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From the 11/12/2021 release of VAERS data:

Found 875,292 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 495 out of 8,753

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VAERS ID: 1808666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211040697

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050244) on 21-OCT-2021 and concerned a 52 year old female. 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, intramuscular, batch number: XD975, expiry: unknown) dose was not reported,1 total, administered on 28-MAY-2021 for unknown indication. No concomitant medications were reported. On 16-SEP-2021, the patient underwent COVID-19 PCR (polymerase chain reaction) test and result found to be positive which indicates patient had SARS-CoV-2 infection (severe acute respiratory syndrome coronavirus-2) hence vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1808811 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fall, Heart rate, Heart rate irregular, Palpitations
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (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: COSENTYX; DIAMOX [ACETAZOLAMIDE SODIUM]; LUNESTA; ZOFRAN [ONDANSETRON]; POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Idiopathic intracranial hypertension; Psoriatic arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: heart beat; Result Unstructured Data: Test Result:60; Comments: bpm; Test Date: 20210916; Test Name: heart beat; Result Unstructured Data: Test Result:180; Comments: bpm; Test Date: 20210916; Test Name: heart beat; Result Unstructured Data: Test Result:50; Comments: bpm; Test Date: 20211010; Test Name: heart beat; Result Unstructured Data: Test Result:240; Comments: bpm
CDC Split Type: CAPFIZER INC202101351055

Write-up: from 60 bpm to 180bpm then drop to 50 bpm in a matter or a minute; I was short of breath when I changed positions; dizzy; have had multiple falls just to get up to use the washroom or get a drink of water.; heart palpitations; This is a spontaneous report received via Regulatory Authority from a contactable other healthcare professional (patient) regarding product BNT162B2. A 28-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot no: FF2595 and Expiration date not reported), via an unspecified route of administration, administered in Arm Left (Deltoid) on 11Sep2021 at 14:30 (age at vaccination 28-year-old), as DOSE 1, SINGLE for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient relevant medical history and concurrent conditions included psoriatic arthritis and idiopathic inter cranial hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications included Secukinumab (COSENTYX), Acetazolamide sodium (DIAMOX [ACETAZOLA-MIDE SODIUM]), Eszopiclone (LUNESTA) and ONDANSETRON (ZOFRAN [ONDANSETRON]), potassium (MANUFACTURER UNKNOWN); all from an unknown date and unknown if ongoing. There was no relevant past drug history. The patient had allergy to an unspecified drug. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Patient reported on 16Sep2021 at 12:00, after 5 days, her heart beat started racing and she was short of breath when she changed positions. Her heart rate would do from 60 bpm to 180bpm then drop to 50 bpm in a matter or a minute, she got very dizzy, and have had multiple falls just to got up to use the washroom or got a drink of water. Now she could be sleeping and she started having heart palpitations and it felt like she could not catch her breath. Her heart rate has been up to 240 bpm on 10Oct2021 and she got so dizzy she could not even get out of bed. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The device date was reported as 10Oct2021. The patient did not receive any treatment for events. The Outcome of events was not resolved for all events. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the Serious event Heart rate irregular 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: 1809259 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Immune thrombocytopenia, Immunisation, Mouth haemorrhage, Off label use, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: platelet count; Result Unstructured Data: Test Result:7 g/l
CDC Split Type: FRPFIZER INC202101350308

Write-up: Idiopathic thrombocytopenic purpura; Some bleeding in mouth; bleeding in nose; Booster; Off label use; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB, regulatory authority number FR-AFSSAPS-BR20213598. A 80-years-old female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, lot number: FG3739), intramuscular, administered in Arm Left on 16Sep2021 (at the age of 80 years old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took historical vaccine bnt162b2 (COMIRNATY, formulation: Solution for injection), via on an unspecified route of administration in Arm Right on 25Jan2021 (lot number: EJ6788) as a dose 1, single and dose 2 via on an unspecified route of administration in Arm Left on 22Feb2021 (Lot number: EP9598) as a dose 2, single both for covid-19 immunisation. On 16Sep2021, the patient received dose 3 (booster and Off label use). On 27Sep2021, the patient experienced idiopathic thrombocytopenic purpura. On an unspecified date, the patient had some bleeding in mouth and bleeding in nose. The patient underwent lab tests and procedures which included platelet count that was 7 g/l on 27Sep2021. The patient was Currently received anticoagulants treatment. The patient was Admitted to Emergency Room and hospitalized in general ward for 5-6 days. It was reported that, there were no signs of seriousness and female patient asymptomatic thereafter. And had good outcome so far with corticosteroid therapy. The outcome of the event idiopathic thrombocytopenic purpura was recovering and other all events outcome was unknown. No follow up attempts possible, no further information expected.


VAERS ID: 1809267 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Injection site pain, Malaise
SMQs:, Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
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: FRMODERNATX, INC.MOD20213

Write-up: Headache; Feeling sick; Injection site pain; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BX20219217) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and MALAISE (Feeling sick) in a 14-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced INJECTION SITE PAIN (Injection site pain). On 20-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and MALAISE (Feeling sick) (seriousness criterion medically significant). At the time of the report, HEADACHE (Headache), MALAISE (Feeling sick) and INJECTION SITE PAIN (Injection site pain) had not resolved. Concomitant medications were not provided. Treatment information was not provided. Company Comment : This is a regulatory case concerning a 14 year-old female patient with no relevant medical history reported who experienced the serious unexpected events of HEADACHE and MALAISE approximately 4 days after receiving the first dose of Spikevax.The rechallenge cannot be assessed since the second dose has not being administered at the time of report. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness was captured as per Regulatory Authority assessment in Source Document. This case was linked to FR-AFSSAPS-BX20219218 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation received on 15-Oct-21 contains no new information.; Sender''s Comments: This is a regulatory case concerning a 14 year-old female patient with no relevant medical history reported who experienced the serious unexpected events of HEADACHE and MALAISE approximately 4 days after receiving the first dose of Spikevax.The rechallenge cannot be assessed since the second dose has not being administered at the time of report. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness was captured as per Regulatory Authority assessment in Source Document. FR-AFSSAPS-BX20219218:


VAERS ID: 1809697 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH CD 6840 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Suffocation feeling, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Angina pectoris (angina pektoris); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Myelitis transverse (tm spinal cord); Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202101385621

Write-up: dizziness, COULDN''T GET UP FOR HALF AN HOUR; unconsciousness/fainting; a feeling of suffocation in the neck; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HR-HALMED-300051110. A 68-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 16Sep2021 (at the age of 68-year-old) (Batch/Lot Number: CD 6840) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included ongoing angina pectoris, osteoporosis, ongoing hypertension and Myelitis transverse (TM) spinal cord. The patient''s concomitant medications were not reported. On 16Sep2021, the patient experienced dizziness, couldn''t get up for half an hour, unconsciousness/fainting, and a feeling of suffocation in the neck. The events were considered as life- threatening. Outcome of events was recovering (also reported stop date as 19Sep2021). The reporter assessed the events as probable/likely (RA Causality).


VAERS ID: 1809733 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2382 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Eyelid oedema, Hypersensitivity, Pruritus, Swelling of eyelid, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Periorbital and eyelid disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (allergy to profilins)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101330353

Write-up: Constriction throat / feeling of constriction to the glottis; Urticaria / Urticaria on almost the entire body; Edema eyelid / eyelid swelling; Edema eyelid / eyelid swelling; itching erythema of the limbs and trunk; itching erythema of the limbs and trunk; allergic reaction; This is a report from Non-Interventional Study source, from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-794312. A 26-year-old female subject received bnt162b2 (COMIRNATY), dose 2 intramuscular on 16Sep2021 08:00 (Lot Number: FF2382) at the age of 26-year-old as single dose for covid-19 immunisation. Medical history included allergy (allergy to profilins) from an unknown date and unknown if ongoing. The subject''s concomitant medications were not reported. The subject experienced constriction throat / feeling of constriction to the glottis, urticaria / urticaria on almost the entire body, edema eyelid / eyelid swelling and itching erythema of the limbs and trunk on 16Sep2021 14:00. The case was reported as serious (medically significant). Clinical course: She arrived at the emergency and admission department for an allergic reaction that occurred this afternoon at around 2:00 pm, following the administration of the second shot of Pfizer this morning at 8:00am. She reported an initial sensation of constriction of the glottis followed by swelling of the eyelids and then itching erythema of the limbs and trunk associated with itching. Diagnosis: Allergic skin reaction (urticaria) after sars-covid-2 vaccination. Measures taken: The subject had administered flebocortid and chlorphenamine maleate (TRIMETON) via intravenous route. Therapy included methylprednisolone acetate (MEDROL) 16 mg 1 tablet in the morning for 3 days, then 1/2 tablet for other 3 days and cetirizine hydrochloride (ZIRTEC) 10 mg 1 tablet in the evening for 6 days. Outcome of events was recovered in 2021. 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. Sender comment: The report comes from the regulatory authority study. All the data in our possession has already been entered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Throat tightness, Eyelid edema, Urticaria, Swelling of eyelid, Erythema, Pruritus, Hypersensitivity and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1809845 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0105 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Hypersensitivity, Hypoaesthesia, Oxygen saturation, Palpitations, Paraesthesia, Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic reaction; Physical deconditioning
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Blood pressure; Result Unstructured Data: Test Result:213/118; Comments: At 16:10; Test Date: 20210916; Test Name: Blood pressure; Result Unstructured Data: Test Result:155/99; Comments: At 16:25; Test Date: 20210916; Test Name: Blood pressure; Result Unstructured Data: Test Result:169/99; Comments: At 16:35; Test Date: 20210916; Test Name: Blood pressure; Result Unstructured Data: Test Result:198/100; Comments: At 16:00; Test Date: 20210916; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: Before vaccination; Test Date: 20210916; Test Name: Pulse rate; Result Unstructured Data: Test Result:61; Comments: At 16:10; Test Date: 20210916; Test Name: Pulse rate; Result Unstructured Data: Test Result:60; Comments: At 16:25; Test Date: 20210916; Test Name: Pulse rate; Result Unstructured Data: Test Result:61; Comments: At 16:35; Test Date: 20210916; Test Name: Pulse rate; Result Unstructured Data: Test Result:66; Comments: At 16:00; Test Date: 20210916; Test Name: Oxygen saturation; Test Result: 98 %; Comments: At 16:10; Test Date: 20210916; Test Name: Oxygen saturation; Test Result: 99 %; Comments: At 16:25; Test Date: 20210916; Test Name: Oxygen saturation; Test Result: 99 %; Comments: At 16:35; Test Date: 20210916; Test Name: Oxygen saturation; Test Result: 99 %; Comments: At 16:00
CDC Split Type: JPPFIZER INC202101245176

Write-up: Mild numbness and tingling sensation appeared on the two lower limbs; Mild numbness and tingling sensation appeared on the two lower limbs; Red rash on the neck; Urticaria / Wheals on the neck; Allergic symptoms / Relapse of allergic conditions; BP 198/100/; BP 213/118; BP 155/99; BP 169/99; Palpitations; Numbness of left upper extremity / Numbness of hands; This is a spontaneous report from a contactable physician received from the regulatory authority report number v21127405. A 52-year and 2-month-old female patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 16Sep2021 at 15:45 (Batch/Lot Number: FH0105 (also reported as FH0151); Expiration Date: 31Dec2021, at age 52-years old at vaccination) as a single dose for COVID-19 immunisation. Medical history included allergic conditions and physical deconditioning. Concomitant medications were not reported. Body temperature before vaccination on 16Sep2021 was 35.7 degrees Centigrade. On 16Sep2021 at 15:45 (the day of vaccination), the patient received the first dose of the BNT162B2 vaccine. On 16Sep2021 at 16:00 (15 minutes after the vaccination), the patient experienced urticaria, numbness of hands / left upper extremity. The symptom continued after 15 min of observation. Palpitation was observed. P- pulse 66; BP- blood pressure 198/100; oxygen saturation 99% (measured while sitting). At 16:10, the patient visited the doctor. P 61; BP 213/118 (clinical measurement); Oxygen saturation 98%. Red rash on the neck was observed. Numbness of the left hand continued. Water intake (red rash on the neck appeared when the patient was in physical deconditioning). At 16:25, P 60; BP 155/99; oxygen saturation 99%. The numbness of left hand was relieved, but mild numbness and tingling sensation appeared on the two lower limbs. There was no abdominal symptoms or dyspnoea. At 16:30, the patient consulted the doctor about the symptoms and about the next vaccination. Since the patient had experienced allergic symptoms, she inquired whether she could receive the second dose or not. At 16:35, P 61; BP 169/99; oxygen saturation 99%. The numbness and tingling sensation continued. There was no dyspnoea. At 16:40, after observation by the doctor, the symptoms were not aggravated. The patient went back home. The patient was told to go to the hospital if the red rash on neck was aggravated. On 16Sep2021 (the day of the vaccination), the outcome of the events was recovering. The course of the event was as follows: After vaccination, palpitations and numbness of left upper extremity occurred. At the time of examination, wheals on the neck was observed, but the patient said that it often appeared due to physical deconditioning, and the causality was unknown. The patient laid down and the symptoms of palpitations and numbness was recovering. There were no dyspnoea, blood pressure decreased or abdominal pain. The reporting physician classified the event as non-serious and assessed that the causality between the events and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was relapse of allergic conditions. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1809909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-16
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Immature granulocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Platelet count, Red blood cell nucleated morphology, Red cell distribution width, Reticulocyte count, Thrombocytopenia, White blood cell count
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: basophils abs; Result Unstructured Data: Test Result:0.07; Comments: high; Test Date: 20210929; Test Name: basophils abs; Result Unstructured Data: Test Result:0.06; Comments: high; Test Date: 20210928; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.11; Comments: high; Test Date: 20210929; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.11; Comments: high; Test Date: 20210930; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.14; Comments: high; Test Date: 20211003; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.11; Comments: high; Test Date: 20210929; Test Name: mean cell Hb; Result Unstructured Data: Test Result:23.9; Comments: low; Test Date: 20210930; Test Name: mean cell Hb; Result Unstructured Data: Test Result:24.2; Comments: low; Test Date: 20211003; Test Name: mean cell Hb; Result Unstructured Data: Test Result:23.8; Comments: low; Test Date: 20210929; Test Name: mean cell Hb conc; Result Unstructured Data: Test Result:31.3; Comments: low; Test Date: 20210928; Test Name: mean cell volume; Result Unstructured Data: Test Result:73.1; Comments: low; Test Date: 20210929; Test Name: mean cell volume; Result Unstructured Data: Test Result:76.5; Comments: low; Test Date: 20210930; Test Name: mean cell volume; Result Unstructured Data: Test Result:74.4; Comments: low; Test Date: 20211003; Test Name: mean cell volume; Result Unstructured Data: Test Result:75.5; Comments: low; Test Date: 20210928; Test Name: monocytes abs; Result Unstructured Data: Test Result:0.74; Comments: high; Test Date: 20210929; Test Name: monocytes abs; Result Unstructured Data: Test Result:0.89; Comments: high; Test Date: 20210928; Test Name: platelets; Result Unstructured Data: Test Result:52; Comments: low; Test Date: 20210929; Test Name: platelets; Result Unstructured Data: Test Result:56; Comments: low; Test Date: 20210930; Test Name: platelets; Result Unstructured Data: Test Result:75; Comments: low; Test Date: 20211003; Test Name: platelets; Result Unstructured Data: Test Result:64; Comments: low; Test Date: 20210928; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.01; Comments: low; Test Date: 20210929; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.0; Comments: low; Test Date: 20210930; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.00; Comments: low; Test Date: 20211003; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.00; Comments: low; Test Date: 20210928; Test Name: red cell distribution width; Result Unstructured Data: Test Result:15.2; Comments: high; Test Date: 20210929; Test Name: red cell distribution width; Result Unstructured Data: Test Result:15.3; Comments: high; Test Date: 20210930; Test Name: red cell distribution width; Result Unstructured Data: Test Result:15.1; Comments: high; Test Date: 20211003; Test Name: red cell distribution width; Result Unstructured Data: Test Result:15.2; Comments: high; Test Date: 20210928; Test Name: reticulocytes abs; Result Unstructured Data: Test Result:94.5; Comments: high; Test Date: 20210928; Test Name: WBCC; Result Unstructured Data: Test Result:10.54; Comments: high; Test Date: 20210929; Test Name: WBCC; Result Unstructured Data: Test Result:11.23; Comments: high; Test Date: 20210930; Test Name: WBCC; Result Unstructured Data: Test Result:10.13; Comments: high
CDC Split Type: MTPFIZER INC202101351017

