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From the 10/15/2021 release of VAERS data:

Found 800,916 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 205 out of 8,010

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VAERS ID: 1779516 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Pt. states that after receiving the 1st dose of Moderna 09/09/2021, started experiencing symptoms 09/12/2021 of pain, tingling throughout the left arm. No noted Primary visit. Symptoms still continuing.


VAERS ID: 1779580 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-08-29
Onset:2021-09-12
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8448 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Hypertension, Palpitations
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad)

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

Write-up: I experienced headaches and heart palpations. I went to see my doctor and we figured out I was having high blood pressure which was causing the symptoms I was having. I talked to my doctor and she prescribed medication. I have an appointment scheduled next month with a cardiologist.


VAERS ID: 1779891 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 301308A / 3 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal discomfort, Asthenia, Chest X-ray, Chills, Exercise tolerance decreased, Fatigue, Glycosylated haemoglobin increased, Headache, Laboratory test, Lymphadenopathy, Oropharyngeal pain, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin; fish oil; calcium; Bone up
Current Illness: No
Preexisting Conditions: Possible glaucoma
Allergies: Aspirin; ibuprofen
Diagnostic Lab Data: Chest X-ray 10/10/2021 normal, lab work 10/11/2021 A1C elevated
CDC Split Type: vsafe

Write-up: I had chills and a fever and felt tired/fatigued about 2 days after the vaccine. I had swelling on the back of my head that was painful. Then gradually my temperature went down but I have continued to feel fatigued throughout the day. I think I have had something going on with my intestines. I have been very thirsty and after the swelling in the back of my head went down, I started to swell on my right temple. It is very painful. My doctor today 10/12/2021 said there is a swollen gland on the side of my head. My throat has also been hurting a little bit. I was unable to finish my exercise class this morning which is unusual for me. My doctor had suggested a few weeks ago to take zinc and vitamin D to help with energy levels but I am still fatigued. This last saturday I called the advice nurse and I went to urgent care 10/10/2021.


VAERS ID: 1782714 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Hypoaesthesia, Injection site haemorrhage, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

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

Write-up: When shot was given it burned throughout my whole arm. In comparison I didnt even feel my 1st shot. My arm all the way to my fingers continued to hurt and was numb for the next 3 weeks. I felt like someone injected me with acid. In addition the injection site bleed for 5 to 10 mins, this also did not occur when i received the 1st shot. To this day, I believe the vaccine was contaminated.


VAERS ID: 1783163 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-03-01
Onset:2021-09-12
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: COVID-19 hospitalization after full vaccination.


VAERS ID: 1784961 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-08
Onset:2021-09-12
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anosmia, COVID-19, Nasopharyngitis, SARS-CoV-2 test positive
SMQs:, Taste and smell disorders (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

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

Write-up: Contracted COVID. Symptoms began appearing 9/12/21 with cold symptoms. On 9/15/21, lost my sense of smell. Tested positive for COVID on 9/17/21.


VAERS ID: 1785478 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-26
Onset:2021-09-12
   Days after vaccination:139
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac disorder, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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

Write-up: Pt onset 9/5 and symptoms progressed . On 9/12 Pt was having difficulty breathing and having heart issues so 911 was called and EMS Transported PT from home address to Hospital and she has been in the hospital since. Pt has AFIB and has history of valve issues. Pt is fully vx and received Dose 2 on 4/26.


VAERS ID: 1695512 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu-like symptoms Age 25 July 2021 Tdap
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Muscle aches. Continued for 48 hours


VAERS ID: 1708293 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal discomfort, Extra dose administered, Pain in extremity, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (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: Nothing
Current Illness: None. This is my third vaccin of faizer
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: After the second vaccine the lege hurt and i cdbt get to the toilet for 3 mounth cause i started suddenly to have stomick problems. Now after the third vaccin i started again suffering from the stomick. And also feeling my legs hurt. Also after 2 days it started blood like peirod but i was early to get this period. It was early in 2 weeks


VAERS ID: 1709986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196555

Write-up: Dizziness; Breathing difficult; Tight chest; This is a spontaneous report from a contactable. This is report received from a regulatory authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109122008537250-2QMJA, Safety Report Unique Identifier number is GB-MHRA-ADR 25929377. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose2, via an unspecified route of administration on 12Sep2021 (Lot number was not reported) as SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were none, not on any medication, no past illnesses. normally fit and well. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced dizziness, breathing difficult, tight chest on 12Sep2021. The case was reported as serious due to Life threatening. The outcome of the events was not recovered. The clinical course was reported as follows: 2nd c19 injection 40mins later symptoms started. Patient has not tested positive for COVID-19 since having the vaccine.Unsure if patient is enrolled in clinical trial. Reaction: Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No".Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Pt has govne to emargeny department". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1714590 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epistaxis
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via RA (Reference number: GB-MHRA-ADR 25937032) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Epistaxis. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. 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. Concomitant product use was not provided by the reporter. Patient experienced chest pain, shortness of breath, general malaise with no palpitations. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient also had cardiology review and ECHO but results were not reported. No treatment information was provided. This case concerns an 18-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 2 days after the second dose of Spikevax and had an unresolved outcome. The rechallenge was unknown since no information about the first dose was disclosed. The reporter did not provide any causality assessment. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns an 18-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 2 days after the second dose of Spikevax and had an unresolved outcome. The rechallenge was unknown since no information about the first dose was disclosed. The reporter did not provide any causality assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1715666 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005885 / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Prednisolone 15 mg/day
Current Illness:
Preexisting Conditions: Crohn''s diasease
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Blod coats in menstrual discharge


VAERS ID: 1717463 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diverticulum intestinal haemorrhagic, Shock
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Gastrointestinal haemorrhage (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101199179

Write-up: Intestinal diverticular bleeding; Shocked; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127814. A 57-year and 2-month-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection) via an unspecified route of administration on 11Sep2021 at 14:45 (Lot number: Unknown, Expiration Date: unknown) at the age of 57-year-old as single dose for COVID-19 immunization. Medical history was none. Body temperature before vaccination was 36.4 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication was not reported. The clinical course was as follows: On 12Sep2021 at 15:00 (1 day after the vaccination), the patient experienced Intestinal diverticular bleeding. On 12Sep2021 (1 day after the vaccination), the patient was admitted to the hospital. Suddenly Intestinal diverticular bleeding occurred and shocked. Visited Emergency Room. No history of Intestinal diverticular bleeding. Carried on Transfusion. The events resulted in hospitalization and emergency room visit. The outcome of the event was recovering. The reporting physician classified the event as serious (caused hospitalization and Life-threatening) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: 24 hours after vaccination, Intestinal diverticular bleeding occurred which had not happened before. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1718673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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: 20210913; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Date: 20210915; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: DEJNJFOC20210933962

Write-up: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnic origin. Initial information was processed along with the additional information received on 17-SEP-2021. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The patient was suffering from severe flu symptoms form 12-SEP-2021 evening. A rapid test done on 13-SEP-2021 and a PCR test on 15-SEP-2021 came out positive (Confirmed clinical vaccination failure and Confirmed covid-19 infection). The patient said he feels really sick and was unlucky to get a breakthrough infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition) This case was associated with Product Quality Complaint (PQC) 90000193578. The suspected product quality complaint has been confirmed to be non voided as the reported allegation could not be confirmed, and a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender''s Comments: V0: 20210933962 -COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1720869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test, Syncope, Tinnitus
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: dizziness; Faint; Ears were ringing also; Light-headed; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25928909) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIZZINESS (Light-headed) and SYNCOPE (Faint) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced DIZZINESS (Light-headed) (seriousness criterion medically significant). On an unknown date, the patient experienced DIZZINESS (dizziness) (seriousness criterion medically significant), SYNCOPE (Faint) (seriousness criterion medically significant) and TINNITUS (Ears were ringing also). At the time of the report, DIZZINESS (dizziness), DIZZINESS (Light-headed), SYNCOPE (Faint) and TINNITUS (Ears were ringing also) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient woke up in the morning, went downstairs and suddenly got hit with dizziness/feeling lightheaded/faint. Had to sit down. Ears were ringing also. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment information was not provided. This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Dizziness. The event occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of Dizziness. The event occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1720883 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Syncope; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25929193) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On 12-Sep-2021, SYNCOPE (Syncope) 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. Concomitant product use was not provided by the reporter. Patient experienced syncope shortly after receiving his vaccine at the vaccination center. Patient had been drinking alcohol that last night and was on minimal diet. On the day of vaccination only fluids were taken. No treatment information was provided. Laboratory information included blood pressure of 124/75 and pulse rate of 64. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. It was unsure if patient was enrolled in clinical trial. Company comment- This case concerns a 19-year-old male patient with no relevant medical history , who experienced the unexpected event of Syncope. The event occurred shortly within an unspecified time after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed . The reporter did not provide any causality assessment. The patient''s history of alcohol consumption previous night and a minimal diet remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report; Sender''s Comments: This case concerns a 19-year-old male patient with no relevant medical history , who experienced the unexpected event of Syncope. The event occurred shortly within an unspecified time after the second dose of mRNA-1273. The rechallenge was unknown since no information about the first dose was disclosed . The reporter did not provide any causality assessment. The patient''s history of alcohol consumption previous night and a minimal diet remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1720896 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuralgia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), COVID-19 (broad)

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

Write-up: Nerve pain; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25929602) on 13-Sep-2021 and was forwarded to Moderna on 13-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NEURALGIA (Nerve pain) in a 63-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced NEURALGIA (Nerve pain) (seriousness criterion medically significant). At the time of the report, NEURALGIA (Nerve pain) 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. Concomitant product use was not provided by the reporter. Patient had extreme pain in left side of gums and up face from there. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. No treatment information was provided. Company Comment: This case concerns a 63 year-old, female subject, who experienced the unexpected not labeled event of neuralgia. The event occurred 5 days after the second dose of Spikevax. The rechallenge was not applicable since only information about the second dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 63 year-old, female subject, who experienced the unexpected not labeled event of neuralgia. The event occurred 5 days after the second dose of Spikevax. The rechallenge was not applicable since only information about the second dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1720898 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

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

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

Write-up: swollen arm where vaccine site is on arm; Itchy rash; Swollen arm; Rash; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25931931) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swollen arm where vaccine site is on arm), PERIPHERAL SWELLING (Swollen arm), RASH (Rash) and RASH PRURITIC (Itchy rash) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Concurrent medical conditions included Anxiety. Concomitant products included CITALOPRAM from 24-Aug-2019 to an unknown date for Anxiety. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant) and RASH (Rash) (seriousness criterion medically significant). On 13-Sep-2021, the patient experienced RASH PRURITIC (Itchy rash) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE SWELLING (swollen arm where vaccine site is on arm) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE SWELLING (swollen arm where vaccine site is on arm) outcome was unknown and PERIPHERAL SWELLING (Swollen arm), RASH (Rash) and RASH PRURITIC (Itchy rash) 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. No treatment medications were provided. Rechallenge is reported as Unknown with respect to event. The patient had swollen arm where the vaccine site is on arm, rash and pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. This case concerns a 28-year-old, female subject with medical history of citalopram intake for anxiety, who experienced the unexpected events of peripheral swelling, rash, rash pruritic and vaccination site swelling. The events peripheral swelling and rash occurred 1 day after the administration of the second dose; the event rash pruritic occurred 2 days after the administration of the second dose. The event start date of vaccination site swelling was not provided. The rechallenge was unknown since no information about the first dose was provided. The medical history of citalopram intake for anxiety, which may cause a less common side effect of skin rash, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant. Of note, there was no mention in the case narrative that the event ''rash pruritic'' occurred; however, the event was retained per Regulatory Authority report.; Sender''s Comments: This case concerns a 28-year-old, female subject with medical history of citalopram intake for anxiety, who experienced the unexpected events of peripheral swelling, rash, rash pruritic and vaccination site swelling. The events peripheral swelling and rash occurred 1 day after the administration of the second dose; the event rash pruritic occurred 2 days after the administration of the second dose. The event start date of vaccination site swelling was not provided. The rechallenge was unknown since no information about the first dose was provided. The medical history of citalopram intake for anxiety, which may cause a less common side effect of skin rash, remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant. Of note, there was no mention in the case narrative that the event ''rash pruritic'' occurred; however, the event was retained per Regulatory Authority report.


VAERS ID: 1722113 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Injection site pain, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Shivering; Pins and needles; Nausea; Pain injection site; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25930978 ) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PARAESTHESIA (Pins and needles), NAUSEA (Nausea), INJECTION SITE PAIN (Pain injection site) and CHILLS (Shivering) in a 30-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The medical history was not provided by the reporter. Concomitant products included SALBUTAMOL SULFATE (VENTOLIN [SALBUTAMOL SULFATE]) from 10-Aug-2008 to an unknown date for Asthma. On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PARAESTHESIA (Pins and needles), NAUSEA (Nausea) and INJECTION SITE PAIN (Pain injection site). On 13-Sep-2021, the patient experienced CHILLS (Shivering). At the time of the report, PARAESTHESIA (Pins and needles), NAUSEA (Nausea), INJECTION SITE PAIN (Pain injection site) and CHILLS (Shivering) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided.; Sender''s Comments: This case concerns a 30-year-old, male subject with no relevant medical history, who experienced the unexpected events of paraesthesia, nausea, injection site pain and chills. The events paraesthesia, nausea and injection site pain occurred on the same day of administration of the second dose; the event chills occurred 1 day after the administration of the second dose. The rechallenge was unknown since no information about the first dose was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting; however, there was no information in the source document supporting that the events are medically significant.


