZENECA COVID-19 VACCINE. Concurrent medical conditions included Asthma. Concomitant products included AMINOPHYLLINE, GLYCOPYRRONIUM BROMIDE and BUDESONIDE, FORMOTEROL FUMARATE for Asthma. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PARAESTHESIA (Tingling in the body/tingling in feet), PARAESTHESIA ORAL (Tongue tingling/ Tingling in mouth), PRESYNCOPE (Almost fainting (never did though)), TREMOR (Trembling body/body was trembling/tremble all over her body/trembling in her legs), PERIPHERAL SWELLING (Swollen hands/feet got swollen), DYSGEUSIA (Salty mouth), FEELING COLD (She was cold), HYPOAESTHESIA (Feet got numb), DIZZINESS (Woke up dizzy), NAUSEA (She has felt a lot of nausea) and HEADACHE (Headaches). On 10-Jan-2022, the patient experienced SEPSIS (Blood infection) (seriousness criterion medically significant). On an unknown date, the patient experienced DRY MOUTH (Dry mouth), PAIN (Pain), MALAISE (Unwell state) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 600 milligram three times a day; PARACETAMOL for Pain and Headache, at a dose of UNK, 15 days and IBUPROFEN (BRUFEN [IBUPROFEN]) for Pain and Headache, at an unspecified dose and frequency. At the time of the report, SEPSIS (Blood infection) outcome was unknown, PARAESTHESIA (Tingling in the body/tingling in feet), PARAESTHESIA ORAL (Tongue tingling/ Tingling in mouth) and DRY MOUTH (Dry mouth) had not resolved and PRESYNCOPE (Almost fainting (never did though)), TREMOR (Trembling body/body was trembling/tremble all over her body/trembling in her legs), PERIPHERAL SWELLING (Swollen hands/feet got swollen), DYSGEUSIA (Salty mouth), FEELING COLD (She was cold), PAIN (Pain), MALAISE (Unwell state), HYPOAESTHESIA (Feet got numb), DIZZINESS (Woke up dizzy), NAUSEA (She has felt a lot of nausea), HEADACHE (Headaches) and CHILLS (Chills) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Blood test: no altered parameters (normal) no altered parameters. On an unknown date, Laboratory test: blood infection (abnormal) Blood infection. On an unknown date, Urine analysis: no altered parameters (normal) no altered parameters. It was stated that on 29-Dec-2021, around 3/4 PM, patient received the vaccine, all was fine; from 8 PM patient started to tremble, she had no fever, she thought she had but she did not. Patient went to the hospital and was there until 3 AM. Patient was given a tranquilizer. She was able to sleep in the night a little better, but not as good as they would have imagined. From what the doctor said, she did not associate his wife''s symptoms with the vaccine, It could have been an anxiety attack. Treatment included and Brufen to alleviate with the pain, the headache for these 15 days. Patient was medicated for the blood infection. Patient felt a little bit better, but she only took medication until last night. GP prescribed some medication to strengthen the bones, one of the medication was without prescription, Ibuprofen 600 mg and 3 pills to take every 24 hours. Patient slept a little more in this night. Company comment: This is a spontaneous case concerning a 57-year-old female patient with medical history of asthma, who experienced the unexpected serious event of Sepsis, as well as numerous aforementioned non serious events after the third dose of mRNA1273 vaccine. The event of Sepsis occurred approximately 12 days after the third dose of mRNA1273 vaccine. It was reported that the blood test revealed blood infection. The COVID-19 test was negative. Limited clinical or treatment details were given. The outcome of Sepsis was reported as unknown. Reportedly, the first two doses of vaccine were of another manufacturer, which suggests Interchange of vaccine products. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a spontaneous case concerning a 57-year-old female patient with medical history of asthma, who experienced the unexpected serious event of Sepsis, as well as numerous aforementioned non serious events after the third dose of mRNA1273 vaccine. The event of Sepsis occurred approximately 12 days after the third dose of mRNA1273 vaccine. It was reported that the blood test revealed blood infection. The COVID-19 test was negative. Limited clinical or treatment details were given. The outcome of Sepsis was reported as unknown. Reportedly, the first two doses of vaccine were of another manufacturer, which suggests Interchange of vaccine products. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2049066 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Asthenia, Chest pain, Fatigue, Pain, Pain in extremity, Stress
SMQs:, Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (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 INC202200019457

Write-up: Anxiety; Fatigue; pain in left shoulder; Pain in left arm; pain in left shoulder, and chest; Feeling weak; Felt very stressed; Pain; This is a spontaneous report received from a contactable reporter (Other HCP) from the RA. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201051151459870-H9MQ1. Other Case identifier(s): GB-MHRA-ADR 26438470. A 49-year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 49 years as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (disability), outcome "recovering", described as "Anxiety"; FATIGUE (disability), outcome "recovering", described as "Fatigue"; ARTHRALGIA (disability), outcome "recovering", described as "pain in left shoulder"; PAIN (disability) with onset 29Dec2021, outcome "not recovered", described as "Pain"; PAIN IN EXTREMITY (disability), outcome "unknown", described as "Pain in left arm"; CHEST PAIN (disability), outcome "unknown", described as "pain in left shoulder, and chest"; ASTHENIA (disability), outcome "unknown", described as "Feeling weak"; STRESS (disability), outcome "unknown", described as "Felt very stressed". Clinical course: The patient experienced pain in her left shoulder, and chest, and left arm. The patient felt fatigue, was feeling weak, she felt very stressed and anxiety levels were high. The patient was still feeling tired. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient did not have a COVID-19 test. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2049102 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Dysphagia, Immunisation, Interchange of vaccine products, Joint range of motion decreased, Migraine, Myalgia, Off label use, Pain, Pain in extremity, SARS-CoV-2 test, Swelling, Tonsillar hypertrophy
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (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: METFORMIN; PARACETAMOL; PREGABALIN; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CY
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Polycystic ovary; Suspected COVID-19 (Unsure when symptoms started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202200019322