Write-up: thrombocytopenia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority, regulatory authority number MT-ADM-1102021. A 15-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FD6840, Expiry date was not reported), via intramuscular route of administration on 30Aug2021 as Dose 2, Single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Sep2021, patient experienced thrombocytopenia. The event caused medically significant. The patient underwent lab tests and procedures which included basophil count was 0.07 on 28Sep2021 (high), basophil count was 0.06 on 29Sep2021 (high), immature granulocyte count was 0.11 on 28Sep2021 (high), immature granulocyte count was 0.11 on 29Sep2021 (high), immature granulocyte count was 0.14 on 30Sep2021 (high), immature granulocyte count was 0.11 on 03Oct2021 (high), mean cell haemoglobin was 23.9 on 29Sep2021 (low), mean cell haemoglobin was 24.2 on 30Sep2021 (low), mean cell haemoglobin was 23.8 on 03Oct2021 (low), mean cell haemoglobin concentration was 31.3 on 29Sep2021 (low), mean cell volume was 73.1 on 28Sep2021 (low), mean cell volume was 76.5 on 29Sep2021 (low), mean cell volume was 74.4 on 30Sep2021 (low), mean cell volume was 75.5 on 03Oct2021 (low), monocyte count was 0.74 on 28Sep2021 (high), monocyte count was 0.89 on 29Sep2021 (high), platelet count was 52 on 28Sep2021 (low), platelet count was 56 on 29Sep2021 (low), platelet count was 75 on 30Sep2021 (low), platelet count was 64 on 03Oct2021 (low), red blood cell nucleated morphology was 0.01 on 28Sep2021 (low), red blood cell nucleated morphology was 0.0 on 29Sep2021 (low), red blood cell nucleated morphology was 0.00 on 30Sep2021 (low), red blood cell nucleated morphology was 0.00 on 03Oct2021 (low), red cell distribution width was 15.2 on 28Sep2021 (high), red cell distribution width was 15.3 on 29Sep2021 (high), red cell distribution width was 15.1 on 30Sep2021 (high), red cell distribution width was 15.2 on 03Oct2021 (high), reticulocyte count was 94.5 on 28Sep2021 (high), white blood cell count was 10.54 on 28Sep2021 (high), white blood cell count was 11.23 on 29Sep2021 (high), white blood cell count was 10.13 on 30Sep2021 (high). The patient was not taking other medications did not suffer from other diseases or allergies. Symptoms continuing. The side-effect was not caused by a medication error. No other information regarding the first dose was available. Sender Comment: Side-effect is listed in SmPC and therefore it is expected. Challenge: compatible, re-challenge: RO and de-challenge; inconclusive, signs and symptoms: very suggestive, lab test: L+ and alternate non-drug explanation: absent. Outcome: c1 & S3 = I2 possible. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1810075 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Electrocardiogram, Erythema, Pharyngeal oedema, Tongue oedema
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal allergic 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse drug reaction (Possible reaction to Novalgeol ampoules)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:150/90 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Test Name: ECG; Result Unstructured Data: Test Result:normogram, f around 90/min
CDC Split Type: RSPFIZER INC202101381258

Write-up: Edema tongue / mild swelling of the tongue; Redness of face; Edema pharynx / mild swelling of the throat; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory Authority report number 515-00-02819-2021-2. A 68-year-old female patient received the first dose of BNT162B2 via intramuscular on 16Sep2021 (Batch/Lot Number: FE6029) at the age of 68-year-old as single dose for COVID-19 immunization. Medical history included reaction to novalgeol (possible reaction to novalgeol ampoules) and unknown if ongoing. Concomitant medication was not reported. The patient previously received voltaren and experienced vomiting (vomiting 15 years ago after oral administration of voltaren). On 16Sep2021, 10 minutes after receiving the first dose of the vaccine, the patient experienced tongue tingling, mild swelling of the tongue and throat, and redness of the face. 10 minutes after receiving therapy, swelling of tongue and throat withdrew, and the patient was forwarded to the internist, while the redness of the face persisted. Symptoms quickly withdrew after the therapy. TA 150/90, heart: action is rhytmical, tones clear without hums. lungs: normal breathing hum. Administered therapy: Lemod solu no I intravenous Synopen I intramuscular Cardiologists'' report: Diagnosis: Urticaria Allergica L 50.0, Finding: The patient is feeling unwell, weak after having received the vaccine. ECG (Electrocardiogram): normogram, f around 90/min, TA 140/80 mmHg, lungs: fainter breathing hum, heart: tones clear. Therapy NaCl 500 ml+Lemod 40mg+Calcihept; Further therapy: Nixar 1x1. Cardiological observation is required. The patient underwent lab tests and procedures which included blood pressure measurement: 150/90 mmhg, blood pressure measurement: 140/80 mmhg, electrocardiogram: normogram, f around 90/min. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1813152 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Chest discomfort, Headache, Nausea, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Nausea; Leg pain; Tummy ache; Painful arm; Headache; Stomach pain; Tight chest; This case was received via United Kingdom MHRA (Reference number: XI-EMA-DD-20211008-kaur_j6-093811) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), ABDOMINAL PAIN (Tummy ache), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache), ABDOMINAL PAIN UPPER (Stomach pain), CHEST DISCOMFORT (Tight chest) and PAIN IN EXTREMITY (Leg pain) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced ABDOMINAL PAIN (Tummy ache) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tight chest) (seriousness criterion medically significant). On 17-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion medically significant) and PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). On 19-Sep-2021, PAIN IN EXTREMITY (Leg pain) had resolved. At the time of the report, NAUSEA (Nausea), ABDOMINAL PAIN (Tummy ache), PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and ABDOMINAL PAIN UPPER (Stomach pain) had not resolved and CHEST DISCOMFORT (Tight chest) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: This case concerns a 42 year-old, female patient with no relevant medical history, who experienced the serious unexpected events of Nausea, Abdominal pain, Leg pain, Painful arm, Headache, and Chest discomfort. The events Nausea and Leg pain occurred 1 day after the first dose of MODERNA COVID-19 VACCINE while events Abdominal pain, Painful arm, Headache, and Chest discomfort occurred less than a day after the first dose of MODERNA COVID-19 VACCINE. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Events assessed as serious (seriousness criterion=other medically significant condition) by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.; Reporter''s Comments: This case is a master made from existing duplicates in EudraVigilance by the EMA duplicate management team. The case numbers of the underlying duplicates are in the Other Case Identifiers section; Sender''s Comments: This case concerns a 42 year-old, female patient with no relevant medical history, who experienced the serious unexpected events of Nausea, Abdominal pain, Leg pain, Painful arm, Headache, and Chest discomfort. The events Nausea and Leg pain occurred 1 day after the first dose of MODERNA COVID-19 VACCINE while events Abdominal pain, Painful arm, Headache, and Chest discomfort occurred less than a day after the first dose of MODERNA COVID-19 VACCINE. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. Events assessed as serious (seriousness criterion=other medically significant condition) by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.


VAERS ID: 1813824 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7204 / UNK LA / IM

Administered by: School       Purchased by: ?
Symptoms: Burning sensation, Facial pain, Fatigue, Headache, Hypoaesthesia, Ophthalmic migraine, Scan, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: plaquenil, valtrex, naproxsyn, amylodipin, vit d
Current Illness: mixed connective tissue disease, Myalgic encephalomyelitis, Raynaud Syndrome
Preexisting Conditions: mixed connective tissue disease, Myalgic encephalomyelitis, Raynaud Syndrome
Allergies:
Diagnostic Lab Data: scan down to RO trombosys
CDC Split Type:

Write-up: 24 after shot I started having a headache and extreme fatigue and a sensation of face numbness (ach and burning feeling), which followed by ophtalmique migraine which lasted 4 days, followed by blurry vision on/off. Head ache remained constant and never went away, fatigue is still very present more than my usual base level and face achs and numbness is still present. Neurologist started me on topomax to try and control the headaches.


VAERS ID: 1815869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1H048A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Hallucination, Headache, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronavirus infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101354873

Write-up: Hallucination; Headache; Anxiety; Vomiting; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100204585. A 64-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 15Sep2021 (Batch/Lot Number: 1H048A) as DOSE NUMBER UNKNOWN, SINGLE (reported as unknown dosage) for COVID-19 immunisation. Medical history included coronavirus infection from 12Dec2020 to an unknown date (was not ongoing). Concomitant medications were not reported. On 16Sep2021, the patient experienced Headache, Vomiting, Hallucination and Anxiety. Relatedness of drug to reaction(s)/event assessed by regulatory authority was A. Consistent causal association to immunization for Headache, Vomiting, Hallucination and Anxiety. Outcome of all the events were resolved on 17Sep2021. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1816130 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-16
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101370191

Write-up: Menstrual flow altered; This is a spontaneous report from a contactable consumer or other non hcp (patient) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20215368. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Aug2021 (Batch/Lot Number: UNKNOWN) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced menstrual flow altered (medically significant) on 16Sep2021 with outcome of recovered with sequelae in 2021. The clinical course was reported as: The second menstrual period after the first covid vaccine started normally but the 2nd and 3rd day were totally leakless until the leak started on the 4th day. The leak somehow was left on: small dripping has continued now for 2.5 weeks since the starting of the menstruation. The patient received the 2nd vaccine yesterday so the effects are not yet known as if the leak will continue after that. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1816181 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCDD2 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Conjunctival haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Conjunctival 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: FRPFIZER INC202101347497

Write-up: Subconjunctival ecchymosis/subconjunctival hemorrhage left eye; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number FR-AFSSAPS-BX20218795. A 71-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: SCDD2), intramuscularly on 13Sep2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced subconjunctival ecchymosis/subconjunctival hemorrhage left eye on 16Sep2021. The outcome of the event was not recovered. Note: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1816764 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-09-16
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Headache, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to metals (chrome allergy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101347208

Write-up: eye and mouth asymmetry. on September 16-17; Bell''s palsy, seventh right cranial nerve diagnosed in emergency room on 24 September; headache; blurry vision; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-795996. A 15-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 29Aug2021 11:30 (Batch/Lot Number: FF7481; Expiration Date: 30Nov2021) as DOSE 2, 0.3 ML SINGLE for Covid-19 immunization. Medical history included allergy to metals (chrome allergy). There were no concomitant medications. Historical vaccine included Comirnaty (lot number: FF4213) on 08Aug2021 for Covid-19 immunization. It was reported that on 29Aug2021 at 11.30 the 2nd dose of the anti-COVID-19 vaccine (batch FF7481, expiry 30Nov2021) was administered to the patient. Symptoms start after 3 weeks. On 24Sep2021, the patient entered the emergency room due to a reported alteration of the face, deviation of the buccal rim, paresthesia of the left half-face. The patient was diagnosed with peripheral paralysis of VII cranial nerve. First symptoms (headache, blurry vision, eye and mouth asymmetry) on September 16-17; Bell''s palsy, seventh right cranial nerve diagnosed in emergency room. Right Eye bandage performed, artificial tears and Deltacortene 25mg were administered. The patient was improving. The mother denies pathologies and concomitant medication. Actions taken (Cortisone deltacortene 50mg X2 per day for 4 days and then reduce to half for 4 days and then to 1/4 for 4 days. Artificial tear for the eye, lipoic acid supplement, plus gastroprotector on the third day.) - Impact on quality of life (6/10). The outcome of events was recovering. Reporter''s comments: allergy to chrome No follow up attempts needed; no further information is expected.; Reporter''s Comments: allergy to chrome


VAERS ID: 1816798 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Dysphoria, Feeling cold, Heart rate, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: blood pressure; Result Unstructured Data: Test Result:82/44; Comments: at 14:03; Test Date: 20210916; Test Name: blood pressure; Result Unstructured Data: Test Result:94/70; Comments: at 14:15; Test Date: 20210916; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210916; Test Name: pulse; Result Unstructured Data: Test Result:58; Comments: at 14:03; Test Date: 20210916; Test Name: pulse; Result Unstructured Data: Test Result:66; Comments: at 14:15.; Test Date: 20210916; Test Name: spo2; Test Result: 99 %; Comments: at 14:03; Test Date: 20210916; Test Name: spo2; Test Result: 99 %; Comments: at 14:15
CDC Split Type: JPPFIZER INC202101246407

Write-up: decreased blood pressure / BP 82/44; Vasovagal reaction; decreased blood pressure and dizziness, due to vasovagal reflex; Dysphoria; feeling cold in the periphery; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21127402. A 27-year and 9-month-old female patient received the first dose of BNT162b2 (COMIRNATY; solution for injection; Lot Number: FH0151; Expiration Date: 31Dec2021) intramuscularly on 16Sep2021 at 13:59 (the day of vaccination, at the age of 27-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 16Sep2021 at 14:03, the patient experienced dysphoria and feeling cold in the periphery and at 14:05 (6 minutes after the vaccination), the patient experienced vasovagal reaction. The course of the event was as follows: Body temperature before vaccination was 36.3 degrees Centigrade on 16Sep2021. At 13:59, the patient received the first vaccination. At 14:03, dysphoria appeared, moved to the emergency room in a wheelchair and had feeling cold in the periphery. BP: 82/44, SPO2: 99%, P: 58. At 14:05, consultation by physician, the lower limbs were raised and observed for 15 minutes on the bed. At 14:15, BP: 94/70, SPO2: 99%, P: 66. Dysphoria decreased. At 14:20, consultation by physician, the physician considered that since there was no standing problem, the patient could go home, and the patient went home alone. The patient experienced symptoms, including decreased blood pressure and dizziness, due to vasovagal reflex; however, these symptoms improved with supine rest. The reporting physician classified the event as non-serious assessed that the event was unrelated to BNT162b2. On 16Sep2021 (the day of vaccination), the outcomes of the events dysphoria and vasovagal reaction were recovering/resolving while the clinical outcome of the event feeling cold in the periphery was unknown. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on the available information, the events decreased blood pressure and dizziness, due to vasovagal reflex, dysphoria and feeling cold in the periphery were deemed to be an anxiety related reactions, unrelated to the suspect product BNT162b2 (COMIRNATY). This case will be re-assessed should additional information becomes available.


