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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 267 out of 8,010

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VAERS ID: 1733644 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cough
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210945224

Write-up: SEVERE COVID 19 PNEUMONIA; COUGH; This spontaneous report received from a pharmacist via a Regulatory Authority [PHIFDA, PH-PHFDA-300106556] concerned a 49 year old male 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: unknown expiry: unknown) dose was not reported, 1 total administered on 12-AUG-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 05-SEP-2021, the patient experienced severe covid 19 pneumonia and cough. The patient was hospitalized (date unspecified), number of days of hospitalization and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, and severe covid 19 pneumonia. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210945224-COVID-19 VACCINE AD26.COV2.S-severe covid 19 pneumonia, cough. 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).


VAERS ID: 1736112 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Paraesthesia, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life 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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via European Medicines Agency (Reference number: IT-MINISAL02-781726) 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 VOMITING , MYALGIA (Febbre(38, PYREXIA mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 immunisation. No Medical History information was reported. On 05-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 05-Sep-2021, the patient experienced VOMITING (Febbre(38),Dolori, muscolari,Mal di testa,vomito,parestesie,brividi.) (seriousness criterion hospitalization), MYALGIA (Febbre(38),Dolori, muscolari,Mal di testa,vomito,parestesie,brividi.) (seriousness criterion hospitalization), CHILLS (Febbre(38),Dolori, muscolari,Mal di testa,vomito,parestesie,brividi.) (seriousness criterion hospitalization), PYREXIA (Febbre(38),Dolori, muscolari,Mal di testa,vomito,parestesie,brividi.) (seriousness criterion hospitalization), PARAESTHESIA (Febbreseriousness criterion hospitalization) and HEADACHE ( (seriousness criterion hospitalization). At the time of the report, VOMITING No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 42-year-old female patient with no relevant medical history who experienced unexpected events of vomiting, myalgia, chills, pyrexia, paraesthesia and headache. The events occurred the same day after receiving a dose of mRNA-1273 (structured field does not specified whether adverse events occurred after the first or second dose). The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information (translation) is the same day after receiving a dose of mRNA-1273 (structured field does not specified whether adverse events occurred after the first or second dose). The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information (translation) is expected.


VAERS ID: 1736436 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214020 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Headache
SMQs:, Anticholinergic syndrome (broad), Vestibular 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: ISOTRETINOIN; IRON.
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority(Reference number: PT-INFARMED-V202109-812) 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 DIZZINESS and HEADACHE in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214020) for COVID-19 immunisation. Concomitant products included ISOTRETINOIN and IRON for an unknown indication. On 04-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 05-Sep-2021, the patient experienced DIZZINESS (seriousness criterion disability) and HEADACHE (seriousness criterion disability). At the time of the report, DIZZINESS and HEADACHE was resolving. No treatment information was provided. Company Comment: This case concerns a 24-year-old female patient, with no reported medical history who experienced the unexpected events of dizziness and headache. The events occurred 2 days after the second dose of Spikevax. Causality for the reported events were not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness for the reported event 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 17-Sep-2021: Translation received on 22-SEP-2021 contains no new information.; Sender''s Comments: This case concerns a 24-year-old female patient, with no reported medical history who experienced the unexpected events of dizziness and headache. The events occurred 2 days after the second dose of Spikevax. Causality for the reported events were not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness for the reported event 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: 1736438 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Dysphagia, Dyspnoea, Feeling hot, Swollen tongue
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anaphylactic reaction; Drug allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROJNJFOC20210944881

Write-up: This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, RO-NMA-2021-SPCOV12528) on 23-SEP-2021 concerned a 31-year-old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: drug allergy, and anaphylactic reaction. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 21C1805 expiry: unknown) 1 dosage forms, 1 total administered on 05-SEP-2021 for covid-19 immunisation. No concomitant medications were reported. On 05-SEP-2021, the patient experienced breathing difficult, swallowing difficult, feeling of warmth transient, anaphylactic reaction, swelling of tongue. The action taken with covid-19 vaccine was not applicable. The outcome of the breathing difficult, swallowing difficult, feeling of warmth transient, anaphylactic reaction and swelling of tongue was not reported. The case was considered serious (Other medically important) by the Sender.


VAERS ID: 1737661 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-05
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness unilateral, Eye inflammation, Fatigue, Palpitations, Pruritus
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101194355

Write-up: Itching; Heart racing/Palpitation when going for a simple walk; Tiredness; Unilateral vision loss; Eye inflammation; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-043898. A 29-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Aug2021 as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Sep2021 the patient experienced Unilateral vision loss, other. On 06Sep2021 the patient experienced Heart racing, other, disabling. On 05Sep2021 the patient experienced Eye inflammation, other, disabling, other. On 06Sep2021 the patient experienced Tiredness, other, disabling, other, disabling. Reduction of visual capacity periodic occurrence of an eye infection, the patient has never seen anything like this before, a second person living in another household is also affected by this. Palpitation when going for a simple walk, fatigue, loss of vision at the left eye, Itching. The outcome of the events was not resolved. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Facial paralysis, Headache, Neck pain
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: RAMIPRIL + HIDROCLOROTIAZIDA; OMEPRAZOL PENSA [OMEPRAZOLE]; EUTIROX; AMLODIPIN [AMLODIPINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cholecystectomy; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101195002