Write-up: myalgia; pain/ whole body was in pain; Migraine; Generalized joint pain; armpit swelled; Armpit pain; Swollen tonsils; pain and difficulty moving my arm; difficulty swallowing; difficulty moving my arm; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201051646132450-ZDTG2 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26440185 (MHRA). A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Polycystic ovary" (unspecified if ongoing); "Suspected COVID-19" (unspecified if ongoing), notes: Unsure when symptoms started and stopped. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication(s) included: METFORMIN taken for polycystic ovaries; PARACETAMOL taken for fibromyalgia; PREGABALIN taken for fibromyalgia; PREGNACARE ORIGINAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FOLIC ACID;IODINE;IRON;MAGNESIUM;NICOTINAMIDE;PHYTOMENADIONE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;SELENIUM;THIAMINE MONONITRATE;TOCOPHERYL. Vaccination history included: Covid-19 vaccine astrazeneca (Dose 2), administration date: 26Jul2021, for COVID-19 vaccination; Covid-19 vaccine astrazeneca (Dose 1), administration date: 28May2021, for COVID-19 vaccination. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Primary immunisation: ASTRAZENECA; Booster: COMIRNATY"; MYALGIA (medically significant), outcome "not recovered", described as "myalgia"; PAIN (medically significant) with onset 31Dec2021, outcome "not recovered", described as "pain/ whole body was in pain"; MIGRAINE (medically significant) with onset 31Dec2021, outcome "not recovered", described as "Migraine"; AXILLARY PAIN (medically significant) with onset 30Dec2021, outcome "recovering", described as "Armpit pain"; TONSILLAR HYPERTROPHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen tonsils"; ARTHRALGIA (medically significant) with onset 31Dec2021, outcome "recovering", described as "Generalized joint pain"; SWELLING (medically significant) with onset 30Dec2021, outcome "unknown", described as "armpit swelled"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "unknown", described as "pain and difficulty moving my arm"; DYSPHAGIA (medically significant) with onset 29Dec2021, outcome "unknown", described as "difficulty swallowing"; JOINT RANGE OF MOTION DECREASED (medically significant) with onset 29Dec2021, outcome "unknown", described as "difficulty moving my arm". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative. Therapeutic measures were taken as a result of myalgia, pain, migraine, axillary pain, tonsillar hypertrophy, arthralgia, swelling, pain in extremity, dysphagia, joint range of motion decreased. The clinical course was reported as follows: The 2nd day after vaccination the patient whole body was in pain. It felt as through it was running through her nervous system like a fibromyalgia attack, except it was constant with no breaks or easing. Paracefamol and ibrufen had little to no effect. The patient''s tonsils and armpit also swelled the day after the vaccine causing pain and difficulty moving arm and swallowing. The armpit that swelled was the same side as the vaccine. The patient had not been tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This report was not related to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2049114 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Ehlers-Danlos syndrome, Fatigue, Immunisation, Interchange of vaccine products, Off label use, Small fibre neuropathy
SMQs:, Peripheral neuropathy (narrow), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CODAMOL; FAMOTIDINE; MIDODRINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ehlers-Danlos syndrome type III; Postural orthostatic tachycardia syndrome; Small fibre neuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200019100

Write-up: Fatigue increased; Joints had also flared from having Ehlers Danlos Syndrome; Condition aggravated; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (Astra Zeneca); Booster: COMIRNATY; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (Astra Zeneca); Booster: COMIRNATY; Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (Astra Zeneca); Booster: COMIRNATY; Patient had small fibre neuropathy, the booster caused a flair up of that condition; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201051841484890-0KF5Z (MHRA). Other Case identifier(s): GB-MHRA-ADR 26440681 (MHRA). A 48 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Small fibre neuropathy" (unspecified if ongoing); "Postural orthostatic tachycardia syndrome" (unspecified if ongoing); "Ehlers-Danlos syndrome type III" (unspecified if ongoing). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Patient last menstrual period date was 04Jan2022. Concomitant medication(s) included: CO-CODAMOL taken for ehlers-danlos syndrome; FAMOTIDINE taken for covid-19 treatment; MIDODRINE taken for postural orthostatic tachycardia syndrome. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN; MANUFACTUERER UNKNOWN), for COVID-19 immunisation; Astra zeneca covid-19 vccine (DOSE NUMBER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Primary immunisation: unknown manufacturer, at least one was non-Pfizer vaccine (Astra Zeneca); Booster: COMIRNATY"; SMALL FIBRE NEUROPATHY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Patient had small fibre neuropathy, the booster caused a flair up of that condition"; FATIGUE (medically significant), outcome "not recovered", described as "Fatigue increased"; EHLERS-DANLOS SYNDROME (medically significant), outcome "unknown", described as "Joints had also flared from having Ehlers Danlos Syndrome"; CONDITION AGGRAVATED (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Condition aggravated". Clinical course: I have small fibre neuropathy, the Pfizer booster caused a flair up of that condition. My joints have also flared from having Ehlers Danlos Syndome and my fatigue has increased. None of these symptoms happened with Astra Zeneca. Patient has not tested positive for COVID-19 since having the vaccine. The report was 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: 2049219 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-27
Onset:2021-12-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Eye swelling, Hypersensitivity, Joint swelling, Mechanical urticaria, Palpitations, Peripheral swelling, Urticaria, Vaccination site pain
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE MODERNA; COVID-19 VACCINE MODERNA; INFLUENZA VIRUS; OMEPRAZOLE; RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: allergic reaction; Hand swelling; Swollen arm; Dermographia; Knee swelling; Palpitations; Eye swelling; Hives; Painful arm; This case was received via RA (Reference number: GB-MHRA-ADR 26453677) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction), URTICARIA (Hives), JOINT SWELLING (Knee swelling), PERIPHERAL SWELLING (Hand swelling), EYE SWELLING (Eye swelling), PERIPHERAL SWELLING (Swollen arm), VACCINATION SITE PAIN (Painful arm), PALPITATIONS (Palpitations) and MECHANICAL URTICARIA (Dermographia) in a 29-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was reported. Concomitant products included ELASOMERAN (COVID-19 VACCINE MODERNA) from 13-Jun-2021 to 08-Aug-2021 and ELASOMERAN (COVID-19 VACCINE MODERNA) for COVID-19 vaccination, INFLUENZA VACCINE (INFLUENZA VIRUS) from 25-Sep-2021 to an unknown date for Flu vaccination, OMEPRAZOLE from 01-May-2019 to an unknown date for GERD, ETHINYLESTRADIOL, LEVONORGESTREL (RIGEVIDON [ETHINYLESTRADIOL;LEVONORGESTREL]) from 01-Aug-2013 to an unknown date for Oral contraception. On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Painful arm) (seriousness criterion medically significant). On 05-Jan-2022, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant) and EYE SWELLING (Eye swelling) (seriousness criterion medically significant). On 06-Jan-2022, the patient experienced JOINT SWELLING (Knee swelling) (seriousness criterion medically significant) and PALPITATIONS (Palpitations) (seriousness criterion medically significant). On 07-Jan-2022, the patient experienced PERIPHERAL SWELLING (Hand swelling) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and MECHANICAL URTICARIA (Dermographia) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) (seriousness criterion medically significant). On 01-Jan-2022, VACCINATION SITE PAIN (Painful arm) had resolved. On 07-Jan-2022, PALPITATIONS (Palpitations) had resolved. On 08-Jan-2022, JOINT SWELLING (Knee swelling) had resolved. At the time of the report, HYPERSENSITIVITY (allergic reaction), URTICARIA (Hives), PERIPHERAL SWELLING (Hand swelling), EYE SWELLING (Eye swelling) and PERIPHERAL SWELLING (Swollen arm) was resolving and MECHANICAL URTICARIA (Dermographia) had not resolved. No treatment information was provided. Reported Patient Last Menstrual Period was 5-JAN-2022. She had Initial pain at vaccination site started within 48 hours but resolved within a few days. Nine days after vaccination, developed hives that worsened over a few days and spread across whole body. She had swelling of knees occurred first before hands, wrists and arms also swelled. Swelling of left hand was most severe resulting in limited hand movement and considerable pain. On the fifth day since hives began, swelling and hives were resolving but dermatographia was persisting. General practitioner confirmed, it appeared to be allergic reaction, possibly to booster and recommended cetirizine to manage. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Company comment: This case concerns a 29-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of hypersensitivity, urticaria, joint swelling, peripheral swelling, eye swelling, peripheral swelling, vaccination site pain, palpitations and mechanical urticaria after the third dose of mRNA-1273. The events could be in association with each other. It was reported pain at vaccination site started within 48 hours but resolved within a few days.9 days after vaccination, developed hives that worsened over a few days and spread across whole body. Swelling of knees occurred first before hands, wrists and arms also swelled. Swelling of left hand was most severe resulting in limited hand movement and considerable pain. On the fifth day since hives began, swelling and hives are resolving but dermotographia is persisting. General practitioner confirmed appears to be allergic reaction, possibly to booster. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.; Sender''s Comments: This case concerns a 29-year-old female patient, with no medical history reported, who experienced the serious (medically significant) unexpected events of hypersensitivity, urticaria, joint swelling, peripheral swelling, eye swelling, peripheral swelling, vaccination site pain, palpitations and mechanical urticaria after the third dose of mRNA-1273. The events could be in association with each other. It was reported pain at vaccination site started within 48 hours but resolved within a few days.9 days after vaccination, developed hives that worsened over a few days and spread across whole body. Swelling of knees occurred first before hands, wrists and arms also swelled. Swelling of left hand was most severe resulting in limited hand movement and considerable pain. On the fifth day since hives began, swelling and hives are resolving but dermotographia is persisting. General practitioner confirmed appears to be allergic reaction, possibly to booster. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events assessed as serious by the Regulatory Authority.