VAERS ID: 1722114 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Diarrhoea, Fatigue, Headache, Lymphadenopathy, Neck pain, SARS-CoV-2 test, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Headache; Sleepy; Joint ache; Pain neck; Exhaustion; Diarrhea; Swollen lymph nodes; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25931238) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes), CHEST PAIN (Chest pain), HEADACHE (Headache), SOMNOLENCE (Sleepy), ARTHRALGIA (Joint ache), NECK PAIN (Pain neck), FATIGUE (Exhaustion) and DIARRHOEA (Diarrhea) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Anxiety. Concomitant products included SERTRALINE for Anxiety. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 12-Sep-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), SOMNOLENCE (Sleepy) (seriousness criterion medically significant), ARTHRALGIA (Joint ache) (seriousness criterion medically significant), NECK PAIN (Pain neck) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant) and DIARRHOEA (Diarrhea) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) had not resolved, CHEST PAIN (Chest pain), HEADACHE (Headache) and DIARRHOEA (Diarrhea) had resolved and SOMNOLENCE (Sleepy), ARTHRALGIA (Joint ache), NECK PAIN (Pain neck) and FATIGUE (Exhaustion) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was provided. Patient has not had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. 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 26-year-old female patient with no relevant medical history, who experienced the unexpected events of Lymphadenopathy, Chest pain, Headache, Somnolence, Arthralgia, Neck pain, Fatigue and Diarrhoea . The event Lymphadenopathy occurred 1 day after second dose of COVID19 Moderna.The onset dates of Chest pain, Headache, Somnolence, Arthralgia, Neck pain, Fatigue and Diarrhoea were not reported. The rechallenge was unknown since no information about the first dose was disclosed . The events Lymphadenopathy, Headache, Arthralgia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID19 Moderna is not affected by this report.Event seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 26-year-old female patient with no relevant medical history, who experienced the unexpected events of Lymphadenopathy, Chest pain, Headache, Somnolence, Arthralgia, Neck pain, Fatigue and Diarrhoea . The event Lymphadenopathy occurred 1 day after second dose of COVID19 Moderna.The onset dates of Chest pain, Headache, Somnolence, Arthralgia, Neck pain, Fatigue and Diarrhoea were not reported. The rechallenge was unknown since no information about the first dose was disclosed . The events Lymphadenopathy, Headache, Arthralgia and Fatigue are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of COVID19 Moderna is not affected by this report.Event seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1722120 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Chills, Decreased appetite, Feeling cold, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Appetite lost; Coldness; Back pain; Muscle pain; Feverish; Shivers; Headache; This case was received (Reference number: GB-MHRA-ADR 25932480) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Appetite lost), FEELING COLD (Coldness), BACK PAIN (Back pain), MYALGIA (Muscle pain), PYREXIA (Feverish), CHILLS (Shivers) and HEADACHE (Headache) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced DECREASED APPETITE (Appetite lost) (seriousness criterion medically significant), FEELING COLD (Coldness) (seriousness criterion medically significant), BACK PAIN (Back pain) (seriousness criterion medically significant), MYALGIA (Muscle pain) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), CHILLS (Shivers) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, DECREASED APPETITE (Appetite lost), FEELING COLD (Coldness), BACK PAIN (Back pain), MYALGIA (Muscle pain), PYREXIA (Feverish), CHILLS (Shivers) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Sep-2021, SARS-CoV-2 test: negative covid-19 test (Negative) Negative COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Laboratory exam was also performed as heart rate on 12-Sep-2021 but the result was not provided. Treatment information was not provided. Company Comment: This case concerns a 35-year-old patient with no relevant medical history, who experienced the unexpected events of decreased appetite, feeling cold, back pain, myalgia, pyrexia, chills, and headache. The events occurred on the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.; Sender''s Comments: This case concerns a 35-year-old patient with no relevant medical history, who experienced the unexpected events of decreased appetite, feeling cold, back pain, myalgia, pyrexia, chills, and headache. The events occurred on the same day after the second dose of Spikevax. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1722128 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Malaise, Myocarditis, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions: Comments: No medical history was reported by reporter
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Myocarditis; General Malaise; Headache; Chills; Fever; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25937060) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by reporter. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]) for Contraception. On 10-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MALAISE (General Malaise), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved and MALAISE (General Malaise), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Sep-2021, SARS-CoV-2 test: negative (Negative) 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 tests Troponin, Cardiology review and Echocardiogram was conducted. Treatment medication were not reported. Patient had experienced chest pain with heaviness, general malaise, fever, chills and headache. Company comment: This case concerns a 19-year-old, female patient with no relevant medical history, who experienced the serious expected event of Myocarditis and additional non-serious expected and unexpected events of Malaise, Pyrexia, Chills and Headache. The event of Myocarditis occurred approximately 02 days after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). Onset and outcome of other added events are unknown. The rechallenge was unknown since no detail information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender''s Comments: This case concerns a 19-year-old, female patient with no relevant medical history, who experienced the serious expected event of Myocarditis and additional non-serious expected and unexpected events of Malaise, Pyrexia, Chills and Headache. The event of Myocarditis occurred approximately 02 days after the second dose of mRNA-1273 (Moderna CoviD-19 Vaccine). Onset and outcome of other added events are unknown. The rechallenge was unknown since no detail information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.


VAERS ID: 1724762 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Body temperature; Result Unstructured Data: High; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Lymph nodes enlarged; High temperature; Aching joints; Rigors; This case was received via the RA (Reference number: GB-MHRA-ADR 25931012) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes enlarged), PYREXIA (High temperature), ARTHRALGIA (Aching joints) and CHILLS (Rigors) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Concomitant products included SERTRALINE from 17-Jul-2015 to an unknown date for Depression. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes enlarged) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), ARTHRALGIA (Aching joints) (seriousness criterion medically significant) and CHILLS (Rigors) (seriousness criterion medically significant). At the time of the report, LYMPHADENOPATHY (Lymph nodes enlarged) and PYREXIA (High temperature) had not resolved, ARTHRALGIA (Aching joints) was resolving and CHILLS (Rigors) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Body temperature: high (High) High. On an unknown date, SARS-CoV-2 test: no (Negative) COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was reported. This case concerns a 24-year-old, female patient with a medical history of depression, who experienced the unexpected events of lymphadenopathy, pyrexia, arthralgia and chills. The events occurred approximately 1 day after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case. The reporter assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 24-year-old, female patient with a medical history of depression, who experienced the unexpected events of lymphadenopathy, pyrexia, arthralgia and chills. The events occurred approximately 1 day after the second dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case. The reporter assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1726103 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Asthenia, Hyperhidrosis, Insomnia, Loss of personal independence in daily activities, Pyrexia, Suspected COVID-19
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101218426

Write-up: he has been having covid-19 symptoms; excessive weakness; no sense of smell; no taste; fever; sweats; cant sleep; hasn''t worked; This is a spontaneous report received from a contactable consumer. This 58 years-old, male consumer reported. A 58 years-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vac-cine, formulation: solution for injection, Lot Number: FD7204) via unknown route of administration in left arm on 09Sep2021 (at the age of 58 years old), as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On 12Sep2021, Since Sunday, the patient had been having covid-19 symptoms, such as no sense of smell, no taste, fever, sweats, can''t sleep, excessive weakness and had not worked since Monday. It was reported that he didn''t want to get this poison in his body but the government was saying he had to. No choice. Works in the Health Care system. He would be going for a Covid-19 test tomorrow at the clinic and he had no family doctor (for three years he had been trying to get one). At the time of this report outcome of the events were unknown.


VAERS ID: 1729151 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, SARS-CoV-2 test, Skin abrasion, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (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? 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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196419

Write-up: Faint; felt light headed; abrasion to the left side of his face / head.; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109121129050420-4UYYC, Safety Report Unique Identifier GB-MHRA-ADR 25929038. A male patient of an unknown age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 12Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. On 12Sep2021, the patient experienced faint, he felt light headed and fainted; as he landed, he caused an abrasion to the left side of his face / head. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. It was reported that, there were no possible blood clots or low platelet counts. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event faint was resolved on 12Sept2021 while that of the event felt light headed and abrasion to the left side of his face / head was unknown at the time of report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729154 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-12
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Costochondritis, Electrocardiogram
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CERELLE; FOSTAIR; MEBEVERINE; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Clinical trial participant (Clinical trial participant Study details: Zoe); Irritable bowel syndrome; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: blood pressure test; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101196452

Write-up: Costochondritis; This is a spontaneous report from a contactable consumer. This is a report received.The Regulatory authority report number GB-MHRA-WEBCOVID-202109121648232090-G9UH8, Safety Report Unique Identifier GB-MHRA-ADR 25929227. A 22-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 23Aug2021, as a single dose for COVID-19 immunisation. Medical history included asthma, irritable bowel syndrome, clinical trial participant (study details: Zoe), steroid therapy (taking regular steroid treatment: orally or rectally). Patient did not have symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and was not currently breastfeeding. Concomitant medications included desogestrel (CERELLE) for birth control; beclometasone dipropionate/formoterol fumarate (FOSTAIR) and salbutamol (MANUFACTURER UNKNOWN) for asthma; mebeverine (MANUFACTURER UNKNOWN) for irritable bowel syndrome; all taken from unknown dates and unknown if ongoing. On 12Sep2021, 20 days after vaccination, the patient experienced costochondritis; reported as serious for hospitalization. On an unknown date, the patient underwent electrocardiogram (ECG) and blood pressure test and the results were unknown. Patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the event costochondritis was resolving 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: 1729191 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004668 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Chest pain; Short of breath; Fever; Fever chills; Frequent headaches; Generalised muscle aches; This case was received via RA (Reference number: -MHRA-ADR 25941101) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPNOEA (Short of breath), PYREXIA (Fever), PYREXIA (Fever chills), HEADACHE (Frequent headaches) and MYALGIA (Generalised muscle aches) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004668) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), DYSPNOEA (Short of breath) (seriousness criterion hospitalization), PYREXIA (Fever) (seriousness criterion hospitalization), PYREXIA (Fever chills) (seriousness criterion hospitalization), HEADACHE (Frequent headaches) (seriousness criterion hospitalization) and MYALGIA (Generalised muscle aches) (seriousness criterion hospitalization). On 14-Sep-2021, PYREXIA (Fever) and PYREXIA (Fever chills) had resolved. At the time of the report, CHEST PAIN (Chest pain), DYSPNOEA (Short of breath), HEADACHE (Frequent headaches) and MYALGIA (Generalised muscle aches) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not reported. It was reported that the patient has not had symptoms associated with COVID-19 and has not tested positive for COVID-19 since having the vaccine. Treatment information was not provided. Company comment:This case concerns a male patient of unknown age , with no relevant medical history, who experienced the unexpected events of Chest pain, Dyspnoea , Pyrexia, Fever chills, Headache and Myalgia. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a male patient of unknown age , with no relevant medical history, who experienced the unexpected events of Chest pain, Dyspnoea , Pyrexia, Fever chills, Headache and Myalgia. The events occurred approximately 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1729430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood bilirubin, Blood culture, Body temperature, Brain oedema, Chills, Computerised tomogram head, Diarrhoea, Disseminated intravascular coagulation, Escherichia infection, Escherichia sepsis, Extra dose administered, General physical health deterioration, Headache, Hepatic failure, International normalised ratio, Liver function test, Loss of consciousness, Malaise, Multiple organ dysfunction syndrome, Nausea, Off label use, Pyrexia, Renal failure, Sopor, Syncope, Systemic bacterial infection, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gilbert''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: bilirubin; Result Unstructured Data: Test Result:10; Test Date: 20210915; Test Name: blood culture; Result Unstructured Data: Test Result:cannot find a bacteria in blood.; Comments: They speculated that it could be ecoli, but they are not sure.; Test Date: 20210916; Test Name: blood culture; Result Unstructured Data: Test Result:ecoli; Test Date: 20210913; Test Name: body temperature; Result Unstructured Data: Test Result:fever elevated; Test Date: 20210915; Test Name: body temperature; Result Unstructured Data: Test Result:40; Test Date: 20210915; Test Name: Brain CT; Result Unstructured Data: Test Result:In brain CT 10 hours after the previous there was; Comments: In brain CT 10 hours after the previous there was a severe brain edema; Test Date: 20210915; Test Name: Brain CT; Result Unstructured Data: Test Result:no change demonstarted; Comments: due to changed consciousness, in retrospect a beginning of edema is visible; Test Date: 20210915; Test Name: INR; Result Unstructured Data: Test Result:very high; Test Date: 20210915; Test Name: liver functions; Result Unstructured Data: Test Result:thousands
CDC Split Type: ILPFIZER INC202101226464

Write-up: sepsis; ecoli bacterial infection; DIC; severe brain edema; Liver failure; renal failure; multi-system crashing; sopor state; general deterioration; chills; Headaches; lost consciousness/collapsed; a general unwell feeling; very high fever/fever elevated; vomiting; nausea; weakness; diarrhea; collapsed; invasive bacterial infection; shaking; Third dose; Third dose; This is a spontaneous report from two contactable consumers (one is patient''s sister) and a physician, received via Pizer medical advisor. A 36-year-old male patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Sep2021 (at 36-year-old) as dose 3, single for COVID-19 immunisation. Medical history included Gilbert''s disease. Concomitant medication was not reported. patient previously received the first dose and second dose of bnt162b2 on unspecified date for COVID-19 immunisation. reporter received at this moment a report from medical manager at Teva pharmaceuticals, who was contacted by her friend, her cousin a 40 year old male normally healthy, received the vaccine third dose (unknown if Pfizer or Moderna, probably Pfizer), probably on Wednesday the evening of the holiday, and a few hours afterwards (13Sep2021) his fever elevated, he started to vomit and collapsed, he as rushed to the intensive care unit. He is hospitalized there over the last 24 hours, he is unstable, with dialysis, in the process of systems crashing. From the unit it was reported that there is probably an invasive bacterial infection. The report may have also been reported by Pfizer colleague. further reported Pfizer corona vaccine: this evening two hours ago reporter received a report from Teva medical advisor: 40 years old male normally healthy, received the vaccine third dose on Wednesday and within a few hours his fever elevated, he started to vomit. He was hospitalized in intensive care unit and is under multi-system crashing, including dialysis. reporter received the report from the patient''s relative, reporter requested for additional information and whether it is possible to contact the family or the physician, up until now she did not come back with details. further information received from the same consumer via Pfizer medical advisor, reporter just received an update for the information: He was 36 years old. Received the vaccine on Sunday and over a duration of two days vomited and felt unwell, and on Wednesday he collapsed in his home. They assume it is Pfizer [vaccine] since the first and second were Pfizer''s. They still cannot find a bacteria in blood. They speculated that it could be ecoli, but they are not sure. further information received from a consumer (the patient''s sister) and a physician via Pfizer medical advisor: Received the vaccine on Sunday morning, On Monday afternoon (13Sep2021) he began to feel unwell (weakness, nausea). Monday night - vomiting, shaking and a general unwell feeling. He took Acamol. On Tuesday feeling unwell, less vomiting. Wednesday morning - headaches, chills, very high fever, lost consciousness and then arrived to the hospital, from there general deterioration and multi-system crashing. In a conversation reporter just held with the intensive care treating physician: Dr. assessed that the case is not related to the vaccine. On Sunday he was administered with the third vaccine, a young man with Gilbert''s disease, with no regular treatment. A 36 years old athlete. On the following day he felt unwell. vomiting, diarrhea, fever. It continued this way until Wednesday. The condition deteriorated from day to day and only on Wednesday they referred to the emergency room, since he was already in a sopor state, fever of 40 with changes in consciousness state. Tests upon admission: INR very high, brain CT no change demonstrated due to changed consciousness, in retrospect a beginning of edema is visible. Was ventilated due to alterations of consciousness, moved to conscious, started DIC (Disseminated intravascular coagulation) treatment, blood plasma and platelets units given. They were able to stabilize the coagulation functions and noticed that his pupils are dilated. In brain CT 10 hours after the previous there was a severe brain edema. He is currently ventilated, unresponsive not to pain or anything else. Pupils dilated. Liver failure and renal failure. Not compatible with HHS (Hyperosmolar hyperglycemic state) and TTP (Thrombotic thrombocytopenic purpura) diagnosis. Liver functions - thousands, bilirubin 10 Hemodynamically stable, small dosages of Noradrenalin. Yesterday (16Sep2021) blood bacterial growth - ecoli. In conclusion - classic presentation of sepsis, not typical for a young and normally healthy man, however he probably deteriorated since he was not treated on time, thinking it was vaccine adverse events. Outcome of the events was unknown. Patient was hospitalized from 15Sep2021. The lot number for [BNT162B2], was not provided and will be requested during follow up.