Write-up: Bell''s palsy; retroauricular pain; Facial droop; cervicalgia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-993841. A 60-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 30Aug2021 (Lot Number: FD9309) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included arterial hypertension from May2021, thyroidectomy, and cholecystectomy. Concomitant medication(s) included hydrochlorothiazide, ramipril (RAMIPRIL + HIDROCLOROTIAZIDA) taken for hypertension from 10Jun2021; omeprazole (OMEPRAZOL PENSA [OMEPRAZOLE]) from 10Jun2021; levothyroxine sodium (EUTIROX) from 10Jun2021; amlodipin [amlodipine] (AMLODIPIN [AMLODIPINE]) taken for hypertension from 18Jun2021. The patient experienced facial droop, cervicalgia on 05Sep2021 with outcome of recovering , bell''s palsy on an unspecified date with outcome of recovering , retroauricular pain on an unspecified date with outcome of unknown. The patient went to the Emergency Service of a hospital and was treated with methylprednisolone. Seriousness criteria reported as medical significant. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1738122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anterograde amnesia, Bradyphrenia, Computerised tomogram head, Electroencephalogram, Face injury, Fall, Generalised tonic-clonic seizure, Loss of consciousness, Musculoskeletal stiffness, Seizure, Somnolence, Specialist consultation
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), Dementia (broad), Convulsions (narrow), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Urgent cranial CT; Result Unstructured Data: Test Result:Study without significant findings; Comments: Findings: In the posterior cerebellum fossa, brainstem structures and IV ventricle show no alterations. Supratentorially the midline is centered. The ventricular system is of normal caliber and morphology. Adequate differentiation gray matter white matter. No signs of intra- or extraaxial bleeding, focal or occupational injuries are observed. With bone window is observed a pneumatization of the tip of both rocks as an anatomical variant.; Test Name: electroencephalogram; Result Unstructured Data: Test Result:normal for age; Test Name: Consultation with maxillofacial surgery; Result Unstructured Data: Test Result:dental fracture is seen without bone fracture
CDC Split Type: ESPFIZER INC202101194695

Write-up: Main diagnosis: Afebrile SEIZURE (first episode); Generalized tonic-clonic seizure; he has fallen to the ground hitting himself in the face; he has fallen to the ground hitting himself in the face; generalized stiffness; 2-3 unconscious minutes; bradypsychia; tendency to drowsiness; anterograde amnesia of about 30 minutes before the episode; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-994651. A 12-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 02Sep2021 (Lot Number: FE4728) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 12Aug2021 for COVID-19 immunisation; First dose, intramuscular; Batch/lot number: FG4442. The patient experienced generalized tonic-clonic seizure, he had fallen to the ground hitting himself in the face, generalized stiffness, 2-3 unconscious minutes on 05Sep2021, bradypsychia, tendency to drowsiness, anterograde amnesia of about 30 minutes before the episode on an unspecified date. Serious criteria was reported as hospitalization for events. The patient admitted from the emergency room for seizures last night on 05Sep2021. The mother reported that, while they were walking on the street, he had fallen to the ground hitting himself in the face and immediately has started with generalized stiffness and distal clonias of limbs less than 1 minutes in duration. After which he remained about 2-3 unconscious minutes recovering spontaneously without requiring medication and without neurological focus. After this he presented a postcritical episode with bradypsychia and a tendency to drowsiness that has been maintained until arrival at the hospitalization floor (about 12 hours). Not apparently antedecent of casual accident. No vomiting, no sialorrhea. No loss of control of sphincters. The patient reports anterograde amnesia of about 30 minutes before the episode, although it seems that he has progressively recovered, maintaining amnesia of the episode. Afebrile. Non-clinical infectious in previous days. No previous skin pallor or sweating. No epidemic environment. Patient with no personal history of interest. No febrile crises in childhood. No similar episodes. Correct piscomotor development. Urgent cranial CT (06Sep2021): study from foramen magnum to cranial vertex is performed without administration of intravenous contrast. Findings: In the posterior cerebellum fossa, brainstem structures and IV ventricle show no alterations. Supratentorially the midline is centered. The ventricular system is of normal caliber and morphology. Adequate differentiation gray matter white matter. No signs of intra- or extraaxial bleeding, focal or occupational injuries are observed. With bone window is observed a pneumatization of the tip of both rocks as an anatomical variant. Conclusion: Study without significant findings. The patient admitted for the study of the first afebrile seizure in a patient with no neurological history and the administration of 2nd dose of Covid vaccine about 72 hours before. During his stay on the hospitalization floor he remains clinically and hemodynamically stable. No new episodes of seizure. Antibiotic therapy was initiated with amoxicillin-clavulanic orally for dirty wound after assessment by surgery, which must be maintained at home until completing the 5-day regimen. Due to the persistence of bradypsychia and tendency to drowsiness during their stay in the emergency room prior to admission, it was decided to perform cranial CT without evidence of pathological findings; recovering neurological normality within 15 hours of the event. Likewise, a study is completed with an electroencephalogram that is reported as normal for age. Consultation with maxillofacial surgery is performed to assess dental involvement caused by the blow, performing orthopanthography in which dental fracture is seen without bone fracture, so assessment by dentist is recommended. Main diagnosis: Afebrile SEIZURE (first episode). Other diagnoses: FACIAL TRAUMA. The outcome of events afebrile seizure, generalized tonic-clonic seizure, fall, face injury, musculoskeletal stiffness, unconscious was recovered on 05Sep2021, the outcome of rest events was recovered on unknown date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738140 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-09-05
   Days after vaccination:206
Submitted: 0000-00-00
Entered: 2021-09-27
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? 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: 20210905; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: COVID Asymptomatic
CDC Split Type: ESPFIZER INC202101199528