VAERS ID: 2049258 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Headache, SARS-CoV-2 test, Vulvovaginal discomfort
SMQs:, 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:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Vulva discomfort; Menstrual cramps; Headache; This case was received via regulatory authority on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DYSMENORRHOEA (Menstrual cramps) and VULVOVAGINAL DISCOMFORT (Vulva discomfort) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) from 17-Jun-2021 to an unknown date and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant). On 31-Dec-2021, the patient experienced DYSMENORRHOEA (Menstrual cramps) (seriousness criterion medically significant). On 01-Jan-2022, the patient experienced VULVOVAGINAL DISCOMFORT (Vulva discomfort) (seriousness criterion medically significant). On 30-Dec-2021, HEADACHE (Headache) had resolved. On 07-Jan-2022, DYSMENORRHOEA (Menstrual cramps) had resolved. At the time of the report, VULVOVAGINAL DISCOMFORT (Vulva discomfort) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No Medical History information was reported. It was reported that, there was no menstrual bleeding occurred, only menstrual cramps which did not alleviate with paracetamol or topical application of deep heat to the abdomen. She normally have 6 day bleeds every 28 days, very regular. She did not had symptoms associated with COVID-19 neither she tested positive for COVID-19 after taking the vaccine. She was not pregnant nor she was breastfeeding. She was not enrolled in clinical trial. It was reported that, her reaction was not related to possible inflammation of the heart (myocarditis or pericarditis). Re-challenge was reported as unknown. Company comment: This is a regulatory case concerning a 25 year-old, female patient with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 4 months prior), who experienced the serious (due to medically important condition) unexpected, events of Headache, Dysmenorrhoea and Vulvovaginal discomfort. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 3 days after the third dose of mRNA-1273 vaccine. The outcome of the events Headache and Dysmenorrhoea was reported as recovered; and the event Vulvovaginal discomfort as recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory case concerning a 25 year-old, female patient with no reported medical history and Interchange of vaccine products (vaccination with two doses of COVID-19 vaccine BioNTech approximately 4 months prior), who experienced the serious (due to medically important condition) unexpected, events of Headache, Dysmenorrhoea and Vulvovaginal discomfort. Events were assessed as serious by the Regulatory Authority. The events occurred the same day to 3 days after the third dose of mRNA-1273 vaccine. The outcome of the events Headache and Dysmenorrhoea was reported as recovered; and the event Vulvovaginal discomfort as recovering. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2049288 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-17
Onset:2021-12-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Menstruation abnormal; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26456694) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruation abnormal) in a 51-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was provided by the reporter. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 28-Mar-2021 to an unknown date for an unknown indication. On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced MENSTRUAL DISORDER (Menstruation abnormal) (seriousness criterion medically significant). At the time of the report, MENSTRUAL DISORDER (Menstruation abnormal) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The timing of the patient''s period after the Moderna vaccine was unexpected (too soon after the previous period). It started on 29 Dec 2021 and on 10 Jan 2022 it was still continuing and was very heavy and debilitating. It just wouldn''t stop and has drained her completely. Patient was not enrolled in clinical trial. No treatment information was provided.; Sender''s Comments: This is an RA case concerning a 51-year-old, female patient with no relevant medical history reported, who experienced the event of menstruation abnormal. Patient refers that after receiving the third dose of mRNA1273 vaccine she had her period earlier than expected. She also refers that it is longer in duration and her flow is much heavier. Event seriousness was captured as provided by the Regulatory Authority. Patient''s age can be considered as a confounder as menopause is known to occur usually between 45 and 55 years old and its first symptoms can be irregular cycles. The benefit-risk relationship of mRNA-1273 in not affected by this report.