VAERS ID: 1729700 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Dyspnoea, Oropharyngeal discomfort
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Egg allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101216120

Write-up: Anaphylaxis; Dyspnoea; Throat discomfort; This is a spontaneous report from a contactable physician (Vaccinator) received from the regulatory authority. Regulatory authority report number is v21127021. The patient was a 19-year-old male. Body temperature before vaccination was 36.3 degrees centigrade on 12Sep2021. Medical history included the patient had Egg allergy. Concomitant medications were not reported. On 12Sep2021 at 11: 13 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FF2018, Expiration date 31Dec 2021) via an unspecified route of administration at the age of 19 years old as a single dose for COVID-19 immunization. On 12Sep2021 at 11: 13 (the day of vaccination), the patient experienced Throat discomfort and Dyspnoea. The reporting physician classified the event as serious (Life-threatening) and assessed that the events was related to BNT162b2. Other possible cause of the events such as any other diseases was not provided. This report met the criteria of Anaphylaxis. The outcome of the events were unknown.


VAERS ID: 1729727 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Hypoaesthesia, Loss of consciousness, Oxygen saturation, Pallor, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210912; Test Name: Blood pressure; Result Unstructured Data: High; Test Date: 20210912; Test Name: oxygen saturation
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Vagal reflex; Numbness of hands and feet; Facial pallor; This case was received via Regulatory Authority (Reference number: 2021TJP089226) on 13-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case was reported by a physician via a medical representative, Loss of consciousness was assessed as serious by the Regulatory Authority. On 12-Sep-2021, the patient received the 1st dose of this vaccine. Facial pallor and numbness of hands and feet developed 13 minutes after the vaccination. The patient lost consciousness but then recovered. Blood pressure was 141/95, oxygen saturation was 97%. A type of vagal reflex was considered. One hour later, the symptoms resolved, and the patient returned home. The outcome of facial pallor, numbness of hands and feet, loss of consciousness, and vagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 44 year-old male patient with no reported medical history, who experienced the unexpected event of Loss of consciousness. The event occurred within an hour after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The seriousness criteria of Medically significant is maintained for consistency with the MAH assessment in the source document.


VAERS ID: 1731087 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Depressed mood, Ear pain, Gait inability, Hypothermia, Impaired work ability, Interchange of vaccine products, Malaise, Monoplegia, Neck pain, Off label use
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (narrow), Arthritis (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hypothyroidism; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101198195

Write-up: I''m terrible; depressed/I am very sad/I''m upset; chills; Nape pain; pain behind the ear; hypothermia; I cannot walk. I''ve been staggering; My arm does not move; I missed a whole day of work.; I took the second dose of pfizer, but it was supposed to be Astrazeneca. I took Pfizer only because I did not have Astrazeneca to complete the second dose; I took the second dose of pfizer, but it was supposed to be Astrazeneca. I took Pfizer only because I did not have Astrazeneca to complete the second dose; This is a spontaneous report from a contactable consumer via Medical Information. A 50-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Sep2021 11:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included no illness, healthy. The patient have hypothyroidism and had my thyroid removed at 14 years old. She exercise. She does not have diabetes. The patient had COVID-19 before. The patient''s concomitant medications were not reported. The patient previously took DOSE 1 of VAXZEVRIA, single on an unspecified date for COVID-19 immunization. The patient reported that she was terrible, upset, disgusted and very sad. She was very sorry to have taken the second dose of Pfizer. The patient took the second dose of Pfizer, but it was supposed to be AstraZeneca only because she did not have Astrazeneca to complete the second dose. The patient was having the same reactions as when she had COVID. Her private physician prescribed ibuprofen. She had chills at night. Nape pain, pain behind the ear. She was terrible. She had hypothermia and felt like hospitalized. She cannot walk. She have been staggering. Her arm does not move. It''s been 24 hours since she got the vaccine. At the vaccination post they advised that she would have no reaction and it would be light. Pass the correct information. The patient missed a whole day of work. She was depressed. Her husband is also very upset to see her like this. The events were assessed as serious (caused disability). Therapeutic measures were taken as a result of terrible, depressed, chills, nape pain, pain behind the ear, hypothermia, cannot walk and arm does not move. The outcome of the events was unknown. Information on the batch number has been requested.


VAERS ID: 1732885 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Nausea, SARS-CoV-2 test, Vaccination site pain, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210901; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205410

Write-up: Injection site pain; Tiredness; Headache; Muscle pain; Chills; Joint pain; Nausea; Blurred vision; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-APPCOVID-20210913205857, Safety Report Unique Identifier GB-MHRA-ADR 25934445. A 25-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Sep2021 (at the age of 25-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. On 01Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 12Sep2021, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and blurred vision; all the events were reported as serious for being medical significant. The clinical outcome of the events injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea was no recovered and that of the blurred vision was resolving at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected


VAERS ID: 1732963 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196469

Write-up: Fainting; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109121443187110-YAPXB with Safety Report Unique Identifier of GB-MHRA-ADR 25929134. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: FF2153) via an unspecified route of administration on 12Sep2021 (at the age of 32-years-old) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient had no symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. Concomitant medications included lansoprazole. On 12Sep2021, the patient experienced fainting. The clinical course was reported as follows: The patient had fainted after having the 1st dose of vaccine, was laid in the recovery bay and given oral fluids. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event fainting was recovered on 12Sep2021, after a duration of 20 minutes. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1732964 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye irritation, Inappropriate schedule of product administration, Pruritus, Rash, Rash erythematous, SARS-CoV-2 test, Skin burning sensation
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Corneal disorders (broad), Hypersensitivity (narrow), Medication errors (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: FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction; Allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196456

Write-up: rash; Itching; Burning skin/eyes and hands started burning; Burning skin/eyes and hands started burning; Deep red rash; Dose 1: 07Jul2021; dose 2: 12Sep2021; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109121459362150-0PUDE with Safety Report Unique Identifier of GB-MHRA-ADR 25929147. A 44-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Sep2021 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic reaction, and allergy. The patient had no symptoms associated with COVID-19. It was unsure whether the patient was enrolled in clinical trial. The patient was not pregnant and was not breastfeeding. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN) from 01Jan2021 for allergic rash. The patient previously took penicillin nos (MANUFACTURER UNKNOWN) for an unknown indication and experienced unspecified allergic reaction; prednisone (MANUFACTURER UNKNOWN) and fexofenadine (MANUFACTURER UNKNOWN) for allergic reactions; all medications were taken on unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 07Jul2021 as a single dose for COVID-19 immunisation. On 09Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 12Sep2021, the patient experienced rash, itching, burning skin and deep red rash. The events rash, itching and burning skin were reported as serious being medically significant. The clinical course was reported as follows: patient had a history of allergies but was ok when she had the first Pfizer vaccine. It was reported that about an hour after receiving the second vaccine, the patient eyes and hands started burning, itching and she also developed a deep red rash. This started spreading to the rest of her face. The patient was familiar with this kind reaction as patient had it while taking penicillin in the past. The patient had informed the clinical team for both the times of vaccine and they said "it would be ok". The patient did not expect a reaction this way. The patient had fexofenadine and prednisone steroids and tried to control the events. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events rash, itching, deep red rash and burning skin/ eyes and hands started burning 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: 1732965 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Off label use, Product use issue, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196507

Write-up: Off label use; Drug use in unapproved population; Vomiting; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109121549087130-GKPQV. Safety Report Unique Identifier GB-MHRA-ADR 25929158. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), first dose via breastfed route of administration on 10Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. No medical history reported. Patient has not had symptoms associated with COVID-19. Patient did not have COVID-19 test. No concomitant medications reported. The patient experienced vomiting on 12Sep2021, off label use on an unspecified date, drug use in unapproved population on an unspecified date. Patient had the 1st Pfizer vaccine on Fri 10th Sept and on 11th patient began vomiting. On Sunday the 12th Sept my 16 week old exclusively breastfed baby began vomiting and has not stopped doing so all day. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of Event for vomiting was not recovered and for others was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1732966 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (Possible asthma); Chronic eczema; Hypermobility syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101196373

Write-up: Urticaria; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory authority report number GB-MHRA-WEBCOVID-202109121608128930-IWORU, Safety Report Unique Identifier of GB-MHRA-ADR 25929187. A 16-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 12Sep2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included hypermobility syndrome, chronic eczema and possible asthma. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient had not enrolled in clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. Concomitant medications were not reported. On 12Sep2021, the patient experienced urticaria; which was reported as serious for causing disability. There were no relevant investigations or tests conducted. The report was not related to possible blood clots or low platelet counts. The patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the event urticaria was recovered on 12Sep2021 at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Decreased appetite, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196406

Write-up: Chest pain; Fever; Appetite lost; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109121927429690-RNRC4, Safety Report Unique Identifier GB-MHRA-ADR 25929353. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19, and was not enrolled in clinical trial. Concomitant medications were not reported. On 12Sep2021, 1 day after the vaccination, the patient experienced chest pain, fever and appetite lost; all reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcomes of the events chest pain, fever and appetite lost were not resolved 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: 1733018 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (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 Date: 20210910; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196563

Write-up: Palpitations; This is a spontaneous report from a contactable consumer from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109122255350490-OCOBT, Safety Report Unique Identifier GB-MHRA-ADR 25929471. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on unspecified date in Sep2021 (Lot Number: FF2153) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not had symptoms associated with COVID-19. Patient was not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on 10Sep2021 No - Negative COVID-19 test. On 12Sep2021 the patient experienced palpitations. The events were assessed as medically significant. Outcome of event was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Chest discomfort, Chest pain, Cough, Electrocardiogram, X-ray
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210913; Test Name: ECG; Result Unstructured Data: Test Result:NORMAL; Test Date: 20210913; Test Name: X-RAY; Result Unstructured Data: Test Result:NORMAL
CDC Split Type: GBPFIZER INC202101205547

Write-up: chest discomfort; started; tightness; Chest pain; fluttering and clenching; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109131115195610-1YHQV. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 25931313. A 34-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on 10Sep2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included folic acid taken for an unspecified indication from 10Aug2021 to an unspecified stop date. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 12Sep2021, the patient experienced started, chest discomfort, tightness started afternoon, progressing to a fluttering and clenching feeling by 8pm that night and chest pain. It was reported that tightness and mild discomfort had continued at time of submitting this on 13/09/21 but no further fluttering / clenching feeling. On 13Sep2021, The patient underwent lab tests and procedures which included electrocardiogram and x-ray approximately at 2:30 am both came back normal. Treatment received for the events tightness, chest pain, fluttering and clenching. Patient went to accident and emergency room where tightness continued along with occasional fluttering and clenching feeling. No shortness of breath and last fluttering/clenching was around midnight and shortly after that given ibuprofen and paracetamol and patient was told all was fine and to take ibuprofen if needed. The outcome of the events chest pain was recovering and other events were recovered on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733051 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201213; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101205507

Write-up: Breathlessness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131224182770-UGPAH. Safety Report Unique Identifier GB-MHRA-ADR 25931570. A male patient of an unspecified age received the second dose of (BNT162B2, Solution for injection) via an unspecified route of administration on 11Sep2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took (BNT162B2), first dose for COVID-19 Immunization. The patient experienced breathlessness (medically significant) on 12Sep2021. 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 underwent lab tests and procedures which included sars-cov-2 test: positive on 13Dec2020 Yes - Positive COVID-19 test. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733063 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Fatigue, Habit cough, Hypokinesia, Influenza, Migraine, Motion sickness, Nausea, Oropharyngeal pain, SARS-CoV-2 test, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mental disorder
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101205564

Write-up: motion sick; flu; migraine; chest pain; my throat is mucusy and so sore; My joints are so sore too to the point I can not move; My vision has been going on and off blurry and it Is hard to focus on things; nauseous; feeling so tired; My joints are so sore too to the point I can not move; Tic cough; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109131454445820-0HTCO. Safety Report Unique Identifier GB-MHRA-ADR 25932266. A 22-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 12Sep2021 (at the age of 22-years-old) as dose 2, single for covid-19 immunization. Medical history included mental disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included sertraline taken for mental disorder, start and stop date were not reported. The patient previously took first dose of bnt162b2 on an unspecified date as dose 1, single for covid-19 immunization. The patient reported that since she had her first covid vaccination her immune system had gone lower she was constantly getting ill with the flu every two - three weeks. Also she had never tested positive for corona and she had not caught it. The patient had her second COVID jab on 12Sep2021 yesterday morning (as reported) and since then she was feeling so tired, but most of all nauseous and motion sick and she have been since. Even after her first one she got a bad migraine which was what she was suffering at the time of reporting, where she could not go out in the day light or turn on her lights because it would strain her eyes. Patient had chest pain also she had not stopped coughing since having the vaccination yesterday, and her throat was mucusy and so sore. Her joints are so sore too to the point patient could not move. Patient vision had been going on and off blurry and it was hard to focus on things. On 12Sep2021, the patient experienced tic cough. Patient had not tested positive for Covid-19 since having the vaccine. The patient has not had symptoms associated with Covid-19. The patient was not currently breastfeeding.The patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of events motion sick, nauseous, flu, migraine, chest pain was recovered on an unspecified date in 2021 while the outcome of the event tic cough was recovering and the outcome of other events was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1733071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Hypoaesthesia, Lethargy, Nasopharyngitis, Pain, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205555

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109131658273100-ABPAU; safety report unique identifier: GB-MHRA-ADR 25932929). A female patient, of an unspecified age, received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiration date: not reported), via an unspecified route of administration, on Sep 12, 2021, single dose, for COVID-19 immunization. The patient previously took the 1st dose of BNT162B2 vaccine (batch/lot# and expiration date: unknown), on an unspecified date, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19, nor had a COVID-19 test. Patient had not tested positive for COVID-19 since the vaccination. Patient was not enrolled in clinical trial. On an unspecified date, patient experienced stomach pain, lethargic, achy and cold on Sep 12, 2021, patient experienced numbness in back of head, pins, and needles. The clinical course of the events included stomach pain and then fell asleep only to wake up with right-side of head all numb and then a pins and needle sensation over the next few hours. Head still does not feel 100% yet. Now feeling lethargic, achy and cold. The outcome of stomach pain, lethargy: recovering; numbness in back of head, pins and needles recovered with sequel on an unspecified date; achy and cold: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1733093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; GABAPENTIN; LOVENOX HP; NUROFEN (GSL); PARACETAMOL; SERTRALINE; SUMATRIPTAN
Current Illness: Costochondritis
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Migraine; Pain; Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped); Tremble
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: NEGATIVE
CDC Split Type: GBPFIZER INC202101205498

Write-up: Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109132254127810-HXSOV, Safety Report Unique Identifier GB-MHRA-ADR 25935506. A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 11Sep2021 as single dose for COVID-19 immunisation. The patient''s medical history included ongoing costochondritis; suspected COVID-19, unsure when symptoms stopped; migraine; tremble; pain and depression. The patient''s concomitant medications included amoxicillin taken for migraine; gabapentin taken for tremor; enoxaparin sodium (LOVENOX HP) taken from 07Sep2021 to 07Sep2021; ibuprofen (NUROFEN (GSL)) taken for pain; paracetamol taken for pain; sertraline taken for depression; and sumatriptan taken for migraine from 2021 to an unspecified stop date. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On 12Sep2021, patient experienced swollen lymph nodes. The pain and swelling started a day after the vaccination (Sunday Morning, on 12Sep2021) and progressed to a very large area swollen under left arm, where the vaccine was administered. Reportedly, it was extremely painful but manageable with heat and OTC medication. The seriousness criteria of the event were medically significant. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative on 03Sep2021. Therapeutic measures (heat and OTC medication) were taken as a result of swollen lymph nodes. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.