Write-up: Asymptomatic COVID-19; Asymptomatic COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. This is a report received from the regulatory authority number -996945. A 39-year-old female patient (unknown if pregnant) received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EM0477, Expiration Date: 30Apr2021), via intramuscular route of administration on 14Jan2021 as dose 1, single for COVID-19 immunisation and received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EM6950, Expiration Date: Not reported), via intramuscular route of administration on 11Feb2021 as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. On 05Sep2021, the patient experienced asymptomatic covid-19. The patient underwent lab tests and procedures which included sars-cov-2 test (COVID-19 PCR test): positive (COVID Asymptomatic) on 05Sep2021. The outcome of the event asymptomatic covid-19 (asymptomatic covid-19) was not recovered. Investigational report conclusion from testing division was: 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 5595397 (see File attachment in this investigation record) The complaint for a cardiac arrest after vaccination of PFIZER-BIONTECH 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 EM0477. 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. Testing concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738708 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chest pain, Dizziness, Dyspnoea, Fatigue, Myalgia, Nausea, Oropharyngeal pain, Pain in extremity, SARS-CoV-2 test, Vaccination site pain, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210907; Test Name: lateral flow test; Test Result: Negative ; Comments: "Lateral flow completed 07Sep2021 + 08Sep2021 - negative"; Test Date: 20210908; Test Name: lateral flow test; Test Result: Negative ; Comments: "Lateral flow completed 07Sep2021 + 08Sep2021 - negative"
CDC Split Type: GBPFIZER INC202101209577

Write-up: difficulty breathing; aching joints; Back pain; Fatigue; vertigo; nausea; Chest pain; Breathlessness; Sore throat; dizziness; sharp pain to injection site; pain in limbs and muscles; pain in limbs and muscles; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202109091043052240-6QHMJ, Safety Report Unique Identifier GB-MHRA-ADR 25917264.A 32-year-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FF3319), dose 2 via an unspecified route of administration on 05Sep2021 18:00 (at the age of 32 years) as dose 2, single for COVID-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. Healthy patient. No apparent underling illnesses. No medication taken. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Historical vaccine included first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced chest pain, breathlessness, sore throat, aching joints, back pain, fatigue, vertigo, nausea on 06Sep2021. Difficulty breathing on 08Sep2021. Dizziness, sharp pain to injection site, pain in limbs and muscles, pain in limbs and muscles on 05Sep2021. Received 2nd dose approx. 6pm 05Sep21 - immediate and sharp pain to injection site. Symptoms began on night of 05Sep2021 - fatigue, dizziness, pain in limbs and muscles. 06Sep2021 - extreme fatigue, nausea, dizziness, aches in limbs, mild vertigo, (needed to be horizontal), aching joints and bones. 07Sep2021 - developed breathlessness, pain in chest, difficulty and pain when swallowing, pain in upper back, around the lungs - took lateral flow - negative. 08Sep2021 - symptoms persist headaches, difficulty talking and breathing, - 2nd lateral flow test negative. 09Sep2021 - symptoms persist - still in pain and difficulty breathing, being upright. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: Lateral flow completed 07Sep2021 + 08Sep2021 - negative. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 04Aug2021 No-Negative COVID-19 test, lateral flow test: negative on 07Sep2021 Lateral flow completed 07Sep2021+08Sep2021 - negative, lateral flow test: negative on 08Sep2021 Lateral flow completed 07Sep2021+08Sep2021 - negative. The outcome of the events difficulty breathing, aching joints, vertigo, nausea, dizziness was recovering and for other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738742 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza, Urinary tract infection
SMQs:, Infective pneumonia (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: Citalopram
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205343

Write-up: Urinary tract infection; Flu; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202109131436506950-GISMB with Safety Report Unique Identifier of GB-MHRA-ADR 25932201. A 50-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Sep2021 as a single dose for COVID-19 immunisation. Medical history included depression; started on an unknown date and unknown if ongoing. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not pregnant and was not breast feeding. The patient was not enrolled in the clinical trial. Concomitant medications included citalopram (MANUFACTURER UNKNOWN) taken for depression from an unknown date and unknown if ongoing. The patient experienced flu on 05Sep2021, 1 day after vaccination; urinary tract infection on 10Sep2021, 6 days after vaccination; both the events were reported as serious for being medically significant. The clinical outcome of the event urinary tract infection was not resolved while that of the event flu was resolved with sequelae on Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased activity, Feeling hot, Inflammation, Joint swelling, Ligament sprain, Pain in extremity, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (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: Headache; Inflammation; Loss of taste; Suspected COVID-19 (lost of taste that still hasn''t fully returned. I can''t taste bacon.); Wrist fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210102; Test Name: COVID-19 virus test; Test Result: Positive; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101211455