VAERS ID: 2049292 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVID-19 VACCINE ASTRAZENECA
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20224

Write-up: Rash; This case was received via Regulatory authority. This regulatory authority case was reported by a physician and describes the occurrence of RASH (Rash) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No medical history was provided by the reporter. Concomitant products included COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) from 14-Apr-2021 to an unknown date for an unknown indication. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced RASH (Rash) (seriousness criterion medically significant). At the time of the report, RASH (Rash) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Unsure if patient had symptoms associated with COVID-19, not had a COVID-19 test . Patient was not pregnant, patient was not currently breastfeeding. Treatment information was not provided. Patient was not tested positive for COVID-19 since had the vaccine. Patient was not enrolled in clinical trial. Company comment: This is a regulatory case concerning a 42-year-old female patient with no medical history reported, who experienced the serious unexpected, according to the Agency, event of rash. The event occurred on the day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This is a regulatory case concerning a 42-year-old female patient with no medical history reported, who experienced the serious unexpected, according to the Agency, event of rash. The event occurred on the day after the third dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 2049341 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Feeling abnormal, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

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

Write-up: spaced out; breathlessness; Palpitations aggravated; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26459641) on 11-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (spaced out), DYSPNOEA (breathlessness) and PALPITATIONS (Palpitations aggravated) in a 29-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for an unknown indication. No Medical History information was reported. On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PALPITATIONS (Palpitations aggravated) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (spaced out) (seriousness criterion medically significant) and DYSPNOEA (breathlessness) (seriousness criterion medically significant). At the time of the report, FEELING ABNORMAL (spaced out) and DYSPNOEA (breathlessness) was resolving and PALPITATIONS (Palpitations aggravated) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Lab data includes Electrocardiogram, Bloods and X-Ray of chest. Patient experiences breathlessness, feeling slightly spaced out, feeling really unfit doing small tasks. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. Company comment: This is a regulatory authority case concerning a 29-years-old male patient, with no medical history reported in the case, who experienced the serious unexpected events of Feeling abnormal, Dyspnoea and Palpitations. The event Palpitations occurred approximately one day after the administration of the third dose of mRNA-1273 vaccine; the events Feeling abnormal and Dyspnoea occurred on an unknown date. The events were assessed with the seriousness criteria of Medically Significant by the reporter and, at the time of the report the outcome for the event Palpitations was Not Recovered/Not Resolved and Recovering/Resolving for the rest of the events. It was informed that the patient had blood tests, electrocardiogram and chest X-ray performed although no results are available. No further information on treatment details were provided. The rechallenge was reported as Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This is a regulatory authority case concerning a 29-years-old male patient, with no medical history reported in the case, who experienced the serious unexpected events of Feeling abnormal, Dyspnoea and Palpitations. The event Palpitations occurred approximately one day after the administration of the third dose of mRNA-1273 vaccine; the events Feeling abnormal and Dyspnoea occurred on an unknown date. The events were assessed with the seriousness criteria of Medically Significant by the reporter and, at the time of the report the outcome for the event Palpitations was Not Recovered/Not Resolved and Recovering/Resolving for the rest of the events. It was informed that the patient had blood tests, electrocardiogram and chest X-ray performed although no results are available. No further information on treatment details were provided. The rechallenge was reported as Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 2049365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Cerebrovascular accident, Computerised tomogram, Hypoaesthesia, Immunisation, Lymphadenopathy, Muscular weakness, Paraesthesia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202201; Test Name: Blood test; Result Unstructured Data: Test Result:unknown result; Test Date: 202201; Test Name: CT scan; Result Unstructured Data: Test Result:unknown result; Test Date: 20210704; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200064377

Write-up: Mouth on right side of face started numb feeling down right side of face, travelling down into right arm; Weakness; Mouth on right side of face started drooping with tingling, travelling down into right arm; Slight weakness in right leg; Glands at front of neck started to swell; Suspected stroke; Primary immunisation: BNT162b2; Booster: COMIRNATY; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority. Regulatory number: GB-MHRA-WEBCOVID-202201121020110010-Q6HIV. Other Case identifier(s): GB-MHRA-ADR 26465421. A 32 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 04Jul2021 (unspecified if ongoing). The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE;Lot Number: unknown; Route of administration: unspecified), for COVID-19 immunisation, reaction(s): "COVID-19", "Drug ineffective"; Bnt162b2 (DOSE 1, SINGLE;Lot Number: unknown; Route of administration: unspecified), for COVID-19 immunisation, reaction(s): "COVID-19", "Drug ineffective". The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 29Dec2021, outcome "unknown", described as "Primary immunisation: BNT162b2; Booster: COMIRNATY"; HYPOAESTHESIA (hospitalization, medically significant), outcome "recovering", described as "Mouth on right side of face started numb feeling down right side of face, travelling down into right arm"; ASTHENIA (hospitalization, medically significant), outcome "recovering", described as "Weakness"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 08Jan2022, outcome "recovering", described as "Suspected stroke"; PARAESTHESIA (hospitalization, medically significant), outcome "unknown", described as "Mouth on right side of face started drooping with tingling, travelling down into right arm"; MUSCULAR WEAKNESS (hospitalization, medically significant), outcome "unknown", described as "Slight weakness in right leg"; LYMPHADENOPATHY (hospitalization, medically significant) with onset 10Jan2022, outcome "unknown", described as "Glands at front of neck started to swell". The events "mouth on right side of face started numb feeling down right side of face, travelling down into right arm", "weakness", "suspected stroke", "slight weakness in right leg" and "glands at front of neck started to swell" were evaluated at the physician office visit. The event "mouth on right side of face started drooping with tingling, travelling down into right arm" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown result; computerised tomogram: (Jan2022) unknown result; sars-cov-2 test: (04Jul2021) yes - positive covid-19 test. Therapeutic measures were taken as a result of cerebrovascular accident. Therapeutic measures were not taken as a result of lymphadenopathy.patient was healthy with on no medication prior to incident.The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. Last menstrual date of the patient was 10Jan2022. The patient was being treated for suspected stroke in meantime and commenced on paracetamol, ASPIRIN. The patient had not been tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200083693 same patient/drug/different dose/ event


VAERS ID: 2049615 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Hypoaesthesia, Malaise, Palpitations, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211228; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 degrees Centigrade; Comments: before vaccination; Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: Test Result:39 degrees Centigrade
CDC Split Type: JPPFIZER INC202200050090