VAERS ID: 1733117 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received via a regulatory authority (Reference number: GB-MODERNATX, INC.-MOD-2021-322829 ) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDITIS (Myocarditis) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-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. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were provided. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Relevant tests conducted: ECQ, X-ray, BLOOD TESTS. Company Comment: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred on the same day after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1733457 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cyanosis, Feeling abnormal
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Blood Pressure; Result Unstructured Data: Test Result:84/40; Test Date: 20210912; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101193351

Write-up: Feels poorly; Blood pressure was measured, 84/40; mild Cyanosis; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126562. The patient was a 29-year and 9-month-old male (age at vaccination). Body temperature before vaccination was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 12Sep2021 at 13:55 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF9944, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date was reported as 12Sep2021 at 14:05 (10 minutes after the vaccination). On 12Sep2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: Ten minutes after the vaccination, the patient said that Feels poorly occurred. Blood pressure was measured, 84/40, Cyanosis occurred, the route was ensured, and the blood pressure did not rise after observation. EpiPen was administered and the patient was emergently transferred to the hospital. The reporting physician classified the event as serious (medically significant) and assessed the events as related to BNT162B2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733458 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to grains; Panic disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101193360

Write-up: darken before eyes appeared/ loss of consciousness; Vasovagal reaction; Malaise; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21126561. A 27-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FJ5790, Expiration Date: 31Dec2021), via an unspecified route of administration on 12Sep2021, at 15:00 (age at vaccination was 27-year and 1-month-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 37.1 degrees Centigrade. Patient''s history according to 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) included allergy to soba and panic disorder. The patient''s concomitant medications were not reported. The patient also previously received influenza vaccine on an unspecified date for immunisation which caused vision blackout, numbness generalized, and convulsion. On 12Sep2021, at 15:15, the patient experienced vasovagal reaction and malaise. The course of the event was as follows: On 12Sep2021, at 15:15 (15 minutes after vaccination), malaise and darken before eyes appeared. Loss of consciousness recovered immediately. The patient recovered from the events on 12Sep2021. The reporter classified the events as non-serious and assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the events such as any other diseases was panic disorder. Reporter comment: Because of Vagal reflex. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733504 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure decreased, Dizziness, Heart rate decreased, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Syncope; Giddiness; Pulse rate fell; Blood pressure decreased; Feeling queasy; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP088738) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This case was reported by a vaccine recipient via the Drug Information Center. Syncope was assessed as serious by the Regulatory Authority. On 12-Sep-2021, the patient received the 1st dose of this vaccine. Thirty seconds after the vaccination, the patient experienced giddiness and feeling queasy, and just after that, the patient had syncope. Although the patient recovered consciousness subsequently, pulse rate fell and blood pressure decreased were noted. The outcome of giddiness, feeling queasy, syncope, pulse rate fell, and blood pressure decreased was unknown. Follow-up investigation will not be possible due to non-cooperation of the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 21 year-old male patient with no reported medical history, who experienced the unexpected event of Syncope. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1733704 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Haematemesis, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOREST 28; NOVALUCOL [ALUMINIUM HYDROXIDE GEL;MAGNESIUM CARBONATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vegetable allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade
CDC Split Type: SEPFIZER INC202101193140

Write-up: Severe vomiting with blood splatter; Sever vomiting; Fever of 38.1; Weakness; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 11Sep2021 09:30 (at the age of 22-year-old) (Lot Number: Fg7898) as dose 2, single for COVID-19 immunization. Medical history included onion allergy. Concomitant medications included ethinylestradiol, norgestimate (AMOREST 28) taken for birth control, start and stop date were not reported; aluminium hydroxide gel, magnesium carbonate (NOVALUCOL [ALUMINIUM HYDROXIDE GEL;MAGNESIUM CARBONATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took paracetamol and experienced drug allergy. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 06Aug2021 09:30 (at the age of 22-year-old) (Lot Number: FF3318) as dose 1, single for COVID-19 immunization. The patient experienced severe vomiting with blood splatter, sever vomiting, fever of 38.1, weakness on 12Sep2021 01:00. The patient did not receive treatment for the events. The outcome of events was recovering. No follow-up attempts are required. No further information is expected.


VAERS ID: 1736072 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210945116

Write-up: FACIAL PALSY; This spontaneous report received from a consumer via a Regulatory Authority (Regulatory Authority, DE-PEI-202100194218) on 23-SEP-2021 and concerned a 33 year old male. The patient''s weight was 82 kilograms, and height was 177 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975) 1 dosage forms, 1 total, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-SEP-2021, the patient experienced facial palsy (Incomplete peripheral facial palsy on the right). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from facial palsy. This report was serious (Other Medically Important Condition).


VAERS ID: 1736510 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Ear discomfort, Headache, Hyperacusis, Nausea, Pelvic venous thrombosis, Photosensitivity reaction
SMQs:, Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hearing impairment (narrow), Vestibular disorders (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:
Current Illness:
Preexisting Conditions: Comments: Pro-Thrombin mutation G20210A
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210947509

Write-up: NAUSEA; EAR DISCOMFORT; HEADACHE; PELVIC VENOUS THROMBOSIS; PHOTOSENSITIVITY; WEAKNESS; LIGHTHEADEDNESS; SOUND SENSITIVITY INCREASED; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-044403) on 24-SEP-2021 and concerned a 19 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Pro-Thrombinmutation G20210A. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: xE393) dose was not reported,1 total, administered on 12-SEP-2021 for product use for unknown indication. No concomitant medications were reported. On 12-SEP-2021, the patient experienced nausea, ear discomfort (pressure in the ears), headache, pelvic venous thrombosis ("felt" existing thrombosis in the left iliac vein, it felt like it was migrating/building up again), photosensitivity, weakness, lightheadedness, and sound sensitivity increased. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn. The patient recovered from nausea, ear discomfort, pelvic venous thrombosis, photosensitivity, weakness, lightheadedness, and sound sensitivity increased, and had not recovered from headache. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Treatment of side effect 1:onset of pain from about 6pmFrom 8pm rapidly increasing pain. Taking a tablet of Novalgin (500mg) at about 10:30pm (no effect)pressure in ears, sensitivity to light, sensitivity to sound, dizziness, nausea, sensation of weakness. Treatment of side effect 2:tried to take it easy for the rest of the day. Treatment of side effect 3:I stayed awake for a long time and observed how the situation was behaving. after much consideration I decided not to go to the hospital/call the ambulance and at some point I fell asleep. Treatment of side effect 4


VAERS ID: 1738730 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205316

Write-up: Armpit pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202109130911491490-HMUOG, Safety Report Unique Identifier GB-MHRA-ADR 25930641. A 24-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 11Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have symptoms associated with COVID-19, and was not enrolled in clinical trial. The patient was not pregnant and not breastfeeding at the time of this report. Concomitant medications were not reported. On 12Sep2021, the patient experienced armpit pain which was reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event armpit pain was not resolved 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: 1738737 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Muscle fatigue, Myalgia, Poor quality sleep, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205341

Write-up: Muscle ache; Muscle fatigue; Administration site pain; Poor sleep; This is a spontaneous report from a contactable consumer, patient. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202109131150437550-NPTUK with Safety Report Unique Identifier of GB-MHRA-ADR 25931359. A 27-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8222) via an unspecified route of administration on 12Sep2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included urticaria and the patient previously took antihistamines cetirizine hydrochloride (PIRITEZE, 1 tablet) almost every day to prevent a recurring urticaria, the cause of which remained undiagnosed. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 06Sep2021, the patient underwent COVID-19 virus test and the result was negative. On 12Sep2021, the patient experienced administration site pain, poor sleep; on 13Sep2021, 1 day after vaccination, the patient experienced muscle ache and muscle fatigue; all the events were reported as serious for being medically significant. The clinical outcome of the events administration site pain, muscle ache and muscle fatigue were resolving, while that of poor sleep was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Temporomandibular joint syndrome
SMQs:, Arthritis (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: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205329

Write-up: TMJ syndrome; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory Authority report number GB-MHRA-WEBCOVID-202109131539146870-PGX42, Safety Report Unique Identifier GB-MHRA-ADR 25932518. A 25-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10Sep2021, as a single dose for COVID-19 immunisation. Medical history included depression. The patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient was not breastfeeding at the time of this report. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN) for depression from an unknown date and unknown if ongoing. On 12Sep2021, 2 days after the vaccination, the patient experienced temporomandibular joint (TMJ) syndrome, reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient has not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event TMJ syndrome was resolving 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: 1738782 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Insomnia, Nasopharyngitis, 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? 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: 20210913; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211464

Write-up: Cold symptoms; Hives; Insomnia; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141104134750-XFTOH. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25938279. A 21-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 12Sep2021 (Lot number was not reported), (at the age of 21 years) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2. Patient had no symptoms associated with COVID-19, Patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. The patient experienced hives and insomnia on 12Sep2021 and cold symptoms on 13Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Sep2021, No - Negative COVID-19 test. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738797 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram, Echocardiogram, Electrocardiogram, Heart rate, Palpitations, Pericarditis, SARS-CoV-2 test, Troponin
SMQs:, Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (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? 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: 20210912; Test Name: CT scan; Result Unstructured Data: Test Result:found to have a trace of pericardial effusion; Comments: Pt had a CT scan to rule out PE - found to have a trace of pericardial effusion.; Test Date: 20210912; Test Name: OP Echocardiogram; Result Unstructured Data: Test Result:Diagnosed as pericarditis; Comments: Discharged home as well in herself now, due to have OP Echocardiogram. Diagnosed as pericarditis following vaccine; Test Date: 20210912; Test Name: ECG; Result Unstructured Data: Test Result:ECG showed t wave inv in V2, III.; Test Date: 20210912; Test Name: HR; Result Unstructured Data: Test Result:100-125; Comments: HR fluctuant at 100-125,; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210912; Test Name: Trop; Test Result: Negative ; Comments: Trop -ve
CDC Split Type: GBPFIZER INC202101211479

Write-up: Pericarditis; chest pain; palpitations; This is a spontaneous report from a contactable physician received from the Uregulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141221062870-8XBKL, Safety Report Unique Identifier GB-MHRA-ADR 25938419. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 11Sep2021 as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 12Sep2021, the patient presented chest pain, palpitations and was diagnosed with pericarditis. All the events were reported as serious with seriousness criteria as other medically important condition. As per the additional details, it was stated that, patient presented on day after second vaccine with L sided (Left sided) chest pain and palpitations, HR (heart rate) was fluctuant at 100-125, ECG showed T wave inv in V2, III, Trop -ve (negative). Patient had a CT scan to rule out PE - found to had a trace of pericardial effusion. Discharged home as well in herself now, due to had OP Echocardiogram, diagnosed as pericarditis following vaccine (tests on 12Sep2021). The patient also underwent COVID-19 virus test on unknown date, which was negative (No - Negative COVID-19 test). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The report was not related to possible blood clots or low platelet counts. The outcome for all the events was reported as recovered (pericarditis recovered on 14Sep2021 and chest pain and palpitations recovered on unspecified date in Sep2021). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Paraesthesia oral, SARS-CoV-2 test
SMQs:, Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chronic rhinitis; Peanut allergy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211449

Write-up: allergy; Allergic reaction; tingling in lips and tongue; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141305342860-HXKWVV and Safety Report Unique Identifier GB-MHRA-ADR 25938734. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, age at vaccination: 30-year-old), dose 2 via an unspecified route of administration on 12Sep2021 10:10 as dose 2, single for covid-19 immunisation. Medical history included peanut allergy, chronic rhinitis and asthma. Concomitant medications included mometasone furoate for chronic rhinitis; budesonide (PULMICORT) for asthma. Historical vaccine includes first dose of BNT162B2 for covid-19 immunization. The patient had the jab at 10:10, on 12Sep2021 at 16:00, the patient realised he had tingling in lips and tongue and allergic reaction. The patient had a peanut allergy so recognised the symptoms. He took piriton and it did not effect and tongue and lips stated to swell. Went to Southampton General next day, as symptoms still there, was given steroids and more antihistamines. Still got symptoms today, but it''s more controlled. The patient experienced allergy on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included Covid-19 virus test: negative on an unknown date. The events were medically significant. The outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1738822 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram, Fatigue, Myocarditis, Nausea, Pericarditis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:UNKNOWN RESULT; Test Name: Chest X-ray; Result Unstructured Data: Test Result:UNKNOWN RESULT; Test Name: ECG; Result Unstructured Data: Test Result:UNKNOWN RESULT
CDC Split Type: GBPFIZER INC202101211461