Write-up: low activity; Right foot under toes are inflamed; Swollen and hurts to walk on; Right wrist went inflamed and felt like a bad sprain.; Was hot to touch and swollen.; Pain in foot/Pain in thumb; Swollen wrists; Foot and thumb inflammation happened less than 24hrs after injection; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the authority report number is GB-MHRA-WEBCOVID-202109141042480980-XMG0F. Senders (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25938290. A female patient of unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Sep2021 as single dose for COVID-19 immunisation. The patient medical history included inflammation, headache, suspected covid-19 from 02Jan2021 to 02Jun2021, lost of taste that still has not fully returned. Cannot taste bacon, ageusia, wrist fracture from 2017 to an unknown date and broke wrist in 2017/wrist fracture. Concomitant medications were not reported. Patient does not take other medicines or prescriptions. Not on birth control pill or have any of the other birth control injections. She would consider herself in shape and lives a healthy lifestyle. Had Covid in Jan 2021 with no inflammation problems. Mostly a headache and loss of taste that still has not fully returned. Cannot taste bacon. She broke her wrist in 2017 and the inflammation attack that happened, after the vax, was on the same wrist. Have no previous injuries to the other areas that are inflamed. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced low activity, right foot under toes were inflamed, swollen and hurts to walk on, right wrist went inflamed and felt like a bad sprain and was hot to touch and swollen. On 05Sep2021, she had swollen wrists, foot and thumb inflammation happened less than 24hrs after injection and on 06Sep2021, she had pain in foot/pain in thumb. Right wrist went inflamed and felt like a bad sprain. Was hot to touch and swollen. Recovered 3 days later. Right foot under toes were inflamed. Swollen and hurts to walk on. Still recovering and ibuprofen was not doing anything to help. Left thumb pain and red on joint. Hurts to bend. Still no improvement. Foot and thumb inflammation happened less than 24hrs after injection and wrist happened moments later. wrist was at its worst 24 hrs later. Have done nothing to provoke such inflammation and pain. Low activity. The patient underwent lab tests which showed sars-cov-2 test as positive on 02Jan2021, yes - positive COVID-19 test. Therapeutic measures were taken as a result of right foot under toes are inflamed (inflammation), swollen and hurts to walk on (peripheral swelling). Outcome was resolved on 08Sep2021, for swollen wrists, not resolved for pain in foot/pain in thumb, unknown for foot and thumb inflammation happened less than 24hrs after injection, resolved on an unspecified date for events right wrist went inflamed and felt like a bad sprain, was hot to touch and swollen and was resolving for rest of the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738789 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Headache, Heavy menstrual bleeding, Hypoaesthesia, SARS-CoV-2 test, Vision blurred
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211301

Write-up: Chest pain; Body numbness; Difficulty focusing eyes; Heavy periods; Headache; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109141142079810-NH06I, Safety Report Unique Identifier GB-MHRA-ADR 25938354. A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 05Sep2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and was not breastfeeding at the time of this report. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 05Sep2021, the patient experienced headache and heavy periods. On 06Sep2021, 1 day after vaccination, the patient experienced chest pain, body numbness, difficulty focusing eyes. Events, headache, heavy periods, chest pain, body numbness and difficulty focusing eyes were reported as serious for being medically significant. It was reported that patient had suspected COVID-19 on 06Sep2021. However, the patient had not tested positive for COVID-19 since having the vaccine. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events headache, heavy periods, chest pain, body numbness and difficulty focusing eyes was not recovered. The patient stated that she regret doing the vaccine and wanted to know if she has the possibility to not do the second vaccine. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738844 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Inappropriate schedule of product administration, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr...); SLE (Recently diagnosed with SLE)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101211445

Write-up: Skin rash; Shortness of breath; Exhaustion; Fever; inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This report received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109142034211090-8VXTO. Safety Report Unique Identifier GB-MHRA-ADR 25941262. A 43-year-old non-pregnant female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/Lot number and Expiration date was not recovered), via an unspecified route of administration on 05Sep2021 as dose 2, single for COVID-19 immunisation. The patient received historical vaccine included first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/Lot number and Expiration date was not recovered), via an unspecified route of administration on 20Jun2021 as dose 1, single for COVID-19 immunisation. The patient medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. Taking regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr. Recently diagnosed with SLE. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced fever and exhaustion on 06Sep2021, shortness of breath on 07Sep2021, skin rash on 08Sep2021, inappropriate schedule of vaccine administered on 05Sep2021. Intense skin burning on face only. The outcome of event skin rash was not recovered. Outcome of events fever, Shortness of breath was recovered on 09Sep2021, Exhaustion on 11Sep2021 and outcome of event inappropriate schedule of vaccine administered was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hypersomnia, Movement disorder, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202101211487

Write-up: nauseous; Felt very tired; Couldn''t work or move; slept for most of afternoon and all night; Nausea; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109142055263050-2OGHT and Safety Report Unique Identifier is GB-MHRA-ADR 25941345. A 24-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date: not reported), dose 2 via an unspecified route of administration on 04Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. On an unspecified date, the patient experienced nauseous, felt very tired, couldn''t work or move, slept for most of afternoon and all night. On 05Sep2021, the patient experienced nausea. Case narrative as reported: Vaccine given on Saturday 4th. Felt very tired on Sunday, and worse on Monday and started feeling very nauseous on Monday evening and all-day Tuesday 8th. Couldn''t work or move and slept for most of afternoon and all night. Felt better on Wednesday 9th September. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of nausea was recovered on 08Sep2021. The outcome of nauseous was recovering. The outcome of other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained, No further information is expected.