VAERS ID: 1816835 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-08
Onset:2021-09-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005289 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.1degree Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Erythema multiforme; This case was received via Pharmaceuticals (Reference number: 2021TJP109043) on 16-Oct-2021 and was forwarded to Moderna on 20-Oct-2021. This case, initially reported to the Agency (A) by a (physician), was received via the A (Ref, v21129478). On an unknown date, body temperature before the vaccination: 36.1 degrees Celsius. On 08-Sep-2021, the patient received the 1st dose of this vaccine. On 16-Sep-2021, skin eruption developed on the extremities, and erythema multiforme was noted. The patient visited a nearby dermatologist and took antihistamines, and betamethasone and d-chlorpheniramine maleate, and topical steroids were used, but the symptom expanded. On 21-Sep-2021, the patient was referred to our department for consultation. On an unknown date, skin eruption tended to improve after the start of oral steroid administration. On 27-Sep-2021, the patient was hospitalized. On 05-Oct-2021, the symptom was resolving, and the patient was discharged from the hospital. The outcome of erythema multiforme was reported as resolving. 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 relationship with this vaccine is suspected from the time of onset.; Sender''s Comments: This case concerns a 37-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Erythema multiforme. The event occurred approximately 9 days after the first dose of COVID 19 Vaccine Moderna. The rechallenge was not applicable as the event occurred after the first dose. The benefit-risk relationship of COVID 19 Vaccine Moderna is not affected by this report.


VAERS ID: 1816854 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 30150BA / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dizziness, Erythema, Nausea, Pruritus, Rash, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC202101359886

Write-up: Erythema/Redness; Pruritus / itching; Dizziness; Nausea; Vomit; Cough; rash; This is a spontaneous report from a non-contactable other hcp. This is a report received from regulatory authority via email. Regulatory authority report number is 17693-10. A 26-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 16Sep2021 (Batch/Lot Number: 30150BA; Expiration Date: 01Nov2021) as DOSE 1, SINGLE for covid-19 immunisation (age at vaccination: 26-year-old). Medical history included Allergy. The patient''s concomitant medications were not reported. The patient was healthy before vaccination with no infectious disease in the last 15 days prior to vaccination and no allergies. In observation 25 minutes after the vaccine, the patient began with Erythema/ Redness, rash, itching/ Pruritus, cough, dizziness, nausea arriving to vomit, she was started medical attention with loratadine tablet, intramuscular diphenylindole hydrocortisone. Patient informed severe allergies which was not commented in triage. The outcome of events was unknown. The case was reported as non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1817008 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: NZPFIZER INC202101363047

Write-up: Herpes zoster, Herpes simplex symptoms that progressed to outbreak of blisters; This is a spontaneous report from a contactable consumer (patient) via the Regulatory authority. Regulatory authority report number is AEFI-A-036138. A 71-years-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 15Sep2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 16Sep2021 at 11:54 PM, the patient experienced herpes simplex symptoms that progressed to outbreak of blisters. Seriousness was reported as medically significant. clinical outcome of the event was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1817436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211048433

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-050289) on 25-OCT-2021 and concerned a 26 year old male of of unknown race and ethnicity. 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, intramuscular, batch number: 21C16-04 expiry: unknown) dose was not reported, 1 total administered on 18-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1817656 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211048353

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-050277) on 25-OCT-2021 concerned a 38 year old female of unspecified race and ethnic origin. 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, intramuscular, batch number: 21C18-03 expiry: unknown) dose was not reported, 1 total administered on 16-AUG-2021 for an unknown indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced severe acute respiratory syndrome coronavirus-2 (sars-cov-2) infection and vaccination failure. Laboratory data included: coronavirus disease-19 polymerase chain reaction (COVID-19 PCR) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product quality complaint.


VAERS ID: 1817739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Haemorrhage, Heavy menstrual bleeding, Menstrual disorder, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361534

Write-up: Haemorrhage; Dysmenorrhoea; Heavy menstrual bleeding; Menstruation irregular; Menstrual disorder; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number is 639202. A 28-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, for covid-19 immunization. Medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced Dysmenorrhoea; Haemorrhage; Heavy menstrual bleeding; Menstrual disorder; Menstruation irregular. The 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: 1818849 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-16
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: CBD OIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to molds (Grass pollen and mold allegy); Anxiety; Pollen allergy (Grass pollen and mold allergy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101373650

Write-up: Bell''''s Palsy - left side of face fully paralyzed for about 1 month; This is a spontaneous report from a contactable consumer (patient). A 28-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 10Jun2021 14:00 (Lot Number: EW0221) (at the age of 28-years-old) as dose 2, single for covid-19 immunisation. Medical history included anxiety and known allergies included grass pollen and mold allergy. Concomitant medications in two weeks included cannabidiol (CBD OIL) taken for an unspecified indication from an unspecified start date and ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 14May2021 14:45 (Lot Number: EW0199) (at the age of 28-years-old) as dose 2, single for covid-19 immunisation. On 16Sep2021 12:00, the patient experienced Bell''s Palsy- left side of face fully paralyzed for about 1 month. It was confirmed by his family doctor and two emergency room doctors. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care visit. The patient received drug treatment with anti-viral and steroid for 1 week for the event. The patient was not hospitalized. The outcome of the event was recovering.


VAERS ID: 1819339 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Immunisation, Nausea, Off label use
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Bloods taken; Result Unstructured Data: Test Result:nil abnormal detected; Comments: Bloods taken after 1 week, nil abnormal detected
CDC Split Type: GBPFIZER INC202101373885

Write-up: Nauseated/Chronic nausea started 24 hrs after vaccine; Off label use; Booster; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority; authority; report number is GB-MHRA-WEBCOVID-202110130945596740-XNJGY, Safety Report Unique Identifier GB-MHRA-ADR 26070311. A 59-year-old female patient received third (booster) dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE8087), via an unspecified route of administration on 16Sep2021 (at age of 59-year-old) at dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Fit and very healthy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient did not take concomitant medications. On 16Sep2021, the patient experienced off label use, booster. On 17Sep2021, nauseated/chronic nausea started 24 hrs after vaccine. Nausea debilitating at times. Antiemetics necessary. Resolved after three weeks. Patient has 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 blood test: nil abnormal detected on an unspecified date (Bloods taken after 1 week, nil abnormal detected). Therapeutic measures were taken as a result of nauseated/chronic nausea started 24 hrs after vaccine. Outcome of event recovered on 06Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1819692 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Bronchospasm, Palpitations, Pruritus, Rash, Urticaria, Wheezing
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: Test Date: 20210916; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101276404

Write-up: wheezing; bronchospasm; itching/ itching on upper limbs and body; urticaria/Wheals/Wheals and itching on upper limbs and body; skin rash; Anaphylaxis; palpitations; This is a spontaneous report from a contactable physician received from the Agency. The regulatory authority report number is v21127778. A 26-year-and-7-month-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: FF9944, Expiration Date: 30Nov2021) via intramuscular at single dose on 16Sep2021 at 10:00 (at the age of 26-years-old) for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade on 16Sep2021. The patient had no medical history, no concomitant medications. No family history. No relevant tests performed. The patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. The patient did not receive other vaccines within four weeks before the vaccination. The patient did not receive any concomitant drugs within two weeks before the vaccination. It was unknown if the patient had allergies to products other than pharmaceuticals such as cosmetics. The first dose was on 19Aug2021 at 10:00 via intramuscular and experienced lip swelling, possible allergy was suspected at 10:00 and delayed allergic reaction at 12:00 (refer to AER 202101290221). The delayed allergic reaction was recovered with no treatment but required visit to physician office. The reporter classified the event as non-serious and assessed that the event was related to BNT162B2 (Reason: reaction strengthened when 2nd dose). On 16Sep2021 at 10:20 (the same day of the vaccination), the patient experienced anaphylaxis. The adverse event required visit to emergency office and physician office. The course of the event was as follows: On 16Sep2021, when the patient received the second vaccination, 20 minutes later, palpitations appeared. No blood pressure decreased. 1 hour later, wheals appeared on 16Sep2021 11:00, steroid hydrocortisone sodium succinate (SOLU-CORTEF) drip received. During the drip, wheezing appeared on 16Sep2021 11:20, after receiving the procaterol hydrochloride (MEPTIN) via inhalation administration, the patient was transported to another hospital emergently. The events did not worsen after transport and improved, so the patient went home. Chronical progression of the event was as follows: 20 minutes later, palpitations appeared. 1 hour later, wheals and itching appeared. 1 hour and 20 minutes later, wheezing appeared. Medical intervention was needed, included corticosteroids, IV fluids and bronchial tube expansion drug. The patient experienced multi-organ disorders (respiratory, dermatological/mucosa), details were as follows: In terms of respiratory symptoms, bilateral wheeze/bronchospasm was observed. Details: wheezing expiratory. In terms of dermatological/mucosal symptoms, generalized pruritus with skin rash was observed. Details: wheals and itching on upper limbs and body. No cardiovascular symptoms, no gastrointestinal symptoms, no other symptoms. The outcome of event anaphylaxis was recovered with no treatment (as reported). The outcome of rest events was recovering. The reporter classified the event anaphylaxis as non-serious and assessed that the event was related to BNT162B2 (reason: reaction was stronger than 1st dose). There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: in terms of situation in which the third dose of vaccination was given, it was considered this would happen when anaphylaxis was aggravated. Even if the third dose was given, general hospital would be ideal. Confirmation was completed by medical institution that events were in according with reporting standards of anaphylaxis. Classification of anaphylaxis (Brighton Classification): Meet Major criteria of "Generalized pruritus with skin rash", "Bilateral wheeze (bronchospasm)" Meet Minor criteria of "Difficulty breathing without wheeze or stridor". Meet Case definition of "Sudden onset", "Rapid progression of signs and symptoms" and "Includes multiple (more than 1) body system manifestations: Level 1:


VAERS ID: 1819982 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005692 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: 36.4 degree Celsius; Test Date: 20210916; Test Name: SpO2; Result Unstructured Data: abnormal
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Regulatory Authority (Reference number: 2021TJP110992) on 19-Oct-2021 and was forwarded to Moderna on 26-Oct-2021. This case, reported by a(physician), was received by Regulatory Authority via Moderna''s adverse reaction reporting site (TASK0022303), and reported to the Regulatory Agency (RA) by a(physician), was received via the RA (Ref, v21129650). Anaphylaxis was assessed as a serious by the health agency. On an unknown date, body temperature before the vaccination: 36.4 degrees Celsius. On 16-Sep-2021, at15:40, the patient received the 1st dose of this vaccination. At 15:46, queasy developed, but vomiting did not occur. At 15:50, anaphylaxis with rapid progression of symptoms suddenly developed. SpO2 decreased to 90%. Mild cyanosis was present, and hyperventilation was not observed. The patient sudden looked pale. The patient lay down on a bed and the patient''s condition was observed. After that, recovery of symptoms was confirmed. The outcome of anaphylaxis was reported as recovered. 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 after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns an 18-year-old male patient, with no information about medical history provided, who experienced the serious expected event of ANAPHYLACTIC REACTION. The event occurred on the same day after receiving the first dose of Spikevax. The rechallenge is not applicable since it is stated on Source document narrative that patient will not be receiving the second dose of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event seriousness was captured as per Regulatory Authority assessment, however there is no evidence suggesting that the reported event met seriousness criteria of medical significance.