Write-up: chest pain; shortness of breath; fatigue; nausea; Myocarditis; Pericarditis; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-MHRA-WEBCOVID-202109141639152960-FKBHA], Safety Report Unique Identifier [GB-MHRA-ADR 25939913]. A 26-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number were not reported), dose 2 via an unspecified route of administration on 30Aug2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient has not tested positive for COVID-19 since having the vaccine. The patient is not enrolled in clinical trial. The patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On 12Sep2021, the patient experienced myocarditis, pericarditis, on an unspecified date chest pain, shortness of breath, fatigue, nausea. Therapeutic measures were taken as a result of myocarditis, pericarditis, chest pain, shortness of breath, fatigue, nausea. Visited A&E (Emergency Room Visit), advised to take ibuprofen. The patient underwent lab tests and procedures which included electrocardiogram, chest x-ray, blood test with unknown result on unknown date. The outcome of the events myocarditis and pericarditis was recovering, chest pain, shortness of breath, fatigue, nausea was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738825 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Lymphadenopathy, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101211311

Write-up: Armpit pain; Swollen lymph nodes; Swollen arm; Arm started hurting; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109141702044590-UOPOF with Safety Report Unique Identifier of GB-MHRA-ADR 25940057. A 35-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 12Sep2021 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 on 04Aug2021 which was ongoing, confirmed by COVID-19 virus test on the same day and result was positive. The patient was not pregnant and not breastfeeding at the time of this report. The patient was not enrolled in clinical trial. On 12Sep2021, the patients arm started hurting soon after the jab and the next day it was worse. On 13Sep2021, the patient experienced swollen arm. On 14Sep2021, the patient woke up with armpit pain and swollen lymph nodes. Events armpit pain, swollen arm and swollen lymph nodes were reported as serious for being medically significant. The patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the events swollen arm, armpit pain, swollen lymph nodes were not recovered, while that of the event arm started hurting was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738863 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Off label use, Product use issue, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210629; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211390

Write-up: Abdominal pain; Fever; Off label use; ongoing breastfeeding, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); This is a spontaneous report from a contactable consumer. This report received from the regulatory authority Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109142249180750-CCEFM. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Sep2021 (Lot Number: FF2153), at the age of 29-years-old, as dose 1, single for COVID-19 immunisation. Medical history included ongoing breast feeding. The patient''s concomitant medications were not reported. The patient experienced off label use and ongoing breastfeeding, received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Sep2021; abdominal pain and fever on 13Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 29Jun2021. The outcome of the events ''abdominal pain'' and ''fever'' was not recovered. Additional information: Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101217264 baby case


VAERS ID: 1738896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (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 Date: 20210915; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217752

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109151324410400-VS41I, Safety Report Unique Identifier GB-MHRA-ADR 25945533. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported and Expiration date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient experienced miscarriage on 12Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 15Sep2021. The clinical outcome of event was recovered on 15Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738990 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness postural, Hypoaesthesia, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre 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), 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: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Dizzy on standing; Numbness in leg; Nausea; Vomited; Fever; Muscle soreness; This case was received via the Regulatory Authority (Reference number: GB-MHRA-ADR 25960974) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizzy on standing), HYPOAESTHESIA (Numbness in leg), NAUSEA (Nausea), VOMITING (Vomited), PYREXIA (Fever) and MYALGIA (Muscle soreness) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced DIZZINESS POSTURAL (Dizzy on standing) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness in leg) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), VOMITING (Vomited) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant) and MYALGIA (Muscle soreness) (seriousness criterion medically significant). At the time of the report, DIZZINESS POSTURAL (Dizzy on standing), HYPOAESTHESIA (Numbness in leg), NAUSEA (Nausea), VOMITING (Vomited), PYREXIA (Fever) and MYALGIA (Muscle soreness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Relevant concomitant product usage was not provided by the reporter. No treatment details were provided. Company Comment: This case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dizziness postural, Hypoaesthesia, Nausea, Vomiting, Pyrexia and Myalgia. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. The listedness of Nausea, Vomiting, Pyrexia and Myalgia are requested to be updated to unlisted as the events are upgraded to serious, as per RA. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.; Sender''s Comments: This case concerns a 24-year-old, female patient with no relevant medical history, who experienced the unexpected events of Dizziness postural, Hypoaesthesia, Nausea, Vomiting, Pyrexia and Myalgia. The events occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. The listedness of Nausea, Vomiting, Pyrexia and Myalgia are requested to be updated to unlisted as the events are upgraded to serious, as per RA. Events assessed as serious by the Regulatory Authority. However, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, none of the events are considered serious.


VAERS ID: 1739031 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome, Lumbar puncture
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (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: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:Guillain-Barre syndrome
CDC Split Type: GBPFIZER INC202101233571

Write-up: Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109191302547550-IRI10 with Safety Report Unique Identifier of GB-MHRA-ADR 25966044. A 31-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and was not breastfeeding at the time of this report. 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. Concomitant medications included ethinylestradiol, levonorgestrel (MICROGYNON) taken for unknown indication, from an unknown date and unknown if ongoing. On 12Sep2021, the patient experienced Guillain-Barre syndrome which was reported as serious for causing hospitalization and for being life-threatening. The patient underwent lumbar puncture test on an unknown date in 2021 and resulted in Guillain-Barre syndrome (diagnosed by lumbar puncture). The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of event Guillain-Barre syndrome was not resolved at the time of this report. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected.


VAERS ID: 1739166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Coronavirus test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Coronavirus test; Test Result: Positive ; Comments: Test of confirmation of corona on 12Sep2021
CDC Split Type: ILPFIZER INC202101197891

Write-up: symptom of weakness only; Test of confirmation of corona on 12Sep2021, symptom of weakness only; Test of confirmation of corona on 12Sep2021, symptom of weakness only; This is a spontaneous report received from a contactable consumer via a Pfizer colleague. This is the fifth of six reports. A 18-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single, for COVID-19 immunization and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The reporter reported that another friend, 18-year-old male, generally healthy, was vaccinated twice for corona a number of months ago with the Pfizer vaccine. Test of confirmation of corona on 12Sep2021, symptom of weakness only. The patient underwent lab tests and procedures which included coronavirus test with result positive on 12Sep2021. The outcome of the events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1739387 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hypoaesthesia, Muscle tightness, Myalgia, Pain in extremity, Vital signs measurement
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals (The patient experienced strong skin symptoms before.); Skin disorder (The patient experienced strong skin symptoms before.)
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before vaccination; Test Date: 20210912; Test Name: vital signs; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101195596

Write-up: Numbness in two hands; strong pain (in two hands); Muscle tightness; Myalgia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126570. A 48-year-old (48-year and 3-month-old) female patient received BNT162b2 (COMIRNATY, solution for injection), dose 1 via an unspecified route of administration on 12Sep2021 10:12 (lot Number: FF9944; Expiration Date: 30Nov2021) (at vaccination age of 48-year-old) as single dose for COVID-19 immunisation. Medical history included the patient had allergy to metals and the patient experienced strong skin symptoms before. The patient''s concomitant medications were not reported. The patient experienced numbness in two hands, strong pain, muscle tightness, myalgia; all was reported as important medically significant; and all events were on 12Sep2021 10:36. As reported, body temperature before vaccination was 36.8 degrees Centigrade on 12Sep2021. The event onset date/time was reported as on 12Sep2021 at 10:36 (24 minutes after the vaccination). The patient had numbness in two hands during the observation after vaccination. Although no problem in Respiratory condition, vital signs and consciousness level, the symptom aggravated and become strong pain in two hands. The patient came to visit physician office due to strong muscle tightness and myalgia. Situation become difficult. The outcome of the events was recovering at the time of reporting. The reporting physician classified the event as serious (important medically significant) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1739429 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-09-12
   Days after vaccination:92
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Endoscopy gastrointestinal, Haematemesis, Haematochezia, Haemoglobin, Haemoglobin decreased
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life 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: 20210912; Test Name: gastrointestinal endoscopy; Result Unstructured Data: Test Result:unknown; Comments: unknown; Test Date: 20210912; Test Name: Haemoglobin; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101201281

Write-up: Haematemesis; Bloody stool; Hb decreased; This is a spontaneous report from a contactable physician in charge of emergency received from the regulatory authority. Regulatory authority report number is v21126666. A 78-year and 2-month-old male (age at second dose of vaccination) patient received the second dose of BNT162b2 (COMIRNATY; solution for injection; Lot number and Expiration date were unknown) via an unspecified route of administration on 12Jun2021 (the day of vaccination, at the age of 78-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. There were 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) as follows: Unknown. On 12Sep2021 at 15:06 (3 months after the vaccination), the patient experienced haematemesis, bloody stool and Hb decreased. On 12Sep2021 (3 months after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 12Sep2021, the patient was transported to the hospital for haematemesis. On 12Sep2021, a gastric lavage was performed. An upper gastrointestinal endoscopy was performed. Hb decreased. Blood transfusion 4U was performed. The patient was admitted to the hospital. The outcome of the events haematemesis, bloody stool and Hb decreased were all unknown. The reporting physician in charge of emergency classified the event as serious (hospitalized from 12Sep2021) and assessed that the causality between the event and BNT162b2 as un-assessable. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1740480 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Arthralgia, Back pain, Chest discomfort, Chills, Headache, Maternal exposure during breast feeding, Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: chills; headache; fever; vomiting; muscle pain; Chest pressure; High temperature; Shivers; High temperature; Muscle ache; Neck stiffness; Backache; Joint ache; Painful arm; lost taste for food; feel to vomit all the time; I am still breastfeeding; This case was received via Regulatory Authority RA (Reference number: GB-MHRA-ADR 25961351) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), PYREXIA (fever), VOMITING (vomiting), MYALGIA (muscle pain), CHILLS (Shivers), the first episode of PYREXIA (High temperature), MYALGIA (Muscle ache), MUSCULOSKELETAL STIFFNESS (Neck stiffness), BACK PAIN (Backache), ARTHRALGIA (Joint ache), PAIN IN EXTREMITY (Painful arm), CHEST DISCOMFORT (Chest pressure) and the second episode of PYREXIA (High temperature) in a 42-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004225) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 03-Jul-2021 to 11-Jul-2021. On 12-Sep-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced CHILLS (Shivers) (seriousness criterion hospitalization), the first episode of PYREXIA (High temperature) (seriousness criterion hospitalization), MYALGIA (Muscle ache) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Neck stiffness) (seriousness criterion hospitalization), BACK PAIN (Backache) (seriousness criterion hospitalization), ARTHRALGIA (Joint ache) (seriousness criterion hospitalization), PAIN IN EXTREMITY (Painful arm) (seriousness criterion hospitalization), the second episode of PYREXIA (High temperature) (seriousness criterion hospitalization) and MATERNAL EXPOSURE DURING BREAST FEEDING (I am still breastfeeding). On 13-Sep-2021, the patient experienced CHEST DISCOMFORT (Chest pressure) (seriousness criterion hospitalization). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion hospitalization), HEADACHE (headache) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), VOMITING (vomiting) (seriousness criterion hospitalization), MYALGIA (muscle pain) (seriousness criterion hospitalization), AGEUSIA (lost taste for food) and NAUSEA (feel to vomit all the time). On 14-Sep-2021, CHILLS (Shivers) and CHEST DISCOMFORT (Chest pressure) had resolved. On 15-Sep-2021, MYALGIA (Muscle ache), MUSCULOSKELETAL STIFFNESS (Neck stiffness), BACK PAIN (Backache), ARTHRALGIA (Joint ache) and PAIN IN EXTREMITY (Painful arm) had resolved. At the time of the report, CHILLS (chills), HEADACHE (headache), PYREXIA (fever), VOMITING (vomiting) and MYALGIA (muscle pain) was resolving, AGEUSIA (lost taste for food) and NAUSEA (feel to vomit all the time) outcome was unknown and MATERNAL EXPOSURE DURING BREAST FEEDING (I am still breastfeeding) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jul-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. No treatment information was provided by the reporter. Lab details were not provided. No concomitant medications were provided by the reporter. This case concerns a 42 year-old female patient, with no details on medical history provided, who experienced the unexpected events of myalgia, musculoskeletal stiffness, back pain, arthralgia, pain in extremity, chest discomfort, vomiting, headache and ageusia. Maternal exposure during breastfeeding was also captured as an event. All events occurred on the same day than the second dose of Spikevax, except for chest discomfort that occurred approximately 1 day after the second dose of Spikevax and ageusia, vomiting and headache for which start date is unknown. Rechallenge is not applicable as there is no information provided regarding the first dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting, however there was no information in the source document supporting that the events met seriousness criteria.; Sender''s Comments: This case concerns a 42 year-old female patient, with no details on medical history provided, who experienced the unexpected events of myalgia, musculoskeletal stiffness, back pain, arthralgia, pain in extremity, chest discomfort, vomiting, headache and ageusia. Maternal exposure during breastfeeding was also captured as an event. All events occurred on the same day than the second dose of Spikevax, except for chest discomfort that occurred approximately 1 day after the second dose of Spikevax and ageusia, vomiting and headache for which start date is unknown. Rechallenge is not applicable as there is no information provided regarding the first dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event terms, onset dates, outcomes and seriousness captured per SD from Regulatory Authority reporting, however there was no information in the source document supporting that the events met seriousness criteria.


