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

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



Case Details (Reverse Sorted by Onset Date)

This is page 415 out of 8,010

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VAERS ID: 1739100 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-08-24
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Juvenile rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: SARS COV-2 rapid test; Result Unstructured Data: Test Result:Positive; Comments: Nasal Swab
CDC Split Type: GRPFIZER INC202101218827

Write-up: herpes zoster; SARS COV-2 rapid test that was positive; SARS COV-2 rapid test that was positive; This is a spontaneous report from a contactable consumer (patient). A 49-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, lot/batch number was not reported), via an unspecified route of administration, administered in arm left on 22Apr2021, 08:15 (age at vaccination was 49 years) as dose 2, single and then via an unspecified route of administration on 01Apr2021, 02:45 as dose 1, single for COVID-19 immunisation at hospital. The patient''s relevant medical history included Juvenile Rheumatoid Arthritis. The patient''s concomitant medications included etanercept (ENBREL) and prednisolone (PREZOLON). The patient previously received aspirin. On 09Sep2021, 22:30 the patient experienced herpes zoster. The adverse event resulted into doctor or other healthcare professional office/clinic visit. On 24Aug2021 the patient underwent a SARS COV-2 rapid test that was positive. Therapeutic interventions included treatment with Brivir, neurobion and discontinuation of treatment with Enbrel. Prior to vaccination, patient was not diagnosed with covid-19 and since the vaccination, patient had tested for COVID-19. The outcome of event herpes zoster was not recovered, and outcome of other events was unknown. Information about lot/batch number has been requested.


VAERS ID: 1739112 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-08-24
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, Rhinorrhoea
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: HRPFIZER INC202101195529

Write-up: Covid-19; Runny nose; Common cold; Drug ineffective; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority-WEB. The regulatory authority number HR-HALMED-300050691. A 25-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number: ET3620) intramuscular on 16Mar2021 as dose 2, 0.3ml single and received of bnt162b2 (COMIRNATY, solution for injection, lot number: EJ6790) intramuscular on 23Feb2021 as dose 1, 0.3ml single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced runny nose, mild common cold, afebrile, drug ineffective and COVID-19. Therapeutic measures were taken as a result of runny nose and common cold. Report from Complaint Team provided from division Regulatory Authority included Conclusion for LOT: EJ6790: 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 EJ6790. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. For LOT: ET3620, no investigation was reported. The outcome of runny nose, common cold and drug ineffective was recovering while the outcome of COVID-19 was unknown. No further follow-up attempts possible. No further information expected.


VAERS ID: 1739155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: IEPFIZER INC202101195038

Write-up: First seizure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. WEB, regulatory authority number IE-HPRA-2021-083398, Safety Report Unique Identifier IE-HPRA-2021-083398. A 14-year-old female patient received first dose of COMIRNATY (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 20Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No relevant medical history or underlying conditions. On 24Aug2021, 4-days late the vaccination, the patient experienced her first seizure, which persisted for 5 minutes. The reporter stated that they were unsure if the episode was related to the vaccine but that it was otherwise unprovoked. The event was serious (medically significant). No treatment was administered to the patient. The outcome of the event was recovered on unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1739260 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005244 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Loss of consciousness, Pericarditis, Pyrexia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-781759) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS, TREMOR, FATIGUE, PYREXIA, and PERICARDITIS in a 47-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005244) for COVID-19 vaccination. No Medical History information was reported. On 23-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) (seriousness criterion medically significant), TREMOR (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) (seriousness criterion medically significant), FATIGUE (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) (seriousness criterion medically significant), PYREXIA (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) (seriousness criterion medically significant) and PERICARDITIS (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm), TREMOR (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm), FATIGUE (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm), PYREXIA (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) and PERICARDITIS (tremori, febbre e stanchezza per 3gg, a 8 gg di distanza dalla vaccinazione, svenimento e fatica a fare qualsiasi cosa. Dopo visita cardiologica, viene diagnosticata Pericardite con versamento di 7mm) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medications were not provided. Treatment information was not provided. On an unknown date patient undergone Cardiological examination resulted in Pericarditis with 7mm effusion. Translated received and reported verbatim mentioned as Tremors, fever and fatigue for 3 days, 8 days after vaccination, fainting and a struggle to do anything. After cardiological examination, Pericarditis with 7 mm effusion is diagnosed. This case concerns 47-year-old male patient with no relevant medical history, who experienced the expected event of Pericarditis and unexpected events of Loss of consciousness, Tremor, Fatigue and Pyrexia, 2 days after receiving the first dose of mRNA-1273 (Spikevax). The rechallenge was unknown as there is no information regarding any similar events following the first dose. No reporter causality was provided. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Event seriousness criteria kept serious as previously reported by the authority. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Events seriousness criteria was updated. On 17-Sep-2021: Translated document received on 22-Sep-2021 included: Patient''s lab data. and translated reported verbatim; Sender''s Comments: This case concerns 47-year-old male patient with no relevant medical history, who experienced the expected event of Pericarditis and unexpected events of Loss of consciousness, Tremor, Fatigue and Pyrexia, 2 days after receiving the first dose of mRNA-1273 (Spikevax). The rechallenge was unknown as there is no information regarding any similar events following the first dose. No reporter causality was provided. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. Event seriousness criteria kept serious as previously reported by the authority.


VAERS ID: 1739303 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Meningism, Musculoskeletal stiffness, Nausea, Neck pain, Tension, Trigeminal neuralgia, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Demyelination (broad), Vestibular disorders (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101195373

Write-up: STIFFNESS; intense cervical pain; TENSION; ONSET OF INTENSIVE VERTIGO; ONSET OF INTENSIVE NAUSEA; ONSET OF INTENSIVE HEADACHE; ONSET OF INTENSIVE TRIGEMINAL NEURALGIA (LEFT JAW-MANDIBULAR); dizziness; meningitic reaction; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-782342. A 66-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Deltoid Left on 19Aug2021 12:44 (Batch/Lot Number: FG4493; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced onset of intensive headache, vertigo, nausea, trigeminal neuralgia (left jaw-mandibular), meningitic reaction (tension, stiffness and intense cervical pain) on 24Aug2021. Description reported as follows: Headache, dizziness, nausea, neuralgia, tension, neck pain, stiffness - Actions taken (specialist visit, neurology. Anti-pain therapy (indomethacin)). The events were serious as medically significant. The outcome of the events were not recovered. Reporter''s comment: Inoculation site: left deltoid. Sender''s comments: Follow up required. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter''s comment: Inoculation site: left deltoid.


VAERS ID: 1739547 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Nausea, Pyrexia, Urticaria
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: FEVER; This case was received via Agency Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00048200) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a nurse and describes the occurrence of URTICARIA, DYSPNOEA, NAUSEA and PYREXIA (FEVER) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for Vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced URTICARIA (seriousness criterion medically significant), DYSPNOEA (seriousness criterion medically significant), NAUSEA (seriousness criterion medically significant) and PYREXIA (FEVER) (seriousness criterion medically significant). On 26-Aug-2021, URTICARIA, DYSPNOEA, NAUSEA and PYREXIA (FEVER) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered URTICARIA, DYSPNOEA, NAUSEA and PYREXIA (FEVER) to be possibly related. The concomitant medication was not reported. The treatment history was not reported. In follow up translation received Reaction/event as reported by primary source Fever, nausea, hives Company comment: This case concerns 32-year-old female patient with no relevant medical history, who experienced the unexpected events of Urticaria, Dyspnoea, Nausea, Pyrexia 2 days after receiving the second dose of mRNA-1273 (Spikevax). The rechallenge was unknown as there is no information regarding any similar events following the first dose. The events were considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. This case was linked to NO-NOMAADVRE-FHI-2021-U2md7n (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation document received on 20 Sep 2021 and reported verbatim updated.; Sender''s Comments: This case concerns 32-year-old female patient with no relevant medical history, who experienced the unexpected events of Urticaria, Dyspnoea, Nausea, Pyrexia 2 days after receiving the second dose of mRNA-1273 (Spikevax). The rechallenge was unknown as there is no information regarding any similar events following the first dose. The events were considered related to the vaccine per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 (Spikevax) is not affected by this report. NO-NOMAADVRE-FHI-2021-U2md7n:


VAERS ID: 1739594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysgeusia, Fatigue, Hypoaesthesia oral, Myalgia, Palpitations, Pharyngeal hypoaesthesia, Pruritus, Rash, Restlessness
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Abstains from alcohol; Bee sting hypersensitivity; Hypersensitivity (has reacted to some drugs, and multiple vaccines); Non-smoker; Non-tobacco user
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101193786

Write-up: ITCHING BODY; NUMBNESS THROAT; NUMBNESS OF TONGUE; MEDICAL TASTE; RASH; TENDERNESS MUSCLE; PALPITATIONS; TIREDNESS; RESTLESSNESS IN BODY; This is a spontaneous report from a non-contactable consumer downloaded from the WEB (Regulatory Authority report number: NO-NOMAADVRE-PASRAPP-2021-Uz8pgd). A 39-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot number and expiration date were not reported), intramuscular on the right arm on 24Aug2021 (11:08) as dose 1, single, for COVID-19 immunization. Medical history included abstaining from alcohol; hypersensitivity (has reacted to some drugs, and multiple vaccines); non-tobacco user; non-smoker; and bee sting hypersensitivity. The patient''s concomitant medications were not reported. On 24Aug2021, the patient had rash. On 24Aug2021 (11:11), the patient had medical taste. On 24Aug2021 (11:13), the patient had numbness of tongue; itching body; and numbness in throat. The patient was hospitalized on an unspecified date in 2021 to an unspecified date in 2021 due to the reported events. On an unspecified date in 2021, the patient had tenderness in muscle; palpitations; tiredness; and restlessness. The patient had received adrenaline as treatment for the events, numbness of tongue, medical taste, rash, itching body and numbness in throat. The outcome of the events was recovered on 24Aug2021 for rash, medical taste, numbness of tongue, itching body, and numbness in throat; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1740494 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-24
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004497 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebellar infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

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

Write-up: Bilateral cerebellar infarction; This case was received via Regulatory Agency (Reference number: JP-TAKEDA-2021TJP094126) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Regulatory Agency (RA) by a physician, was received via the RA (Ref, v21126640). The patient had past medical history of pyrexia (in the 3rd year of junior high school) due to influenza vaccine and of Hashimoto''s disease. On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before vaccination: 36.4 degrees Celsius. On 09-Aug-2021, the patient received the 2nd dose of this vaccine. On 24-Aug-2021, at 08:10, the patient felt dizzy upon waking up and was transported to the hospital by ambulance. The patient was diagnosed with bilateral cerebellar infarction by head MRI. The patient received treatment with ozagrel sodium and clopidogrel sulfate. The patient had ataxia of limbs with left dominance and gait disturbance. Venous thrombosis in the lower extremities was noted, and oral administration of edoxaban tosilate hydrate was started. The patient was hospitalized. Transesophageal echocardiography showed no abnormalities. Chest catheter showed no apparent occluded vessels. Cerebral embolism was strongly suspected, but the cause was unknown. On 13-Sep-2021, gait disturbance remained as a sequela. The outcome of bilateral cerebellar infarction was reported as sequela. 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 a 44 year-old female patient with no relevant medical history, who experienced the unexpected event of Cerebellar infarction. The event occurred 15 days after the most recent dose of mRNA-1273 vaccine. It is unclear whether the most recent dose was the first or second dose based on the information provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1740669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Dyspnoea, Headache, Myalgia, Oropharyngeal pain, Presyncope, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tachyarrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101212446

Write-up: Cardiac flutter; Dyspnoea; headache; Myalgia; Oropharyngeal pain; Presyncope; pyrexia; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is 618195. A 33-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 20Aug2021 as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac flutter; dyspnoea; headache; myalgia; oropharyngeal pain; presyncope; pyrexia on 24Aug2021. 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: 1742056 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Dyspnoea, Fatigue, Palpitations, Pyrexia, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypothyreosis; Primary hypogonadism
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:more than 39 Centigrade; Test Date: 20210308; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Test Result:3964,8
CDC Split Type: CZPFIZER INC202101249628

Write-up: Fatigue extreme; Palpitation; Difficulty breathing; Fever; Weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). This is the second of two reports. The first report is a report downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21010370. This is a report for second dose of Comirnaty. A male patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Lot number- FE7051), intramuscularly on 24Aug2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number- FE8244), intramuscularly on 03Aug2021 as DOSE 1, SINGLE for covid-19 immunization and experienced weakness, Hemialgia, vaccination site pain, Mobility decreased deterioration and fatigue. Medical history included ongoing hypothyroidism, ongoing primary hypogonadism, covid-19 from an unknown date. The patient''s concomitant medications were not reported. On 24Aug2021, the patient developed fatigue extreme, palpitation, difficulty breathing, fever and weakness. On 08Mar2021, the patient underwent lab tests which included SarS-CoV-2 antibody test and result was 3964,8 AU/ml. On 24Aug2021, the patient had his body temperature checked and results stated temperature more than 39 centigrade. The outcome of the events was reported as recovered on 28Aug2021. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202101215834 same patient, same product but different doses and events


VAERS ID: 1742772 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225801

Write-up: Heavy periods; Painful periods; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority (RA). The regulatory authority report number is -MHRA-WEBCOVID-202109160048597680-NF8MK. A 25-year-old female patient (Non-pregnant) received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Lot Number: FF3319), via an unspecified route of administration, on 24Aug2021, as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, and not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Historical vaccine included BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), on 15Jun2021, as dose 1, single for covid-19 immunization and experienced severe increase in amount of bleeding. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. On 12Sep2021 experienced painful periods. On 14Sep2021, the patient experienced heavy periods. On 24Aug2021, the patient had inappropriate schedule of vaccine administered. The outcome of the events heavy periods and painful periods were not recovered.; Sender''s Comments: Linked Report(s) : -PFIZER INC-202101217754 Same patient/ product, different dose and events


VAERS ID: 1742894 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101203830

Write-up: left facial paralysis; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-783156. A 38-years-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: FF7481), via an unspecified route of administration, administered in left arm on 23Aug2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient had experienced left facial paralysis which resulted in emergency room visit and physician office visit. The patient underwent lab tests and procedures which included ENT examination and neurological examination, results unknown at the time of reporting. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Posted


VAERS ID: 1742895 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), 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: ITPFIZER INC202101203329

Write-up: Immediately after the vaccine she passed out. The night after is the day after flu symptoms; Immediately after the vaccine she passed out. The night after is the day after flu symptoms; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-783196. A 24-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Aug2021 (at the age of 24-year -old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 24Aug2021, the patient experienced immediately after the vaccine she passed out and the night after is the day after flu symptoms. Outcome of the events was recovered on 25Aug2021. No follow-up attempts are possible, information about lot number cannot be obtained.; Reporter''s Comments: Sent from Agency.