VAERS ID: 1738858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation delayed, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101211363

Write-up: Delayed period; This is a spontaneous report from a contactable consumer. This is a report received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109142223200620-R18TW. Safety Report Unique Identifier GB-MHRA-ADR 25941843. A female patient of an unspecified age received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), dose 1 via an unspecified route of administration on 03Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 07Feb2021 to an unknown date unsure when symptoms stopped. The patient''s concomitant medications were not reported. The patient experienced delayed period (medically significant) on 05Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive COVID-19 test on 07Feb2021. The outcome of the event was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1738880 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-05
   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 FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Heart rate, Heart rate decreased, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Heart rate low
Allergies:
Diagnostic Lab Data: Test Date: 2020; Test Name: Heart rate; Result Unstructured Data: Test Result:Low; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101217619

Write-up: low heart; Exhaustion/ fatigue; This is a spontaneous report from a contactable healthcare professional, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109151026124290-YQEPD, Safety Report Unique Identifier of GB-MHRA-ADR 25944654. A patient of unknown age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 31Aug2021 as a single dose for COVID-19 immunisation. Medical history included COVID-19 and low heart rate; started on an unknown date in 2020 (it was also reported that, the patient was fit and healthy). The patient had no symptoms associated with COVID-19 and was not enrolled in clinical trial. Concomitant medications were not reported. On 05Sep2021, the patient experienced exhaustion/ fatigue, and patient also had low heart on unspecified date; the events was reported as serious being medically significant. The clinical course was reported as follows: the patient was absolutely exhausted and not able to do sport. The patient daily commuted to work and back by bike was about all patient had been able to manage for past week, patient was resting. It was reported the patient was not getting better. The patient had COVID in 2020 and had low heart rate for 3 months, only training the patient able to return sport. So, that''s why patient was worried about having the vaccine. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the event exhaustion/ fatigue was not resolved at the time of this report, while that of event low heart was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1738976 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Ovulation pain; Period pains; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25957799) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (Period pains) and OVULATION PAIN (Ovulation pain) in a 24-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Hormone level abnormal (High Prolactin hormone). On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced DYSMENORRHOEA (Period pains) (seriousness criteria hospitalization and medically significant). On 13-Sep-2021, the patient experienced OVULATION PAIN (Ovulation pain) (seriousness criteria hospitalization and medically significant). On 11-Sep-2021, DYSMENORRHOEA (Period pains) had resolved. On 15-Sep-2021, OVULATION PAIN (Ovulation pain) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID -19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Got the jab on the Friday, period then was early and started on Saturday, then ovulation pain happened early and the pain was so severe. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment: This case concerns a 24-year old female patient, with a medical history of high prolactin hormone, who experienced the unexpected events of Dysmenorrhoea and Ovulation pain. The event Dysmenorrhea occurred 2 days after the second dose of MODERN A COVID-19 VACCINE and the event Ovulation pain occurred 10 days after the second dose of MODERN A COVID-19 VACCINE. The medical history of high prolactin hormone remains a confounder. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. The events were assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.; Sender''s Comments: This case concerns a 24-year old female patient, with a medical history of high prolactin hormone, who experienced the unexpected events of Dysmenorrhoea and Ovulation pain. The event Dysmenorrhea occurred 2 days after the second dose of MODERN A COVID-19 VACCINE and the event Ovulation pain occurred 10 days after the second dose of MODERN A COVID-19 VACCINE. The medical history of high prolactin hormone remains a confounder. The benefit-risk relationship of MODERNA COVID-19 VACCINE is not affected by this report. The events were assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious.


VAERS ID: 1739040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   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: Abdominal pain upper, Appendicectomy, Appendicitis, Disturbance in attention, Fatigue, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101252607

Write-up: Constant fatigue; no concentration; Fainted; Pain in lower stomach; Appendectomy; Appendicitis; This is a spontaneous report from a contactable healthcare professional received from the. Regulatory authority report number is GB-MHRA-WEBCOVID-202109220054593340-ZRJNC, Safety Report Unique Identifier is GB-MHRA-ADR 25977217. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Sep2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced appendicitis on 05Sep2021 with outcome of unknown, appendectomy on 10Sep2021 with outcome of recovered on an unspecified date, constant fatigue on an unspecified date with outcome of unknown, no concentration on an unspecified date with outcome of unknown, fainted on an unspecified date with outcome of unknown and pain in lower stomach on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on an unspecified date No - Negative COVID-19 test. The events appendicitis was reported as serious, life-threatening, while the other events were reported serious, medically significant and life-threatening. Case narrative: Constant fatigue after the vaccine, pain in lower stomach, no concentration. Fainted taken to hospital and appendix had leaked needing emergency surgery. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1739047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-09-05
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 20210902; Test Name: COVID-19 Test; Test Result: Negative ; Test Date: 20210905; Test Name: COVID-19 Test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101210277

Write-up: tested positive for COVID-19; vaccination failure; This is a spontaneous report from a contactable other hcp. A 54-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 09Aug2021 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 18Jul2021, as dose 1, single for COVID-19 immunization. The patient was tested positive for covid-19 on 05Sep2021. on an unspecified date on 2021 patient had vaccination failure. Patient traveled on 03Sep2021. She tested negative on 02Sep2021. Her specimen collected on 05Sep2021 tested positive for COVID-19 and she remains asymptomatic. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 02Sep2021, sars-cov-2 test was positive on 05Sep2021. The outcome of all the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: As per available information, the causal association between the event vaccination failure and Covid 19 and the suspect drug BNT162B2 cannot be excluded.