Write-up: Palpitations; Giddiness; Numbness in hands and feet; Malaise; 39 degrees Centigrade Pyrexia; This is a spontaneous report received from a contactable reporter(s) (Physician) from Regulatory Authority. Regulatory number: v21132758. A 38-year-old male patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 11:15 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient was a 38-year and 1-month-old (age at vaccination). The patient had no relevant medical history. The patient''s concomitant medications were not reported. 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). Clinical course: On 29Dec2021 (1 day after the vaccination), the patient experienced malaise. On 11Jan2022 (14 days after the vaccination), the outcome of the events malaise, palpitations, giddiness, numbness in hands and feet was not recovered. The outcome of 39 degrees Centigrade pyrexia was recovered on 29Dec2021. The course of the event was as follows: On 28Dec2021, the patient received the first dose. The patient had a 39 degrees Centigrade Pyrexia (start date: 29Dec2021) temporarily, but it has resolved spontaneously. Since then, malaise had become stronger. The patient''s work was suffering, so the patient asked for a leave. Malaise, Palpitations, Giddiness, Numbness in hands and feet (start date: 29Dec2021). The patient underwent the following laboratory tests and procedures: body temperature: (28Dec2021) 36.0 degrees, notes: before vaccination. The reporting physician classified the events 39 degrees Centigrade pyrexia, malaise, palpitations, giddiness, numbness in hands and feet as serious (medically Significant) and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows that it was difficult to determine the direct relationship with the vaccine. There were no specific abnormalities of organ in the consultation. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2050238 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021F21A / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute coronary syndrome, Blood pressure measurement, Chest discomfort, Dizziness, Dyspnoea, Headache, Hypertensive urgency, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: BP; Result Unstructured Data: 191/93 4 hours before coming to hospital.; Test Date: 20211229; Test Name: Oxygen saturation; Result Unstructured Data: 5 hours before coming to hospital 99 percentage.
CDC Split Type: THMODERNATX, INC.MOD20224

Write-up: Hypertensive urgency; NSTEMI; Dizziness; Chest tightness; Palpitations; Difficulty in breathing; Headache; This case was received via Regulatory Authority (Reference number: MOD-2022-277) on 10-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of HYPERTENSIVE URGENCY (Hypertensive urgency), ACUTE CORONARY SYNDROME (NSTEMI), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), PALPITATIONS (Palpitations), DYSPNOEA (Difficulty in breathing) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 021F21A) for an unknown indication. No Medical History information was reported. On 29-Dec-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced HYPERTENSIVE URGENCY (Hypertensive urgency) (seriousness criteria hospitalization and medically significant), ACUTE CORONARY SYNDROME (NSTEMI) (seriousness criteria hospitalization and medically significant), DIZZINESS (Dizziness) (seriousness criteria hospitalization), CHEST DISCOMFORT (Chest tightness) (seriousness criterion hospitalization), PALPITATIONS (Palpitations) (seriousness criteria hospitalization), DYSPNOEA (Difficulty in breathing) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criteria medically significant). The patient was hospitalized on 29-Dec-2021 due to ACUTE CORONARY SYNDROME, CHEST DISCOMFORT, DIZZINESS, DYSPNOEA, HYPERTENSIVE URGENCY and PALPITATIONS. At the time of the report, HYPERTENSIVE URGENCY (Hypertensive urgency), ACUTE CORONARY SYNDROME (NSTEMI), DIZZINESS (Dizziness), CHEST DISCOMFORT (Chest tightness), PALPITATIONS (Palpitations), DYSPNOEA (Difficulty in breathing) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2021, Blood pressure measurement: 191/93 (abnormal) 191/93 4 hours before coming to hospital.. On 29-Dec-2021, Oxygen saturation: 99 (normal) 5 hours before coming to hospital 99 percentage.. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. Suspect vaccine serial No. 1072203. On 29-Dec-2021, 5 hours before visiting hospital she had headache, dizziness, chest tightness. 4 hours before hospital visit, she had symptoms of dizziness, palpitations, chest tightness, difficulty in breathing, no fever, no nausea, no vomiting so she came to the hospital. The patient received unspecified treatment on 29-Dec-2021. This case concerns a 71-year-old female patient with no medical history, who experienced the unexpected serious events of Hypertensive Urgency, Dizziness, Chest Discomfort, Palpitations, Dyspnea, Headache, and adverse event of special interest, Acute Coronary Syndrome, the events led to the hospitalization of the patient as reported by the regulatory authority. The events occurred in 1 day after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. The patient was hospitalized due to Acute Coronary Syndrome, Chest Discomfort, Dizziness, Dyspnea, Hypertensive Urgency and Palpitations, Blood Pressure measurement showed high results while Oxygen Saturation Levels were normal, no other clinical or treatment details were given. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender''s Comments: This case concerns a 71-year-old female patient with no medical history, who experienced the unexpected serious events of Hypertensive Urgency, Dizziness, Chest Discomfort, Palpitations, Dyspnea, Headache, and adverse event of special interest, Acute Coronary Syndrome, the events led to the hospitalization of the patient as reported by the regulatory authority. The events occurred in 1 day after receiving the second dose of mRNA-1273 Vaccine. The rechallenge was reported as not applicable by the regulatory authority. The patient was hospitalized due to Acute Coronary Syndrome, Chest Discomfort, Dizziness, Dyspnea, Hypertensive Urgency and Palpitations, Blood Pressure measurement showed high results while Oxygen Saturation Levels were normal, no other clinical or treatment details were given. It was reported that the outcome of the events was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.


VAERS ID: 2051700 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20220109; Test Name: RAT test; Result Unstructured Data: Test Result:Positive; Comments: RAT test for COVID-19
CDC Split Type: AUPFIZER INC202200028362

Write-up: Positive RAT test for COVID-19; Developed symptoms Sunday 2 January - not severe - escalated and took RAT test showing positive; Had comirnary booster shots on 29 December; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 1), administration date: 08Jul2021, for COVID-19 IMMUNISATION, reaction(s): "vaccination site pain", "Localised feeling of warmth", "Neck pain", "Headache"; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 IMMUNISATION. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Had comirnary booster shots on 29 December"; DRUG INEFFECTIVE (medically significant) with onset 09Jan2022, outcome "unknown", described as "Positive RAT test for COVID-19"; COVID-19 (medically significant) with onset 02Jan2022, outcome "unknown", described as "Developed symptoms Sunday 2 January - not severe - escalated and took RAT test showing positive". The clinical course of events was as follows: Positive RAT test for COVID-19 on Sunday 09Jan22. Developed symptoms Sunday 02Jan22 - not severe - escalated and took RAT test showing positive 09Jan22. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (09Jan2022) positive, notes: RAT test for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2051701 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Immunisation, 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? 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: 20220106; Test Name: nasal swab; Result Unstructured Data: Test Result:Positive; Comments: PCR test
CDC Split Type: AUPFIZER INC202200028678

Write-up: caught covid; caught covid; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 17 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 29Dec2021 15:00 (Lot number: Unknown) at the age of 18 years as dose 3 (booster), single, intramuscular, administration date 28Aug2021 10:00 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 31Jul2021 10:00 (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: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 06Jan2022 18:00, outcome "recovered" and all described as "caught covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: PCR test. Therapeutic measures were not taken as a result of covid-19, vaccination failure. The lot number for bnt162b2 was not provided and will be requested during follow up.