VAERS ID: 1742978 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dry eye, Dysmenorrhoea, Headache, Insomnia, Menstruation delayed, Myalgia, Urticaria
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Fertility disorders (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210951156

Write-up: INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; INSOMNIA, HEADACHE, JOINT AND MUSCLE PAIN, BONE PAIN, OBSCURED VISION AND DRY EYES, DIFFUSE URTICARIA, CONTINUOUS AND THROBBING HEADACHES, DELAYED AND PAINTFUL PERIODS, INTERNAL BURNING; This spontaneous report received from a consumer via a Regulatory authority (EVHUMAN Vaccines, IT-MINISAL02-790097) on 27-SEP-2021 and concerned a 36 year old female of unspecified race and ethnic origin. The patient''s weight was 59 kilograms, and height was 166 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C19-02 expiry: UNKNOWN) dose was not reported, 1 total administered on 24-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced insomnia, headache, joint and muscle pain, bone pain, obscured vision and dry eyes, diffuse urticaria, continuous and throbbing headaches, delayed and paintful periods, internal burning The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from insomnia, headache, joint and muscle pain, bone pain, obscured vision and dry eyes, diffuse urticaria, continuous and throbbing headaches, delayed and paintful periods, internal burning, insomnia, headache, joint and muscle pain, bone pain, obscured vision and dry eyes, diffuse urticaria, This report was serious (Life Threatening).; Reporter''s Comments: None


VAERS ID: 1743155 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Loss of consciousness, Pyrexia, Vaccination site reaction
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Arthritis (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:39s Centigrade; Comments: at 23:00
CDC Split Type: JPPFIZER INC202101216292

Write-up: Loss of consciousness; pyrexia of 39s centigrade; chills; limbs arthralgia; vaccine side reaction; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21126892. A 33-year and 4-month-old male patient received the second dose of bnt162b2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number and Expiration date unknown) via an unspecified route of administration on 24Aug2021 at unknown time (at the age of 33-year-old ) as a single dose for COVID-19 immunization. Medical history and concomitant drugs were unknown. On 24Aug2021 at unknown time (the day of vaccination), the patient received bnt162b2. On 24Aug2021 at 23:00 (the day of vaccination), the patient experienced vaccine side reaction. On 25Aug2021 (1 day after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: After the vaccination of the second dose, the same day at 23:00, the patient had pyrexia of 39 centigrade, chills and limbs arthralgia. On 25Aug2021 in the afternoon, emergency request due to loss of consciousness at home, and the patient was transferred to the hospital. When the patient arrived at the hospital, consciousness was restored. But the patient was hospitalized to observe the condition. After the patient was hospitalized, his symptoms improved under the anti-inflammatory and analgesics. On 26Aug2021, the patient was discharged. On 26Aug2021 (2 days after the vaccination), the outcome of the event was recovering. The reporting physician classified the event as serious (hospitalized from 25Aug2021 to 26Aug2021) and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was not provided. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1743192 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-24
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Headache
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Headache; Coronavirus infection; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP089434) on 14-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case was reported by a patient who received the vaccine via the Regulatory Authority. Coronavirus infection was assessed as serious by the RA. On 29-Jul-2021, the patient received the 1st dose of this vaccine. On 24-Aug-2021, the patient visited a medical institution and coronavirus infection was noted. The patient was going to be relief period. On an unknown date, headache developed. On 04-Sep-2021, the patient recovered from coronavirus infection, and completed the relief period. On an unknown date, the patient was aware of headache in the evening. On 14-Sep-2021, the headache from the evening persisted. The outcome of coronavirus infection was reported as recovered. The outcome of headache was reported as ongoing. No follow-up investigation will be made due to lack of cooperation from the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 32-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID 19. The event occurred approximately 26 days after the first dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since no information about the second dose was available. The reporter assessed the events as related to the product. Based on the current available information, the Moderna COVID-19 Vaccine does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per information provided in source documents.


VAERS ID: 1743232 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005239 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: Asthma (Asthma (childhood))
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile convulsion (Febrile convulsion (around a year and a half old))
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Convulsion; Vasovagal reflex; This case was received via regulatory authority on 17-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21127011). Convulsion was assessed as serious by the RA. On an unknown date, body temperature before vaccination: 36.3 degrees Celsius. On 24-Aug-2021, at 16:27, the patient received the 1st dose of this vaccine. At 16:32, vasovagal reflex developed. Several seconds of systemic convulsion was observed. BP 82/48 and PR 54. The patient recovered consciousness in a few seconds. At 16:49, BP 105/69, and HR 71. At 17:01, the symptoms improved, and the patient returned home. The outcome of vasovagal reflex and convulsion was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 22-year-old female, with history of febrile convulsion, who presented with a serious unexpected event of seizure, as wells as non-serious presyncope. Event latency 5 minutes after first dose mRNA-1273. Event resolved. Rechallenge was not reported. Reporter causality reported as possibly related. Causality possible based on temporal association. Events are consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1743340 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Nasopharyngitis, Polymerase chain reaction, Pyrexia
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210831; Test Name: RT-PCR; Result Unstructured Data: Test Result:positive
CDC Split Type: PHPFIZER INC202101219838

Write-up: COVID-19; COVID-19; fever; cough; cold; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300105504 A 23-years-old female patient received bnt162b2 (COMIRNATY, Formulation:Solution for injection, Batch/Lot Number: FF8871) (at age of 23-years-old) via intramuscularly on 18Aug2021 as Dose Number Unknown, Single for Covid-19 immunization. The patient medical history and concomitant medications were not reported.On 24Aug2021, the patient experienced fever, cough and cold.The patient underwent lab tests and procedures which included polymerase chain reaction: positive on 31Aug2021. The outcome of the events was recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1743354 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-08-24
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 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: 20210824; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Positive IU international unit(s)
CDC Split Type: PTPFIZER INC202101229763

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable other Healthcare Professional downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-T202108-3904. A 50-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Dose: 0.3 mL, Lot number: EX8680, Expiration date: unknown) intramuscular, administered at an unspecified anatomical location on 14May2021 (age at vaccination was unknown) as dose 1, 0.3 ml single and second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FA4632, Expiration date: unknown) intramuscular, administered at an unspecified anatomical location on 11Jun2021 (age at vaccination was unknown) as dose 2, 0.3 ml single for COVID-19 immunization. The patient''s medical history was unknown. The patient''s concomitant medications were not reported. The patient experienced adverse drug reaction after second dose. On 24Aug2021, the patient experienced COVID-19 (vaccination failure). The patient underwent lab test which included SARS-CoV-2 test: Positive (Positive IU international unit(s) on 24Aug2021. The reporter''s assessment of the causal relationship of the (vaccination failure, COVID-19) with the suspect product was: Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. The case was assessed as non-serious. The outcome of the event was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1744548 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SC

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 1.CaC 1000 plus 2. Pregnovit 3. Combivair 400mg 4. Tri hemic
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Dust and pollen allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Uneventful pregnancy 1.LMP 22/12/12019 2.EDD 28-09-2021. 3. Birth 25/08/2021 Birth weight 2.67 kg Adverse event: preterm rupture of membranes on 24/08/2021


VAERS ID: 1745860 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Arthralgia, Body temperature, Disorientation, Headache, Lymph node pain, Lymphadenopathy, Myalgia, Pyrexia, Sleep disorder, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), 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: Dust allergy; Mite allergy; Pollen allergy; Seasonal allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade
CDC Split Type: CZPFIZER INC202101180443

Write-up: Joint pain; Blurred vision; Disorientation; Muscle pain; Swollen lymph nodes; Upset gastrointestinal; Headache; Fever 39.2 centigrade; Sleep disorder; Lymph node tenderness; This is a spontaneous report received from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is CZ-CZSUKL-21010269. A 31-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Aug2021 (Batch/Lot Number: FD6840) at the age of 31-years-old as dose 2, single for covid-19 immunisation. Medical history included ongoing mite allergy, dust allergy, pollen allergy and seasonal allergy. There were no concomitant medications. The patient previously received first dose of Comirnaty vaccine on 03Aug2021 for Covid-19 immunization and experienced abdominal discomfort, headache, pyrexia, sleep disorder, arthralgia and myalgia. On 24Aug2021, 12 hours after vaccination, the patient experienced upset gastrointestinal, headache, fever 39.2 centigrade, sleep disorder, lymph node tenderness and swollen lymph nodes; joint pain, blurred vision, disorientation and muscle pain on 25Aug2021. Events upset gastrointestinal, headache, fever 39.2 centigrade, sleep disorder were assessed serious, medically significant. The patient received Paralen, rest mode, acylpyrin, magnesium, cooling of the affected area, enough fluids (3 l) as treatment for the events. The outcome of events upset gastrointestinal, fever, blurred vision and disorientation was recovering; headache, sleep disorder was resolved with sequel while lymph node tenderness, joint pain, swollen lymph nodes and muscle pain were not recovered. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : CZ-PFIZER INC-202101233620 same patient, suspect drug and event; different dose


VAERS ID: 1746218 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005242 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depression, Dizziness, Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Nausea, Vaccination site reaction
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad)

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

Write-up: Depressed state; Fatigue; Bleeding menstrual heavy; Menses painful; Dizzy; Vaccination site reaction; Nausea; This case was received via the Regulatory Agency (Reference number: FR-AFSSAPS-AN20213510) on 08-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEPRESSION (Depressed state) and FATIGUE (Fatigue) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005242) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Adenomyosis since 2020. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced DEPRESSION (Depressed state) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HEAVY MENSTRUAL BLEEDING (Bleeding menstrual heavy), DYSMENORRHOEA (Menses painful), DIZZINESS (Dizzy), VACCINATION SITE REACTION (Vaccination site reaction) and NAUSEA (Nausea). At the time of the report, DEPRESSION (Depressed state), FATIGUE (Fatigue), HEAVY MENSTRUAL BLEEDING (Bleeding menstrual heavy) and DYSMENORRHOEA (Menses painful) had not resolved and DIZZINESS (Dizzy), VACCINATION SITE REACTION (Vaccination site reaction) and NAUSEA (Nausea) was resolving. Concomitant drug details not provided. Treatment details not provided. Company comment This case concerns a 44-year-old female patient, with no relevant medical history, who developed the serious and unexpected events of depression and fatigue, 8 days after receiving the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. The event of fatigue is unexpected as it is retained as serious per the regulatory authority source document.; Sender''s Comments: This case concerns a 44-year-old female patient, with no relevant medical history, who developed the serious and unexpected events of depression and fatigue, 8 days after receiving the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. The event of fatigue is unexpected as it is retained as serious per the regulatory authority source document.