VAERS ID: 1820060 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Anxiety, Chest discomfort, Cold sweat, Depressed level of consciousness, Dizziness, Dyspnoea, Epistaxis, Fatigue, Feeling of body temperature change, Flushing, Headache, Lethargy, Menstrual disorder, Myalgia, Nausea, Pallor, Palpitations, Presyncope, Pyrexia, Seizure, Syncope, Tachycardia, Tremor, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101362750

Write-up: Agitation; anxiety; chest discomfort; Depressed level of consciousness; dizziness; Dyspnoea; Epistaxis; Feeling of body temperature change; flushing; headache; lethargy; Menstrual disorder; Myalgia; nausea; palpitations; Presyncope; pyrexia; seizure; Syncope; Tachycardia; tremor; vision blurred; tired; pale; clammy; This is a spontaneous report from a contactable Nurse from the agency. Regulatory authority report number is AEFI-A-031606. A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 16Sep2021 11:05 at 31 years old (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced agitation, anxiety, chest discomfort, depressed level of consciousness, dizziness, dyspnoea, epistaxis, feeling of body temperature change, flushing, headache, lethargy, menstrual disorder, myalgia, nausea, palpitations, presyncope, pyrexia, seizure, syncope, tachycardia, tremor, vision blurred, tired, pale and clammy on 16Sep2021 11:10. Reporter''s description of AEFI: She had a short run of unconscious VT. Vaccine administered elsewhere. Patient called (we are her current registered GP), states she noticed symptoms starting after 5 minutes post vaccination. Decided to eat and drink something which made her feel better. After the 20 minutes post vaccine she was asked if she was feeling ok, told the vaccinator she felt tired, dizzy and nauseous. Was told to go home and sleep it off, however proceeded to becomes more unwell with palpitations etc as mentioned above. Phoned an ambulance which unfortunately was not coded as urgent. Contacted us as her GP, brought down for assessment by family member. She presented pale, clammy, dizzy needed assistance to the bed. No signs of anaphylaxis throughout. Heart ''pounding'' no chest pain, SOB, very anxious, periods of VT and tachycardia which we proceeded to apply defibrillator (fortunately not needing to use). Collected by ambulance for transfer to ED. Still ongoing symptoms currently, 2nd ED presentation 30Sep2021 as still symptomatic. The outcome of the events was recovering. Seriousness was hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820061 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Burning sensation, Chest discomfort, Depressed level of consciousness, Diplopia, Disease recurrence, Dizziness, Dyspnoea, Gait inability, Headache, Lethargy, Muscular weakness, Myasthenia gravis, Myasthenic syndrome, Nausea, Presyncope, Respiratory arrest, Syncope, Throat tightness, Vaccination site pain, Vision blurred, Visual impairment, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Malignancy related conditions (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myasthenia gravis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101362751

Write-up: Abdominal pain; Burning sensation; chest discomfort; Depressed level of consciousness; dizziness; Dyspnoea; headache; injection site pain; lethargy; Muscular weakness; Myasthenic syndrome; nausea; Presyncope; Respiratory arrest; Syncope; Throat tightness; vision blurred; Visual impairment; vomiting; relapse for myasthenia gravies; relapse for myasthenia gravies; double vision; stopped being able to walk; This is a spontaneous report from a contactable consumer (patient) from the Regulatory Authority. Regulatory authority report number is AEFI-A-031616. A 34-year-old female patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on 16Sep2021 (Batch/Lot number was not reported) for covid-19 immunisation at age of 34-year-old. The patient''s medical history included myasthenia gravies. Concomitant medications were not reported. The patient experienced abdominal pain, burning sensation, chest discomfort, depressed level of consciousness, dizziness, dyspnoea, headache, injection site pain, lethargy, muscular weakness, myasthenic syndrome, nausea, presyncope, respiratory arrest, syncope, throat tightness, vision blurred, visual impairment, and vomiting on 16Sep2021 at 14:00 (1 minute after the vaccination). After one minute, the patient experienced double vision, headache, breathing compromised as it become hard to breath. burning in legs and arms and then she stopped being able to walk until the end of the day. Respiratory arrest while in ambulance. It started a relapse for myasthenia gravies. The events reported as serious as hospitalisation. Outcome of the 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: 1820063 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ataxia, Dizziness, Nausea, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101362753

Write-up: Ataxia; dizziness; vertigo; vomiting; nausea; This is a spontaneous report from a contactable consumer from the Medsafe. Regulatory authority report number is AEFI-A-030525. A 31-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced ataxia, dizziness, vertigo, vomiting and nausea on 16Sep2021 21:00. Reporter''s description of AEFI: Severe Vertigo issues and nausea and vomiting last night which started at 2100hrs 16Sep2021. The outcome of the events was not recovered. Seriousness was Medically Significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820084 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Dizziness, Face oedema, Lethargy, Lip swelling, Palpitations, Rash erythematous, Rash pruritic, Swelling, Tachycardia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal allergic conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: NZPFIZER INC202101362775

Write-up: Angioedema; dizziness; Face oedema; lethargy; lip swelling; palpitations; Rash erythematous; Rash pruritic; swelling; Tachycardia; Urticaria; This is a spontaneous report from a contactable consumer via the Regulatory Authority. Regulatory authority report number is AEFI-A-030235. A 31-years-old female patient received first dose of bnt162b2 (COMIRNATY), at the age of 31-years-old via an unspecified route of administration on 16Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced angioedema, dizziness, face oedema, lethargy, lip swelling, palpitations, rash erythematous, rash pruritic, swelling, tachycardia, urticaria (medically significant) on 16Sep2021 14:00. The outcome was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Pelvic venous thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
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: Buttock pain
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: CT chest/abdo/plevis; Result Unstructured Data: Test Result:incidentally found bilateral pulmonary emboli.
CDC Split Type: NZPFIZER INC202101363082

Write-up: Pulmonary embolism; leg common iliac vein thrombosis; This is a spontaneous report from a contactable nurse from the Medsafe. Regulatory authority report number is AEFI-A-034961. A 31-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Sep2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included buttock pain. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolism, leg common iliac vein thrombosis both on 16Sep2021 09:47 with outcome of recovering. The patient underwent lab tests and procedures which included CT chest/abdo/plevis: incidentally found bilateral pulmonary emboli. on 16Sep2021. Therapeutic measures were taken as a result of both events as rivaroxaban for minimum six months, likely lifelong. Clinical details reported as follows: 5/7 history of L) buttock pain before presenting to Hospital on 21Sep2021. Diagnosed same day on 16Sep2021 with L) leg common iliac vein thrombosis. Went forward to CT chest/abdo/plevis on 16Sep2021 which incidentally found bilateral pulmonary emboli. Nil other findings. Commend rivaroxaban for minimum six months, likely lifelong. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820855 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211051080

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050260) on 25-OCT-2021 concerned a 39 year old male. 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, intramuscular, batch number: 21C11-01, expiry: unknown) dose was not reported, 1 total administered on 10-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection. On the same day he underwent laboratory test included: COVID-19 polymerase chain reaction (PCR) test with result positive and had vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1820857 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211051039

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050264) on 25-OCT-2021 and concerned a 33 year old female. 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, intramuscular, batch number: XD975 and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 06-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1820858 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211051812

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050273) on 25-OCT-2021 and concerned an 18 year old male. 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, intramuscular, batch number: 21C16-04 expiry: UNKNOWN) dose was not reported,1 total, administered on 26-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1822234 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-16
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site reaction
SMQs:

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

Write-up: Injection site reaction; This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction) in a 48-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced INJECTION SITE REACTION (Injection site reaction) (seriousness criterion medically significant). At the time of the report, INJECTION SITE REACTION (Injection site reaction) had not resolved. No concomitant medication reported. No treatment medication reported. Company Comment: This case concerns a 48 year-old female patient with no medical history provided, who experienced the unexpected event of Injection site reaction (seriousness criterion medically significant). This event occurred on the same day as the patient received her second dose of mRNA-1273 (COVID-19 Vaccine Moderna).The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation document received on 20-Oct-2021, case narrative and sender''s comment were updated. containing no new information; Reporter''s Comments: The causality is considered possible due to the temporal correlation. The reaction is listed. Sender''s Comments: This case concerns a 48 year-old female patient with no medical history provided, who experienced the unexpected event of Injection site reaction (seriousness criterion medically significant). This event occurred on the same day as the patient received her second dose of mRNA-1273 (COVID-19 Vaccine Moderna).The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.


VAERS ID: 1822716 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
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, Dizziness, Electrocardiogram, Malaise, Palpitations, SARS-CoV-2 test, Syncope, Urine analysis
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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? Yes
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: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:unknown results; Test Name: Chest x ray; Result Unstructured Data: Test Result:unknown results; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Name: Urine test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101400459

Write-up: Palpitations; faint; Lightheaded; Sick; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory Authority report number GB-MHRA-WEBCOVID-202110181717577700-A6N72, Safety Report Unique Identifier GB-MHRA-ADR 26086923. A 23-year-old female patient received the second dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration on 16Sep2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 28Dec2020 to 03Jan2021. On 28Dec2020, the patient underwent COVID-19 virus test and the result was positive. The patient did not have any medical history of illness. The patient was not enrolled in the clinical trial. The patient was not pregnant and was not breastfeeding at the time of this report. On 16Sep2021, the patient was sick. On 21Sep2021, the patient experienced palpitations; the event was reported as serious for disabling. On 21Sep2021, the patient experienced lightheaded and faint. The clinical course reported was as follows: On the second Pfizer vaccine was sick that night. Then 5 days after had heart palpitations and lightheaded/faint. Went to hospital to have tests done. On an unknown date, the patient underwent electrocardiogram (ECG), urine test, chest X-ray and blood tests and the results were unknown. It was reported that patient''s report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient had not tested positive for COVID-19 since the vaccination. The clinical outcome of the event palpitations was not resolved while that of sick, lightheaded and faint was unknown 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: 1822721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-09-16
   Days after vaccination:195
Submitted: 0000-00-00
Entered: 2021-10-27
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, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400384

Write-up: Menstrual flow altered; Last 2 periods heavier than normal with noticeable clots; Last 2 periods heavier than normal with noticeable clots; Pulmonary embolism; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110181848394020-8AABY with Safety Report Unique Identifier of GB-MHRA-ADR 26087381. A 47-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 05Mar2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had her last menstrual period on 18Oct2021. The patient had no 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. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Feb2021 as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced pulmonary embolism and on 16Sep2021, the patient experienced menstrual flow altered; both reported as serious for being medically significant. The clinical course was reported as follows: On an unknown date in 2021, the patient experienced last 2 periods heavier than normal with noticeable clots. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. It was reported that patients report did not relate to possible inflammation of the heart (myocarditis or pericarditis). The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event periods heavier than normal with noticeable clots, menstrual flow altered were not resolved; while for pulmonary embolism was unknown 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: 1822799 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-09-16
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hemiparesis, Ischaemic stroke, Magnetic resonance imaging head
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heavy smoker (HE SMOKES 2 PACKETS OF CIGARETTES PER DAY)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: MRI brain; Result Unstructured Data: Test Result:it showed a recent ischaemic infarct of the left l; Comments: it showed a recent ischaemic infarct of the left lobe
CDC Split Type: GRPFIZER INC202101370231

Write-up: Ischaemic stroke; transient episode of muscle weakness of the right limbs; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-202108563. Sender''s (Case) Safety Report Unique Identifier: GR-GREOF-202108563. A 41-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 09Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Medical history included ongoing Heavy smoker (he smokes 2 packets of cigarettes per day). The patient was a heavy smoker and smokes 2 packets of cigarettes per day. The patient''s concomitant medications were not reported. On 16Sep2021, the patient experienced ischaemic stroke and hemiparesis (right). On 16Sep2021, he presented with a transient episode of muscle weakness of the right limbs. On 20Sep2021, he underwent a brain MRI that showed a recent ischemic infarct of the left lobe. On 26Sep2021, he presented again with right hemiparesis and he was admitted at the Neurological Clinic of a hospital. The patient underwent lab tests and procedures which included MRI Brain (magnetic resonance imaging head): it showed a recent ischaemic infarct of the left lobe on 20Sep2021. Events were considered serious (disability and required hospitalization). Outcome of the events was recovering. No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.


VAERS ID: 1823007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Hyperpyrexia, Malaise, Nasopharyngitis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: hyperpyrexia; Result Unstructured Data: Test Result:40.5 to 42 Centigrade
CDC Split Type: NLPFIZER INC202101364660

Write-up: Fever: 40.5 to 42 degrees Celsius; Not feeling well; Fatigue; nose cold; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00685830. A 15-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot Number: FF2834) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose 1 on 25Aug2021 for COVID-19 immunization and experienced none. The patient experienced common cold, fatigue, malaise, hyperpyrexia (40.5 to 42 degrees Celsius) following administration of covid-19 vaccine Pfizer solution for injection on 16Sep2021. Treatment: Hyperpyrexia is treated with Paracetamol and malaise is treated with Paracetamol. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823008 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chest pain, Fatigue, Hyperpyrexia, Malaise, Nausea, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210918; Test Name: Fever; Result Unstructured Data: Test Result:40.5 to 42 Centigrade
CDC Split Type: NLPFIZER INC202101364142

Write-up: Fever: 40.5 to 42 degrees Celsius inclusive; Nausea; Reaction at or around the injection site: swelling, occurring within one week of vaccination; Reaction at or around the injection site: pain; Pain in the joints; stabbing chest; Inflammatory reaction at the reaction site: heat, pain, swelling, occurring within one week of vaccination; Reaction at or around the injection site: heat; Fatigue; Not feeling well; This is a spontaneous report from a contactable consumer from the regulatory authority number NL-LRB-00686371. A 30-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Sep2021 (Lot Number: FF2834) as single dose (at the age of 30-years-old) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced fever: 40.5 to 42 degrees Celsius inclusive on 18Sep2021, fatigue on 16Sep2021, pain in the joints on 17Sep2021, stabbing chest on 17Sep2021, not feeling well on 16Sep2021, nausea on 18Sep2021, inflammatory reaction at the reaction site: heat, pain, swelling, occurring within one week of vaccination on 17Sep2021. The patient underwent lab tests and procedures which included body temperature: 40.5 to 42 Centigrade on 18Sep2021. Verbatim: This spontaneous report from a consumer or other non-health professional concerns a female aged 30 years, with chest pain, nausea, generalized joint pain, malaise, fatigue, injection site warmth, injection site pain, injection site swelling, injection site inflammation, hyperpyrexia following administration of COVID-19 vaccine Pfizer injection (action taken: not applicable) for COVID 19 immunisation. The patient has not recovered from fatigue, has not recovered from generalized joint pain, has not recovered from injection site inflammation, has not recovered from injection site pain, has not recovered from injection site swelling, has not recovered from injection site warmth, has not recovered from malaise, has not recovered from nausea, is recovering from chest pain and is recovering from hyperpyrexia. Drugs and latency: 1. covid-19 vaccine pfizer injection: malaise, fatigue: within 1 day, injection site warmth, chest pain, generalized joint pain, injection site pain, injection site swelling, injection site inflammation: 1 days after start, hyperpyrexia, nausea: 2 days after start Sender Diagnosis: Injection site inflammation Case Summary and Reporter Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Redness or Swelling. Extensive swelling of vaccinated limb: no. Stinging chest: Additional information ADR: At rest several times a day. Citizen service number available: yes. COVID19 Previous COVID-19 infection: No No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Redness or Swelling. Extensive swelling of vaccinated limb: no. Stinging chest: Additional information ADR: At rest several times a day. Citizen service number available: yes. COVID19 Previous COVID-19 infection: No


VAERS ID: 1823060 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Headache, Heart rate irregular, Malaise, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Unwell; Arrhythmic heartbeat; Stomach ache; Pain in arm; pain and pressure in the chest.; pain and pressure in the chest.; Pain in the body; Nausea; Headache; Fever; This case was received via Agency Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00055517) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE (Unwell) in a 26-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In 2021, the patient experienced HEART RATE IRREGULAR (Arrhythmic heartbeat), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Pain in arm), CHEST DISCOMFORT (pain and pressure in the chest.), CHEST PAIN (pain and pressure in the chest.), PAIN (Pain in the body), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). On 16-Sep-2021, the patient experienced MALAISE (Unwell) (seriousness criterion hospitalization). At the time of the report, MALAISE (Unwell), HEART RATE IRREGULAR (Arrhythmic heartbeat), ABDOMINAL PAIN UPPER (Stomach ache), PAIN IN EXTREMITY (Pain in arm), CHEST DISCOMFORT (pain and pressure in the chest.), CHEST PAIN (pain and pressure in the chest.), PAIN (Pain in the body), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. Concomitant medication information was not provided by reporter. Treatment medication information was not provided by reporter. The patient reported that the latency of Unwell was 8 hours, and then got unwell again 11 days later. Very limited information regarding these events has been provided at this time. Events seriousness was assessed as per Regulatory Authority reporting This case concerns a 26 year old female patient with no relevant medical history,who experienced the serious unexpected event of Malaise. The event occurred on the same days after second dose of Spikevax. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per RA from Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Translation document received include event verbatim translated .; Sender''s Comments: This case concerns a 26 year old female patient with no relevant medical history,who experienced the serious unexpected event of Malaise. The event occurred on the same days after second dose of Spikevax. The rechallenge was not applicable as the outcome of the events is unknown. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per RA from Regulatory Authority reporting.