VAERS ID: 1739237 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FG6273 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101194023

Write-up: loss of consciousness (20-25 minutes); syncope with non-rapid resolution; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority-WEB IT-MINISAL02-781475. A 41-years-old male patient received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Lot number: FG6273) via intramuscularly in left arm on 05Sep2021 at 9:19 (at the age of 41-year-old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history concomitant medications were not reported. On 05Sep2021, after vaccination the patient experienced syncope with non-rapid resolution loss of consciousness (20-25 minutes) and patient was sent to emergency room. Patient was hospitalised for event. At the time of this report the outcome of the events were recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739267 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Muscular weakness, Paraesthesia oral
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hyperthyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (allergic to nickel, thimerosal, anti-inflammatory drugs and antibiotics); Allergy to chemicals; Basedow''s disease (currently in relapse); Nickel sensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101194113

Write-up: Tingling in the middle of the face with inability to drink and swallow on the same side; weakness in the outer part of the arms up to the little finger, ditto in the legs; I could not even swallow; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-781828. A 35-year-old female patient received first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: FG6273), via intramuscular, administered in arm left on 03Sep2021 as dose 1, single for COVID-19 immunization (at the age of 35-year-old). Medical history included allergy (allergic to anti-inflammatory drugs and antibiotics), allergic to nickel, allergic to thimerosal, ongoing hyperthyroidism and basedow (currently in relapse). The patient''s concomitant medications were not reported. On 05Sep2021, the patient experienced tingling in the middle of the face with inability to drink and swallow on the same side, weakness in the outer part of the arms up to the little finger, ditto in the legs and could not even swallow. It was reported that the patient went to home from work due to tingling left side of the face and limbs, especially the outer side up to the little finger of all 4 limbs. In the emergency room no one examined him yesterday because it was classified with a green code, the attending physician explicitly told me that this reaction is due to the drug Pfizer. For me the reaction is serious as it is disabling to carry out any normal activity. The first day after the onset of these symptoms patient could not even swallow from the tingling side and he also have a heavy jaw as if it were going to freeze at any moment. Impact on quality of life (10/10). The patient was treated with vitamin b12 as a therapeutic measure for tingling in the middle of the face with inability to drink and swallow on the same side, weakness in the outer part of the arms up to the little finger, ditto in the legs and could not even swallow. The outcome of the events was not recovered. Reporter''s comment: The seriousness of the case is not shared. No follow-up attempts possible. No further information expected. Information on lot number already obtained.


VAERS ID: 1739270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Objective examination; Result Unstructured Data: Test Result: Lucid, eupnoeic, apiretic; Comments: symmetrical limbs, normo-thermal skin, JHollow and Omans negative.
CDC Split Type: ITPFIZER INC202101194117

Write-up: atraumatic right lower extremity pain; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority number IT-MINISAL02-781846 received via regulatory authority. A 43-year-old female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: FG6273, Expiration Date: 30Nov2021) via an intramuscularly administered in arm left (shoulder) on 04Sep2021 at 11:50 as DOSE 2, 0.3 ML SINGLE and first dose (Lot number: not reported) via an unspecified route of administration, administered in arm left on an unspecified date as DOSE 1, SINGLE both for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced atraumatic right lower extremity pain. On an unspecified date, the patient underwent lab tests and procedures which included podiatric examination lucid, eupnoeic, apiretic (symmetrical limbs, normo-thermal skin, JHollow and Omans negative). Patient appeared in the emergency room. Therapeutic measures were taken as a result of atraumatic right lower extremity pain with ketorolac 30 mg administered in 100 cc intravenously. Rest was recommended and brufen 600 mg on a full stomach as needed. It was reported that, the patient arrived at the emergency room on the morning of 05Sep2021 due to pain in the right lower limb mainly in the posterior thigh, popliteal fossa, and leg. She reported having been vaccinated with the pfizer vaccine second dose and that the pain had also occurred with the first dose. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1739279 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FG7378 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Chest pain, Dizziness, Feeling abnormal, Hypotension, Panic reaction, Syncope, Tachycardia, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: Test Result:low
CDC Split Type: ITPFIZER INC202101195537

Write-up: extreme weakness; panic; dizziness; low blood pressure; severe chest pain; Tachycardia; tremors; fainting; sense of imminent death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority. Regulatory authority number IT-MINISAL02-782133. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left(reported as left shoulder) on 05Sep2021 (Batch/Lot Number: FG7378) at the age of 39-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 01Aug2021 for COVID-19 immunisation. The patient experienced Tachycardia, severe chest pain, tremors, dizziness, fainting, low blood pressure, sense of imminent death, extreme weakness, panic; all on 05Sep2021 with outcome of not recovered. The events were serious as hospitalization. Actions taken (First aid and consultation with the attending physician. Pharmacological therapy in progress.). Impact on quality of life (10/10).