VAERS ID: 1746249 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-08-24
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Influenza like illness, 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: Medical History/Concurrent Conditions: COVID-19; Comments: Dose 1 : Vaccin Pfizer/BioNTech - COMIRNATY, le 16/05/2021, Bras gauche, Injection intramusculaire, N? Lot : FA4598
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101187497

Write-up: Vaccination failure; covid-19; flu-like symptoms; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-GR20213986. A 51-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection), dose 2 intramuscularly administered in Arm Left on 25Jun2021 (Batch/Lot Number: FE1248; Expiration Date: 31Oct2021) as dose 2, single and dose 1 intramuscular on 16May2021 (Batch/Lot Number: FA4598) as dose 1, single both for covid-19 immunisation. The patient medical history included covid-19 from an unknown date and unknown if it was ongoing. The patient''s concomitant medications were not reported. On 24Aug2021, the patient experienced vaccination failure, covid-19 and flu-like symptom. Duration of vaccination failure was reported as, 1 week. The patient underwent lab tests and procedures which included sars-cov-2 test that was positive on 24Aug2021. Outcome of the vaccination failure was recovering whereas, covid-19 and flu-like symptom were unknown. Conclusion: The final scope was determined to be the associated lot(s) of the reported lot FE1248 Expiry date: 31Oct2021 and FA4598 Expiry date: blank. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Site concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The system 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.; Reporter''s Comments: Covid19 infection: flu-like symptoms


VAERS ID: 1746366 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1573 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Deep vein thrombosis, Echocardiogram, Fibrin D dimer, N-terminal prohormone brain natriuretic peptide, Pulmonary embolism, Troponin
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pancreatitis; Chronic pancreatitis; Chronic respiratory failure; Cognitive disturbance; Depressive disorder; Esophagitis; Gout; Hepatic steatosis; Hypertension arterial; Prostate neoplasia; Pyelonephritis; Sleep apnea syndrome; TIA; Unspecified hypertensive heart disease
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:38 mg/l; Test Date: 20210824; Test Name: Echodoppler; Result Unstructured Data: Test Result:Occurrence of pulmonary embolism in bilateral..; Comments: ..deep vein thrombosis of the lower limbs (left twin veins, left posterior tibial, right peroneal and left and right soleus) confirmed; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Absence of significant valve disease..; Comments: ..Good right and left ventricular systolic function.; Test Name: Dimers; Result Unstructured Data: Test Result:1930 ng/ml; Test Name: NT Pro BNP; Result Unstructured Data: Test Result:175 ng/L; Test Name: Troponin; Result Unstructured Data: Test Result:21 ng/L
CDC Split Type: FRPFIZER INC202101222606

Write-up: Pulmonary embolism; Deep vein thrombosis of the lower limbs; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is FR-AFSSAPS-PO20214728. An 83-year-old male patient received BNT162B2 (COMIRNATY; solution for injection), intramuscularly administered in the right arm on 05Aug2021 (lot number: FE1573) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included hepatic steatosis, depressive disorder, sleep apnea syndrome, acute pancreatitis, esophagitis, chronic pancreatitis, prostate neoplasia, chronic respiratory failure, gout, cognitive disturbance, hypertension arterial, pyelonephritis, unspecified hypertensive heart disease, and transient ischemic attack (TIA). The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on 01Jul2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. On 24Aug2021, the patient experienced occurrence of pulmonary embolism in bilateral deep vein thrombosis of the lower limbs (left twin veins, left posterior tibial, right peroneal and left and right soleus) confirmed by Echo-doppler. Transthoracic echocardiography showed absence of significant valve disease, good right and left ventricular systolic function. Biology report showed troponin: 21 ng/l, NT Pro BNP: 175 ng/l, dimers: 1930 ng/ml, and CRP 38 mg/l. It was reported that the remaining "bilans" was normal. Treatment with an anticoagulant was started. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746661 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Menstruation irregular, Pain assessment, Pain in extremity, Pelvic pain, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Date: 20210906; Test Name: pelvic pain; Result Unstructured Data: Test Result:7 out of 10
CDC Split Type: GBPFIZER INC202101225441

Write-up: bleeding, period came a couple of days earlier than usual, heavier bleeding and more painful than usual; period came a couple of days earlier than usual, heavier bleeding and more painful than usual; period came a couple of days earlier than usual; Spotting menstrual; Pain pelvic/pelvic pain; Menstruation abnormal; Pain in arm; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160949436900-DW736, Safety Report Unique Identifier is GB-MHRA-ADR 25951392. A 34-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Aug2021 (lot number: Ff3319) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if she has had symptoms associated with COVID-19. She was not pregnant, not currently breastfeeding, and not enrolled in clinical trial. The patient experienced bleeding on an unspecified date; pain in arm on 24Aug2021; menstruation abnormal on 25Aug2021; spotting menstrual and pain pelvic/pelvic pain on 06Sep2021. Case narrative: Her period came a couple of days earlier than usual, heavier bleeding and more painful than usual. Pelvic pain (sharp stabbing pain that came and went lasting around a minute a time, pain around 7 out of 10, comparable to contractions when in labour) and spotting between periods, possibly around the time of ovulation. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on an unspecified date. The patient recovered from Pain in arm on 25Aug2021, while outcome of other events was unknown. Case was reported as medically significant by health authority. No follow-up attempts are needed. No further information is expected.~


VAERS ID: 1746939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-08-24
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Fatigue, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: Computed Tomography (CT) for E gene; Result Unstructured Data: Test Result:unknown; Comments: Computed Tomography (CT) for E gene; Test Date: 20210827; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 20210915; Test Name: Computed Tomography (CT) for SarsCov2 gene; Result Unstructured Data: Test Result:unknown; Comments: Computed Tomography (CT) for SarsCov2 gene
CDC Split Type: HRPFIZER INC202101221805

Write-up: Vaccination failure; PCR positive; mild fatigue; slightly elevated temp.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number HR--300050679. A 56-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection), via intramuscular route on 29Apr2021 (Lot Number: EX3599) as 0.3ml, single dose and patient received second dose of bnt162b2 (COMIRNATY, solution for injection), via intramuscular route on 05Jun2021 (Lot Number: FD1921) as 0.3ml, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Disturbances developed only on 24Aug2021. On 24Aug2021, the patient experienced slightly increased temperature and mild fatigue. Polymerase chain reaction (PCR) tested positive on 27Aug2021. Home isolation. The patient underwent lab tests and procedures which included Sars-cov-2 test: positive on 27Aug2021, Computed Tomography (CT) for SarsCov2 gene: result unknown on 15Sep2021, Computed Tomography (CT) for E gene: result unknown on 17Sep2021. The outcome of COVID-19, fatigue and elevated temp was recovering and for other event it was unknown, at the time of this report. Additional information on 17Sep2021, included Product Quality Complaint investigation results. Complaint record received from the PQC site. Information obtained for Batch EX3599 included conclusion: For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5937614 (see File attachment in this investigation record) The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX3599. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. Information obtained for Batch FD1921 included conclusion: For this lot Adverse Event Safety Request for Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 6078283 (see File attachment in this investigation record) The complaint for PFIZERBIONTECH COVID-19 VACCINE was investigated. 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 FD1921 A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blindness transient, Blood test, Chest pain, Dyspnoea, Electrocardiogram, Neck pain, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN [SALBUTAMOL]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood test; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results; Test Date: 20210824; Test Name: ECG; Result Unstructured Data: Test Result:Unknown Results; Comments: Unknown Results
CDC Split Type: IEPFIZER INC202101193686

Write-up: Vomiting; Severe pain upper neck / Base of skull; Breathing difficulty (not asthma attack); Chest pain; Weakness; Temporary complete loss of sight / blindness; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-083252. Safety Report Unique Identifier IE-HPRA-CVARR2021082418391. A 17-year-old female patient received second dose of BNT162B2 (COMIRNATY COVID-19 mRNA vaccine, solution for injection, lot number: FE9174), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included Asthmatic (asthma) from an unknown date and unknown if ongoing. Concomitant medications included salbutamol (VENTOLIN [SALBUTAMOL]) (when required) taken for asthma, start and stop date were not reported; paracetamol (500mg 4 times daily) brand unspecified taken for an unspecified indication from 23Aug2021 to 24Aug2021. Patient previously received first dose of BNT162B2 (COMIRNATY COVID-19 mRNA vaccine, solution for injection, lot number: unknown), first dose via an unspecified route of administration on 02Aug2021 as dose 1, single for COVID-19 immunisation. The patient experienced on 24Aug2021 3:00, the patient experienced severe pain in her upper neck and base of skull, temporary complete loss of sight/ blindness, chest pain, breathing difficulty (not asthma attack), weakness and vomiting. The duration of the reaction was reported as approximately 15 minutes. The patient attended the Accident and Emergency department by ambulance. No treatment was administered. The patient lab test which included blood tests and electrocardiogram (ECG) were carried out (results of which were not provided in the report) unknown results on 24Aug2021. The reporter noted that symptoms (breathing, chest pain, blindness) resolved slowly post-vomiting. The outcome of the events was unknown at the time of reporting. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746980 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101188473

Write-up: Abscess lymph node bundle armpit right; Abscess lymph node bundle armpit right; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority[IT-MINISAL02-781879]. A 35-year-old male patient received the second dose of bnt162b2 (COMIRNATY) Intramuscularly in right shoulder on an unspecified date (lot unknown) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced the appearance of a lymph node bundle abscess in the right axilla on 24Aug2021. The patient is taking antibiotic-based drug therapy. The outcome of the event was unknown. Senders comment: 02Sep2021 RLFV: requests for further information from the reporter such as batch, date and time of vaccination, clinical evolution, outcome of the reaction, information on the first dose, clinical history, any allergies, any drugs taken. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1747215 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003652 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Chills, Coordination abnormal, Dizziness, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Arrhythmia; Coordination disturbance; Dizziness; Chills; Pyrexia; Headache; This case was received via Agency Regulatory Authority(Reference number: LT-SMCA-5805N) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia) in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003652) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes mellitus. Concomitant products included METFORMIN and HYDROCHLOROTHIAZIDE, VALSARTAN (VALSACOMBI) for an unknown indication. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) at an unspecified dose. On 24-Aug-2021, the patient experienced ARRHYTHMIA (Arrhythmia) (seriousness criterion medically significant), COORDINATION ABNORMAL (Coordination disturbance), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Pyrexia) and HEADACHE (Headache). At the time of the report, ARRHYTHMIA (Arrhythmia), COORDINATION ABNORMAL (Coordination disturbance), DIZZINESS (Dizziness), CHILLS (Chills), PYREXIA (Pyrexia) and HEADACHE (Headache) outcome was unknown. Treatment medication was not provided by the reporter. Company Comment: This case concerns a 68-year-old female patient with relevant medical history of Diabetes mellitus ,who experienced the serious unexpected event of Arrhythmia.The event occurred on the same day after second dose of Spikevax on 24-Aug-2021,The rechallenge was unknown since no information about the first dose was disclosed.The patient''s advanced age and medical history Diabetes mellitus remains as confounders . The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 68-year-old female patient with relevant medical history of Diabetes mellitus ,who experienced the serious unexpected event of Arrhythmia.The event occurred on the same day after second dose of Spikevax on 24-Aug-2021,The rechallenge was unknown since no information about the first dose was disclosed.The patient''s advanced age and medical history Diabetes mellitus remains as confounders . The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1747231 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Hyperthermia, Inflammation, Myalgia, Oedema, Oedema peripheral, Pain, Pyrexia, Sensitive skin, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:Fever greater than or equal to 38 Celsius degrees
CDC Split Type: MXPFIZER INC202101190279

Write-up: Fever greater than or equal to 38 Celsius degrees; Pain; Sensitivity; Edema/edema of the left thoracic limb that includes up to the neck; Inflammation; Myalgia; Arthralgia; Hyperthermia; pain at the application site; edema of the left thoracic limb that includes up to the neck; This is a spontaneous report from a non-contactable other health professional. This is a report received from Regulatory Authority (RA) via email. The regulatory authority report number is 17508-9. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), intramuscular, administered in left arm, on 23Aug2021 (Batch/Lot Number: FF2595; Expiration Date: 31Dec2021), at age 37 years old, as dose 2, single, for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes mellitus type 2 and dyslipidemia both from unknown dates, not reported if ongoing or not. Th patient did not have an infectious disease in the past 15 days prior to vaccination. The patient has no allergies. Concomitant medications were not reported. On 24Aug2021, 15 hours after the vaccination, the patient experienced fever greater than or equal to 38 Celsius degrees, pain, sensitivity, edema/edema of the left thoracic limb that includes up to the neck, inflammation, myalgia, arthralgia, hyperthermia, and pain at the application site. Treatment for the events included paracetamol 1 gram, diclofenac every 12 hours and intramuscular dexamethasone single dose. "Treatment received before receiving medical attention: No" was reported. The outcome of the events was unknown. ESAVI type was reported as non-serious No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747396 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-08-24
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / 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: 20210828; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: PTPFIZER INC202101216232

Write-up: Vaccine response impaired; SARS-CoV-2 virus infection; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory authority-WEB. This is a report received from Regulatory authority report number [PT-INFARMED-T202108-3860] with Safety Report Unique Identifier [PT-INFARMED-T202108-3860]. The spontaneous report refers to a case sent by other health professional about a 48-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD1921), via intramuscular on 09Jun2021 as DOSE 1, 0.3 ML SINGLE and second dose of COMIRNATY (Batch/Lot Number: FE6029), via intramuscular on 07Jul2021 as DOSE 2, 0.3 ML SINGLE; both doses for COVID-19 immunisation. The dose interval was 28 days, cumulative dose of 1 mL. Clinical history, as well as previous infection with the SARS-CoV-2 virus, was unknown. Information on previous reactions to other drugs or identified allergies was unknown. Concomitant medications were not reported. The patient presented "Vaccine response impaired" associated with the use of Comirnaty/ mRNA vaccine against COVID -19 (with modified nucleoside). Adverse reaction (ADR) was identified on 24Aug2021, approximately 7 weeks after inoculation of the second dose (11 weeks after the first dose). The duration of the reaction was unknown. No information was provided as to whether the SARS-CoV-2 virus infection was symptomatic. The suspected drug was not suspended, as the initially planned 2-dose schedule was fulfilled. There was no suspicion of drug interactions. The need for specific treatment of SARS-CoV-2 infection was unknown, Additional data: no information was provided on the contact/situation that may have caused this contagion. Biological collection PCR test was performed on 28Aug2021, with a positive result on the same day. The reporter''s assessment of the causal relationship of the [Vaccination failure, COVID-19] 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. Evolution and outcome of the adverse drug reaction was unknown. Reporter''s comments: Other information-Collection PCR on 28Aug2021, at (PRIVACY), with positive result on the same day. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Other information-Collection PCR on 28Aug2021, at (PRIVACY), with positive result on the same day.