VAERS ID: 1824099 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-16
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Perimyocardite; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Perimyocardite) in a 29-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for SARS-CoV-2 immunisation. The patient''s past medical history included Smoker (Smoking). On 07-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MYOCARDITIS (Perimyocardite) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Perimyocardite) was resolving. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDITIS (Perimyocardite) to be probably related. Patient underwent Troponin T, Creatine kinase, C reactive protein lab test on 18-Sep-2021 and Troponin T and Creatine kinase (CK) lab test on 21-Sep -021 and results were unknown. On 16-Sep-2021, patient experienced severe asthenia and on 17-Sep-2021, he had a central thoracic pain with breathing difficulties. He also reported Odynodysphagia with submandibular adenopathy (side unknown). On 19-Sep-21, Patient was seen in Emergency room, hypotensive (103/61 mmHg). Patient had ECG with a regular sinus rhythm, with slightly descending PR in DII. Laboratory data also included an inflammatory syndrome (CRP 100 mg/L, norm <5 mg/L) and a slight increase in troponins (troponin THS 35 ng/L, norm <14 ng/L) with CK in the norm (CK 46 u/l, norm <190 U/L). Serology and PCR for SARS-Cov-2 on admission were negative. The trans-thoracic echocardiography showed a preserved LVEF of 60 percent. Patient was presented with syncope with asystole of 30 seconds monitored in the immediate aftermath of an injection of enoxaparin (Clexane). A vaso-vagal aetiology of the syncope was concluded. On 18-Sep-2021 patient was treated with a-inflammatory Aspegic and paracetamol (Dafalgan). Patient was discharged on 21-Sep-2021. On 24-Sep-2021 the patient experienced the persistence of mild chest pain on exertion without associated dyspnea. Patient''s current condition included tobacco user (active smoker). No relevant concomitant medications were reported. Company Comment :This case concerns a 29 year old male with no relevant history who experienced the serious, listed AESI of Myocarditis 9 days after dose 1 of mRNA-1273. Re-challenge is unknown as no information about dose 2 is provided. Benefit-risk relationship of mRNQ-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Translation document received on 25-OCT-2021. Current condition, lab data, dosage text, events and symptoms details and treatment detail are updated in case narrative.; Reporter''s Comments: The patient developed perimyocarditis 9 days after administration of the Moderna COVID-19 Vaccine. The occurrence of pericarditis as an adverse event is not described in the MODERNA COVID-19 vaccine monograph, however, Regulatory Authority evaluated all the available data in August 2021 and recognised a causal association between mRNA COVID-19 vaccines (including the Moderna COVID-19 vaccine) and myocarditis and pericarditis. As a result of this, a supplement to the patient information leaflet to include pericarditis and myocarditis as possible side effects is expected to be published soon in the Moderna patient information leaflet. By July 2021, the Regulatory Authorities had received 40 reports of myocarditis and/or pericarditis related to Covid-19 vaccines while 5.7 million doses of the Moderna COVID-19 Vaccine and 2.9 million doses of the Comirnaty vaccine had been administered. The number of cases of pericarditis/myocarditis is likely to be higher, as some cases are not diagnosed and only some of these are reported to the health authorities. Cases of post-mRNA vaccine myocarditis and pericarditis occur most often a few days after the second dose in young men. The progression is mostly favourable and similar to pericarditis of other aetiologies. In view of the above, the causality of the Moderna? vaccine in the occurrence of this patient''s pericarditis is therefore considered probable; Sender''s Comments: This case concerns a 29 year old male with no relevant history who experienced the serious, listed AESI of Myocarditis 9 days after dose 1 of mRNA-1273. Re-challenge is unknown as no information about dose 2 is provided. Benefit-risk relationship of mRNQ-1273 is not affected by this report.


VAERS ID: 1824902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211056199

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050350) on 28-OCT-2021 concerned a 22 year old male. 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, intramuscular, batch number: 21C16-04 expiry: UNKNOWN) dose was not reported,1 total, administered on 17-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1824904 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211056702

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-050385) on 28-OCT-2021 and concerned a 33 year old female. 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, intramuscular, batch number: XD955 expiry: unknown) dose was not reported, 1 total, administered on 22-JUN-2021 for product used for unknown indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection. Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1824905 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211054694

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (AT-BASGAGES-2021-050664) on 27-OCT-2021 and concerned a 23 year old male. 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, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 05-JUL-2021 for product use for unknown indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-COV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1826341 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-09-16
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Herpes zoster, Papilloedema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Optic nerve disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101379359

Write-up: Papilloedema; headache; fever; Herpes zoster/shingles; This is a spontaneous report from a contactable Consumer or other non HCP downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-TO20218466. A 13-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 13Jul2021 (Batch/Lot Number: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included covid-19. The patient''s concomitant medications were not reported. On 16Sep2021 the patient experienced intense headache and fever, herpes zoster; On 23Sep2021 the patient experienced shingles. On unspecified date, the patient experienced papilledema. He was put on Diamox for papilledema. The outcome of events was recovering. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1826510 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Haemorrhage, Heavy menstrual bleeding
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101380814

Write-up: Bleeding; pains in lower abdominal area; Heavier menstrual; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110141618124730-ADFCX, Safety Report Unique Identifier GB-MHRA-ADR 26078394. A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number were not reported), dose 1 via an unspecified route of administration on 15Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient had prolonged menstrual bleeding that still continues 30 days after vaccination. Heavier than usual including pains in lower abdominal area. On 16Sep2021, the patient experienced bleeding, on an unspecified date in 2021, pains in lower abdominal area, heavier menstrual. The event bleeding assessed as serious (medically significant). The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of the event bleeding was not recovered, pains in lower abdominal area, heavier menstrual was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1826559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (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; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400458

Write-up: Worsening of tinnitus, Tinnitus; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202110161754118480-XZTUV, Safety Report Unique Identifier GB-MHRA-ADR 26085061. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 15Sep2021, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. On an unknown date, the patient experienced tinnitus; on 16Sep2021, the patient experienced worsening of tinnitus; both the events were reported as serious for being medically significant. It was reported that within few hours of receiving second vaccine, the tinnitus had become noticeably worse and had continued to be so. 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 tinnitus was unknown whereas that of the event worsening of tinnitus was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826808 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Erythema, Headache, Malaise, Nausea, Pruritus, Pruritus genital, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthropod bite; Generalised urticaria; Swelling
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101376214

Write-up: Itching in the genital area; feeling queasy; Vomiting; neck redness; neck itching/Itching in Armpit and other places; headache; malaise; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority report number is v21129351. A 46-year and 4-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FF2782; Expiration Date: 30Nov2021), via an unspecified route of administration on 16Sep2021 at 14:00 (the day of vaccination, at the age of 46-year and 4-month-old), as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees Centigrade on 16Sep2021. The patient had a medical history of bitten by bees, generalized urticaria occurred and bubble swollen. The patient''s concomitant medications were not reported. On 16Sep2021 at 14:00 (same day of the vaccination), the patient experienced reported events. On an unspecified date, the outcome of the event was recovering. The course of the event was as follows: On 16Sep2021 14:20 (20 minutes after the vaccination), the patient experienced neck redness and itching, vomiting, headache and malaise occurred. 30 minutes later, antiallergics orally taken. Next day, the patient visited the hospital again for examination. Itching in the genital area and Armpit and other places. Headache, feeling queasy continued but on the next day, symptoms slightly improved. The reporting other HCP classified the event as serious (applied for a medical center for help and received an answer of not being able to offer help.) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible causes of the event such as any other diseases was reported as unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1827045 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: SARS-CoV-2; Test Result: Positive.
CDC Split Type: PTPFIZER INC202101398707

Write-up: Drug ineffective; COVID19; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority, regulatory authority number PT-INFARMED-T202110-72. A 94-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EL0725, Expiration date: unknown), via intramuscular, administered at an unspecified anatomical location on 10Feb2021 as dose 2, 0.3 mL, single for COVID-19 immunization and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via intramuscular, administered at an unspecified anatomical location on an unspecified date as dose 1, 0.3 mL, single for COVID-19 immunization. The patient''s medical history was unknown. Concomitant medications were reported as none. On 16Sep2021, the patient experienced drug ineffective and covid-19. The adverse reaction was detected by a PCR test for SARS-CoV 2 about seven months after the second dose of the vaccine. The infection by SARS-CoV 2 was symptomatic (exhaustion, shortness of breath, oxygen saturation decreased) that''s why patient had to be hospitalized. Suspect product was not withdrawn. The vaccination scheme was completed with the two doses as it was expected. days after the second inoculation, lasting 10 days. According to the notifier, the patient is asymptomatic and without associated comorbidities. There is no suspicion of drug interactions. It also mentions that the patient has no previous reactions to other drugs, or identified allergies. The patient underwent lab tests and procedures which included sars-cov-2 test which showed positive result in Sep2021. It was unknown if patient received any treatment for the infection. The outcome of the event covid-19 was unknown. The reporter''s assessment of the causal relationship of the [Drug ineffective] with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible.Health authority comment- Other information: Oxygen saturation decreased, Patient required hospitalization and PCR remains positive.No follow-up attempts are possible. No further information is expected.


VAERS ID: 1828078 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-09-16
   Days after vaccination:231
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       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: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via Regulatory Authority (Reference number: AT-BASGAGES-2021-050308) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 300042721 and 300042698) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Treatment informations were reported. Concomitant medication not provided. Company Comment: This case concerns a 45-year-old, male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred approximately 6 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translation document received on 25 Oct 2021 included dosage text.; Sender''s Comments: This case concerns a 45-year-old, male patient with no relevant medical history, who experienced the unexpected events of COVID-19 and Vaccination failure. The events occurred approximately 203 days after administration of the second dose of the Spikevax. The rechallenge is not applicable as the AEs occurred after the second dose. Very limited information regarding clinical course of the events has been provided at this time. The benefit-risk relationship of the Spikevax is not affected by this report.


VAERS ID: 1828129 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-09-16
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214013 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Extrasystole ventricular; Familial hyperlipidemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Tachycardia; This case was received via European Medicines Agency (Reference number: ES-AEMPS-1028613) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 3005703 and 214013) for COVID-19 vaccination. Concurrent medical conditions included Familial hyperlipidemia and Extrasystole ventricular since 03-Sep-2019. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Tachycardia) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 03-Aug-2021. Concomitant medication were not provided. Treatment information was not provided. Company Comment - This case concerns a 34 year old patient of an unknown gender with relevant medical history of Extrasystole ventricular and Familial hyperlipidemia, who experienced the serious unexpected event of Tachycardia. The event occurred 17 days after second dose of Spikevax .The rechallenge was not applicable.mRNA-1273 (Spikevax) was reported withdrawn .The medical history of Extrasystole ventricular and Familial hyperlipidemia remains as confounders. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translated document received on 25-Oct-2021 includes dosage text updated.; Sender''s Comments: This case concerns a 34 year old patient of an unknown gender with relevant medical history of Extrasystole ventricular and Familial hyperlipidemia,who experienced the serious unexpected event of Tachycardia.The event occurred 17 days after second dose of Spikevax .The rechallenge was not applicable.mRNA-1273 (Spikevax) was reported withdrawn .The medical history of Extrasystole ventricular and Familial hyperlipidemia remains as confounders.The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1828269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211056198

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050326) on 28-OCT-2021 and concerned a 38 year old male. 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, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total, first dose was administered on 08-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.