VAERS ID: 1739465 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005691 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Gaze palsy, Loss of consciousness, Presyncope
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), Accidents and injuries (narrow), Ocular motility 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Rolling of the eyes; Loss of consciousness; Fall; Vasovagal reflex; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP092050 ) on 19-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, initially reported to the Regulatory Authority (Ref, v21126941). Rolling of the eyes and loss of consciousness were assessed as serious by the RA. A patient with syncope(2 or 3 times on the train, etc.) On 05-Sep-2021, at 10:30, the patient received the 1st dose of this vaccine. At 10:40, during follow-up, the patient''s condition appeared strange. When the patient was spoken to nearby, rolling of the eyes developed, and after that, the patient lost consciousness and fell off a chair. Consciousness recovered immediately. It was considered a symptom of vasovagal reflex. There were no other symptoms. The symptoms subsequently resolved. The outcome of rolling of the eyes, loss of consciousness, fall, and vasovagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 29 year-old, female patient with no relevant medical history, who experienced the unexpected events of gaze palsy, loss of consciousness, fall and presyncope. The events occurred the same day after the first dose of Spikevax The rechallenge was not applicable, as the events happened after the first dose. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1739532 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
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: COVID-19 immunisation, Chest pain, Electrocardiogram, Myocarditis, Troponin I
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Electrocardiogram; Result Unstructured Data: Electrocardiogram shows ST-depression.; Test Date: 20210905; Test Name: Troponin I; Test Result: Inconclusive ; Result Unstructured Data: inconclusive; Test Date: 202109; Test Name: Troponin I; Test Result: Inconclusive ; Result Unstructured Data: inconclusive
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Agency Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00049377) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 IMMUNISATION, CHEST PAIN and MYOCARDITIS in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for COVID-19 vaccination. Previously administered products included for Vaccination: Comirnaty (5''capped mRNA encoding full length SARS-CoV-2 spike protein). On 03-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced COVID-19 IMMUNISATION (seriousness criterion hospitalization), CHEST PAIN (seriousness criterion hospitalization) and MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 IMMUNISATION, CHEST PAIN and MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Electrocardiogram: abnormal (abnormal) Electrocardiogram shows ST-depression.. On 05-Sep-2021, Troponin I: 400 (Inconclusive) inconclusive. In September 2021, Troponin I: 29633 (Inconclusive) inconclusive. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered COVID-19 IMMUNISATION, CHEST PAIN and MYOCARDITIS to be possibly related. No concomitant medications were provided by the reporter No treatment information was provided by the reporter. This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the unexpected events of chest pain and revaccination with different Covid vaccine and expected event of myocarditis. The events of chest pain and myocarditis occurred approximately 2 days after the dose of Moderna COVID-19 Vaccine. The patient received Comirnaty vaccine previously. The rechallenge was not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Chest pain could be the symptom of myocarditis. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document received on 22-SEP-2021 included suspect drug related additional information and dosage form updated.; Reporter''s Comments: 07-sep-2021: requested additionalinformation. If new medical information is received, ; Sender''s Comments: This case concerns a 19-year-old, male patient with no relevant medical history, who experienced the unexpected events of chest pain and revaccination with different Covid vaccine and expected event of myocarditis. The events of chest pain and myocarditis occurred approximately 2 days after the dose of Moderna COVID-19 Vaccine. The patient received Comirnaty vaccine previously. The rechallenge was not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Chest pain could be the symptom of myocarditis.


VAERS ID: 1739659 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dizziness, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210945717

Write-up: STROKE; DIZZINESS; VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300106333] concerned a 67-year-old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total, administered on 27-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 05-SEP-2021 at 06:00, the patient experienced stroke, dizziness and vomiting. The patient was hospitalized (unspecified date), Number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness, vomiting, and stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210945717-COVID-19 VACCINE AD26.COV2.S-Stroke, Dizziness, 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). 20210945717-COVID-19 VACCINE AD26.COV2.S- Vomiting. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1739664 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Drug ineffective, Headache, Lymphadenopathy, Polymerase chain reaction, SARS-CoV-2 test positive, Throat irritation
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: RT-PCR; Result Unstructured Data: Test Result:positve
CDC Split Type: PHPFIZER INC202101219830

Write-up: COVID-19 positive; COVID-19 positive; Lymphadenopathy; cough; itchy throat; headache; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report numberPH-PHFDA-300105403. A 25-years-old female patient received unknown dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FF8871 ), via intramuscular on 21Aug2021 (at the age of: 25-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Sep2021 21:00 the patient experienced headache. On 06Sep2021 21:00 she had itchy throat. On 07Sep2021 10:00 she had cough. Lymphadenopathy on 07Sep2021 21:00 and On 09Sep2021 patient had covid-19 positive (drug ineffective). The patient underwent lab tests and procedures which included polymerase chain reaction with positive on 09Sep2021. The outcome of the events covid-19 positive, headache, cough was recovered on 2021 and lymphadenopathy, itchy throat was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-05
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cardiac telemetry, Electrocardiogram, Investigation, Myocarditis, Nasopharyngitis, Troponin, Viral test, X-ray
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALVEDON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: telemetry; Result Unstructured Data: Test Result:normal; Test Name: CRP; Result Unstructured Data: Test Result:75-54; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Name: NPH; Result Unstructured Data: Test Result:No findings; Test Name: tropnin; Result Unstructured Data: Test Result:440; Comments: max.; Test Name: virus test; Result Unstructured Data: Test Result:no findings; Test Name: lung x-ray; Result Unstructured Data: Test Result:normal
CDC Split Type: SEPFIZER INC202101194174

Write-up: Perimyocarditis; It is described that the man has a cold right now.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-082177. Other Safety Report Unique Identifier SE-VISMA-1631010159268. A 16-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Aug2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included paracetamol (ALVEDON) taken for an unspecified indication, start and stop date were not reported. It was mentioned that the patient had a father with Mb Bechterew. The patient did not take any medication except for Alvedon if needed. Reported suspect adverse events were perimyocarditis and started 20 Days after the vaccination on 05Sep2021. It was described that the man woke up with pressure over the chest and pain. Normal ECG, lung X-ray and telemetry but troponin admission, max 440. CRP 75-54. The pain was improved but not yet completely gone. No findings in virus diagnostics or NPH. MRI not performed. The patient would undergo a work test in 2-3 months. It was described that the patient had a cold right now. Outcome of the event perimyocarditis was recovering/resolving and outcome of cold was unknown. Report assessed as serious, hospitalization for perimyocarditis. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1740684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
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: Abdominal pain upper, Migraine, Pruritus, Pyrexia, Rectal haemorrhage
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101212898

Write-up: Rectal haemorrhage; Abdominal pain upper; migraine; Pruritus; pyrexia; This is a spontaneous report from a contactable HCP via the Regulatory Authority. Regulatory authority report number is 619342. A 39-year-old female patient received an unknown dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 05Sep2021, the patient experienced abdominal pain upper, migraine, pruritu, pyrexia and rectal haemorrhage. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-09-05
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (COVID-19 has passed)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101209683