VAERS ID: 1747398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-08-24
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 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: 20210826; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Iu international unit(s)
CDC Split Type: PTPFIZER INC202101236778

Write-up: Vaccine against COVID-19 - Vaccine failure - User with a complete vaccine schedule for $g2 weeks had COVID-19; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. This is a report received from regulatory authority report number PT-INFARMED-T202109-144 with Safety Report Unique Identifier PT-INFARMED-T202109-144. A 61-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: FA4632, Expiry date: Unknown) via intramuscularly on 15Jun2021 as dose 2, 0.3 ml single and bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: EX8680, Expiry date: Unknown) via intramuscularly on 18May2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced vaccine against covid-19, vaccine failure user with a complete vaccine schedule for $g2 weeks had covid-19. Onset of symptoms associated with SARS-CoV-2 infection approximately 2 days prior to testing. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Aug2021 Iu international units. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected. The reporter''s assessment of the causal relationship of the [Vaccination failure, COVID-19] 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.; Reporter''s Comments: Other information-Symptoms starting on 24Aug2021 Test carried out on 26Aug2021


VAERS ID: 1747410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 infection
Allergies:
Diagnostic Lab Data: Test Date: 20201205; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: ROPFIZER INC202101222571

Write-up: Pain stomach; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) WEB, regulatory authority number RO-NMA-2021-SPCOV12510. A 35-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Aug2021 (Batch/Lot Number: FD4555) as single dose for covid-19 immunisation. Medical history included SARS-CoV-2 infection (confirmed by a PCR test effectuated on 05Dec2020). The patient was not diagnosed with SARS-CoV-2 infection after vaccination. The patient''s concomitant medications were not reported. The patient received first dose COMIRNATY as historical vaccine on 02Aug2021, lot number FD4555. The patient experienced pain stomach on 24Aug2021. The event was serious with life-threatening. The outcome of the event was unknown.


VAERS ID: 1747447 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-24
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004955 / 2 - / OT

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

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

Write-up: This case was received via regulatory authority (Reference number: SE-MPA-2021-083095) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE, ARTHRALGIA and MYALGIA in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004955) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2021, the patient experienced MYALGIA (seriousness criterion disability). On 24-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced FATIGUE (seriousness criterion disability) and ARTHRALGIA (seriousness criterion disability). At the time of the report, FATIGUE and ARTHRALGIA had not resolved and MYALGIA outcome was unknown. Concomitant product use was not provided by reporter. Treatment information was not provided. Company Comment : This case concerns a 46-year-old, male patient with no relevant medical history, who experienced the serious, unexpected event of Fatigue, Arthralgia and Myalgia. The events of Fatigue and Arthralgia occurred 47 days after the second dose of mRNA-1273 and Myalgia occurred unknown days after the second dose of mRNA-1273. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translated document received on 27 Sep 2021 include no new information.; Sender''s Comments: This case concerns a 46-year-old, male patient with no relevant medical history, who experienced the serious, unexpected event of Fatigue, Arthralgia and Myalgia. The events of Fatigue and Arthralgia occurred 47 days after the second dose of mRNA-1273 and Myalgia occurred unknown days after the second dose of mRNA-1273. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1749211 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCPT7 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101231360

Write-up: This is a spontaneous report from a noncontactable consumer or other non-HCP, downloaded via the regulatory authority (DE-PEI-202100191243). A 56-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# SCPT7; expiry date: not reported), at the vaccination age of 56, via an unspecified route of administration, on Aug 17, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. The historical vaccine included the 1st dose of BNT162B2 (Comirnaty, Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot/batch# FD9234; expiry date: not reported), via an unspecified route of administration, on Jul 7, 2021, single dose, for COVID-19 immunization. On Aug 24, 2021, patient had peripheral facial nerve palsy; with outcome of not recovered. Sender''s comments: First vaccination with Comirnaty FD9234 on Jul 7, 2021. Result of Assessment: Comirnaty/event(s): D. Unclassifiable. Batch/lot number: SCPT7. No follow-up attempts possible. No further information expected.


VAERS ID: 1750664 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Fatigue, Maternal exposure during pregnancy, Myalgia, Pain in extremity, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIMODERNATX, INC.MOD20213

Write-up: Vaccine exposure during pregnancy; Miscarriage; Abdominal pain; Pain in arm; Exhaustion; Myalgia; Pyrexia; This case was received via Regulatory Agency (Reference number: FI-FIMEA-20214750) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), ABORTION SPONTANEOUS (Miscarriage), ABDOMINAL PAIN (Abdominal pain), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Exhaustion), MYALGIA (Myalgia) and PYREXIA (Pyrexia) in a 34-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 24-Aug-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) (seriousness criterion medically significant), ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain in arm) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), MYALGIA (Myalgia) (seriousness criterion medically significant) and PYREXIA (Pyrexia) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Spontaneous Abortion NOS. On 24-Aug-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. At the time of the report, ABORTION SPONTANEOUS (Miscarriage), ABDOMINAL PAIN (Abdominal pain), PAIN IN EXTREMITY (Pain in arm), FATIGUE (Exhaustion), MYALGIA (Myalgia) and PYREXIA (Pyrexia) was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No concomitant and treatment medication were provided This case concerns a 34-year-old pregnant female with no relevant medical history, who experienced the unexpected serious events of maternal exposure during pregnancy, spontaneous abortion, abdominal pain, pain in the extremity, fatigue, myalgia and pyrexia. The event spontaneous abortion occurred on the same day after the first dose of Moderna mRNA-1273 vaccine. The gestational age of pregnancy/LMP was not reported. The rechallenge is not applicable as the events occurred after the first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine in not affected by this report.; Sender''s Comments: This case concerns a 34-year-old pregnant female with no relevant medical history, who experienced the unexpected serious events of maternal exposure during pregnancy, spontaneous abortion, abdominal pain, pain in the extremity, fatigue, myalgia and pyrexia. The event spontaneous abortion occurred on the same day after the first dose of Moderna mRNA-1273 vaccine. The gestational age of pregnancy/LMP was not reported. The rechallenge is not applicable as the events occurred after the first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine in not affected by this report.


VAERS ID: 1750801 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-24
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101222872

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number FR-AFSSAPS-RN20212760. A 26-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date not reported), intramuscular, administered in left arm on 06Aug2021 as dose 2, single for covid-19 immunisation. The patient had no medical history (reported as no previous history), no covid-19 history and no known allergy. The patient was not tested for COVID-19. The patient''s concomitant medications were not reported. At the time of vaccination, the patient was pregnant (1st trimester of pregnancy) (without additional information). On 24Aug2021, 18 days after vaccination, she had a miscarriage. She consulted a doctor. The event was reported as disabling symptoms. The patient recovered with sequelae on 24Aug2021 from the event miscarriage. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1750910 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Dizziness, Feeling abnormal, Headache, Inappropriate schedule of product administration, Joint stiffness, Musculoskeletal stiffness, Neck pain, Pain in extremity, Photophobia, SARS-CoV-2 test, Seizure, Tremor, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Duac
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Stress.
Allergies:
Diagnostic Lab Data: Test Name: CT brain; Result Unstructured Data: Test Result: Normal; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101226831

Write-up: seizure; neck pain; headache; blurred vision; shaking/shaking symptoms; Pain in extremity/pain in arms; dizziness; Photophobia/sensitivity to light; Feeling abnormal; Joint stiffness/stiffening of the jaw; Musculoskeletal stiffness/stiffening of limbs; brain fog; received first dose on 28Jun2021; received second dose on 24Aug2021; This is a spontaneous report from a contactable other HCP. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202109141853124470-EMKDV, Safety Report Unique Identifier GB-MHRA-ADR 25940746. A 29-year-old female patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: FF3319; expiration date not provided) via an unspecified route of administration on 24Aug2021 (at the age of 29-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. Patient''s medical history included stress and acne from unspecified dates and unknown if ongoing. It was unsure if patient has had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Concomitant medication included benzoyl peroxide, clindamycin phosphate (DUAC) from 17May2017 to 25Mar2021 for acne. Patient previously received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: FD5613; expiration date not provided) via an unspecified route of administration on 28Jun2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient experienced seizure, neck pain, headache, blurred vision, ''shaking/shaking symptoms'', ''pain in extremity/pain in arms'', dizziness, ''photophobia/sensitivity to light'', feeling abnormal, ''joint stiffness/stiffening of the jaw'', ''musculoskeletal stiffness/stiffening of limbs'', and brain fog on unspecified dates; ''received first dose on 28Jun2021; received second dose on 24Aug2021''. Patient''s clinical course was as follows: It was reported that patient decided to go ahead with second vaccine to protect covid given mild symptoms vs risk of covid. Patient experienced some shaking symptoms and stiffening of the jaw. It was also reported that after second vaccination on 24Aug2021, patient reported a seizure - no fitting or LOC (as reported), no incontinence with stiffening of limbs. Patient also had neck pain, headache, blurred vision, sensitivity to light, pain in arms, dizziness, and brain fog. Patient was seen on two occasions in hospital (A&E) secondary Care. CT brain was normal. Patient has been advised that it was likely related to stress rather than vaccine. Patient did not have symptoms prior to the vaccinations. Awaits appointment with Neurology. The event ''received first dose on 28Jun2021; received second dose on 24Aug2021'' was assessed as non-serious; the remaining events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included CT brain with result of ''normal'' and COVID-19 virus test with result of ''negative; No - Negative COVID-19 test'' on unspecified dates. It was also mentioned that the report does not relate to possible blood clots or low platelet counts. Outcome of the event seizure was not recovered; outcome of the remaining events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1750959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypomenorrhoea, Menstrual disorder, Menstruation delayed, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), Medication errors (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101226653

Write-up: ongoing breastfeeding; ongoing breastfeeding; Short menstruation; Menstrual flow altered; Menstruation delayed; This is a spontaneous report from a contactable consumer. This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109170851396240-RYKET, Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25957722. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included ongoing breast feeding. Patient is not pregnant The patient''s concomitant medications were not reported. The patient experienced menstruation delayed on 24Aug2021, short menstruation on 31Aug2021, menstrual flow altered on 31Aug2021. Additional information reported: note that menstrual flow altered selected above refers specifically to flow very reduced compared to normal. The events were considered medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 19May2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101233435 baby


VAERS ID: 1750992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chromaturia, Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test, Urine odour abnormal, Vaginal discharge
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210903; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226968

Write-up: Urine is brighter and smells different; Urine is brighter and smells different; Period has been much more painful and heavier; Period has been much more painful and heavier; Discharge - light brown, smells different; This is a spontaneous report from a contactable consumer, received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109171204591780-JARHD, Safety Report Unique Identifier GB-MHRA-ADR 25958565. A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Aug2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 First dose on unknown date for COVID-19 immunization on an unspecified date. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. On 24Aug2021, the patient experienced Discharge - light brown, smells different. Urine is brighter and smells different from unknown date. Period has been much more painful and heavier since 26Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 03Sep2021 No - Negative COVID-19 test. Outcome of the events Discharge - light brown, smells different was not recovered. Outcome of events Period has been much more painful and heavier was recovered in 2021. Outcome of Urine is brighter and smells different was unknown. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1751039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s disease; Hypermobility syndrome; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Myalgic encephalomyelitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226553

Write-up: Menstrual cycle abnormal; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109171653436610-ZUUWQ, Safety Report Unique Identifier GB-MHRA-ADR 25960221. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 17Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included crohn''s disease, inflammatory bowel disease (taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis) from an unknown date and unknown if ongoing, hypermobility, ME (myalgic encephalomyelitis) from an unknown date and unknown if ongoing. Patient not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Concomitant medication included budesonide taken for crohn''s disease from 15Jul2021 to an unspecified stop date. The patient experienced menstrual cycle abnormal on 24Aug2021. Clinical course: period has come on three times since having the vaccine-usually 4 weeks in between, regular periods. Timeframe between vaccination and starting of event was 7 days. Since the vaccination, the patient was not tested positive for COVID-19. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751188 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hallucination, auditory, Pain in extremity, Rhinorrhoea, Sneezing, Sudden hearing loss
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hearing impairment (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (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: Tinnitus (for around 13 years.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226760

Write-up: Loss of hearing; Sore arm 3days; Sudden hearing loss; Sneezing; Runny nose; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109182024320780-XS96L, Safety Report Unique Identifier is GB-MHRA-ADR 25965191. A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: Ff3319), via an unspecified route of administration on 22Aug2021 as dose 1, single for covid-19 immunization. The patient medical history included tinnitus (have suffered for around 13 years) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 24Aug2021, the patient had sneezing and runny nose. On 27Aug2021, the patient had sudden hearing loss. On an unspecified date, had loss of hearing and sore arm 3days. Sore arm 3days, runny nose and sneezing on 3rd day. With slight hearing loss. 5th day really noticeable loss of hearing in his left ear. No recovery. The reporter considered the events as serious (disability). The outcome of all events was not recovered. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: GP visit, amoxicillin pills suspected infection. No follow-up attempts possible. No further information expected.