VAERS ID: 1740500 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Acute pericarditis; This case was received via Regulatory Agency (Reference number: JP-TAKEDA-2021TJP094994) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Agency (RA) by a physician, was received via the RA (Ref, v21127826). On an unknown date, the patient received 1st dose of the vaccine. On an unknown date, body temperature before vaccination: 36.2 degrees Celsius. On 11-Sep-2021, at 11:30, the patient received 2nd dose of the vaccine. On 12-Sep-2021, at 08:00, the patient visited a nearby hospital with a complaint of chest pain on inspiration. Electrocardiogram showed that elevated ST was seen in wide range of leads, and blood test showed no elevated cardiac enzymes. The diagnosis of acute pericarditis was made. On 13-Sep-2021, the patient was hospitalized due to acute pericarditis. On 14-Sep-2021, it was confirmed that the symptom resolved. The outcome of acute pericarditis was reported as resolved. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed next day after administration of the vaccine, and the reporting physician is considering the possibility of other virus infection or auto immune disease. However, the event could be related to the vaccine if there are no other apparent causal factors.; Sender''s Comments: This case concerns a 28 year-old, male patient with no relevant medical history, who experienced the expected event of pericarditis. The event occurred approximately 1 day after the second dose of Moderna COVID-19 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The event was considered related to the vaccine per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1742216 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardiogenic shock, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210951571

Write-up: RENAL FAILURE; SHOCK CARDIOGENIC; ACUTE MYOCARDIAL INFARCTION, TRUE POSTERIOR WALL INFARCTION; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021181923) on 27-SEP-2021 concerned a 66 year old female of unspecified race and ethnic origin. The patient''s weight was 70 kilograms, and height was 163 centimeters. The patient''s concurrent conditions included arterial hypertension. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C16-01 and expiry: unknown) dose was not reported, 1 total administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-SEP-2021, the patient experienced renal failure, cardiogenic shock, had acute myocardial infarction, true posterior wall infarction and was hospitalized (on date unspecified) for unspecified number of days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from renal failure, shock cardiogenic, and acute myocardial infarction, true posterior wall infarction. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1742548 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? 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; Comments: Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101217936

Write-up: Chest pain; Low aching pain I had for around 36 hours; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109151441274150-8GR84. Safety Report Unique Identifier GB-MHRA-ADR 25945751. A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient had no symptoms associated with COVID-19. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. It was reported that the patient experienced chest pain on 12Sep2021 and low aching pain the patient had for around 36 hours on an unspecified date. The patient was hospitalized for the event chest pain. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date (Negative COVID-19 test). Treatment was received for the event chest pain. Outcome of the event chest pain was reported as recovered on 15Sep2021 while for the other event was unknown. No follow-up attempts are possible, information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1743041 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cough, Erythema, Heart rate, Pruritus, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: blood pressure; Result Unstructured Data: Test Result:96/57 mmHg; Test Date: 20210912; Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Comments: before vaccination; Test Date: 20210912; Test Name: Pulse; Result Unstructured Data: Test Result:70/m
CDC Split Type: JPPFIZER INC202101199172

Write-up: generalized redness; Wheals; Pruritus(mainly upper part of the body); cough; Wheezing; BP 96/57 mmHg; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126580. A 14-year and 5-month-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration on 12Sep2021 at 13:00 (at the age of 14-year -old) as a single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. Body temperature before vaccination was 36.7 degrees Centigrade. On 12Sep2021 at 13:00 (the day of vaccination), the patient received the first dose of bnt162b2. Event onset date was reported as on 12Sep2021 at 18:00 (5 hours after vaccination) The course of the event was as follows: The patient did not feel any symptoms just recently after vaccination, in the evening, generalized redness, wheals, and pruritus (mainly upper part of the body) appeared. Past 18:00, the patient visited the hospital, took orally histamine H1 receptor antagonist and steroid, symptoms disappeared temporarily. On 13Sep2021(the next day after vaccination), in the morning, around 04:30, cough, wheezing, generalized redness, wheals, and pruritus (facial, lips, all fingers, upper and lower limbs) appeared again, visited the reporter''s department, BP 96/57 mmHg, P 70/m. On 13Sep2021 (a day after the vaccination), the outcome of the event was recovering. The seriousness of the event was not provided. The reporting physician assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: After the conditions improved with oral treatment, the patient again experienced generalised skin and mucosal symptoms as well as respiratory symptoms (cough and wheezing). No circulatory disorder or gastrointestinal symptoms were noted. Follow up attempts are completed. Further information is not expected.


VAERS ID: 1743051 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Loss of consciousness, Oxygen saturation, Presyncope, Pulse absent
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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: BP; Result Unstructured Data: Test Result:110 mmHg; Test Date: 20210912; Test Name: HR; Result Unstructured Data: Test Result:50 to 60 /min; Test Date: 20210912; Test Name: SpO2; Result Unstructured Data: Test Result:97 to 98 %
CDC Split Type: JPPFIZER INC202101201012

Write-up: lost conscious temporarily; Was not able to feel the pulse; Vasovagal reflex / vagal reflex; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126693. A 12-year-old male patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FD0349; Expiration Date: 31Oct2021) via an unspecified route of administration on 12Sep2021 at 13:00 (at 12 years) as single dose for covid-19 immunisation. Medical history was none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient had no family history. The patient''s concomitant medications were not reported. On 12Sep2021 afternoon (the day of the vaccination), the patient experienced Vasovagal reflex . The course of the event was as follows: The patient lost conscious temporarily right after COVID-19 vaccination on 12Sep2021. Was not able to feel the pulse, but a moment later, consciousness was back and able to feel the pulse too. Let the patient lay in bed for about 15 minutes. At last on 12Sep2021, blood pressure was 110mmHg, SpO2 97 to 98%, HR 50 to 60/min. Consciousness clear.No dyspnoea and patient went back home by walking.On 12Sep2021 (the day of the vaccination), the outcome of the event was recovered. The reporter classified the event as non-serious and assessed that the event was unrelated to bnt162b2. Other possible cause(s) of the event such as any other diseases was Vasovagal reflex.The reporter commented as follows: It was vagal reflex and nothing to do with the drug (as reported).; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Loss of Consciousness and the administration of the vaccine is unlikely. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1743054 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenopia, Eye pain, Eye swelling, Facial paralysis, Feeling hot, Heart rate increased, Hemiplegia, Hypoaesthesia, Impaired work ability, Insomnia, Limb discomfort, Pain, Pain in extremity, Sensory disturbance, Sluggishness, Somnolence, Swelling, Swelling of eyelid
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Corneal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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 Date: 20210913; Test Name: heart beating; Result Unstructured Data: Test Result:faster
CDC Split Type: JPPFIZER INC202101204409

Write-up: From the top to bottom of the body, half of the body, there was strong paralysis-like symptoms.; pain; felt a warm sensation; Left arm started throbbing with pain; couldn''t sleep, so stayed awake until the morning (of 13Sep2021); heart was beating faster; left side of face was in Paralysis condition; left eye started to feel strangely like the feeling of seriously swollen/ patient looked in the mirror and saw that it was not actually swollen/patient could feel like swelling; swelling and heaviness around eye; swelling and heaviness around eye; getting harder and harder to open the patient''s eyes/left eye almost closed; more and more painful to open eyes; left arm became heavy and sluggish; left arm became heavy and sluggish; left leg felt like it had been anesthetized by a dentist/ bottom part of left foot felt bumpy/numbness or it was symptoms like paralysis with interval/numbness came on all at once; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information team. A 59-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration, administered in the left arm on 12Sep2021 at 18:00 (the day of vaccination) at the age of 59 years old (Batch/Lot number and Expiration date were unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received influenza vaccine for immunization and never had a reaction to it. The detail of the reaction was reported as follow: On 12Sep2021, Sunday, near evening 18:00, the patient received the first dose of Pfizer''s vaccine. Ten (10) minutes after (as reported), he went home. Gradually, it was vaccinated on left arm, but the patient''s left eye started to feel strangely like the feeling of seriously swollen. There was swelling and heaviness around eye. It was getting harder and harder to open the patient''s eyes. It became more and more painful to open eyes; it was in bad condition if the patient didn''t close eyes. The patient came home with left eye almost closed. Actually it was about 1 hour after vaccination (12Sep2021 at 19:00). It started from face. The left side of face was in paralysis condition. The left arm became heavy and sluggish. Eventually, left leg felt like it had been anesthetized by a dentist; all the left side, from face, hand to leg. When the patient was walking, the bottom part of left foot felt bumpy. It was unpleasant, like stepping on a konjac. This condition continued for several hours, and the patient still felt that on next day (13Sep2021) morning. It was around midnight 24:00 on 12Sep2021 (as reported), left arm started throbbing with pain. The patient couldn''t sleep, so stayed awake until the morning (of 13Sep2021). It was like half anesthesia, and the patient''s heart was beating faster. The patient knew it was beating fast. On 13Sep2021 in the morning, the patient was a bit stable and slept quietly all day the day prior reporting (13Sep2021), hoping that sleeping would help. At the time of the report (14Sep2021), the patient felt a little better, but took the day off from work. It was pretty stable at the time of the report. The patient still had a little bit of paralysis on the left half of face. It was developed from the face firstly, and it remained at last. When the patient talked, it felt like the anesthesia was still in left jaw area. There was numbness or it was symptoms like paralysis with interval. From the top to bottom of the body, half of the body, there was strong paralysis-like symptoms. The patient was vaccinated on left arm, so the symptoms probably appeared on the left arm. The numbness came on all at once. The patient looked in the mirror and saw that it was not actually swollen. The patient could feel like swelling. Hands and feet were not swollen or red or changing color in any way. As a reaction, pain occurred. The patient also felt a warm sensation. After vaccination, the patient was in the vaccination site for 15 minutes to see the condition. The patient didn''t have any symptoms, so the patient took bike and left. The patient was not recovered from the events "left side of face was in paralysis condition and numbness," the outcome of the events "from the top to bottom of the body, half of the body, there was strong paralysis-like symptoms; pain; and felt a warm sensation" was unknown, while the patient was recovering from the rest of the events at the time of the report. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1743084 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Depressed level of consciousness, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: BP; Result Unstructured Data: Test Result:97/57; Test Date: 20210912; Test Name: BP; Result Unstructured Data: Test Result:102/52; Test Date: 20210912; Test Name: BP; Result Unstructured Data: Test Result:99/55; Test Date: 20210912; Test Name: P; Result Unstructured Data: Test Result:95; Comments: /min; Test Date: 20210912; Test Name: P; Result Unstructured Data: Test Result:82; Comments: /min; Test Date: 20210912; Test Name: P; Result Unstructured Data: Test Result:67; Comments: /min; Test Date: 20210912; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101207870

Write-up: Consciousness decreased; BP 97/57; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126701. A 16-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 12Sep2021 at 15:00 (the day of vaccination, at the age of 16-year-old), as dose 1, single for COVID-19 immunization. Medical history was none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient concomitant medications were not reported. On 12Sep2021 at 15:00 (the day of vaccination), the patient experienced consciousness decreased, bp 97/57 (blood pressure diastolic decreased). The course of the events was reported as follows: On 12Sep2021, after vaccination, Consciousness decreased occurred, when the physician confirmed, Consciousness was clear. BP 97/57 P95/min to BP 102/52, P82/min. Stayed still and received IV treatment, Consciousness clear, BP 99/55, P67, SpO2 97%. Told the patient and his mother about the symptoms and let him go home (received diagnosis the next day). The patient underwent lab tests and procedures on 12Sep2021 which included blood pressure measurement: 97/57, blood pressure measurement: 102/52, blood pressure measurement: 99/55, heart rate: 95/min, heart rate: 82/min, heart rate: 67/min, oxygen saturation: 97 %. Therapeutic measures were taken as a result of the events. On 12Sep2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1743165 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101219106

Write-up: Anaphylaxis; Dyspnoea; Cough; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127022. A 12-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, via an unspecified route of administration on 12Sep2021 11:10, at 12 years of age, (Batch/Lot Number: FF2018; Expiration Date: 31Dec2021) as single dose for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees Centigrade. Medical history was none: there were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 12Sep2021 at 11:27 (17 minutes after vaccination), the patient experienced anaphylaxis, dyspnoea and cough. At the time of the report the events outcome was unknown. The reporting physician classified the events as non-serious and assessed that the events were related to bnt162b2. The Company assessed the event anaphylaxis as medically significant.


VAERS ID: 1743201 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005694 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactoid reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: JPMODERNATX, INC.MOD20213

Write-up: Anaphylactoid symptom; This case was received via Pharmaceutical Company (Reference number: 2021TJP091294) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a physician via a medical representative. Anaphylactoid symptom was assessed as serious by the Regulatory Authority. On 11-Sep-2021, the patient received the 1st dose of this vaccine. After the vaccination, a symptom of itching developed. On 12-Sep-2021, anaphylactoid symptom developed. On 13-Sep-2021, the patient visited the dermatologist. The patient was diagnosed with anaphylaxis because wheal on the whole body and diarrhea were confirmed. The outcome of anaphylactoid symptom was unknown. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Although the causal relationship with the vaccine could not be ruled out because the patient was prone to diarrhea basically, the physician told the patient to thoroughly consult a physician in charge of medical interview at the venue for the 2nd vaccination because the patient had gastrointestinal symptoms. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 47 year old male patient with no medical history reported, who experienced the unexpected serious event of Anaphylactoid Reaction, within 1 day after the first dose of mRNA-1273 vaccine. Rechallenge is unknown. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1743205 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Bradycardia; Vasovagal reflex; This case was received via Regulatory Authority (Reference number:-2021TJP093234) on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case was reported by a physician via a medical representative. Bradycardia was assessed as serious. On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 12-Sep-2021, the patient received the 1st dose of this vaccine. After the vaccination, when walking to the waiting space, light-headedness and plenty of excessive sweating developed. At 14:27, the patient was transferred to the first-aid room. Blood pressure 83/42 mmHg, heart rate 32 beats/min, SP02 97% to 98% (room air). The patient was diagnosed with vasovagal reflex by a physician and was instructed to rest in bed because bradycardia slightly improved. At 14:45, during medical examination by a physician, the patient was awake and alert with clear respiratory sound in the chest and had no cardiac murmur with regular heart sounds. Blood pressure 112/68 mmHg, heart rate 50 beats/min, and SPO2 97 to 98% (room air). Blood pressure in the standing position was 98/60 mmHg. The patient was followed up on the bed in the end seating position. At 14:57, recovery was confirmed. Physical condition improved, and the patient went home walking without assistance. The outcome of vasovagal reflex and bradycardia was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. Sender''s Comments: This case concerns a 22 -year-old male patient with no medical history, who experienced the unexpected events of Bradycardia and Presyncope. The events occurred on the same day after the first dose of mRNA-1273, Moderna COVID-19. Event seriousness assessed as per Regulatory Authority reporting. The rechallenge was Not Applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 is not affected by this report.