VAERS ID: 1828291 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension arterial; Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: CHMODERNATX, INC.MOD20213

Write-up: Flu-like symptoms; This regulatory authority case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 72-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 pneumonia in October 2020. Concurrent medical conditions included Diabetes mellitus, Hypothyroidism and Hypertension arterial. On 16-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms) (seriousness criterion hospitalization). On 18-Sep-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu-like symptoms) to be probably related. Patient had type II diabetes, substituted hypothyroidism, arterial hypertension, atrial fibrillation, morbid obesity and walking disorders of multifactorial origin. Her usual treatment was Meto Zerok retard 50 mg per day, Torasemide 10 mg per day, Allopur 300 mg per day, Euthyrox 75 mcg per day, Tramadol- Paracetamol-Mepha 75/650 mg 3x per day, Jardiance Met 5/1000 mg per day, folic acid 5 mg per day, Calcimagon D3 Forte 1 tablet per day. She received her first dose on 16 Sep 2021. Few hours after she developed severe asthenia, a feverish state measured at 39.5?C, myalgia and headaches. As the patient was no longer able to move around, she was transferred to the emergency room the same day. On 16 Sep 2021 patient had undergone tests like C-reactive protein, Leucocyte count, Creatinine and chest x-ray admission. On admission an inflammatory syndrome was indicated with CRP of 101 mg/L and standard value was reported less than 5 mg/L as well as a slight increase in creatinine of 93 mcmol/L was reported. She had undergone chest x-ray and it didn''t show any focus. Leucocyte count result was unknown. The fever subsided on 17 Sep 2021, and all symptoms resolved spontaneously on 18 Sep 2021. Biologically, the inflammatory syndrome disappeared, and serum creatinine returned to normal. With regular physiotherapy exercises, the patient regained her former mobility and left hospital to return home on 22 Sep 2021. To date she has mentioned the persistence of slight asthenia. On 22 Sep 2021 she had undergone C-reactive protein test and its result was also unknown. Company comment- This case refers to a 72-year-old female patient with no relevant medical history who experienced the unexpected event of Influenza Like Illness on the same day after receiving the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Translation document received on 22 Oct 2021, senders comment was added.; Reporter''s Comments: Systemic influenza-like reactions are described in the Moderna COVID-19 vaccine monograph [1]. Symptoms/signs resolve spontaneously usually within 1?3 days. Women are slightly more affected than men. These reactions tend to be more frequent in people who have had a COVID-19 infection, even a while after the infection. One study shows a slight increase in the risk of hospitalisation [2-4]. In view of the temporal relationship and the absence of any other cause, the involvement of the Moderna COVID-19 vaccine is considered highly probable in this case. The patient''s co-morbidities (morbid obesity, multifactorial walking disorders) very probably played a role in the severity of the functional impact and the indication for short hospitalization.; Sender''s Comments: This case refers to a 72-year-old female patient with no relevant medical history who experienced the unexpected event of Influenza Like Illness on the same day after receiving the first dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable. The event was considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1828384 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-16
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Dyspnoea, Hypoaesthesia, Palpitations
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Sexual dysfunction (broad)

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

Write-up: HEART PAIN; PALPITATIONS; NUMB ARMS; SHORTNESS OF BREATH; This case was received via Regulatory Authority (Reference number: SE-MPA-2021-089348) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (HEART PAIN), PALPITATIONS (PALPITATIONS), HYPOAESTHESIA (NUMB ARMS) and DYSPNOEA (SHORTNESS OF BREATH) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Arm injury in 2016 and Wrist surgery. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced ANGINA PECTORIS (HEART PAIN) (seriousness criteria medically significant and life threatening), PALPITATIONS (PALPITATIONS) (seriousness criterion life threatening), HYPOAESTHESIA (NUMB ARMS) (seriousness criterion life threatening) and DYSPNOEA (SHORTNESS OF BREATH) (seriousness criterion life threatening). On 29-Sep-2021, ANGINA PECTORIS (HEART PAIN), PALPITATIONS (PALPITATIONS), HYPOAESTHESIA (NUMB ARMS) and DYSPNOEA (SHORTNESS OF BREATH) had resolved with sequelae. The concomitant medications were not reported. The treatment information was not provided. Company comment: This case concerns a 28-year-old male patient with a history of arm injury and wrist surgery, who experienced the unexpected, serious (life threatening) events of angina pectoris, palpitations, hypoaesthesia and dyspnoea. The event occurred approximately 51 days after the first dose of mRNA-1273 and 6 days after the second dose of mRNA-1273. The rechallenge was not applicable. The medical history of arm injury and wrist surgery is a confounder for hypoaesthesia. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translated document received on 26 oct 2021 includes Pharmaceutical dosage form updated and event verbatim translated.; Sender''s Comments: This case concerns a 28-year-old male patient with a history of arm injury and wrist surgery, who experienced the unexpected, serious (life threatening) events of angina pectoris, palpitations, hypoaesthesia and dyspnoea. The event occurred approximately 51 days after the first dose of mRNA-1273 and 6 days after the second dose of mRNA-1273. The rechallenge was not applicable. The medical history of arm injury and wrist surgery is a confounder for hypoaesthesia. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1828557 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211057277

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a regulatory authority (regulatory authority, AT-BASGAGES-2021-050338) on 28-OCT-2021 and concerned a 40 year old male. 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, intramuscular, batch number: XD985 expiry: unknown) dose was not reported,1 total administered on 05-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case was associated with product complaint.


VAERS ID: 1828558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211057608

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050371) on 28-OCT-2021 and concerned a 24 year old female. 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, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and SARS-COV-2 (severe acute respiratory syndrome coronavirus 2) infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-COV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This spontaneous report received from a physician by a Business partner (regulatory authority, AT-BASGAGES-2021-050371) on 28-OCT-2021 was received on 28-OCT-2021 and concerned a 24 year old female. 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, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure. On 16-SEP-2021, the patient experienced sars-cov-2 infection. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1828560 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211057725

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050380) on 28-OCT-2021 and concerned a 33 year old male. 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, intramuscular, batch number: XD974 expiry: unknown) dose was not reported, 1 total, administered on 10-JUL-2021 for product used for unknown indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced vaccination failure and SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection. Laboratory data included: COVID-19 PCR (polymerase chain reaction) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and SARS-CoV-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1828561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211056859

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-050381) on 28-OCT-2021 and concerned a 40 year old male. 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, intramuscular, batch number: 21C10-03 expiry: Unknown) dose was not reported, 1 total, administered on 28-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient experienced Severe acute respiratory syndrome-coronavirus 2 (Sars-Cov-2) infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and Sars-Cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1828562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-16
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 20210916; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211057734

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via regulatory authority (regulatory authority, AT-BASGAGES-2021-050411) on 28-OCT-2021 and concerned a 20 year old female. 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, intramuscular, batch number: XD985 expiry: unknown) dose was not reported,1 total administered on 01-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 16-SEP-2021, the patient underwent Covid-19 polymerase chain reaction test (PCR), and was tested positive for severe acute respiratory syndrome coronavirus -2 (Sars-cov-2 infection) (vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1829566 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-09-16
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101384318

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-058905. A 44-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection with Lot Number: FD6840), via intramuscular route on 24Jun2021 as dose 2 single and via intramuscular route (Batch/Lot Number: FC0681) on 22May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had vaccination failure and sars-cov-2 infection on 16Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test as positive on 16Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. The events were assessed as serious (medically significant). The events outcome was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1829739 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-22
Onset:2021-09-16
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002183 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, 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:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: COVID-19; Vaccination failure; This case was received via the RA (Reference number: DE-PEI-202100207445) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) in a 59-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3003183 and 3002183) for Prophylactic vaccination. No Medical History information was reported. On 22-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 03-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) and VACCINATION FAILURE (Vaccination failure) had not resolved. No concomitant medications were reported. Treatment information was not provided. The patient initial was reported as M-S. PCR evidence on 16 Sep 2021 showed positive results. CT values were reported as 22.0/22.4. The symptoms reported included fever, limb pain, loss of smell and taste, and runny nose affecting bronchi. Company comment:This case concerns a 59 year-old female patient with no reported medical history who experienced the unexpected event of COVID-19 and vaccination failure. The events occurred approximately 2 months, 14 days after the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. The event of vaccination failure does not meet criteria for coding as the two doses were administered 43 days apart; seriousness assessed as per Regulatory Authority reporting. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 25 Oct 2021 and narrative was updated with translated information from senders comment.; Sender''s Comments: This case concerns a 59 year-old female patient with no reported medical history who experienced the unexpected event of COVID-19 and vaccination failure. The events occurred approximately 2 months, 14 days after the second dose of mRNA-1273 (Spikevax). The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. The event of vaccination failure does not meet criteria for coding as the two doses were administered 43 days apart; seriousness assessed as per Regulatory Authority reporting.


VAERS ID: 1830382 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Blood pressure increased, Blood pressure measurement, Body temperature, Fall, Feeling abnormal, Malaise, Presyncope
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Accidents and injuries (narrow), Hypertension (narrow), 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: Obesity
Allergies:
Diagnostic Lab Data: Test Name: Sugar blood; Result Unstructured Data: Test Result:162; Comments: m/dl; Test Name: Blood pressure; Result Unstructured Data: Test Result:162/111 mmHg; Test Date: 20210916; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101228385

Write-up: blood pressure increased to 162/111 mmHg; Vasovagal reaction; felt bad; sugar blood 162 was m/dl; felt bad; fell down; This is a spontaneous report from a contactable physician received through the regulatory authority: Regulatory authority report number v21127096. A 35-year-old adult female received the first dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot FH0151 expiry 31Dec2021) as a single dose on 16Sep2021 at 15:43 (at 35-years-old; the day of vaccination) for COVID-19 immunisation. Body temperature before vaccination was 35.8 degrees Centigrade. Relevant medical history included obesity. The patient had no family history. 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, etc.). There were no concomitant medications reported. On 16Sep2021 at about 15:43 it was noted that the patient fell down and at 15:58 the patient felt bad, blood sugar was 162 m/dl, blood pressure increased to 162/111 mmHg and the patient experienced vasovagal reaction. The reporter described the course of events as follows: At about 15:43, it was noticed that patient fell down. The patient also felt bad, blood pressure was 162/111 mmHg. Blood sugar was 162m/dl. There was no arrhythmia. Rest in bed for 30-40 minutes and went home after that. The outcome of the events fell down, felt bad, blood sugar was 162 m/dl, blood pressure increased to 162/111 mmHg and vasovagal reaction was recovered on 16Sep2021 (the day of the vaccination). The reporting physician has assessed that the causality between the events and BNT162B2 as unrelated. There was no other possible cause of the event such as any other diseases. The reporting physician commented: The blood sugar was high and there was obesity. Went home by advice from local doctor visit. (Now was in losing weight). Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on available information and a possible contributory role of suspect product BNT162B2 to the development of events BP increased, presyncope, fall, feeling abnormal, blood glucose increased and malaise cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1832453 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-09-16
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Coordination abnormal, Fatigue, Flashback, Headache, Hyperpyrexia, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MAALOX [ALGELDRATE;MAGNESIUM HYDROXIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: hyperpyrexia; Result Unstructured Data: Fever: 40.5 through 42 degrees Celsius
CDC Split Type: NLMODERNATX, INC.MOD20213

Write-up: Fever: 40.5 through 42 degrees Celsius; Feeling unwell; Anger and sadness from the past stirred up. Nightlong PTSS flashbacks. Was stable. Had it only one night. I think the 40.5 fever caused it; Bad motor function and coordination; Fatigue; Joint pain; Chills; Muscle pain; Nausea; Headache; This case was received via regulatory authority(Reference number: NL-LRB-00686600) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA (Fever: 40.5 through 42 degrees Celsius) in a 57-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004493) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 on 14-Jul-2020. Concomitant products included ALGELDRATE, MAGNESIUM HYDROXIDE (MAALOX [ALGELDRATE;MAGNESIUM HYDROXIDE]) for an unknown indication. On 13-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced HYPERPYREXIA (Fever: 40.5 through 42 degrees Celsius) (seriousness criterion medically significant), MALAISE (Feeling unwell), FLASHBACK (Anger and sadness from the past stirred up. Nightlong PTSS flashbacks. Was stable. Had it only one night. I think the 40.5 fever caused it), COORDINATION ABNORMAL (Bad motor function and coordination), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), CHILLS (Chills), MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache). On 17-Sep-2021, NAUSEA (Nausea) had resolved. On 18-Sep-2021, FLASHBACK (Anger and sadness from the past stirred up. Nightlong PTSS flashbacks. Was stable. Had it only one night. I think the 40.5 fever caused it), COORDINATION ABNORMAL (Bad motor function and coordination) and HEADACHE (Headache) had resolved. At the time of the report, HYPERPYREXIA (Fever: 40.5 through 42 degrees Celsius), MALAISE (Feeling unwell), ARTHRALGIA (Joint pain), CHILLS (Chills) and MYALGIA (Muscle pain) was resolving and FATIGUE (Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, Hyperpyrexia: 40.5-42 (High) Fever: 40.5 through 42 degrees Celsius. No treatment medication was provided. company comment: This is a regulatory case concerning a 57-year-old, male patient with no relevant history reported, who experienced the unexpected serious event of hyperpyrexia. The event occurred approximately 2 month and 4 days after the 2nd dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable. This is also a case of "innapropriate schedule of product administration" The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translation received on 25-OCT-2021 contain significant information that include lab data updated Concomitant product of dosage text updated and All event of Description as Reported updated.; Sender''s Comments: This is a regulatory case concerning a 57-year-old, male patient with no relevant history reported, who experienced the unexpected serious event of hyperpyrexia. The event occurred approximately 2 month and 4 days after the 2nd dose of mRNA-1273 Moderna vaccine. The rechallenge was not applicable. This is also a case of "innapropriate schedule of product administration" The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1832521 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-16
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Limb injury, SARS-CoV-2 test
SMQs:, Accidents and injuries (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: Shoulder injury; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 26091162) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LIMB INJURY (Shoulder injury) in a 40-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced LIMB INJURY (Shoulder injury) (seriousness criterion medically significant). At the time of the report, LIMB INJURY (Shoulder injury) 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. No concomitant medications reported by reporter. Patient was normal sore arm hours after vaccine. Patient was experienced neck and shoulder pain after 48 hours. Patient was unable to turn neck to the left and painful to move shoulder. Pain was radiate down arm and hand. Tingling in hand and weakness in shoulder and arm. No treatment medications provided by the reporter. Company comment This case concerns a 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of limb injury, neck pain paresthesia and inappropriate schedule of product administration. The events occurred approximately 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. 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 40-year-old, female patient with no relevant medical history, who experienced the unexpected event of limb injury, neck pain paresthesia and inappropriate schedule of product administration. The events occurred approximately 2 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. 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: 1832787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-09-16
   Days after vaccination:230
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101391499

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority AT-BASGAGES-2021-050117. A 49-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29Jan2021 (Lot Number: EJ6136) as Dose 2, single, dose 1 intramuscular on 08Jan2021 (Lot Number: EJ6796) as Dose 1, single for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Variant PCR-based: B.1.617.2; Sequenced variant: n501y-positive: No) on 16Sep2021. Seriousness criteria reported as medical significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1832794 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-09-16
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101391553

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority AT-BASGAGES-2021-050134. This is master case - first of two cases. A 40-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 17Jun2021 (Lot Number: FD4555), dose 1 intramuscular on 06May2021 (Batch/Lot Number: Unknown) both as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced sars-cov-2 infection, vaccination failure (medically significant) on 16Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 (Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No). The outcome was unknown. No follow-up attempts are possible; information about lot/batch number of 1st dose cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101406376 same patient, different event


VAERS ID: 1832815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-16
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101391732

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority AT-BASGAGES-2021-050301. A 25-year-old female patient received BNT162B2, dose 2 intramuscular on 07Aug2021 (Lot Number: FE8244) at singe dose, dose 1 intramuscular on 03Jul2021 (Lot Number: FD4555) at single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests included COVID-19 PCR test: positive on 16Sep2021. The outcome of events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1832816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-09-16
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 nothing differentiated Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101391733

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-050302. A 51-years-old female patient received bnt162b2 (COMIRNATY), via intramuscular, the first dose on 20May2021 (Batch/Lot Number: FC068) and the second dose on 01Jul2021 (Batch/Lot Number: FD6840), both as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced sars-cov-2 infection on 16Sep2021, vaccination failure (as reported) on 16Sep2021. The events were reported as serious due to medically significant. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617 nothing differentiated, Variant Sequenced: n501y-positive: No). The outcome of the events was unknown. No follow-up attempts are possible, no information is expected.; Sender''s Comments: Linked Report(s) : AT-PFIZER INC-202101407258 same patient and drug, different events