VAERS ID: 1751418 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema multiforme, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101222320

Write-up: Erythema multiforme exudativum; eruption of limbs/Skin eruption; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21127057. A 64-year-old (also reported as: 64-year and 4-month-old) female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Aug2021 (the day of vaccination) (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. On 01Aug2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# number and Expiration date were unknown) for COVID-19 immunisation. On 24Aug2021 around 15:00 (2 days after the vaccination), the patient experienced Erythema multiforme exudativum. The course of the event was as follows: On 22Aug2021, the 2nd vaccination against Coronavirus was performed. On 23Aug2021, the patient took oral BUFFERIN. On 24Aug2021, the patient had eruption of limbs and presented to our hospital on 25Aug2021. Skin eruption was scattered on the limbs and trunk, and the patient was diagnosed with erythema multiforme exudativum on physician office visit. The treatment started with PSL (prednisolone) at the dose of 10mg, which was being tapered to 5mg on 30Aug2021. Skin eruption is showing improving tendency. On 30Aug2021 (8 days after the vaccination), the outcome of the event was recovered. The reporting physician classified the event as serious (Medically significant) and assessed that the event was related to bnt162b2. Other possible cause(s) of the event such as any other diseases was oral BUFFERIN. Reporter''s Comment: The reporting physician commented as follows: While the possibility of BUFFERIN causing the event cannot be ruled out because the patient took it orally on the following day of the vaccination, the onset of the event is probably due to vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reporter''s Comments: The reporting physician commented as follows: While the possibility of BUFFERIN causing the event cannot be ruled out because the patient took it orally on the following day of the vaccination, the onset of the event is probably due to vaccination.


VAERS ID: 1751526 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-24
   Days after vaccination:84
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Fatigue, Headache, SARS-CoV-2 test, SARS-CoV-2 test positive, Sneezing, Tinnitus
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hearing impairment (narrow), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: COVID-19 rapid POC; Result Unstructured Data: Test Result:positive
CDC Split Type: NLPFIZER INC202101210792

Write-up: I did a rapid test and it came out positive; I did a rapid test and it came out positive; severe headache which made my ear peep; severe headache which made my ear peep; Had to sneeze every 5-10 minutes; tired; This is a spontaneous report from a contactable consumer. A 29-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Jun2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE (at the age of 29 years) for covid-19 immunisation. The patient received first dose of Comirnaty on 11May2021 for Covid-19 immunization and did not experience any adverse events. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 25Aug2021 the patient experienced "I did a rapid test and it came out positive" (medical significant) with outcome of unknown, severe headache which made my ear peep on 24Aug2021 with outcome of unknown, had to sneeze every 5-10 minutes on 24Aug2021 with outcome of unknown and tired on 24Aug2021 with outcome of unknown. Treatment was received for severe headache which made my ear peep, had to sneeze every 5-10 minutes, and tired. The patient was treated with paracetamol. The patient had a positive SARS-CoV-2 test on 25Aug2021 which was positive.


VAERS ID: 1751538 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA FE2090 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 immunisation, Retinal vein occlusion, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: grenvenetrombose; grenvenetrombose; Revaccination with different COVID-19 vaccine; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00049230) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of RETINAL VEIN OCCLUSION (grenvenetrombose) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch no. FE2090) for Vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Vaccination: Comirnaty. Past adverse reactions to the above products included No adverse reaction with Comirnaty. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). On 28-Aug-2021, the patient experienced RETINAL VEIN OCCLUSION (grenvenetrombose) (seriousness criteria hospitalization and medically significant). At the time of the report, RETINAL VEIN OCCLUSION (grenvenetrombose) had resolved and COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered RETINAL VEIN OCCLUSION (grenvenetrombose) to be possibly related. No further causality assessment was provided for COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine). Concomitant medications use were not provided. Patient had acute retinal vein branch occlusion and loss of vision upwards to the right of the right eye and blurred vision. Then admitted to hospital due to acute symptoms of blurred vision and reduced vision. Patient was discharged after two days. Symptoms was normalized on control after two weeks. No treatment information was provided. Company Comment: This is a case of revaccination with different Covid-19 vaccine for this 53-year-old, female patient with no relevant medical history, who experienced the unexpected event of retinal vein occlusion and vision blurred. The events retinal vein occlusion and vision blurred occurred 5 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable because the patient received other brand of Covid 19 vaccine (Comirnaty) for the first dose. The event retinal vein occlusion was considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translated document received on 27-Sep-2021 included no new information.; Sender''s Comments: This is a case of revaccination with different Covid-19 vaccine for this 53-year-old, female patient with no relevant medical history, who experienced the unexpected event of retinal vein occlusion and vision blurred. The events retinal vein occlusion and vision blurred occurred 5 days after the second dose of mRNA-1273 vaccine administration. The rechallenge was not applicable because the patient received other brand of Covid 19 vaccine (Comirnaty) for the first dose. The event retinal vein occlusion was considered possibly related to the product per the reporter''s assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1751575 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-08-24
   Days after vaccination:194
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: Test done on 23Aug2021, positive result on 24Aug2021.
CDC Split Type: PTPFIZER INC202101250467

Write-up: asymptomatic COVID-19; Vaccination failure associate with COMIRNATY use; This is a Spontaneous report from a contactable Pharmacist downloaded from the WEB. This is a report received from INFARMED Regulatory authority report number PT-INFARMED-F202109-1574 with Safety Report Unique Identifier PT-INFARMED-F202109-1574. A 61-years-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular on 11Feb2021 (Batch/Lot Number: EM6950) as dose 2, 0.3 ml single, dose 1 intramuscular on 21Jan2021 (Batch/Lot Number: EL1484) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications. Information on previous infection with the SARS-CoV-2 virus was unknown. No previous reactions to other drugs or identified allergies are known. There was no suspicion of drug interactions. There was no reference to the taking of concomitant medications and/or reference to the concomitant consumption of other types of products. There was no history of comorbidities. It was reported patient had good clinical conditions. On 24Aug2021, the patient experienced asymptomatic covid-19. The vaccination failure was identified around 192 days after the dose 2 of the vaccine, with an approximate duration of 10 days. According to information provided by the institutions occupational medicine, the individual was currently asymptomatic. The need for specific treatment of SARS-CoV-2 infection was unknown. The patient tested positive for SARS-Cov-2 infection on 24Aug2021 (PCR test performed on 23Aug2021). No risk contact was reported. Patient did not perform immunity test. At the time of this report, the outcome of asymptomatic covid-19 was recovered on 02Sep2021. Reporter comment: Information contained in the attached document. The reporter''s assessment of the causal relationship of the event (COVID-19 and vaccination failure) with the suspect product was: Relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: Definitive. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: r information: Information contained in the attached document.


VAERS ID: 1751576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-08-24
   Days after vaccination:217
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: COVID-19 antibody test; Result Unstructured Data: Test Result:3590.3 AU/ml; Comments: immunity study was done by immunoassay of particles by chemiluminescence to IgG anti S (EIA - version 3); Standardized unit OMS: BAU/ml = 0.142xUA/ml. medicine under additional monitoring; Test Date: 20210823; Test Name: SARS-Cov-2 PCR test; Test Result: Positive ; Comments: tested positive for SARS-Cov-2 infection on 24Aug2021 (PCR test performed on 23Aug2021).
CDC Split Type: PTPFIZER INC202101250459

Write-up: Vaccine failure associated with the use of Comirnaty; Vaccine failure associated with the use of Comirnaty; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number PT-INFARMED-F202109-1579. A 55-year-old female patient received BNT162B2 (COMIRNATY, 30 ug, mRNA vaccine, formulation: Solution for injection, Lot Number: EL1484), via intramuscular route of administration on 19Jan2021 as dose 2, 0.3 ml single and received BNT162B2 (COMIRNATY, 30 ug, mRNA vaccine, formulation: Solution for injection, Lot Number: EJ6797), via intramuscular route of administration on 29Dec2020 as dose 1, 0.3 ml single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was stated that, the vaccine was given at an interval of at least 21 days between each dose. Information on previous infection with the SARS-CoV-2 virus is unknown. There is no suspected interaction between medications. The vaccination failure was identified about 217 days after the 2nd dose of the vaccine, with an approximate duration of 10 days. No previous reactions to other drugs or known allergies. There is no history of comorbidity. No risk contact was reported. On 24Aug2021, the patient experienced vaccine failure associated with the use of COMIRNATY (asymptomatic, with modified nucleoside). The patient underwent lab tests and procedures which included SARS-Cov-2 infection on 24Aug2021 (PCR test performed on 23Aug2021) and immunity study: 3590.3 AU/ml on 26Aug2021 (The immunity study was done by immunoassay of particles by chemiluminescence to IgG anti S (EIA - version 3); Standardized unit OMS: BAU/ml = 0.142xUA/ml. medicine under additional monitoring). The seriousness of the event was serious and medically significant. The outcome of the event was recovered on 02Sep2021. The reporter assessment of the causal relationship of the (vaccination failure, COVID-19) with the suspect product was Source of assessment: reporter, Method of assessment: unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-Information contained in the attached document.


VAERS ID: 1753056 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-08-24
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No.
CDC Split Type: ATPFIZER INC202101238846

Write-up: Inappropriate schedule of vaccine administered; Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number AT-2021-044508. A 68-years-old female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD1921) via intramuscular route of administration on 03Jun2021 as single dose, first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EW4815) via intramuscular on 21Apr2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 24Aug2021 the patient experienced SARS-CoV-2 infection, other, Vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on unspecified date Variant PCR-based: B.1.617.2 Sequenced variant: n.a. n501y-positive: No. No follow-up attempts possible. No further information expected.


VAERS ID: 1754398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-24
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Herpes zoster, Mixed anxiety and depressive disorder, Panic attack
SMQs:, Depression (excl suicide and self injury) (narrow), Hypoglycaemia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202101228572

Write-up: Panic attacks; Herpes zoster; Anxiodepressive syndrome; Acute anxiety; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21010526. A 32-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection) intramuscularly on 24Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient had not tested positive for COVID-19 since having the vaccine, patient was not enrolled in clinical trial. It was reported that the patient 1 month after vaccination experienced panic attacks, herpes zoster, anxiodepressive syndrome and acute anxiety on 24Aug2021. The events seriousness was assessed as medically significant. The clinical outcome of events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.


VAERS ID: 1754700 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-08-24
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: This case was received via regulatory authority (Reference number: ES-AEMPS-986796) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PALPITATIONS and CHEST PAIN in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 2) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced PALPITATIONS (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced CHEST PAIN (seriousness criterion medically significant). At the time of the report, PALPITATIONS was resolving and CHEST PAIN had not resolved. mRNA-1273 (Spikevax) (Unknown) and mRNA-1273 (Spikevax) (Intramuscular) was withdrawn in July 2021. No concomitant medications were not reported. No treatment medications were not provided. Company Comment: This case concerns a 27-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of chest pain and palpitations. The event of palpitations occurred on the same day after the second dose of Spikevax and the event of chest pain occurred around 2 days after the second dose of Spikevax. The rechallenge was not applicable, as the event occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of Spikevax in not affected by this report.; Sender''s Comments: This case concerns a 27-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of chest pain and palpitations. The event of palpitations occurred on the same day after the second dose of Spikevax and the event of chest pain occurred around 2 days after the second dose of Spikevax. The rechallenge was not applicable, as the event occurred after the second dose and no additional dosing will be given. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1754798 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-24
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, C-reactive protein, Chest pain, Dyspnoea, Fibrin D dimer, Investigation, Prostatic specific antigen, Pulmonary embolism, Pulmonary infarction, Pulmonary pain, Respiratory rate, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Angiography; Result Unstructured Data: Test Result:bilateral segmental pulmonary embolism; Comments: + right base pulmonary infarction; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30; Test Name: D-Dimer; Result Unstructured Data: Test Result:1925; Test Name: Thrombophilia test; Result Unstructured Data: Test Result:Pending; Test Name: prostate-specific antigen test; Result Unstructured Data: Test Result:Pending; Test Date: 20210822; Test Name: respiratory status; Result Unstructured Data: Test Result:normal; Comments: with exertion; Test Date: 20210825; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative
CDC Split Type: FRPFIZER INC202101229269

Write-up: Right base pulmonary infarction; Pulmonary embolism / bilateral segmental pulmonary embolism; right lung pain; serious shortness of breath during physical activity / exertion dyspnea; right chest pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-BR20213431. A 48-year-old male patient received the first dose of BNT162b2 (COMIRNATY), intramuscular on 26Jul2021 (Batch/Lot Number: FF3318) 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 pulmonary embolism/bilateral segmental pulmonary embolism, right lung pain, serious shortness of breath during physical activity/exertion dyspnea, right chest pain, all on 24Aug2021; and right base pulmonary infarction on an unspecified date. The clinical course was as follows: On 24Aug2021, pulmonary embolism detected after right lung pain and serious shortness of breath during physical activity. No known risk factors. Hospitalization report: patient was a high-level athlete, no alcohol or tobacco intoxication with strong endurance activity recently (cycling). No specific personal or family history of cardiovascular disease or thrombosis. On 22Aug2021, normal respiratory status with exertion. On 23Aug2021, road trip. Since 24Aug2021, exertion dyspnea + right chest pain appeared with effort while cycling. SARS-CoV-2 test on 25Aug2021 was negative. On an unknown date, blood work-up shows D-Dimer at 1925 and C-reactive protein at 30, angiography revealed bilateral segmental pulmonary embolism + right base pulmonary infarction, thrombophilia test was pending as well as a prostate-specific antigen test. Patient was admitted to the hospital. Upon discharge, patient was on Xarelto for 6 months then to be re-evaluated. Outcome of the events was recovering.