VAERS ID: 1743222 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Depressed level of consciousness
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Depressed level of consciousness; Anaphylaxis; This case was received via Pharmaceutical Company(Reference number: 2021TJP095760) on 16-Sep-2021 and was forwarded to Company on 28-Sep-2021. This case, reported by a physician, was received by Pharmaceutical Company via Company adverse reaction reporting site (TASK0021762), and reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21126989, v21127077) The patient had a history of allergy to bugs. The patient also had a history of vagal reaction, and pyrexia and vomiting with influenza. On an unknown date, body temperature before vaccination: 36.6 degrees Celsius. On 12-Sep-2021, the patient received 1st dose of the vaccine. At 10:29, approximately 8 minutes after the vaccination, the patient experienced feeling sick and nausea while under observation. At this time, BP was 142/85, pulse rate was 98, respiratory rate was 20, and SpO2 was 98 %. Around 10:37, the patient experienced cold feeling and vomiting. The patient was laid down and then vomited with depressed level of consciousness. The patient was diagnosed with anaphylaxis and was placed on a stretcher. Adrenaline 0.5 was intramuscularly administered. The patient was transported to the first-aid room and was treated with normal saline solution. Oxygen was administered. Around 10:44, the patient was awake and alert with BP 131/67, pulse rate 95, and Spo2 98%. The patient was also treated with antihistamine steroids and H2-receptor antagonist. The patient was hospitalized for 1 day for observation. On 13-Sep-2021, the symptoms resolved, and the patient was discharged from the hospital. The outcome of anaphylaxis and depressed level of consciousness was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 23- year-old female patient with a history of allergy to bugs and vagal reaction with influenza, who experienced the serious unexpected event Depressed level of consciousness and serious expected event Anaphylactic reaction. The events occurred on the same day after the first dose of mRNA-1273 Moderna vaccine. The medical history of allergies and previous vagal reaction could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1746772 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-12
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Pain, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 04/01/2021; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC202101224964

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109161758453810-KKWO; safety report unique identifier: GB-MHRA-ADR 25954494). A 27-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, on Aug 26, 2021, single dose, for COVID-19 immunisation. The patient previously received BNT162B2, dose 1, on an unspecified date, for COVID-19 immunization. Medical history included COVID-19 from Apr 1, 2021 to an unknown date. Concomitant medications not reported. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. On an unspecified date, patient experienced excessive bleeding during menstruation and strong pain. On Sep 12, 2021, experienced abnormal menstruation and change in usual cycle (other medically important condition). The patient underwent lab tests and procedures, which included COVID-19 virus test: Yes - Positive COVID-19 test on Apr 1, 2021. The outcome for abnormal menstruation: resolving; and outcome for other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1746903 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-09-12
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: PCR; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202101263032

Write-up: PCR Covid test positive 16/9/2021 with Symptoms; PCR Covid test positive 16/9/2021 with Symptoms; migraine; This is a spontaneous report from a contactable physician (patient). A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular, administered in left arm on 10Jun2021 (Lot Number: FA5843) (at the age of 26-years-old) as dose 1, single and intramuscular, administered in left arm on 20Jul2021 (Lot Number: FE1510) (at the age of 26-years-old) as dose 2, single, for covid-19 immunisation. Medical history was none. The patient did not receive any other concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was tested for COVID-19 since the vaccination. The patient experienced symptoms of migraines, aching, cold type symptoms, blocked nose on 12Sep2021. The patient had PCR (polymerase chain reaction) Covid test positive on 16Sep2021. The patient did not receive any treatment for the events. The outcome of the events was recovering.; Sender''s Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events


VAERS ID: 1747140 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Fall, Muscular weakness, Skin abrasion, Syncope, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: X-ray; Result Unstructured Data: Test Result:No problem with bones
CDC Split Type: JPPFIZER INC202101219626

Write-up: syncope/possibility of micturition syncope/Lost consciousness; Bruised chin and cheek/Bruised right lower thigh; Fell down; scrape on the chest against the wall; Weakness of limbs; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 13-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on 11Sep2021 (the day of vaccination), as dose 1, single, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 12Sep2021 at 10:00 (1 day after the vaccination), the patient got up. The patient walked about 5 meters after she went to the bathroom, after urination the patient had syncope and then she lost consciousness and fell down. The patient bruised bruised chin, cheek, right lower thigh and there was a scrape on the chest against the wall. The patient regained consciousness after the fall and went to the hospital on 12Sep2021 at 10:40 and saw a doctor. Weakness of limbs developed. The injury was treated. The patient underwent lab tests and procedures which included X-ray and the result showed no problem with bones on 12Sep2021. The patient was recovering from the state of syncope while the outcome for other events was unknown. Seriousness and causality of the events were not provided. It was considered that the event might be loss of consciousness as an adverse reaction of COMIRNATY. The possibility of micturition syncope was also considered. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the event Syncope and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1747165 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Fall, Loss of consciousness, Muscular weakness, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: X-ray; Result Unstructured Data: Test Result:No bone problems
CDC Split Type: JPPFIZER INC202101227674

Write-up: Loss of consciousness; falling; The fall caused bruise on right lower leg, scrape mark on chest wall; Weakness of limbs; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. A 13-year-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) Solution for injection, via an unspecified route of administration on 11Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 12Sep2021 (1 day after the vaccination), the patient experienced loss of consciousness at 10:00 and weakness of limbs. After the administration of the vaccine the patient went to the restroom and walked about 5 meters before losing of consciousness and falling. The fall caused bruise on right lower leg, scrape mark on chest wall. She recovered consciousness after the fall and came to the hospital at 10:40. She had feeling of weakness of limbs. The patient received the wound treatment. X-rays showed no bone problems. At 14:40 on 16Sep2021 (5 days after the vaccination), the reporter from "I &I" considered that there was a possibility of loss of consciousness as an adverse reaction to circus movement tachycardia (CMT) or urinary apoplexy (as reported). The outcome of the event "loss of consciousness" was recovered on 12Sep2021. The outcome of the event "Weakness of limbs" was not provided. Seriousness and causality of the events were not provided. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Loss of consciousness and BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1747201 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Feeling cold, Nausea, Oropharyngeal discomfort, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Pharynx strange sensation; Dizziness; Nausea; Chills; Skin rash on the neck and abdomen; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP095077) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21126785). On an unknown date, body temperature before vaccination: 37.0 degrees Celsius. On 12-Sep-2021, at 17:23, the patient received the 1st dose of this vaccine. At 17:33, pharynx strange sensation, dizziness, nausea, chills, and skin rash on the neck and abdomen developed. There were no abnormalities in vital signs. Oral antiallergic medication and adrenaline were administered, and the patient was transported to the reporting hospital. Pharyngeal discomfort, dizziness, and nausea remained slightly on arrival, but these symptoms tended to improve. The patient was admitted to the hospital for follow-up. On 13-Sep-2021, recovery of the symptoms was confirmed, and the patient was discharged from the hospital. The outcome of pharynx strange sensation, dizziness, nausea, chills, and skin rash on the neck and abdomen was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The patient''s conditions at the peak of the symptoms and at the time of the onset are unknown, but the symptoms were mild on arrival at the hospital. Hospitalization was aimed just for follow-up. Allergen contamination or somatoform disorders are considered to be other factors.; Sender''s Comments: This case concerns a 15-year-old female patient with a history of food allergy, who experienced the unexpected, serious (hospitalization) events of oropharyngeal discomfort, dizziness, nausea, feeling cold and rash. Events nausea and rash are considered unexpected due to seriousness assessment by reporter. The event occurred approximately 10 minutes after the first dose of mRNA-1273. The rechallenge was not applicable according to source document. The medical history of food allergy is a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1747202 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

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

Write-up: Loss of consciousness; Anaphylaxis; This case was received via The Regulatory Authority (Reference number: 2021TJP095238) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via the RA (Ref, v21126970). Loss of consciousness and anaphylaxis were assessed as serious. On an unknown date, body temperature before vaccination 35.9 degrees Celsius. On 12-Sep-2021, 10:10, the patient received 1st dose of the vaccine. At 10:15, the patient lost consciousness, which resolved in about 15 seconds. BP 120/82, PR 56, and SpO2 95% (RA). The patient was placed at bed rest for 30 minutes. Twenty minutes later, the patient was examined. Vitals were unremarkable, but the patient had abdominal pain and difficulty breathing. The patient was considered to experience the symptoms of anaphylaxis and started treatment with intravenous drip infusion of hydrocortisone 100 mg and famotidine 20 mg, dissolved with normal saline 100 mL. Thereafter, peripheral extravasation occurred. The symptoms improved at the point where 20 ml of the solution was injected, and the injection needle was thus removed. Subsequently, the symptom improved, and therefore, the patient was instructed to revisit in the event of problems and was sent home. The outcome of loss of consciousness and anaphylaxis was reported as resolving. Follow-up investigation will be made. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 30-year-old female patient with no reported medical history, who experienced the serious unexpected event Loss of consciousness and expected Anaphylaxis. The events occurred on the same day after the first dose of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.


VAERS ID: 1751020 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Heart rate abnormal, Palpitations, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Abstains from alcohol; Non-tobacco user; Vegetarian
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226869

Write-up: palpitations; headache; fatigue; Heart rate; This is a spontaneous report from a contactable consumer. This report is received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109171416286830-QFKVW. Safety Report Unique Identifier GB-MHRA-ADR 25959390. A 39-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot number not reported), via an unspecified route of administration on 11Sep2021 as single dose for covid-19 immunisation. Medical history included vegetarian from an unknown date and unknown if ongoing. Patient was very healthy vegetarian, eats well, don''t smoke, don''t drink alochol and practice yoga 2 hours a day for 10 years. Until she took this vaccine. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced "heart rate" on 12Sep2021; headache, palpitations, and fatigue on an unspecified date. All the events were reported as serious for being medically significant. Clinical course of the events was as follows: Since the vaccination patient have had a headache, fatigue and points throughout the day when patient do some movements she get increased heart rate and palpitations. Patient have been a practitioner of yoga for 10 years and move her body often. She can now barely practice with fear of these heart palpitations. Due to this she will not be taking a second vaccine until more data has been collected on these vaccines. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 31Aug2021. Other relevant investigations or tests conducted was reported as none. Patient has not tested positive for COVID-19 since having the vaccine. The patient had not recovered from "heart rate" while outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751434 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Grip strength decreased, Heart rate, Mydriasis, Oxygen saturation, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: blood pressure; Result Unstructured Data: Test Result:100/50 mmHg; Comments: After Vaccination; Test Date: 20210912; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before Vaccination; Test Date: 20210912; Test Name: Pulse rate; Result Unstructured Data: Test Result:74; Comments: After Vaccination; Test Date: 20210912; Test Name: O2; Test Result: 99 %; Comments: After Vaccination
CDC Split Type: JPPFIZER INC202101228026

Write-up: feelings of weakness and no grip strength at left hand; feelings of weakness and no grip strength at left hand; Tremor of upper limbs; Pupils dilated; This is a spontaneous report from a contactable physician from the regulatory authority. Regulatory authority report number v21127159. A 14-year and 10-month-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12Sep2021 12:00 (Batch/Lot Number: FG0978; Expiration Date: 30Nov2021) at the age of 14-years-old as dose 1, 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was 36.4 degrees centigrade. On 12Sep2021 at 12:15 (15 minutes after the vaccination), the patient experienced feelings of weakness and no grip strength at left hand, pupils dilated and tremor of upper limbs. The patient''s consciousness was normal. Blood pressure was 100/50 mmHg, pulse rate was 74 and O2 was 99%. The outcome of the events was unknown. The reporting physician classified the event as serious events because the patient was required hospitalization from 12Sep2021 to unspecified date 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; the effect of BNT162b2 to the events could not be denied.


VAERS ID: 1751466 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: Blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Decreased
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Syncope; Decreased blood pressure; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP08932) on 13-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This case was reported by a physician via a medical representative. Syncope was assessed as serious by the agency. On 12-Sep-2021, the patient received this vaccine (number of doses was unknown). After the vaccination, syncope and decreased blood pressure developed. The symptoms resolved with rest in about 1 hour. The outcome of syncope and decreased blood pressure was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns an adult patient of unknown age and gender with a serious unexpected event of syncope, as well as non-serious blood pressure decreased. Latency within 24 hours after first dose mRNA-1273. Event reported as resolved. Rechallenge not applicable. Reporter causality possibly related. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1752937 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia
SMQs:, Infective pneumonia (narrow), 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: JPMODERNATX, INC.MOD20213

Write-up: COVID-19 positive (pneumonia); This case was received via Regulatory Authority (Reference number: 2021TJP094183) on 21-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case was reported by a family member of a vaccine recipient . COVID-19 positive (pneumonia) was assessed as serious . On 10-Sep-2021, the patient received the 1st dose of this vaccine. On 12-Sep-2021, the patient had pyrexia of 39 degrees Celsius. On 16-Sep-2021, the patient visited a medical institution. The patient was diagnosed COVID-19 positive and pneumonia and was hospitalized. On an unknown date, the symptoms were resolving. The outcome of COVID-19 positive(pneumonia) was reported as resolving. No follow-up investigation will be possible due to the reporter''s non-cooperation. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 61 year-old male patient with no reported medical history, who experienced the unexpected serious event of COVID-19 infection. The event occurred 3days after the first dose of mRNA-1273 vaccine. The event was considered related to the mRNA-1273 vaccine per assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Seriousness criteria of Medically significant maintained for consistency with Regulatory Authority report, however source document notes hospitalization.


VAERS ID: 1752979 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005885 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: PT-INFARMED-V202109-1657) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM in a 46-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005885) for COVID-19 immunisation. The patient''s past medical history included Smoker. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 12-Sep-2021, the patient experienced PULMONARY EMBOLISM (seriousness criteria hospitalization prolonged, medically significant and life threatening). At the time of the report, PULMONARY EMBOLISM outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered PULMONARY EMBOLISM to be possibly related. concomitant medications included was oral contraceptive user medication. No treatment information was provided. Company Comment: This case concerns a 46-year-old female patient with relevant medical history of smoker and oral contraceptive user, who experienced serious unexpected events of pulmonary embolism. The event occurred approximately 10 days after the first dose of mRNA-1273. The rechallenge was unknown, since at the time of report no information about second dose is available. The event was considered related to the product per the reporter''s assessment. Medical history of smoker and oral contraceptive user remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 28-Sep-2021 contain significant information that include other medical history added, Reporter causality updated and I narrative updated.; Sender''s Comments: This case concerns a 46-year-old female patient with relevant medical history of smoker and oral contraceptive user, who experienced serious unexpected events of pulmonary embolism. The event occurred approximately 10 days after the first dose of mRNA-1273. The rechallenge was unknown, since at the time of report no information about second dose is available. The event was considered related to the product per the reporter''s assessment. Medical history of smoker and oral contraceptive user remain confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1754430 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101228935

Write-up: exacerbated COPD; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority WEB (regulatory authority number: DE-PEI-202100188977). A 78-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, strength: 0.3 ml, lot number was unknown), intramuscular on 10Sep2021 (received at the age of 78-year-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced exacerbated COPD (chronic obstructive pulmonary disease) and pyrexia on 12Sep2021. The patient was hospitalized for the events. Outcome of the events was unknown. Sender''s comment: One day after vaccination (as reported), acute exacerbation of COPD with fever and accompanying cardiac decompensated components, but also with an overall reduced general condition. Was outpatient treatment necessary?: No. The assessment for all the events with the suspect product Comirnaty is: D. Unclassifiable . The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1755057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lower respiratory tract infection, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210912; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101233794

Write-up: Chest infection; Fever; Head pain; This is a spontaneous report from a contactable consumer or other non-health care professional. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109191411505710-T3R9O, Safety Report Unique Identifier GB-MHRA-ADR 25966072. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: was not reported) via an unspecified route of administration on 11Sep2021 as dose 2, single for COVID-19 immunization. Patient received historical vaccine first dose of BNT162B2 on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest infection (medically significant) on 13Sep2021, fever and head pain on 12Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (No - Negative COVID-19 test) on 12Sep2021. 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 Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the events was reported as recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast mass, Breast pain, Inappropriate schedule of product administration, Malaise
SMQs:, Lipodystrophy (broad), Medication errors (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 INC202101233764