VAERS ID: 2051943 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 3 - / OT

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

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

Write-up: Headache; ACUTE HEADACHE, FEVER, JOINT PAIN; Arthralgia; This case was received via regulatory authority (Reference number: ES-AEMPS-1079129) on 14-Jan-2022 and was forwarded to Moderna on 14-Jan-2022. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache), PYREXIA (ACUTE HEADACHE, FEVER, JOINT PAIN) and ARTHRALGIA (Arthralgia) in a 51-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2021, the patient received third dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Dec-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (ACUTE HEADACHE, FEVER, JOINT PAIN) (seriousness criterion medically significant) and ARTHRALGIA (Arthralgia) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), PYREXIA (ACUTE HEADACHE, FEVER, JOINT PAIN) and ARTHRALGIA (Arthralgia) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged. No concomitant medication was reported. No treatment details was reported.; Sender''s Comments: This case concerns a patient, with medical history (not reported), who experienced the serious (Medically Significant) unexpected events of headache, pyrexia and arthralgia. The events started occurring approximately within 1 day after the 3rd dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 2052158 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Headache, Immunisation, Interchange of vaccine products, Lethargy, Off label use, Pain, Pain in extremity, Parosmia, Pyrexia, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (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: FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211229; Test Name: Body temperature; Result Unstructured Data: Test Result:41; Comments: High temperature of 41
CDC Split Type: GBPFIZER INC202200026788

Write-up: Aching so much; Felt weak; Pain in arm; Smell affected; Breathing affected; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Primary immunisation: ASTRAZENECA; Booster: COMIRNATY; Extreme aches in legs and head; Extreme aches in legs; Temperature of 41; Lethargy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the regulatory authority (UK-MHRA). The reporter is the patient. Regulatory number: GB-MHRA-EYC 00270535 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26430457 (MHRA). A 54 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history was not reported. Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Covid-19 vaccine astrazeneca (DOSE 1), for COVID-19 immunisation, reaction(s): "Generalised aching", "Pain in arm"; Covid-19 vaccine astrazeneca (DOSE 2), for COVID-19 immunisation, reaction(s): "Generalised aching", "Pain in arm". The following information was reported: OFF LABEL USE (medically significant), INTERCHANGE OF VACCINE PRODUCTS (medically significant), IMMUNISATION (medically significant) all with onset 29Dec2021, outcome "unknown" and all described as "Primary immunisation: ASTRAZENECA; Booster: COMIRNATY"; HEADACHE (medically significant) with onset 29Dec2021, outcome "recovering", described as "Extreme aches in legs and head"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "recovering", described as "Extreme aches in legs"; PYREXIA (medically significant) with onset 29Dec2021, outcome "recovering", described as "Temperature of 41"; LETHARGY (medically significant) with onset 29Dec2021, outcome "recovering", described as "Lethargy"; PAIN (medically significant), outcome "unknown", described as "Aching so much"; ASTHENIA (medically significant), outcome "unknown", described as "Felt weak"; PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Pain in arm"; PAROSMIA (medically significant), outcome "unknown", described as "Smell affected"; RESPIRATION ABNORMAL (medically significant), outcome "unknown", described as "Breathing affected". The patient underwent the following laboratory tests and procedures: body temperature: (29Dec2021) 41, notes: High temperature of 41. Clinical course: It was reported that patient had AstraZeneca for the first two jabs where she was aching and sore arm. But this time, her smell and breathing had been affected as well as the other symptoms. She was really poorly as she was aching so much and felt weak (wet herself trying to go to the toilet). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, 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 Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202200031924

Write-up: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from the Regulatory Authority-WEB. Regulatory number: GB-MHRA-WEBCOVID-202201010915341990-W6PMY (RA). Other Case identifier(s): GB-MHRA-ADR 26423768 (RA). A female patient received BNT162B2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose-1), for COVID-19 immunisation; BNT162b2 (Dose-2), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Swollen lymph nodes". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. 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: 2052507 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Lymphadenopathy, Menstruation irregular, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (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: COVID-19 (had Covid twice Mar2021 and Sep2021); Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200026665

Write-up: Irregular periods; Chronic anxiety; Muscle pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202201062321561290-5R82X, Safety Report Unique Identifier GB-MHRA-ADR 26446345. A 37-year-old female patient received the first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 29Dec2021 (at the age of 37-year-old) as a dose 1, single for COVID-19 immunisation. Medical history included suspected covid-19 (started from 05Mar2021 to 18Mar2021), and covid-19 (two times, in Mar2021 and Sep2021). The patient was not enrolled in the clinical trial. Concomitant medications were not reported. On 05Sep2021, the patient underwent COVID-19 virus test and the result was positive. On 29Dec2021, the patient experienced swollen lymph nodes; On 30Dec2021, muscle pain; On 31Dec2021, chronic anxiety; On 01Jan2022, irregular periods; all were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events chronic anxiety was recovering, swollen lymph nodes, muscle pain, and irregular periods was not recovered at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052521 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9706 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Lymphadenopathy, Myalgia, Pain in extremity, SARS-CoV-2 test, Sciatica
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Infection
Allergies:
Diagnostic Lab Data: Test Date: 20201012; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202200026818