VAERS ID: 1754835 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-02-01
Onset:2021-08-24
   Days after vaccination:570
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Ascites, Blood creatinine, Blood triglycerides, Immunisation, Investigation, Off label use, Pancreatitis acute, Respiratory distress, Splenomegaly, Ultrasound scan
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EU
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Insufficiency renal; Myeloma
Allergies:
Diagnostic Lab Data: Test Name: baseline creatinine; Result Unstructured Data: Test Result:14 mg/l; Test Date: 20210831; Test Name: triglycerides; Result Unstructured Data: Test Result:1.15 g/l; Comments: return to normal at 1.15 g/L; Test Name: aetiological investigation; Result Unstructured Data: Test Result:alcoholic origin: no evidence of excessive alcohol; Comments: alcoholic origin: no evidence of excessive alcohol consumption -lithiasis origin: absence of biliary lithiasis demonstrated by abdominal ultrasound.; Test Name: investigation; Result Unstructured Data: Test Result:10,575 IU/l; Comments: Lipasemia was found to be 10,575 IU/L (normal value: <160 IU/L); Test Name: Ultrasound; Result Unstructured Data: Test Result:reveals a discrete splenomegaly and a small slopin; Comments: reveals a discrete splenomegaly and a small sloping peritoneal effusion
CDC Split Type: FRPFIZER INC202101222681

Write-up: Acute pancreatitis; acute respiratory failure; respiratory distress; discrete splenomegaly; peritoneal effusion; off label use/ dose 3 of bnt162b2; off label use/ dose 3 of bnt162b2; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB FR-AFSSAPS-LL20216327. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 24Aug2021 (Batch/Lot Number: Unknown) at the age of 67-years-old as dose 3 (boster), single for covid-19 immunisation; daratumumab, intravenous from Feb2020 (Batch/Lot Number: Unknown) to 13Aug2021 for myeloma; lenalidomide (REVLIMID), oral from Feb2020 (Batch/Lot Number: Unknown) to 22Aug2021, at cycled 1 capsule/day for myeloma; sulfamethoxazole, trimethoprim (BACTRIM), oral from Feb2020 (Batch/Lot Number: Unknown) to 31Aug2021 for prophylaxis; for unspecified dosing frequency. Medical history included hypertension arterial, insufficiency renal without dialysis (baseline creatinine 14 mg/L) and immunoglobulin G kappa myeloma from an unknown date and unknown if ongoing. In the context of a myeloma, the patient was treated with a 1st line of treatment with Velcade-Thalidomide-Dexamethasone (VTD) (bortezomib, thalidomide, dexamethasone) in 2015-2016 followed by an autotransplant of haematopoietic stem cells after intensification with high-dose melphalan, and then a 2nd line of treatment with DRD (DARZALEX (daratumumab), REVLIMID (lenalidomide), and dexamethasone) initiated in 2020 with a complete response since Sep2021. Note the poor digestive and neurological tolerance of lenalidomide. Concomitant medications included crataegus spp., quinine benzoate (OKIMUS) from Feb2020; dexamethasone from Feb2021; urapidil (EUPRESSYL); nicardipine; celiprolol; ezetimibe; prednisolone; rosuvastatin calcium (CRESTOR) start date to 31Aug2021; esomeprazole; pregabalin from May2020; racecadotril (TIORFAN) from Jun2021; diosmectite (SMECTA) from Jun2021; diclofenac from Jun2021 and oxycodone from Jul2021. On 28Aug2021, the patient experienced acute pancreatitis. The patient was admitted to the emergency room on 28Aug2021 due to vomiting and abdominal pain. Lipasemia was found to be 10,575 IU/L (normal value: <160 IU/L). A diagnosis of acute pancreatitis was made. An aetiological investigation was carried out: alcoholic origin: no evidence of excessive alcohol consumption; lithiasis origin: absence of biliary lithiasis demonstrated by abdominal ultrasound. Ultrasound reveals a discrete splenomegaly and a small sloping peritoneal effusion; iatrogenic origin: suspected. On 30Aug2021 the patient experiences acute respiratory failure and respiratory distress. On 31Aug2021, no hypercalcaemia found and triglycerides return to normal at 1.15 g/L (normal value: 0.35-1.35 g/L). On 31Aug2021, discontinuation of BACTRIM and CRESTOR (rosuvastatin). The outcome of event pancreatitis was not recovered; all other events was unknown. No follow-up attempts possible. No further information expected. Information on batch number cannot be obtained.


VAERS ID: 1754899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-24
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Basedow's disease, Blood thyroid stimulating hormone, Thyroid stimulating immunoglobulin, Thyroxine free, Tri-iodothyronine free
SMQs:, Optic nerve disorders (broad), Hyperthyroidism (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seasonal allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: TSH; Result Unstructured Data: Test Result:<0.005 mUI/L; Test Date: 20210903; Test Name: TSH receptor antibodies; Result Unstructured Data: Test Result:positive at 9.4IU/L; Test Date: 20210902; Test Name: FT4; Result Unstructured Data: Test Result:78.8 pmol/L; Test Date: 20210902; Test Name: FT3; Result Unstructured Data: Test Result:21.84 pmol/L
CDC Split Type: FRPFIZER INC202101229327

Write-up: Basedow''s disease/Grave''s disease; This is a spontaneous report from a contactable other health professional downloaded from the RA. The regulatory authority number is FR-AFSSAPS-PO20214868. A 39-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, in the left arm, on 30Jul2021 (Lot number unknown), as dose 1, 0.3 ml single, for COVID-19 immunisation. Relevant medical history included seasonal allergy from an unknown date, not reported if ongoing or not. The patient has no history of COVID-19 infection. Concomitant medications were not reported. In mid Aug2021, after the first vaccination, there was onset of orbitopathy. On 24Aug2021, the patient experienced Basedow''s disease/Grave''s disease (diagnosis). On 25Aug2021, the patient received the second dose of COMIRNATY 0.3 ml, via intramuscular route in the left arm. Biological check-up on 02Sep2021 showed blood thyroid stimulating hormone (TSH) (normal range: 0.27-4.20): <0.005 mUI/L; thyroxine free (FT4) (normal range: 12.0-22.0): 78.8 pmol/L; and tri-iodothyronine free (FT3) (normal range: 3.10-6.80): 21.84 pmol/L. On 03Sep2021, TSH receptor antibodies was positive at 9.4IU/L. The outcome of the event was not resolved. The health authority assessed this report as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1754979 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004234 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bradycardia, Cardiac failure, General physical health deterioration, Parkinson's disease
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (narrow), Cardiomyopathy (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: Atrial fibrillation; Cardiac failure; Disease Parkinson''s
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Cardiac failure aggravated; Parkinson''s disease aggravated; Reduced general condition; Bradycardia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-PO20214865) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC FAILURE (Cardiac failure aggravated), PARKINSON''S DISEASE (Parkinson''s disease aggravated), GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) and BRADYCARDIA (Bradycardia) in an 86-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004234) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 24-Feb-2021. Concurrent medical conditions included Cardiac failure, Atrial fibrillation and Disease Parkinson''s. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter once a day. On 24-Aug-2021, the patient experienced CARDIAC FAILURE (Cardiac failure aggravated) (seriousness criterion life threatening), PARKINSON''S DISEASE (Parkinson''s disease aggravated) (seriousness criterion life threatening), GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) (seriousness criterion life threatening) and BRADYCARDIA (Bradycardia) (seriousness criterion life threatening). On 26-Aug-2021, BRADYCARDIA (Bradycardia) had resolved. At the time of the report, CARDIAC FAILURE (Cardiac failure aggravated), PARKINSON''S DISEASE (Parkinson''s disease aggravated) and GENERAL PHYSICAL HEALTH DETERIORATION (Reduced general condition) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. Company Comment: This case concerns a 86-year-old, female patient with relevant medical history of Cardiac failure, Atrial fibrillation and Disease Parkinson''s. The patient experienced serious events of Cardiac failure, Parkinson''s disease, general physical health deterioration and Bradycardia 8 days after the 1st dose of Spikevax. Rechallege is unknown (no information about second dose) The events are confounded by medical history of Cardiac failure, Atrial fibrillation and Parkinson''s disease . The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 28-Sep-2021 containing no new information.; Sender''s Comments: This case concerns a 86-year-old, female patient with relevant medical history of Cardiac failure, Atrial fibrillation and Disease Parkinson''s. The patient experienced serious events of Cardiac failure, Parkinson''s disease, general physical health deterioration and Bradycardia 8 days after the 1st dose of Spikevax. Rechallege is unknown (no information about second dose) The events are confounded by medical history of Cardiac failure, Atrial fibrillation and Parkinson''s disease . The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1755059 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Body temperature, Chest discomfort, Dyspnoea, Headache, Heart rate, Inappropriate schedule of product administration, Menstruation delayed, Migraine, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Fertility disorders (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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 (Unsure when symptoms stopped); Vaccination site swelling (Previous weak reactions to other jabs (e.g., HPV jabs experienced very red swollen rashy arm))
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:high; Comments: high temperature and advised to get a COVID test.; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101233767

Write-up: short of breath; headache; heart rate; Tight chest; Painful arm; High temperature; Delayed period; Frequent headaches; Shortness of breath; Migraine; Armpit pain; dose 1 on on 29Jun2021 and dose 2 on on 24Aug2021; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109191423345290-ZNTM8. Safety Report Unique Identifier GB-MHRA-ADR 25966089. A patient of an unspecified age and gender received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 2 via an unspecified route of administration on 24Aug2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. Medical history included vaccination site swelling (Previous weak reactions to other jabs (e.g., HPV jabs experienced very red swollen rashy arm), suspected covid-19 from 27Aug2021 (unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 29Jun2021 for covid-19 immunisation. On an unknown date, the patient experienced short of breath, headache, heart rate, tight chest, painful arm, high temperature and delayed period. On 25Aug2021, the patient experienced short-ness of breath, migraine, armpit pain, frequent headaches. On 24Aug2021 Inappropriate schedule of vaccine administered. Previous weak reactions to other jabs (e.g., HPV jabs experienced very red swollen rashy arm). The patient took 3 days off work due to side effects. On Friday 27Aug2021, after experiencing a tight chest/shortness of breath along with a strong headache from the 25Aug2021 to 26Aug2021, the patient was seen by patient doctors. The patient could still breathe and hold a conversation normally but felt like someone was sat on chest and struggled to walk more than 5 minutes down the road (for reference the patient regularly walked 5k each day prior to the vaccine). Heart rate, oxygen concentration and breathing were all deemed to be in the normal range. The doctor noticed the patient had a high temperature and advised to get a COVID test as they were not sure if the reaction was due to the vaccine or as a result of contracting COVID prior to this. The medical advice was if patient felt worse over the weekend to go to A&E immediately. The patient went and got a PCR test/ COVID-19 virus test and this came back negative. At this point patient started to feel better but continued to feel tight chested/short of breath when walking for the next week. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events short of breath, headache, heart rate was recovering and for the event tight chest recovered on 08Sep2021, the event shortness of breath recovered on 04Sep2021, the event migraine recovered on 26Aug2021, the armpit pain recovered on 02Sep2021, the event painful arm recovered on 01Sep2021, the event frequent headaches recovered in Sep2021 and the event high temperature and delayed period recovered on an unknown date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1755176 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101240423

Write-up: Painful arm; First dose on 28Jun2021, second dose on 24Aug2021; This is a spontaneous report from a contactable consumer. This is second of 2 reports. The first report is a report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109191045422400-LVZ4O, Safety Report Unique Identifier GB-MHRA-ADR 25965980. A 21-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not known) via an unspecified route of administration on 24Aug2021 (age at vaccination: 21-year-old) as single dose for COVID-19 immunisation. Medical history included suspected covid-19 from an unknown date and unknown if ongoing and unsure when symptoms started and unsure when symptoms stopped. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number not known) via an unspecified route of administration on 28Jun2021 as single dose for COVID-19 immunization and experienced painful arm on an unspecified date. The patient experienced painful arm on 24Aug2021. The patient underwent lab tests and procedures which included Covid-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of painful arm was reported as resolved on 31Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101233644 same patient, same product, different dose/event


VAERS ID: 1755316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body temperature, Dysentery, Headache, Laboratory test, Pyrexia, Ultrasound abdomen
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
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: body temperature; Result Unstructured Data: Test Result:38.5; Test Name: Impact on quality of life; Result Unstructured Data: Test Result:4/10; Test Name: ultrasound abdomen; Result Unstructured Data: Test Result:results unknown
CDC Split Type: ITPFIZER INC202101231174