VAERS ID: 1832817 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-09-16
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101391736

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-050303. A 20-year-old male patient received the first dose of bnt162b2 (COMIRNATY) on 19Jul2021 (lot number: FE6208) Intramuscularly at single dose; the second dose of bnt162b2 (COMIRNATY) on 09Aug2021 (lot number: FE8244) Intramuscularly at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. Lab data included: COVID-19 PCR test on 16Sep2021: positive, Variant PCR-based: Sequenced variant: n501y-positive: Unknown. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1832819 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-09-16
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101391737

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050305. A 52-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Jun2021 (Batch/Lot Number: FD4555) as dose 2, single; dose 1 intramuscular on 01Jun2021 (Batch/Lot Number: FC2473) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021 (Variant PCR-based: B.1.617.2. Variant Sequenced: . n501y positive: No). The patient''s outcome was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1832820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-09-16
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101391739

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority [AT-BASGAGES-2021-050307]. A 73-year-old female patient received BNT162B2 (COMIRNATY Solution for injection; lot number: EW4815 and expiration date: not reported), via intramuscular on 23Apr2021, as dose 1, single then BNT162B2 (COMIRNATY Solution for injection; lot number: EY7015 and expiration date: not reported), via intramuscular on 14May2021, as dose 2, single both for covid-19 immunization. Relevant medical history reported as none. No concomitant medication was reported. The patient experienced vaccination failure and sars-cov-2 infection on 16Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. The outcome of the events was unknown at time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1832821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-09-16
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101394577

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number AT-BASGAGES-2021-050311. A 44-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 11Jul2021 (Batch/Lot Number: FE6208) as single dose, first dose of bnt162b2 (COMIRNATY) intramuscular on 06Jun2021 (Batch/Lot Number: FD1921) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test on 16Sep2021: positive, Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No. The outcome of the events was unknown. The report was serious with the criteria of medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1832822 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-09-16
   Days after vaccination:223
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101394584

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050314. An 87-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 05Feb2021 (Batch/Lot Number: EK9788) as single dose, first dose of bnt162b2 (COMIRNATY) intramuscular on 15Jan2021 (Batch/Lot Number: EJ6796) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test on 16Sep2021: positive, Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No. The outcome of the events was unknown. The report was serious with the criteria of medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1832823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-09-16
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET 7205 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No
CDC Split Type: ATPFIZER INC202101395005

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from a Regulatory Authority, regulatory authority number AT-BASGAGES-2021-050317. An 81-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 30Mar2021 (Batch/Lot Number: ET 7205) as single dose, first dose of bnt162b2 (COMIRNATY) intramuscular on 09Mar2021 (Batch/Lot Number: ET1831) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test on 16Sep2021: positive, Variant PCR-based: B.1.617.2, Sequenced variant: n501y-positive: No. The outcome of the events was unknown. The report was serious with the criteria of medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1834362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-09-16
   Days after vaccination:125
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Diabetes; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210923; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101384636

Write-up: COVID-19; Drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority EE-SAM-527921092831. A 72-years-old male patient received bnt162b2 (Solution for injection) via intramuscular route of administration on 14May2021 (Batch/Lot Number: EW6126; Expiration Date: 31Jul2021) as dose 2, 0.3 ml single, and via intramuscular route of administration on 01Apr2021 (Batch/Lot Number: ER9480; Expiration Date: 31Jul2021) as dose 1, 0.3 ml single for both taken COVID-19 immunisation. Medical history included ongoing hypertension, ongoing atrial fibrillation, ongoing diabetes and concomitant medications were not reported. On 16Sep 2021, the patient developed COVID infection and Drug Ineffective. The course of the disease was severe, the patient was hospitalized between 24Sep2021 and 29Sep2021. Treatment for event included oxygen therapy. The patient underwent lab test and procedure which included SARS-CoV-2 PCR test: positive on 23Sep2021. The patient recovered from event COVID infection and was discharged home on 29Sep2021. Product Quality Complaints Conclusion included: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type.The final scope was determined to be the associated lot(s) of the reported lot ER9480. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Regulatory Authority concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type.The final scope was determined to be the associated lot(s) of the reported lot EW6126. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Regulatory Authority concluded that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Sender Comment: Serious vaccine ineffectiveness report. The causal relationship is considered possible. Follow-up attempts are possible. No further information is expected. ; Sender''s Comments: Linked Report(s) : EE-PFIZER INC-202101415744 Same patient/2nd dose/LOE


VAERS ID: 1834495 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9428 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Ischaemic stroke, Magnetic resonance imaging head
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease coronary artery (Stented coronary artery disease site)
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: celebral MRI; Result Unstructured Data: Test Result:ischemic stroke; Comments: aspect compatible with a range of recent ischemic stroke less than 4 hours, deep right territory.
CDC Split Type: FRPFIZER INC202101391564

Write-up: Ischemic stroke; booster; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-LY202111877. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 16Sep2021 (Lot Number: FG9428) as dose 3 (booster), single for covid-19 immunisation. Medical history included Disease coronary artery (Stented coronary artery disease site). The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 08Feb2021 (Lot Number EJ6788) as single dose for covid-19 immunization; second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 06Mar2021 (Lot Number EP2166) as single dose for covid-19 immunization. The patient experienced ischemic stroke (hospitalization) on 17Sep2021. 17Sep2021: the patient presents an ischemic stroke on the deep right Sylvian territory, of recent constitution. Clinically objectivable at 6:45 a.m. (i.e. 18 hours after the injection), confirmatory cerebral MRI at 9 a.m. before thrombolysis (constitution of less than 4 hours). Cerebral MRI: aspect compatible with a range of recent ischemic stroke less than 4 hours, deep right territory. The events resulted in hospitalization. The outcome of the event Ischemic stroke was recovered on 17Sep2021, event booster was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834685 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-09-16
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electromyogram, Monoplegia, Neuralgic amyotrophy, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Name: EMG study; Result Unstructured Data: Test Result:Unknown Result; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101401040

Write-up: Parsonage-Turner syndrome; Loss of full use of right arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110170951059070-2RFU0, Safety Report Unique Identifier GB-MHRA-ADR 26085299. A 40-year-old female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FD8813) via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization. Patient was not pregnant and was not currently breastfeeding (at the time of report). Medical history included anxiety. Unsure if patient has had symptoms associated with COVID-19. The concomitant medication included citalopram taken for anxiety from 20May2018 to an unspecified stop date. Historical vaccine included first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- FW3143) via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. On 16Sep2021, patient experienced parsonage-turner syndrome. Excruciating pain in right shoulder area followed by loss of full use of right arm on an unspecified date in 2021. The time frame between vaccination and event parsonage-turner syndrome onset was reported as 258 days. The event was assessed as serious (disability, medically significant). Patient had 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 EMG study with unknown result and COVID-19 virus test with result as negative. The outcome of the event parsonage-turner syndrome was not resolved and that of the event loss of full use of right arm was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1834985 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Embolism venous, Fibrin D dimer, Hemiparesis, Specialist consultation, Speech disorder, Venous thrombosis
SMQs:, Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: Computerized tomography neck without and with contrast media-basal enephalon-angio computerized tomography cerebral arteries-perfusion; Result Unstructured Data: Test Result:no significant densitometric alterations observed; Comments: no significant densitometric alterations were observed in acute phase of brain parenchyma in supra- and subtentorial location; no dilatation of the ventricular system, midline structures on axis; regular origin of epiaortic trunks; pervious carotid axes in the absence of significant parietal plaques; pervious vertebral arteries in the absence of hemodynamically significant parietal plaques; non-significant alterations in the major vessels of the intracranial arterial circulation; faint alteration of perfusion parameters in the temporal lobes bilaterally, in particular on the right side, extending also to the parietal area and to the trunk; however, these sites appear poorly explorable with perfusion testing; a slight nuanced alteration of perfusion parameters was also observed in the right anterior frontal area, at this level there was a modest increase in Mean Transit Time and reduction of cerebral blood flow; there was no significant reduction of cerebral blood volume, the findings described appear to be of unequivocal interpretation could be compatible with areas of hypoperfusion, however, require specialist clinical correlation; examination performed before and after administration of intravenous contrast media and aimed at evaluating the pulmonary arterial circulation; no evidence of filling defects related to thromboembolic phenomena in the pulmonary arterial circulation at the level of the main pulmonary arteries, lobar arteries, and segmental and subsegmental branches appreciable with the method; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:more than 1500; Test Date: 20210920; Test Name: neurological objective examination; Result Unstructured Data: Test Result:appeared mildly disarticulated; Comments: patient with language barrier, appeared mildly disarticulated
CDC Split Type: ITPFIZER INC202101390558

Write-up: if positive for venous thrombosis/embolism; left hemiparesis; if positive for venous thrombosis/embolism; speech disorder; This is a spontaneous report from a contactable physician, downloaded from a regulatory authority-WEB. The regulatory authority number is IT-MINISAL02-798979. A 43-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly, administered in left deltoid (also reported as left shoulder) on 11Sep2021 (Batch/Lot Number: FG7387, Expiration date: unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history was not reported. There were no concomitant medications. The patient had no notable pathologies and did not take home therapy. On 16Sep2021, the patient experienced left hemiparesis and speech disorder, which required hospitalization on an unspecified date. It was further reported that on 11Sep2021, the patient received 1st dose of anticovid vaccine and from 4 days, there was an onset of speech disorder in the articulation of the word and limb strength deficit. On an unspecified date, examinations revealed fibrin D dimer of more than ($g)1500. Neurological objective examination on 20Sep2021 showed a patient with language barrier, who appeared mildly disarticulated. There was good comprehension. Blurred left crural facio-brachial hemisyndrome was noted. They performed computerized tomography skull with contrast media, angiography with triphasic seq and thorax. If positive for venous thrombosis/embolism, indication for scoagulation was given. If negative for venous thrombosis/embolism, the patient should be treated with Fletadol 250+gastroprotection and Clexane 4000/day. On 20Sep2021, computerized tomography neck without and with contrast media-basal enephalon-angio computerized tomography cerebral arteries-perfusion revealed no significant densitometric alterations were observed in acute phase of brain parenchyma in supra- and subtentorial location; no dilatation of the ventricular system, midline structures on axis; regular origin of epiaortic trunks; pervious carotid axes in the absence of significant parietal plaques; pervious vertebral arteries in the absence of hemodynamically significant parietal plaques; non-significant alterations in the major vessels of the intracranial arterial circulation; faint alteration of perfusion parameters in the temporal lobes bilaterally, in particular on the right side, extending also to the parietal area and to the trunk; however, these sites appear poorly explorable with perfusion testing; a slight nuanced alteration of perfusion parameters was also observed in the right anterior frontal area, at this level there was a modest increase in Mean Transit Time and reduction of cerebral blood flow; there was no significant reduction of cerebral blood volume, the findings described appear to be of unequivocal interpretation could be compatible with areas of hypoperfusion, however, require specialist clinical correlation; examination performed before and after administration of intravenous contrast media and aimed at evaluating the pulmonary arterial circulation; no evidence of filling defects related to thromboembolic phenomena in the pulmonary arterial circulation at the level of the main pulmonary arteries, lobar arteries, and segmental and subsegmental branches appreciable with the method. The patient denied noteworthy pathologies and did not take home therapy. Therapeutic measures were taken as a result of all the events. The outcome of the events was unknown. Sender''s Comments: a regulatory authority required clinical evolution, clinical report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1834987 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-16
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Investigation, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: examinations; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101390566

Write-up: Paresthesias of the 4 limbs and face; Paresthesias of the 4 limbs and face; Severe headache; This is a spontaneous report from a contactable consumer downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number IT-MINISAL02-798981. A 27-year-old female patient received the first dose of BNT162b2 (COMIRNATY), intramuscular, administered in right arm (also reported as right shoulder) in Sep2021 (Batch/Lot Number: FG7387) as at 30 ug single dose for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Occurring 2-3 days after the first dose, the patient experienced paresthesias of the 4 limbs and face, and severe headache, both on 16Sep2021 (as reported). The patient was hospitalized due to the events. Impact on quality of life (10/10) (disabling). Examinations done on unknown date with unknown results. Therapeutic measures were taken as result of the events. Outcome of the events was recovering. Sender''s comments: Local PV centre requested/solicited date of vaccination, results of diagnostic investigations, clinical evolution, clinical report, concomitant diseases and therapies. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1835192 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-16
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Menstruation irregular
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Knee ligament repair (Cruciate ligament surgery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101384189

Write-up: Menstrual disorder/ period has now been absent; menstruation has become irregular after have taken both doses; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-089340. A 23-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Aug2021 (lot number: FF2832; expiry date: unknown) as dose 2, single for Covid-19 immunisation. Medical history included knee ligament repair (cruciate ligament surgery) from Sep2018 to an unknown date. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), on 16Jul2021 (lot number: FF3318) for Covid-19 immunisation. On 16Sep2021, the patient experienced menstrual disorder/ period has now been absent. It reported that the patient''s menstruation became irregular after two doses. Her period has now been absent for almost 20 days. Pregnancy was excluded as several pregnancy tests have been done. Outcome of the events was not recovered. The case was assessed as a serious, permanent disability. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1835833 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-09-16
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001943 / 1 - / OT

Administered by: Unknown       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: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: Vaccination failure; SARS-CoV-2 infection; This case was received via Medicines Agency (Reference number: AT-BASGAGES-2021-050187) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) in a 36-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3002545 and 3001943) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant) and COVID-19 (SARS-CoV-2 infection) (seriousness criterion medically significant). At the time of the report, VACCINATION FAILURE (Vaccination failure) and COVID-19 (SARS-CoV-2 infection) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant product was provided. No treatment information was provided. Company Comment : This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected events of COVID-19 and vaccination failure. The events occurred 3 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation received on 26-OCT-2021, Dosage Text translated; Sender''s Comments: This case concerns a 36-year-old, female patient with no relevant medical history, who experienced the unexpected event of COVID-19 and the event vaccination failure. The events occurred 3 months after administration of the second dose of the Moderna COVID-19 Vaccine. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1836236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-09-16
   Days after vaccination:222
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101394598

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency (RA) -WEB, regulatory authority number AT-BASGAGES-2021-050312. A 24-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: EJ6797) via intramuscular on 16Jan2021 as dose 1, single for covid-19 immunization and second dose of bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot Number: EK9788) via intramuscular on 06Feb2021 as dose 2, single for covid-19 immunization. Relevant medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other and vaccination failure. The report was assessed as serious by health authority. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (variant PCR-based: sequenced variant: n501y-positive: unknown) on 16Sep2021. The outcome of both the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1836239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-09-16
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101394555

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. -WEB AT-BASGAGES-2021-050318. A 55-years-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: FD1921, Expiry date: Unknown) via intramuscularly on 14Jun2021 as dose 2, single, and first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FA4598, Expiry date: Unknown) via intramuscularly on 18May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 16Sep2021, the patient experienced sars-cov-2 infection, and vaccination failure. On 16Sep2021, the patient underwent lab tests and procedures which included SARS-cov-2 test: positive (Variant PCR-based: B.1.617 not differentiated Sequenced variant: n501y-positive: No). The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1836240 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-09-16
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101394561

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number AT-BASGAGES-2021-050320. A 36-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, lot number: FD6840) via intramuscular on 09Jul2021 as dose 2, single and received first dose of bnt162b2 (COMIRNATY, solution for injection, lot number: FD1921) via intramuscular on 17Jun2021 as dose 1, single both for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab tests and procedures which included variant PCR-based: B.1.617.2, sequenced variant: n501y, positive: no. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1838314 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE 4728 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), 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? 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: GRPFIZER INC202101415011

Write-up: numbness of right leg and arm; pain in arm; pain in right leg; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number GR-GREOF-202108802, Safety Report Unique GR-GREOF-202108802. A 29-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FE 4728) via an unspecified route of administration on 16Sep2021 (at age of 29-years-old) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 16Sep2021, patient experienced numbness of right leg and arm, pain in right leg and arm. events reported as medically significant. The outcome of events was not resolved. No follow-up attempts possible. No further information expected.