Write-up: Sciatic pain; Muscle aches; Lymph nodes under left arm /Swollen lymph nodes; Fatigue; Aching in limb; This is a spontaneous report received from a contactable reporter (Consumer) from the RA. Regulatory number: GB-MHRA-WEBCOVID-202201070723214210-ZHEXB. Other Case identifier: GB-MHRA-ADR 26447121. A 50-year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 28Dec2021 (Lot number: FK9706) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Infection" (unspecified if ongoing); "COVID-19", start date: 12Oct2020, stop date: 27Dec2020. Regular antibody testing prior to first vaccination indicated sustained levels of immunity circa 150u/ml 12 months after prior infection. Patient is not pregnant and not currently breastfeeding. The patient''s concomitant medications were not reported. The following information was reported: SCIATICA (medically significant), outcome "not recovered", described as "Sciatic pain"; LYMPHADENOPATHY (medically significant) with onset 29Dec2021, outcome "recovered" (03Jan2022), described as "Lymph nodes under left arm /Swollen lymph nodes"; FATIGUE (medically significant) with onset 29Dec2021, outcome "recovered" (03Jan2022), described as "Fatigue"; PAIN IN EXTREMITY (medically significant) with onset 29Dec2021, outcome "recovered" (01Jan2022), described as "Aching in limb"; MYALGIA (medically significant), outcome "unknown", described as "Muscle aches". The patient underwent the following laboratory test: sars-cov-2 test: (12Oct2020) yes - positive covid-19 test. Clinical course: Lymph nodes under left arm (vaccine site was left arm). Muscle aches were on whole of left side, including sciatic pain and into face and neck, all on left side. 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). Please provide details of any relevant investigations or tests conducted: "None" No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052564 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Dyspnoea, Head injury, Headache, Immunisation, Loss of consciousness, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200028225

Write-up: struggling for breath; sharp pains in my left side of my chest; Headache; Fainting; Booster; passed out; dizzy; hitting head; This is a spontaneous report received from a contactable Consumer from the RA. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201071026469750-EADPT. Other Case identifier(s): GB-MHRA-ADR 26447947. A 26 year-old female patient received BNT162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 26 years as dose 3 (booster), single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Vaccination history included: BNT162b2 (Dose 1), for COVID-19 immunisation; BNT162b2 (Dose 2), for COVID-19 immunisation. The following information was reported: The patient stated she felt dizzy the morning after the vaccine and passed out in the bathroom hitting her head on 29Dec2021. Since then she had had headaches from falling. But also a few days after the vaccine she was struggling for breathe and had sharp pains in her left side of her chest on an unspecified date. The patient also experienced fainting on 30Dec2021. All the events were considered serious as medically significant. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event fainting was recovered with sequelae on 30Dec2021, of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052579 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Body temperature, Diarrhoea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Suspected COVID-19, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Daughter had covid in june 2021)
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:High; Test Date: 20220105; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200027505

Write-up: sore throat; vomiting; back ache; Backache; Temperature very high; dioreha; Suspected COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). The reporter is the parent. Regulatory number: GB-MHRA-WEBCOVID-202201071116445760-42TC6 (MHRA). Other Case identifier(s): GB-MHRA-ADR 26448335 (MHRA). A 17 year-old female patient received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Lot number: FK9712) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Jun2021 (unspecified if ongoing), notes: Daughter had covid in june 2021. The patient was healthy and last menstrual period date was 20Dec2021. Patient has 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: OROPHARYNGEAL PAIN (medically significant), outcome "recovered", described as "sore throat"; VOMITING (medically significant), outcome "recovered", described as "vomiting"; BACK PAIN (medically significant), outcome "recovered", described as "back ache"; BACK PAIN (medically significant), outcome "recovering", described as "Backache"; SUSPECTED COVID-19 (medically significant) with onset 29Dec2021, outcome "unknown", described as "Suspected COVID-19"; PYREXIA (medically significant), outcome "unknown", described as "Temperature very high"; DIARRHOEA (medically significant), outcome "unknown", described as "dioreha". The patient underwent the following laboratory tests and procedures: body temperature: (unspecified date) high; sars-cov-2 test: (05Jan2022) negative, notes: No - Negative COVID-19 test. Clinical information: All symptoms of covid. Sore throat. Temperature very high. Back ache. Continual vomiting and dioreha. Symptoms lasted over a week. Daughter had covid in june 2021. Not as bad as this reaction. Came on within 24 hours of dose. Emergency Doctors wanted to admit to North Staffs Royal Stoke but decided as cases high to try and stay at home. Adverse reaction did not occur as a result of an exposure during pregnancy. The report does not relate to possible inflammation of the heart (myocarditis or pericarditis). No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Immunisation, SARS-CoV-2 test
SMQs:, Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200027984

Write-up: Shingles; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from the Regulatory Agency. Regulatory number: GB-MHRA-WEBCOVID-202201071939548780-IGNAJ (RA). Other Case identifier(s): GB-MHRA-ADR 26451307 (RA). A 59 year-old female patient received bnt162b2 (COMIRNATY, reported as COVID-19 MRNA VACCINE BIONTECH), administration date 29Dec2021 (Lot number: Not Known) as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation; Bnt162b2 (Dose 2), for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; HERPES ZOSTER (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Shingles". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative covid-19 test. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052687 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-28
Onset:2021-12-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202200027835

Write-up: myocarditis; Fainting; 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-202201072015358850-FJGRB. Other Case identifier(s): GB-MHRA-ADR 26451421. A 15 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 28Dec2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Date of last menstrual period: 20Dec2021. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: MYOCARDITIS (medically significant), outcome "not recovered", described as "myocarditis"; SYNCOPE (medically significant) with onset 29Dec2021, outcome "recovered" (30Dec2021), described as "Fainting". Clinical course: Patient has not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not currently breastfeeding. 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.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202200037523 Same pt/doses, different events


VAERS ID: 2052724 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FK9712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Immunisation, Interchange of vaccine products, Muscular weakness, Off label use, Pain in extremity, Pelvic pain, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20211229; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200027935

Write-up: Weakness to legs; leg pain; back ache; Off label use; Interchange of vaccine products; Booster; Chronic pelvic pain syndrome; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Regulatory number: GB-MHRA-WEBCOVID-202201072333433110-UYM3F (MHRA). Other Case identifier(s): GB-MHRA-ADR 26451794 (MHRA). A 48 year-old female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 11:50 (Lot number: FK9712) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (dose 2, manufacturer unknown), for COVID-19 Immunization. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "Interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; PELVIC PAIN (medically significant) with onset 29Dec2021, outcome "recovered", described as "Chronic pelvic pain syndrome"; MUSCULAR WEAKNESS (medically significant) with onset 30Dec2021, outcome "unknown", described as "Weakness to legs"; BACK PAIN (medically significant) with onset 29Dec2021, outcome "unknown", described as "back ache"; PAIN IN EXTREMITY (medically significant) with onset 30Dec2021, outcome "unknown", described as "leg pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) negative, notes: No - Negative COVID-19 test. Clinical course: Patient has not had symptoms associated with COVID-19. Booster given at 11.50, back ache started early evening. Woke early hours of the 30th unable to get out of bed. Severe, back, pelvic and leg pain. Weakness to legs. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 2052766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Depression, Fatigue, Immunisation, Influenza like illness, Interchange of vaccine products, Off label use, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Depression (excl suicide and self injury) (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: Emotional disorder (Have experienced emotional and physical trauma in the past); Myalgic encephalomyelitis (suffered from ME); Trauma (Have experienced emotional and physical trauma in the past)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202200027761