Write-up: Sudden bursts of dysentery; fever 38.5; stomach pain; severe headache; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-786017. A 20-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FG4493), intramuscular, administered in arm left on 17Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021 (about 7 days after administration of the first dose of the vaccine), the patient experienced sudden bursts of dysentery. This case is serious (medically significant). On the same day, the patient had fever 38.5, stomach pain and severe headache. On an unspecified date, the patient underwent lab tests and procedures which included body temperature: 38.5 and impact on quality of life: 4/10, ultrasound abdomen: results unknown. Therapeutic measures were taken as a result of sudden bursts of dysentery (dysentery). The patient prescribed milk enzymes. On an unspecified date, outcome of all the events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1755396 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angina pectoris, Gait disturbance, Injection site erythema, Injection site pain, Insomnia, Lymph node pain, Paraesthesia, Tachycardia, Vaccination site reaction, Vascular access site swelling
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Other ischaemic heart disease (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: BRINTELLIX; XANAX
Current Illness: Dependence on tranquillisers (Dependence on Alprazolam since 2017.); Depression (Diagnosis of depression in 2017.); Obesity (Mild obesity.)
Preexisting Conditions: Medical History/Concurrent Conditions: Mediterranean anemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Cardiac pain; Walking difficulty; Tachycardia; Insomnia; Tingling skin; Vaccination site reaction; Lymph node pain; Vascular access site swelling; Injection site redness; Pain injection site; This case was received via regulatory authority (Reference number: IT-MINISAL02-788150) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Cardiac pain) in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Mediterranean anemia. Concurrent medical conditions included Depression (Diagnosis of depression in 2017.) since 2017, Obesity (Mild obesity.) and Dependence on tranquillisers (Dependence on Alprazolam since 2017.). Concomitant products included VORTIOXETINE HYDROBROMIDE (BRINTELLIX) for Anxiety depression, ALPRAZOLAM (XANAX) for an unknown indication. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced ANGINA PECTORIS (Cardiac pain) (seriousness criterion medically significant), GAIT DISTURBANCE (Walking difficulty), TACHYCARDIA (Tachycardia), INSOMNIA (Insomnia), PARAESTHESIA (Tingling skin), VACCINATION SITE REACTION (Vaccination site reaction), LYMPH NODE PAIN (Lymph node pain), VASCULAR ACCESS SITE SWELLING (Vascular access site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PAIN (Pain injection site). At the time of the report, ANGINA PECTORIS (Cardiac pain), GAIT DISTURBANCE (Walking difficulty), TACHYCARDIA (Tachycardia), INSOMNIA (Insomnia), PARAESTHESIA (Tingling skin), VACCINATION SITE REACTION (Vaccination site reaction), LYMPH NODE PAIN (Lymph node pain), VASCULAR ACCESS SITE SWELLING (Vascular access site swelling), INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE PAIN (Pain injection site) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. On 26 Aug 2021, echocardiogram and ultrasound doppler was performed (result not reported). Company comment: This case concerns a 34-year-old female patient with medical history of obesity, who experienced the unexpected, serious event of Angina pectoris. The event occurred on the same day after vaccination with Spikevax. Dose number was not reported, hence the rechallenge was not applicable. The medical history of obesity, remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document. Event angina pectoris was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation received on 29-sep-2021 contains details of medical history was added.; Sender''s Comments: This case concerns a 34-year-old female patient with medical history of obesity, who experienced the unexpected, serious event of Angina pectoris. The event occurred on the same day after vaccination with Spikevax. Dose number was not reported, hence the rechallenge was not applicable. The medical history of obesity, remains as a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Coding, seriousness, and dates of events were captured as per Regulatory Authority assessment provided in Source Document. Event angina pectoris was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.


VAERS ID: 1756451 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003607 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle twitching, SARS-CoV-2 test
SMQs:, Dyskinesia (broad), Dystonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Twitching; This case was received via a regulatory authority (Reference number: XI-EMA-DD-20210913-shaik_i-075040) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Twitching) in a 40-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003607) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced MUSCLE TWITCHING (Twitching) (seriousness criterion medically significant). At the time of the report, MUSCLE TWITCHING (Twitching) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. No treatment information was provided. This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the unexpected event of muscle twitching. The events occurred approximately 4 days after the first dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Reporter''s Comments: This case is a master made from existing duplicates in RA. The case numbers of the underlying duplicates are in the Other Case Identifiers section.; Sender''s Comments: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the unexpected event of muscle twitching. The events occurred approximately 4 days after the first dose of Moderna Covid-19 vaccine. The rechallenge is not applicable in this case. The reporter''s assessment was not provided. The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1757943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211001895

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046402) was received on 01-OCT-2021 and concerned a 47 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 administered on 17-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. 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: 1757947 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211001523

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046436) on 01-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: XD975 expiry: unknown) dose was not reported, 1 total administered on 14-JUL-2021 for drug used for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2) and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2) and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1757979 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-24
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Adenocarcinoma gastric, C-reactive protein, Laboratory test, Metastases to liver, Neoplasm progression, White blood cell count
SMQs:, Malignancy related conditions (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Lymph node metastases (partial remission after palliative no special type-lime chemotherapy)
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: C-reactive protein elevated; Result Unstructured Data: Test Result:C-reactive protein elevated; Comments: C-reactive protein elevated; Test Date: 202105; Test Name: Laboratory results; Result Unstructured Data: Test Result:Anaemia (progressive); Comments: Anaemia (progressive); Test Date: 202105; Test Name: Leukocytes; Result Unstructured Data: Test Result:leukocytes elevated; Comments: leukocytes elevated
CDC Split Type: DEPFIZER INC202101229001

Write-up: Adenocarcinoma gastric; Liver metastases; Tumor progression; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100190487. A 68 years old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 15Jul2021 (at age of 68 years old, Lot Number: FF0900) as a single dose for covid-19 immunization. The patient medical history included progressive lymph nodes, Last May2021 partial remission after palliative no special type-lime chemotherapy. Anaemia (progressive) from May2021. The patient previously took the first dose of bnt162b2 (COMIRNATY) on 10Jun2021 (at age of 68 years old, lot# FC3095) for covid-19 immunization. The patient''s concomitant medications were not reported. On 24Aug2021 the patient experienced Adenocarcinoma gastric, Liver metastases, Tumor progression. The outcome of the events was not recovered. Sender comment: progressive lymph nodes, Last May2021 partial remission after palliative no special type-lime chemotherapy. Laboratory results: Anaemia (progressive), C-reactive protein elevated, leukocytes elevated. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1758007 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Diarrhoea, Dyspnoea, Full blood count, Investigation, Malaise, Mucous stools, Paraesthesia, Paraesthesia oral, Respiratory distress, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Egg allergy; Lactose intolerance
Allergies:
Diagnostic Lab Data: Test Name: Hemogram; Result Unstructured Data: Test Result:No alterations; Test Name: Digestive study; Result Unstructured Data: Test Result:No alterations; Test Date: 20210826; Test Name: COVID-19 antigen test negative; Test Result: Negative
CDC Split Type: ESPFIZER INC202101229235

Write-up: Distress respiratory; Asthenia/Strength loss of; Paraesthesia; Diarrhea; paresthesia in lip region; stools with mucous; polyarthrmialgias; dyspneic sensation; general malaise; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1000395. A 34-years-old male patient received BNT162B2 (COMIRNATY), at the age of 34 years old, dose 1, via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lactose intolerance, food allergy. No hypertension, no diabetes mellitus, no dyslipidemias, no chronic obstructive respiratory disease, no cardiac pathology, no digestive. The patient''s concomitant medications were not reported. The patient experienced distress respiratory (hospitalization, disability) on 24Aug2021 with outcome of recovering, asthenia (hospitalization, disability) on 24Aug2021 with outcome of recovering, paraesthesia (hospitalization, disability) on 24Aug2021 with outcome of recovering , strength loss of (hospitalization, disability) on 24Aug2021 with outcome of recovering, diarrhea (hospitalization, disability) on 24Aug2021 with outcome of recovering, paresthesia in lip region (hospitalization, disability) on 24Aug2021 with outcome of recovering. Before vaccination he was an athlete performing high-strength ports. Now he can''t even climb stairs after 20 days of vaccination. Symptoms appeared from 4 hours after vaccination and developed worsening until 10 days later. Consultation several times for general malaise, asthenia, polyarthrmialgias, dyspneic sensation without semiology of respiratory infection, chronic cardiac insufficiency, without thoracic pain or palpitations, with dysthermic sensation (unspecific), after administration of 1st dose Vaccination Covid Pfizer refers paresthesia in lip region. Refers to diarrheal stools with mucous remains without blood remains. Digestive study without finding alterations according to patient. Blood count and biochemistry without pathological findings of interest. Private neurological report after going to urgency on several occasions, Pluriesthesias (unspecific) after normal neurological exploration diagnose of possible sequelae after corona virus vaccine. The patient underwent lab tests and procedures which included full blood count: no alterations, investigation: no alterations, sars-cov-2 test negative: negative on 26Aug2021. Therapeutic measures were taken for all events: Prednisone 60mg 1 week progressive reduction, triptizole 25mg: oral, for recovery phase. Urbason, valium, paracetamol. Gastric protector: intravenous in two last hospitalizations. No follow-up attempts are possible, information about lot/batch number cannot be obtained.No further information is expected.


VAERS ID: 1758071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Breast discomfort, Haemorrhage, Inappropriate schedule of product administration, Menstruation delayed, Muscle spasms
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101233738

Write-up: leg cramps; bleeding; stomach cramps; still not started my period; breasts feeling heavy; first dose received on 26Jun2021; second dose on 24Aug2021; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports for second dose. This is a report received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-APPCOVID-20210919211226, Safety Report Unique Identifier GB-MHRA-ADR 25966338. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FF3319), via an unspecified route of administration on 24Aug2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: Not reported) on 26Jun2021 at single dose for COVID-19 immunisation and experienced period came a week early. The patient experienced leg cramps, bleeding, stomach cramps, breasts feeling heavy, still not started her period, all in Sep2021. It was reported that patient''s period tracker (Health app) predicted she was due to start her period on 07Sep2021. Until 19Sep2021 and she had noticeable pre-menstrual symptoms for 3 days (stomach cramps, leg cramps, breasts feeling heavy) and had still not started her period. The outcome of events leg cramps, bleeding and stomach cramps was not recovered; outcome of the other events was unknown. This report was reported as serious due to disability. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101260211 Same patient and product/ different dose and event.


VAERS ID: 1759890 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-08-24
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis, C-reactive protein, C-reactive protein increased, Peritonitis
SMQs:, Gastrointestinal perforation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Von Willebrand''s disease
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result:over 300; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Value still 100 after a week on antibiotics
CDC Split Type: DEPFIZER INC202101238933

Write-up: Peritonitis; C-reactive protein value over 300; Appendicitis; This is a spontaneous report from a non-contactable consumer downloaded from a Regulatory Authority, regulatory authority number DE-PEI-CADR2021174838. A 14-year-old male patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 14Jul2021 (Lot Number: FF3318, expiration date unknown) as 0.3ml, a single dose for covid-19 immunisation. Medical history included mild type 1 von willebrand disease. The patient''s concomitant medications were not reported. The patient experienced appendicitis (hospitalization) on 24Aug2021, peritonitis and c-reactive protein value over 300, both on an unspecified date. The patient''s hospitalization was prolonged as a result of appendicitis. The patient underwent lab tests and procedures which included c-reactive protein: over 300, value still 100 after a week on antibiotics, both on an unspecified date. Therapeutic measures were taken as a result of appendicitis, c-reactive protein value over 300. The outcome of ''Appendicitis'' was not recovered, rest events was unknown. Sender comment: Do you or the person concerned have any known allergies? If so, which ones? No. Details of risk factors or previous illnesses. Mild type 1 Von Willebrand disease. Emergency surgery at PRIVACY. Appendectomy. Peritonitis. C-reactive protein value over 300. Administration of intravenous antibiotics. Long-term hospitalisation. C-reactive protein value still 100 after a week on antibiotics. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1759930 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Neck pain, Pyrexia, SARS-CoV-2 test, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood analysis; Result Unstructured Data: Test Result:unknown results; Test Date: 20210903; Test Name: COVID-19 PCR; Result Unstructured Data: Test Result:unknown results; Test Name: Urine analysis; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ESPFIZER INC202101239583

Write-up: Pyrexia; neck pain/cervicalgia; Asthenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-1004457. A 48-years-old male patient received the first dose of bnt162b2 (COMIRNATY) intramuscular, administered in Deltoid Left on 24Aug2021 (Lot Number: FF2832) as dose 1, 0.3 ml single (at age of 48-years-old) for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced pyrexia, neck pain/cervicalgia, asthenia. Analytical results are pending. He continued with evening fever and asthenia without other symptoms and took paracetamol. Therapeutic measures were taken as a result of pyrexia, neck pain/cervicalgia, asthenia. All events were assessed as serious with seriousness criteria of medically significant. The patient underwent lab tests and procedures which included Blood analysis: unknown results, COVID-19 PCR: unknown results on 03Sep2021, urine analysis: unknown results. Outcome of the events was not recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1760872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Inappropriate schedule of product administration, Polymenorrhoea, SARS-CoV-2 test
SMQs:, Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101254407

Write-up: Frequent periods; Painful periods; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer (patient). This is the second of 2 reports for the second dose. The second report is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109201537428710-0UWPK. A 28-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Aug2021 (Lot Number: FE3380) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included the suspected COVID-19 from 08Jan2021 (Unsure when symptoms stopped). Patient was not pregnant or was not currently breastfeeding. Historical vaccine included the first dose of BNT162B2 on 18Jun2021 for COVID-19 immunization and experienced late period and painful periods. The patient''s concomitant medications were not reported. The patient experienced frequent periods and painful periods (medically significant) both on an unspecified date, inappropriate schedule of vaccine administered on 24Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: Yes - Positive COVID-19 test on an unknown date. The outcome of event frequent periods was recovering, of event painful periods was not recovered. The clinical course was reported as follows: After the first vaccine my period was 2 weeks late and after the second dose my period was a week early. My period have been very regular for the last year and I have not changed any habits that may have affected it. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101242956 Same patient and product, different event/dose.