Write-up: noticed breasts feeling painful; first dose on 09Jul2021, second dose on 08Sep2021; Breast pain; Lumpy breasts; This is a spontaneous report from a contactable consumer or other non HCP. This is a report received from the Regulatory authority (RA). Regulatory authority report number (GB-MHRA-WEBCOVID-202109192244444040-FQRVC). Safety Report Unique Identifier (GB-MHRA-ADR 25966420). A 37-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Lot number: FE8087, Expiration date was not reported), via an unspecified route of administration on 08Sep2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not pregnant and not currently breastfeeding. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 09Jul2021, as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced noticed breasts feeling painful. On 12Sep2021, 4 days after second dose patient experienced breast pain, Lumpy breasts. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event noticed breasts feeling painful was unknown, while outcome of events breast pain and Lumpy breasts was not recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1755168 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205516

Write-up: Leg pain; Ache; regulatory authority This is a solicited report from the regulatory authority program from a contactable consumer. This is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202109132041201470-K1AFW, Safety Report Unique Identifier is GB-MHRA-ADR 25934310. A 16-year-old female patient received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 12Sep2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. She has not had symptoms associated with COVID-19, not had a COVID-19 test, not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient experienced ache on 12Sep2021 with outcome of recovering and leg pain on 13Sep2021 with outcome of not recovered. Events were reported as medically significant by health authority. The reporter''s assessment of the causal relationship of the events 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, information about batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the available information in the case, the causal association between the events pain, pain extremity and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1755531 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, C-reactive protein, COVID-19 immunisation, Chest pain, Echocardiogram, General physical health deterioration, Headache, Myocarditis, Pyrexia, Troponin
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vaccination (Dose number 1. Vaccination site: Right arm; Intramuscular.)
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: C-reactive protein; Result Unstructured Data: 55 milligram per liter High; Test Date: 20210914; Test Name: Cardiac ultrasound; Result Unstructured Data: Normal findings. Good heart pumping function.; Test Date: 20210914; Test Name: Troponin NOS; Result Unstructured Data: 659 nanogram per liter
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: ;Revaccination with different COVID-19 vaccine; Reduced general condition; Arthralgia; Headache; Fever; This case was received via Regulatory Agency (Reference number: NO-NOMAADVRE-E2B_00050917) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CHEST PAIN and MYOCARDITIS in a 24-year-old male patient who received mRNA-1273 (Spikevax) for Vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Vaccination (Dose number 1. Vaccination site: Right arm; Intramuscular.) on 07-Jul-2021. On 11-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), ARTHRALGIA (Arthralgia), HEADACHE (Headache) and PYREXIA (Fever). On 14-Sep-2021, the patient experienced CHEST PAIN (seriousness criterion hospitalization) and MYOCARDITIS (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On 14-Sep-2021, PYREXIA (Fever) was resolving. At the time of the report, CHEST PAIN, MYOCARDITIS and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown and GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), ARTHRALGIA (Arthralgia) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Sep-2021, C-reactive protein: 55 (High) 55 milligram per liter High. On 14-Sep-2021, Echocardiogram: normal (normal) Normal findings. Good heart pumping function.. On 14-Sep-2021, Troponin: 659 (High) 659 nanogram per liter. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered CHEST PAIN, MYOCARDITIS, COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition), ARTHRALGIA (Arthralgia), HEADACHE (Headache) and PYREXIA (Fever) to be possibly related. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case concerns a 24 year-old, male subject, with no relevant medical history, who experienced the unexpected event of Chest pain, and the expected serious and AESI event of Myocarditis. Additional event of Revaccination with different COVID-29 vaccine was captured. The events occurred approximately 4 days after a dose of Spikevax. The rechallenge was not applicable since the first dose was different from Spikevax. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 27-Sep-2021 included drug information and sender''s comments.; Reporter''s Comments: Thank you for your report of a suspected adverse reaction following vaccination. As the vaccine is new, it is subject to special monitoring in order to identify new safety information as quickly as possible. It is particularly important that serious and/or unusual adverse reactions are reported. Your report is therefore important for increasing knowledge about adverse reactions that have not been identified in the studies, and it is an important contribution to the international cooperation aimed at maintaining safe vaccination worldwide. Reports after Coronavirus vaccination in the Adverse Reaction Registry are processed by the Department of Health in cooperation with the Regional Medicines Information and Regulatory Authority. We do not currently have the capacity to send individual assessments of adverse reaction reports. The Medicines Agency publishes weekly summaries of reports of suspected adverse reactions following vaccination: Causal links are assessed in accordance with international criteria (1). If you have any further information concerning the event such as information about outcome, copies of case notes/discharge notes/laboratory results and/or other investigations, this can be sent in reply to this message. The information is processed securely, and this dialogue is automatically deleted after 4 months. The processing and storage of personal data take place in accordance with the Database Filing System Act. For updated information and advice about use of the vaccines and precautionary measures, Questions about corona vaccines that cannot be answered by technical experts locally can be directed to regulatory authority. Please do not send special categories of personal data (health data) by e-mail. If it is not possible to ask a question without including such information, we recommend that you call the vaccine telephone line. ; Sender''s Comments: This case concerns a 24 year-old, male subject, with no relevant medical history, who experienced the unexpected event of Chest pain, and the expected serious and AESI event of Myocarditis. Additional event of Revaccination with different COVID-29 vaccine was captured. The events occurred approximately 4 days after a dose of Spikevax. The rechallenge was not applicable since the first dose was different from Spikevax. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755659 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH2496A05 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma chronic; Bicuspid aortic valve; Drug allergy (Allergy to drugs except asthma and allergy drugs)
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101236646

Write-up: Suspected anapylaxis (Symptoms: nausea, vomiting, swelling of uvula, redness of uvula, numbness of tongue and surroundings, redness of arms); acute allergic reaction (Symptoms: nausea, vomiting, swelling of uvula, redness of uvula, numbness of tongue and surroundings, redness of arms); This is a spontaneous report from a contactable HA. This is a report received from the Health Authority (HA). Regulatory authority report number {E-54398317-510.01.05-542829}. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: FH2496A05), intramuscular, administered in left deltoid on 12Sep2021 11:42 as single dose for COVID-19 immunisation. The patient''s medical history included chronic asthma, chronic bicuspid aorta, and allergy to drugs (allergy to drugs except asthma and allergy drugs). Concomitant medications included levocetirizine dihydrochloride, montelukast sodium (LEVMONT) and budesonide, formoterol fumarate (SYMBICORT), both taken for an unspecified indication, start and stop date were not reported. The patient experienced acute allergic reaction and suspected anapylaxis (symptoms for both: nausea, vomiting, swelling of uvula, redness of uvula, numbness of tongue and surroundings, redness of arms) on 12Sep2021 12:02. Therapeutic measures were taken as a result of acute allergic reaction (hypersensitivity) and suspected anapylaxis (anaphylactic reaction) (symptoms for both: nausea, vomiting, swelling of uvula, redness of uvula, numbness of tongue and surroundings, redness of arms). The patient used Avil vial as treatment for adverse effects. The outcome of the events was recovered on 12Sep2021. The reporter pharmacist selected serious for the seriousness criteria in the local form completed by himself/herself.


VAERS ID: 1757828 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-12
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Ruptured cerebral aneurysm
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

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

Write-up: Ruptured brain aneurysm; This spontaneous case was reported by a consumer and describes the occurrence of RUPTURED CEREBRAL ANEURYSM (Ruptured brain aneurysm) in a 48-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Aneurysm cerebral. On 19-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced RUPTURED CEREBRAL ANEURYSM (Ruptured brain aneurysm) (seriousness criteria medically significant and life threatening). At the time of the report, RUPTURED CEREBRAL ANEURYSM (Ruptured brain aneurysm) outcome was unknown. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment medications were not reported. The reporter states that the patient had not other vaccines received within 1 month prior to the date of vaccination, and patient had brain Aneurysm however there is no diagnosis confirmation submitted. This case concerns a 48 year-old male patient with reported history of brain aneurysm and a BMI of 30.76 (obesity grade 1), who expected the Serious Unexpected event of Ruptured cerebral aneurysm. The event ocurred 25 days after the first dose of Covid 19 Vaccine Moderna and the outcome is unknown. Rechallenge is unknown since the second dose has not been administered. The medical history of brain aneurysm and obesity, remain confounders for the case. The benefit-risk relationship of Covid 19 Vaccine Moderna is not affected by this report.; Sender''s Comments: This case concerns a 48 year-old male patient with reported history of brain aneurysm and a BMI of 30.76 (obesity grade 1), who expected the Serious Unexpected event of Ruptured cerebral aneurysm. The event ocurred 25 days after the first dose of Covid 19 Vaccine Moderna and the outcome is unknown. Rechallenge is unknown since the second dose has not been administered. The medical history of brain aneurysm and obesity, remain confounders for the case. The benefit-risk relationship of Covid 19 Vaccine Moderna is not affected by this report.


VAERS ID: 1758012 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Drug eruption, Malaise, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Exanthematic drug eruption; Vomited; This case was received via Regulatory Agency (Reference number: 1006492) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MALAISE, DRUG ERUPTION (Exanthematic drug eruption) and VOMITING (Vomited) in a 12-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 12-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced MALAISE (seriousness criterion medically significant), DRUG ERUPTION (Exanthematic drug eruption) (seriousness criterion medically significant) and VOMITING (Vomited) (seriousness criterion medically significant). At the time of the report, MALAISE (Exanthematic drug eruption) and VOMITING (Vomited) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided. Company Comment: This case concerns a 12-year-old, female patient with no reported medical history experienced serious events of Malaise, drug eruption and vomiting 1 day after the first dose of Spikevax. The event''s causality was not provided by reporter. Patient experienced AEs after the first dose, not resolved at the time of this reported and the patient has not received second dose rechallenge unknown. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received no new information was added. On 28-Sep-2021: Translation received on 30-sep-2021 includes no new information.; Sender''s Comments: This case concerns a 12-year-old, female patient with no reported medical history experienced serious events of Malaise, drug eruption and vomiting 1 day after the first dose of Spikevax. The event''s causality was not provided by reporter. Patient experienced AEs after the first dose, not resolved at the time of this reported and the patient has not received second dose rechallenge unknown. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1758090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-12
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Fatigue, Headache, Heavy menstrual bleeding, Lethargy, Malaise, Off label use, Pain in extremity, Product use issue, Tension headache, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Medication errors (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226519

Write-up: Headache tension; Period pains; Pain in arm; Heavy periods; Prolonged periods; Felt generally ill; sore arm at injection site; Maternal exposure during breast feeding; Maternal exposure during breast feeding; headache; feeling really drained; Lethargic; This is a spontaneous report from a contactable consumer (patient). This is first of two reports. This is a report received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109190237121530-ILPMZ, Safety Report Unique Identifier GB-MHRA-ADR 25965310. This consumer reported information for both mother and baby. This is the maternal case. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included ongoing breast feeding. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Historical vaccine included first dose of BNT162B2, on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of recovered an unspecified date, feeling really drained on an unspecified date with outcome of unknown, lethargic on 12Sep2021 with outcome of recovered on 15Sep2021, headache tension on an unspecified date with outcome of recovered an unspecified date, period pains on an unspecified date with outcome of recovered an unspecified date, pain in arm on an unspecified date with outcome of recovered an unspecified date, heavy periods on an unspecified date with outcome of recovering, prolonged periods on an unspecified date with outcome of recovering, felt generally ill on an unspecified date with outcome of recovered an unspecified date, sore arm at injection site on an unspecified date with outcome of unknown. The events were assessed as serious and medically significant. The patient also experienced maternal exposure during breast feeding on an unspecified date with outcome of unknown. Patient has not tested positive for COVID-19 since having the vaccine. The clinical course was reported as follows: Came on my period on the day of the vaccine. Wasn''t due for a few more days yet. Period was very heavy with a lot of period pains also a lot of blood clots. Quite unusual for me. Headache, sore arm at injection site and feeling really drained and lethargic the day after the vaccination which lasted a few days. 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-202101234954 Baby case


VAERS ID: 1758447 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-12
   Days after vaccination:87
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Catheterisation cardiac, Echocardiogram, Interchange of vaccine products, Magnetic resonance imaging heart, Myocarditis, Off label use
SMQs:, Cardiomyopathy (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Unknown results; Result Unstructured Data: Test Result:Unknown results; Test Name: Echo; Result Unstructured Data: Test Result:Unknown results; Test Name: cardiac- Magnetic Resonance Imaging (MRI); Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101239263

Write-up: Off-Label use; Interchange of vaccine products; Perimyocarditis; This is a spontaneous report from a physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100192976. A 22-year-old male patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN), dose 2 via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: Unknown) at the age of 21-year-old as dose 2 (initial Pfizer dose), 0.3 mL single for covid-19 immunisation. The patient medical history was not reported. Historical Vaccine included Vaxzevria for COVID-19 vaccination on 25Mar2021. The patient''s concomitant medications were not reported. The patient experienced perimyocarditis on 12Sep2021 with outcome of unknown, off-label use on an unspecified date with outcome of unknown , interchange of vaccine products on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included catheterisation cardiac: unknown results on unknown date, echocardiogram: unknown results on unknown date, magnetic resonance imaging heart: unknown results on unknown date. Seriousness criteria of the event perimyocarditis was medically significant. This report is non-serious. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1758450 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-12
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Paralytic lagophthalmos
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101254873

Write-up: Paralytic lagophthalmos; Facial palsy left; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100194223. A 24-year-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 23Jun2021 (at the age of 23-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included patient previously took of first dose of bnt162b2 (COMIRNATY; Solution for injection; Lot Number: Unknown), via an unspecified route of administration on 02Jun2021 (at the age of 23-year-old) as single dose for covid-19 immunisation. On 12Sep2021, the patient experienced facial palsy and paralytic lagophthalmos. At the time of this report, the outcome of events was not recovered. Health Authority Commnet: Initials privacy First vaccination Comirnaty on 02Jun2021 Second page missing. Result of Assessment: Comirnaty/ all event(s):/ Regulatory Authority: D. Unclassifiable. No follow-up attempts possible. No further information expected. Information about LOT/Batch number cannot be obtained.


VAERS ID: 1760612 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthmatic crisis, Periorbital oedema, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic to horses; Asthma; Mite allergy; Nettle rash
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101238279

Write-up: Asthmatic crisis/Asthma attack; Edema periorbital; Generalized urticaria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20217956. A 16-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FF2834), intramuscularly administered in the right arm on 11Sep2021 as dose 1, single for COVID-19 immunization. Medical history included asthma, mites and horses allergy and nettle rash, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced asthmatic crisis/asthma attack, edema periorbital and generalized urticaria on 12Sep2021 requiring consultation. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 11Sep2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


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