VAERS ID: 1838361 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Face oedema, Lip oedema
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? 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: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101398797

Write-up: edema of the face; edema of the lips; This is a spontaneous report received from a contactable other healthcare professional downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-798917. A 34-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration administered in left arm (left shoulder) on 13Sep2021 at age of 34-year-old (Batch/Lot Number: FG6273) as single dose for covid-19 immunisation. Medical history included symptomatic covid-19 and not ongoing. The concomitant medications were not reported. On 16Sep2021, after 3 days from the vaccine, the patient experienced edema of the face and edema of the lips, symptoms re-manifested on 09Oct2021. On 16Sep2021, it is necessary to access the emergency room for pharmacological treatment. Both events were considered serious per hospitalization. Cortisone and antihistamines therapy drug used for the events. The outcome of the events was not recovered. Reporter''s comment: Adverse allergic reaction to covid vaccine never manifested since birth PRIVACY. Treated with corticosteroids and antihistamines. hospitalization/admission to psychiatric care necessary. Symptoms recurred one month later and relapsed after cortisone and antihistamines were taken at home. Pfizer covid 19 vaccine first dose in non-allergic patient formerly symptomatic covid 19 Sender''s comment: 13Oct2021 Local Center requested emergency room visit report. Pending.; Reporter''s Comments: Adverse allergic reaction to covid vaccine never manifested since birth PRIVACY. Treated with corticosteroids and antihistamines. hospitalization/admission to psychiatric care necessary. Symptoms recurred one month later and relapsed after cortisone and antihistamines were taken at home. Pfizer covid 19 vaccine first dose in non-allergic patient formerly symptomatic covid 19


VAERS ID: 1838517 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Fatigue, Malaise, Pyrexia, Respiratory distress, Syncope, Throat tightness, Vaccination site haematoma, Vaccination site inflammation, Vaccination site pain, Vaccination site warmth
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (time: 22:00; disease symptoms: quite)
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC202101371733

Write-up: Fainting; The distress arose after this, the patient felt like she was only getting 50 percentage of her oxygen and her windpipe was being squeezed; Extreme shortness of breath/Felt like she was only getting 50 percentage of her oxygen; Felt like her windpipe was being squeezed; Fever: 38 to 40.5 degrees Celsius; Fatigue; Not feeling well; Reaction at or around the injection site: pain; Reaction at or around the injection site: heat; Reaction at or around the injection site: inflammation; Reaction at or around the injection site: bruising; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number is NL-LRB-00689345. A 29-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; strength: 0.3 ml; lot number: FF2834), via an unspecified route of administration on 16Sep2021 (at the age of 29-years-old) as dose 1, 0.3 ml single for COVID-19 immunization. Medical history included suspected COVID-19 (disease symptoms: quite) from 16Feb2020 22:00. The patient''s concomitant medications were not reported. On 16Sep2021, the patient experienced reaction at or around the injection site: pain, heat, inflammation, and bruising. On 17Sep2021 (1 day after the vaccination), the patient experienced fainting, extreme shortness of breath, throat constriction, fever: 38 to 40.5 degrees Celsius, fatigue, and not feeling well. The fainting was about five times. The distress arose after this, the patient felt like she was only getting 50 percentage of her oxygen and her windpipe was being squeezed. The doctor gave her a bronchodilator with anti-inflammatory a week prior to the report, it made her feel a little less stuffy but was still not what it should be. The patient did not have diagnostic procedures as the general practitioner (GP) did not want to receive her because of the policy of the practice. Therapeutic measures were taken as result of the events fainting, dyspnea, and throat constriction which included QVAR Extra fine Aerosol. The outcome of events was as follows: reaction at or around the injection site: pain, heat, inflammation, bruising was recovered on 18Sep2021; fever, not feeling well was recovered on 19Sep2021; fainting, dyspnea, throat constriction, respiratory distress was recovering; and fatigue was not recovered. No follow-up attempts are possible. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: Respiratory distress was added as event. Dyspnea and throat tightness was upgraded to serious.


VAERS ID: 1839723 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-09-16
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No.
CDC Split Type: ATPFIZER INC202101413864

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050185. A 53-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 23Jun2021 (Batch/Lot Number: FD4555) as dose 2, single and 1 intramuscular on 19May2021 (Batch/Lot Number: FA4598) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection (covid-19) (medically significant) on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Variant PCR-based: B.1.617.2. Sequenced variant: n501y-positive: No.) on 16Sep2021. No follow up attempts needed, no further information is expected.


VAERS ID: 1839724 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-16
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101413741

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050189. A 23-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 07Aug2021 (Batch/Lot Number: FE6208) as dose 2, single and intramuscular on 03Jul2021 (Batch/Lot Number: FD4555) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection (medically significant) on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No. No follow-up attempts possible. No further information expected.


VAERS ID: 1839725 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-09-16
   Days after vaccination:106
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based/Sequenced variant/n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101414048

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050197. A 30-year-old male patient received two doses of BNT162b2 (COMIRNATY), dose 2 intramuscular on 02Jun2021 (Lot Number: FC2473) and dose 1 intramuscular on 10May2021 (Lot Number: EY3014), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/vaccination failure on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant PCR-based/Sequenced variant/n501y-positive: Unknown) on 16Sep2021. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1839726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-09-16
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0168 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101413819

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050209. A 70-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Jun2021 (Batch/Lot Number: FD0168) as dose 2, single, and dose 1 intramuscular on 18May2021 (Batch/Lot Number: FA4598) as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, Vaccination failure. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 16Sep2021, Variant PCR-based: Variant Sequenced: n501y-positive: Unknown. The clinical outcome of the event SARS-CoV-2 infection, Vaccination failure was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1839728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-09-16
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2473 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: PCR-based variant: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101413952

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-050178. A 53-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 29May2021 (Batch/Lot Number: EY7015) as single dose and dose 1 intramuscular on 02May2021 (Batch/Lot Number: EW4815) as single dose for COVID-19 immunisation. The patient had no medical history. The patient''s concomitant medications were none. The patient experienced sars-cov-2 infection on 16Sep2021 with outcome of unknown. The patient underwent lab test which included sars-cov-2 test: positive on 16Sep2021 (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No). No follow-up attempts possible. No further information expected.


VAERS ID: 1839733 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-09-16
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Variant Sequenced: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101405631

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050509. A 45-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 19Jul2021 (Batch/Lot Number: FE6208) as DOSE 2, SINGLE, dose 1 intramuscular on 14Jun2021 (Batch/Lot Number: FD0168) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection, vaccination failure on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Sep2021 Variant PCR-based: Variant Sequenced: n501y-positive: Unknown. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1839772 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-09-16
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No
CDC Split Type: ATPFIZER INC202101414029

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-050615. A 57-year-old male patient received two doses of BNT162b2 (COMIRNATY), dose 2 intramuscular on 15May2021 (Lot Number: EY7015) and dose 1 intramuscular on 24Apr2021 (Lot Number: EW4815), both as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection/vaccination failure on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive (Variant PCR-based: B.1.617.2 Variant Sequenced: n501y positive: No) on 16Sep2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1841048 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCJU6 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiovascular evaluation, Dizziness, Feeling abnormal, Headache, Loss of personal independence in daily activities, Neurological examination, Ocular discomfort, Palpitations, Somnolence, Superficial vein thrombosis
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Diagnostic workup by cardiology and neurology; Result Unstructured Data: Test Result:Unknown results; Test Date: 2021; Test Name: Diagnostic workup by cardiology and neurology; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101405261

Write-up: Superficial thrombophlebitis; Ocular discomfort; problems with the eyes; Heart racing; palpitations; Fogged feeling; General weakness; Unable to work; incapable of physical exertion; everyday activities restricted; Dizziness; Drowsiness; Increased headaches; This is a spontaneous from a non-contactable consumer (patient) received. Downloaded from The regulatory authority report number is: DE-PEI-CADR2021190307 (Safety Report Unique Identifier DE-PEI-202100207684). A 45-year-old female patient received BNT162B2 (COMIRNATY; Strength: 0.3 mL, Lot Number: SCJU6), via an unspecified route of administration, on 16Sep2021 (at the age of 45 years), as dose number unknown, 0.3 mL, single, for COVID-19 immunization. The patient''s medical history included asthma. The patient''s concomitant medications were not reported. The patient had no known allergies. On 16Sep2021, the patient experienced superficial thrombophlebitis, ocular discomfort, and heart racing; these were considered serious as important medical events. On 16Sep2021, the patient also got fogged feeling, general weakness, and problems with the eyes; this now for 3 weeks, unable to work. Diagnostic workup by cardiology and neurology (2021). Off sick for the last 3 weeks (since 16Spe2021) due to being incapable of physical exertion - everyday activities restricted by dizziness and palpitations, mild drowsiness only occasionally, and increased headaches. The patient had not recovered from the events. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841067 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-09-16
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: Sequenced variant: n501y-positive: Unknown
CDC Split Type: ATPFIZER INC202101413784

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-050206. A 57-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Lot: EL1491) on 19Jan2021 and the second dose of BNT162b2 (COMIRNATY, Lot: EJ6790) on 12Feb2021, both as single doses via intramuscular route for COVID-19 immunization. Medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The events were reported as serious for medically significant. Lab data included COVID-19 PCR test on 16Sep2021: positive (Variant PCR-based: not reported, Sequenced variant: not reported, n501y-positive: Unknown). The patient''s outcome was unknown for SARS-CoV-2 infection, unknown for Vaccination failure. No follow-up attempts possible. No further information expected.


VAERS ID: 1841069 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-09-16
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive, 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: 20210916; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Variant Sequenced: n501y-positive: No
CDC Split Type: ATPFIZER INC202101414478

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB [AT-BASGAGES-2021-050219]. A 21-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 20May2021 (Batch/Lot Number: FC0681) as single dose, dose 2 intramuscular on 24Jun2021 (Batch/Lot Number: FD6840) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure (medically significant) on 16Sep2021 with outcome of unknown, Sars-cov-2 infection (medically significant) on 16Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included: Sars-cov-2 test: positive (Variant PCR-based: B.1.617.2. Variant Sequenced: n501y-positive: No) on 16Sep2021. No follow-up attempts possible. No further information expected.


VAERS ID: 1841712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Lymph node pain, Lymphadenopathy, Magnetic resonance imaging breast, Syncope, Ultrasound breast
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELICEA Q-TAB
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Magnetic resonance imaging breast; Result Unstructured Data: Test Result:empty axillae; Test Date: 202107; Test Name: Ultrasound breast; Result Unstructured Data: Test Result:empty axillae
CDC Split Type: HRPFIZER INC202101416596

Write-up: painful lymph nodes of the right axilla; painful lymph nodes of the right axilla; unconsciousness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority Number: HR-HALMED-300051284 A 43-year-old female patient received first dose of BNT162B2 (COMIRNATY Lot Number: FE8244), intramuscular on 16Sep2021 as 0.3 mL single for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medication included escitalopram oxalate (ELICEA Q-TAB) taken for an unspecified indication, start and stop date were not reported. On 16Sep2021 3 minutes after vaccination patient experienced unconsciousness and fainted. On 23Sep2021, 7 days after the vaccine, she felt 2 lumps under her right armpit. It was also informed that on examination in the beginning of July this year on ultrasound breast and magnetic resonance imaging breasts, axillae were empty. The patient recovered from unconsciousness on an unspecified date, while had not yet recovered from other reported events. No follow-up attempts possible. No further information expected.


VAERS ID: 1841734 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Facial paralysis, Impaired quality of life, Quality of life decreased, Tongue paralysis
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hearing impairment (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: Impact on quality of life; Result Unstructured Data: Test Result:5/10
CDC Split Type: ITPFIZER INC202101405869

Write-up: Impact on quality of life (5/10); Paralysis of cheeks and tongue and inability to swallow; Paralysis of cheeks and tongue and inability to swallow; Paralysis of cheeks and tongue and inability to swallow; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number IT-MINISAL02-799092. A 53-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FG3739), via intramuscular, administered in right arm on 16Sep2021 as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 16Sep2021 the patient experienced paralysis of cheeks and tongue and inability to swallow; and on an unspecified date impact on quality of life (5/10). No specific tests were performed (eg: Brain Magnetic Resonance Imaging) nor did she visit the emergency room. She denies risk factors such as obesity, metabolic syndrome, diabetes, HIV, recurrent herpes simplex, previous or recent herpes zoster, recurrent or recent respiratory tract and oral cavity infections, recurrent or recent otitis, salivary glands diseases, neuropathies and maxillofacial surgery, where it was reported as Impact on quality of life (5/10). On an unspecified date, the patient underwent lab tests and procedures which included quality of life decreased resulted 5/10. The outcome of event paralysis of cheeks and tongue and inability to swallow was recovered on an unspecified date in 2021, and event impaired quality of life was unknown. Health authority comment: 15Oct2021: Seriousness criteria changed to "other clinically relevant condition" No follow-up attempts are possible, no further information is expected.


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