VAERS ID: 1761076 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211005256

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046489) on 04-OCT-2021 and concerned a 22 year old male of an 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: XE393 expiry: unknown) dose was not reported, frequency time 1 total was administered on 09-JUL-2021 for drug used for an unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and 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). The case was associated with product quality complaint (PQC).


VAERS ID: 1761079 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211005486

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046499) on 04-OCT-2021 concerned a 53 year old male. The patient''s height, and weight were not reported. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported and expiry: unknown) dose was not reported, 1 total administered on 25-MAY-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 24-AUG-2021, the patient experienced SARS-CoV (severe acute respiratory syndrome coronavirus)-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV (severe acute respiratory syndrome coronavirus)-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1761086 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211005626

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046682) on 04-OCT-2021 concerned a 26 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 18-MAY-2021 for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. 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: 1761087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211004990

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician by a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046692) on 04-OCT-2021 concerned a 27 year old female patient of an 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: XD985, expiry: unknown) dose was not reported, 1 total (first dose), administered on 10-JUN-2021 for drug use for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and 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: 1761139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101243997

Write-up: Abortion spontaneous; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 626175. A 30-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced abortion spontaneous on 24Aug2021. Onset Time in Days- 19 days. Outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1763438 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101243611

Write-up: Urticaria; Rash generalised; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127411. A 25-year and 11-month-old female patient (age at second dose of vaccination) received the second dose of BNT162B2 (COVID-19 VACCINE- MANUFACTURER UNKNOWN; lot number unknown; expiry unknown) via an unspecified route of administration on 22Aug2021 (at 25-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On24Aug2021 (2 days after the vaccination), the patient experienced urticaria. On 03Sep2021, the outcome of the event was recovering. After receiving the second dose of the BNT162B2 vaccination, 2 days later, urticaria occurred. Due to rash generalised occurred, the patient went to hospital to have an office visit. Steroid systemic administration (from the former physician; details were unknown). On27Aug2021, the patient visited the reporter''s department. It was confirmed that whole body of urticaria. Prednisolone 20mg was orally started. There were no other symptoms except skin symptom. After one week, the symptom was recovering and reduced the weight of prednisolone. After that the patient did not visit the hospital again and the follow-up was unknown. The clinical outcomes of the events were recovering. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162B2 as un-assessable. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1763569 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Headache, Hyperhidrosis, Loss of consciousness, Malaise, Nausea, Pallor, Paraesthesia, Vertigo
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: MDJNJFOC20211002890

Write-up: LOSS OF CONSCIOUSNESS; EXCESSIVE PERSPIRATION; PALE TEGUMENTS; VERTIGO; MALAISE; HEADACHE; NAUSEA; OVERALL MARKED WEAKNESS; PARESTHESIA IN THE LIMBS; This spontaneous report received from a health care professional via a Regulatory Authority (MD-MMDA-300004014) concerned a 26 year old female with unspecified 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, route of admin not reported, batch number: 206C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021 at 11:02, approximately 2 minutes after vaccination, the patient experienced overall marked weakness, excessive perspiration, pale teguments, loss of consciousness for about 10 seconds, vertigo, malaise, headache, nausea, and paresthesia in the limbs. The condition improved in supine position, however, the overall weakness, vertigo, nausea, headache, and paresthesia in the limbs remained. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of consciousness on 24-AUG-2021, and malaise, was recovering from excessive perspiration, and pale teguments, and had not recovered from headache, nausea, overall marked weakness, vertigo, and paresthesia in the limbs. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211000817, 20211002832 and 20211002894.; Sender''s Comments: V0: 20211002890-covid-19 vaccine ad26.cov2.s- loss of consciousness, excessive perspiration, pale teguments, vertigo. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211002890-covid-19 vaccine ad26.cov2.s- malaise, headache, nausea, overall marked weakness, paresthesia in the limbs.. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1764439 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211008216

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046578) on 05-OCT-2021 and concerned a 32 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 24-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. 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: 1764440 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007498

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046594) on 05-OCT-2021 was received on 05-OCT-2021 and concerned a 19 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 04-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. 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: 1764442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211008095

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046604) on 05-OCT-2021 and concerned a 37 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 and expiry: unknown) dose was not reported, 1 total, administered on 27-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and 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 report was associated with product quality complaint.


VAERS ID: 1764444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211008142

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046698) was received on 05-OCT-2021 and concerned an 18 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: XD974 expiry: unknown) dose was not reported, 1 total administered on 23-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection and 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).


VAERS ID: 1764445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211008191

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via regulatory authority (regulatory authority, AT-BASGAGES-2021-046701) was received on 05-OCT-2021 and concerned a 53 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 unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient had severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection and (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).


VAERS ID: 1764446 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007123

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046705) was received on 05-OCT-2021 and 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 24-AUG-2021, the patient experienced sars-cov-2 infection and 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 report was associated with product quality complaint.


VAERS ID: 1764447 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007588

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046729) on 05-OCT-2021 and concerned a 43 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 in total, administered on 10-JUL-2021 for an unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced severe acute respiratory syndrome covid-2 infection which indicates vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and severe acute respiratory syndrome covid-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality number.


VAERS ID: 1764448 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007198

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via regulatory authority (regulatory authority, AT-BASGAGES-2021-046732) was received on 05-OCT-2021 and concerned an 18 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: XE393 expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection (severe acute respiratory syndrome). 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: 1764449 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007577

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046736) on 05-OCT-2021 and concerned a 36 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: 21C11-01 expiry: UNKNOWN) dose was not reported, 1 total, administered on 28-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection and 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 report was associated with a product quality complaint.


VAERS ID: 1764450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007584

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via regulatory authority (regulatory authority, AT-BASGAGES-2021-046744) on 05-OCT-2021 and concerned an 18 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: unknown) dose was not reported, 01 total, administered on 15-JUN-2021 used for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection and 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 report was associated with product quality complaint:


VAERS ID: 1764452 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007655

Write-up: Vaccination failure; SARS-CoV-2 infection; This spontaneous report received from a physician via Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046753) on 05-OCT-2021 and concerned a 36 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 (form of admin unknown, intramuscular, batch number: XD985, expiry: unknown) dose was not reported,1 total, administered on 11-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient had vaccination failure and sars-cov-2 infection. 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 is associated with Product Quality Complaint.


VAERS ID: 1764453 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007125

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046754) was received on 05-OCT-2021 and concerned a 40 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: 21C17-05) dose was not reported, 1 total, first dose, administered on 10-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure, SARS-CoV-2 infection (severe acute respiratory syndrome coronavirus 2) 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). The case was associated with product quality complaint.


VAERS ID: 1764456 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007973

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046775) on 05-OCT-2021 concerned a 43 year old male. The patient''s weight, height, and medical history were not 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 27-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection and 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 report was associated with product quality complaint.


VAERS ID: 1764457 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211007195

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046781) was received on 05-OCT-2021 and concerned a 42 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: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection and 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 report was associated with product quality complaint.


VAERS ID: 1769332 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, Maternal exposure timing unspecified
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101298216

Write-up: Herpes zoster; were pregnant in the administration of the vaccine: YES; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number ES-AEMPS-996187. This consumer reported information for both mother and fetus. This is a maternal report. A 36-year-old pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on 24Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patients concomitant medication included diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) taken for immunization on 10Aug2021. The patient was pregnant during the administration of the vaccine. The patient did not pass COVID-19. On 06Sep2021 the patient experienced herpes zoster. The patient reported she became pregnant while taking bnt162b2. Paracetamol and acyclovir cream were taken as therapeutic measure as a result of herpes zoster. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1769904 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004669 / UNK RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Cerebral haemorrhage, Coma, Vaccination site erythema, Vaccination site oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (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: VIGABATRIN; POTASSIUM CITRATE; BECLOMETASONE DIPROPIONATE; LANSOPRAZOLE; LEVETIRACETAM; CLOBAZAM; CLONAZEPAM; OXYGEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Encephalitis herpes (Herpetic encephalitis since birth)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-789892) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE, VACCINATION SITE OEDEMA, COMA and CARDIAC ARREST in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004669) for SARS-CoV-2 immunisation. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Encephalitis herpes (Herpetic encephalitis since birth). Previously administered products included for Product used for unknown indication: LEVETIRACETAM, BECLOMETHASONE DIPROPIONATE and CLOBAZAM. Past adverse reactions to the above products included No adverse event with BECLOMETHASONE DIPROPIONATE, CLOBAZAM and LEVETIRACETAM. Concomitant products included VIGABATRIN, POTASSIUM CITRATE, BECLOMETASONE DIPROPIONATE, LANSOPRAZOLE, LEVETIRACETAM, CLOBAZAM, IPRATROPIUM BROMIDE, SALBUTAMOL, CLONAZEPAM and OXYGEN for an unknown indication. On 03-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced CEREBRAL HAEMORRHAGE (seriousness criteria medically significant and life threatening), VACCINATION SITE OEDEMA (seriousness criterion life threatening), COMA (seriousness criteria medically significant and life threatening), CARDIAC ARREST (seriousness criteria medically significant and life threatening) and VACCINATION SITE ERYTHEMA (Redness in right arm). At the time of the report, CEREBRAL HAEMORRHAGE, VACCINATION SITE OEDEMA, COMA, CARDIAC ARREST and VACCINATION SITE ERYTHEMA (Redness in right arm) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. The patient experienced swelling and redness in the right arm, cardiac arrest, brain hemorrhage, and coma. The patient was currently hospitalized. No treatment medication was provided. Company Comment:This case concerns a 17 year old male patient with medical history of encephalitis herpetic, who experienced serious unexpected events of cerebral haemorrhage, cardiac arrest and coma after dose of mRNA-1273. The events occurred 22 days after dose of mRNA-1273.The re-challenge is unknown. Patient?s history of herpetic encephalitis and polypharmacy remain confounders. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation received on 01-Oct-2021 contains translated event verbatim and sender''s comment.; Sender''s Comments: This case concerns a 17 year old male patient with medical history of encephalitis herpetic, who experienced serious unexpected events of cerebral haemorrhage, cardiac arrest and coma after dose of mRNA-1273. The events occurred 22 days after dose of mRNA-1273.The re-challenge is unknown. Patient?s history of herpetic encephalitis and polypharmacy remain confounders. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1771313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211012707

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046644) on 07-OCT-2021 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: XD974 expiry: unknown) dose was not reported, 1 total, administered on 15-JUN-2021 for product used for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) infection and 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 report was associated with a product quality complaint.


VAERS ID: 1771314 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211012839

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046648) on 07-OCT-2021 and concerned a 20 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 06-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and SARS-cov-2 (severe acute respiratory syndrome coronavirus 2) infection. 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: 1771315 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211012765

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046650) on 07-OCT-2021 and concerned a 36 year old male 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: XE393 expiry: unknown) dose was not reported, 1 total administered on 24-JUL-2021 for drug used for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced SARS-COV-2(severe acute respiratory syndrome coronavirus 2) infection and 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 report was associated with Product Quality Complaint.


VAERS ID: 1771316 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211012932

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046651) on 07-OCT-2021 concerned a 19 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, administered on 04-JUL-2021 for product used for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient had sars-cov-2 infection(severe acute respiratory syndrome coronavirus 2 infection) which indicates 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 report was associated with a product quality complaint.


VAERS ID: 1771317 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211013798

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046654) on 07-OCT-2021 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: XD974, expiry: unknown) dose was not reported, 1 total administered for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2) and 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 report was associated with a product quality complaint.


VAERS ID: 1771318 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211013801

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046657) on 07-OCT-2021 concerned a 19 year old female of unspecified 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: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 28-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and sars-cov-2 infection. 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: 1771319 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211013795

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046808) on 07-OCT-2021 and concerned a 22 year old female of unspecified 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: XD985 expiry: UNKNOWN) dose was not reported,1 total administered on 01-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced sars-cov-2 infection and 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 report was associated with product quality complaint


VAERS ID: 1771320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211012617

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046819) on 07-OCT-2021 and concerned a 26 year old female of an 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: XD985 expiry: unknown) dose was not reported, frequency time 1 total was administered on 04-JUL-2021 for drug used for an unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) infection. 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). The case was associated with product quality complaint (PQC).


VAERS ID: 1771321 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211013568

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-046826) on 07-OCT-2021 and concerned a 25 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 09-JUL-2021 for product used for unknown indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and 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 report was associated with product quality complaint.


VAERS ID: 1771322 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       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: ATJNJFOC20211013583

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (regulatory authority, AT-BASGAGES-2021-046829) on 07-OCT-2021 concerned a 50 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: 21c11-01 expiry: unknown) dose was not reported, 01 total administered on 02-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 24-AUG-2021, the patient experienced severe acute respiratory syndrome coronavirus 2( sars-cov-2) infection. On 24-AUG-2021, the patient experienced 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 report was associated with product quality complaint.


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