Write-up: Bruising of arm; Flu-like aching; Depressed state; Fatigue; 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 Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory number: GB-MHRA-WEBCOVID-202201080955274520-BD2PO (MHRA). Other Case identifier(s): GB-MHRA-ADR 26452325 (MHRA). A female patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Trauma/ physical trauma " (unspecified if ongoing), notes: Have experienced emotional and physical trauma in the past; "emotional trauma" (unspecified if ongoing), notes: Have experienced emotional and physical trauma in the past; "ME" (unspecified if ongoing), notes: suffered from ME. The patient''s concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; CONTUSION (medically significant) with onset 30Dec2021, outcome "not recovered", described as "Bruising of arm"; INFLUENZA LIKE ILLNESS (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Flu-like aching"; DEPRESSION (medically significant) with onset 30Dec2021, outcome "recovering", described as "Depressed state"; FATIGUE (medically significant) with onset 30Dec2021, outcome "recovered" (01Jan2022), described as "Fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: No - Negative COVID-19 test. Clinical course: Patient had not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052804 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Incorrect route of product administration, Interchange of vaccine products, Limb injury, Loss of consciousness, Mobility decreased, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (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 Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202200027974

Write-up: server pain since and loss of mobility in his whole arm; server pain since and loss of mobility in his whole arm; knocked the patient unconscious; off label use; interchange of vaccine products; booster; Injection administered too high; Arm injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Regulatory Agency (RA). The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201081407325800-J3HTD (RA). Other Case identifier(s): GB-MHRA-ADR 26452603 (RA). A 37 year-old male patient received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer unknown), for COVID-19 immunisation; Covid-19 vaccine (Dose: 2, Manufacturer unknown), for COVID-19 immunisation. The following information was reported: OFF LABEL USE (medically significant) with onset 29Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Dec2021, outcome "unknown", described as "interchange of vaccine products"; IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "booster"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Injection administered too high"; LIMB INJURY (medically significant) with onset 29Dec2021, outcome "not recovered", described as "Arm injury"; PAIN IN EXTREMITY (medically significant), MOBILITY DECREASED (medically significant), outcome "unknown" and all described as "server pain since and loss of mobility in his whole arm"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "knocked the patient unconscious". The events "injection administered too high", "arm injury", "server pain since and loss of mobility in his whole arm", "server pain since and loss of mobility in his whole arm" and "knocked the patient unconscious" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative. Clinical course: The patient had not had symptoms associated with COVID-19. Injection administered too high. Needle hit a nerve, knocked the patient unconscious. The patient had server pain since and loss of mobility in his whole arm. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. This report did not relate to possible inflammation of the heart (myocarditis or pericarditis). Details of any relevant investigations or tests conducted: "Spoken to 2 doctors". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 2052854 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-29
Onset:2021-12-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Dyspnoea, Headache, Immunisation, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202200028252

Write-up: Breathless; headaches; pain in back; Generalized chest pain/pain in chest; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from the Agency Regulatory Authority. The reporter is the patient. Regulatory number: GB-MHRA-WEBCOVID-202201082107077620-DMIW7 Regulatory Authority. Other Case identifier(s): GB-MHRA-ADR 26452994 Regulatory Authority. A 47 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Suspected COVID-19", start date: 10Mar2020 (unspecified if ongoing), notes: Unsure when symptoms stopped. Patient is not pregnant. Patient is not currently breastfeeding. Date of last menstrual period was 08Jan2022. The patient''s concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for covid-19 immunisation; Bnt162b2 (DOSE 2), for covid-19 immunisation. The following information was reported: IMMUNISATION (medically significant) with onset 29Dec2021, outcome "unknown", described as "Booster"; CHEST PAIN (medically significant) with onset 01Jan2022, outcome "not recovered", described as "Generalized chest pain/pain in chest"; DYSPNOEA (medically significant), outcome "unknown", described as "Breathless"; HEADACHE (medically significant), outcome "unknown", described as "headaches"; BACK PAIN (medically significant), outcome "unknown", described as "pain in back". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: no - negative. 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: 2053176 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-12-29
   Days after vaccination:147
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Ultrasound abdomen, Ultrasound pelvis
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? 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: 20211229; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: Abdominal US; Result Unstructured Data: Test Result:unknown results; Test Name: Pelvic US; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202200053113

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; 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. A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Aug2021 (Batch/Lot number: unknown) as dose 2, single and administration date 05Jun2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. Patient last menstrual period date was on 05Jan2022. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021, outcome "recovered" (06Jan2022) and all described as "SARS-CoV-2 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) yes - positive covid-19 test; ultrasound abdomen: (unspecified date) unknown results; ultrasound pelvis: (unspecified date) unknown results. 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-202200027504 same reporter/patient, different event/vaccine dose


VAERS ID: 2053651 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-12-24
Onset:2021-12-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2022-01-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021F21A / 2 - / OT

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

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

Write-up: Fever; Headache; This case was received via Pharma (Reference number: MOD-2022-276) on 10-Jan-2022 and was forwarded to Moderna on 11-Jan-2022. This regulatory authority case was reported by an other health care professional and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 021F21A) for an unknown indication. No Medical History information was reported. On 24-Dec-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) was resolving. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. There was no concomitant medication reported. Unknown treatment received on 29 Dec 2021. Serial no reported as 11092MO011221005. This is a regulatory case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected events of pyrexia and headache. The events occurred approximately 5 days after the second dose of mRNA ? 1273 vaccine. All the events were reported as medically significant and at the time of report all were resolving. 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 52-year-old female patient with no medical history reported, who experienced the unexpected events of pyrexia and headache. The events occurred approximately 5 days after the second dose of mRNA ? 1273 vaccine. All the events were reported as medically significant and at the time of report all were resolving. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1984274 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-12-27
Onset:2021-12-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 33130BA / 3 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Chills, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: COVID 19 Pfizer Vaccine
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills Left arm pain


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