Write-up: Menstrual flow excessive; Shortening of menstrual cycle; This is a spontaneous report from a contactable consumer (patient) downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB. The Regulatory Authority report number is ES-AEMPS-998344. A 31-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 06Jul2021 (Batch/Lot Number: FE6208) as dose 1, 0.3 ml single for COVID-19 immunisation. Medical history included COVID-19 which has passed. Concomitant medication included cyanocobalamin, folic acid, potassium iodide (YODOCEFOL) Prescribed for future pregnancy from 09Aug2021. The patient experienced menstrual flow excessive and shortening of menstrual cycle on 05Sep2021. The outcome of the events was unknown. The reporter assessed the events as serious (medically significant). No follow-up attempts are possible. No further information is expected.


VAERS ID: 1742430 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-05
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Electrocardiogram, Investigation, Pain in extremity
SMQs:, Hearing impairment (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210907; Test Name: clinical examination; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202101203789

Write-up: Idiopathic acute peripheral facial nerve palsy; pain in her left arm (injected arm); This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-SE20212398. A 73-year-old female patient received BNT162B2 (COMIRNATY), intramuscular in the left arm on 21Aug2021 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunization. Medical history included slight arthritis and overweight. The patient''s concomitant medications were not reported. The patient was at risk of developing a severe form of COVID-19 due to age. The patient had no background treatment. The patient presented in the aftermath with pain in her left arm (injected arm) and then she presented with right peripheral facial paralysis on 05Sep2021. On 07Sep2021, the rest of the clinical examination was normal with a normal ECG, no signs of neurological focus. It was most likely a frigore paralysis. The patient put on cortisone for a fortnight. Evolution was unknown. Conclusion: Peripheral facial paralysis at D15 of BNT162B2 of unknown evolution. The outcome of the events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1742441 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-05
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: NONE
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101204398

Write-up: miscarriage; psychological pain; This is a spontaneous report from a contactable consumer (patient) reference number FR-COVAES-9b33d19a-8caa-4cd1-98c9-f3f94cb6ebb0. This consumer or other non hcp reported information for both mother and fetus/baby. This is the maternal report. A 32-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration, administered in Arm Left on 15Jul2021 (at the age of 32 years old) (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s and concomitant medications were not reported. The patient reported she was 2 weeks pregnant at the time of injection on 15Jul2021 (last menstrual period on 29Jun2021; pregnancy due date 29Mar2022). Then she reported that on 05Sep2021 (at 9 weeks), her baby''s heart suddenly stopped without reason one and a half month after the injection whereas there was no anomaly. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. The patient also experienced psychological pain after the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The events resulted in Emergency room/department or urgent care. The outcome of the events was reported as not recovered.


VAERS ID: 1742610 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Inappropriate schedule of product administration, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101224793

Write-up: bleeding; Irregular periods; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer. This report was received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109160810107350-81YKY. Safety Report Unique Identifier GB-MHRA-ADR 25950550. A 22-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 2 via an unspecified route of administration on 05Sep2021 (age at vaccination was 22-year-old) as dose 2, single for COVID-19 immunisation. The patient was not pregnant at time of vaccination. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient had not a COVID-19 test. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included desogestrel (CERELLE) taken for an unspecified indication from 01Sep2017 to an unspecified stop date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported), dose 1 via an unspecified route of administration on 02Jul2021 as dose 1, single dose for COVID-19 immunisation with no adverse event. She haven''t had a period since she started Cerelle in 2017 aside from a year ago when she intentionally stopped taking pill. Usually when she gets a period, the actual bleeding lasts 3 days maximum and no matter what was on the same days of the month (starts on the first of the month). This was irregular days and an extended amount of time. She haven''t missed any days taking pill. On an unspecified date, the patient experienced bleeding, on 05Sep2021 patient had inappropriate schedule of vaccine administered, on 08Sep2021 patient experienced irregular periods. Outcome of the events bleeding was recovered on an unspecified date; irregular periods was not recovered, and rest of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742768 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Premature baby
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Neonatal disorders (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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101216641

Write-up: Preterm birth; Maternal exposure during pregnancy Third-trimester (29-40 weeks).; This is a spontaneous report from a contactable healthcare professional received from the regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109131347079490-WBLYP, Safety Report Unique Identifier GB-MHRA-ADR 25932190. This healthcare professional reported for both the mother and the fetus. This is the fetal report. A fetus patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via transplacental route of administration on 2021 as dose 1, single for COVID-19 immunization. Medical history included vitamin supplementation from an unknown date and unknown if ongoing. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy third-trimester (29-40 weeks) on 2021 with outcome of unknown, and preterm birth with outcome of recovered. The mother reported she became pregnant while taking bnt162b2. The mother underwent lab tests and procedures which included sars-cov-2 test: negative on 05Sep2021 No - Negative COVID-19 test, ultrasound scan: anomaly scan normal on 2021. The events were reported as serious, medically significant. Case narrative: Patient''s mother had not tested positive for COVID-19 since having the vaccine. Patient''s mother was not enrolled in clinical trial. Patient''s mother was exposed to the medicine Third-trimester (29-40 weeks). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101205356 Mother case


VAERS ID: 1743214 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
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: Blood creatine phosphokinase, Blood creatine phosphokinase MB, Body temperature, C-reactive protein, Pericarditis, Troponin, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: CK; Test Result: Inconclusive ; Result Unstructured Data: 98 IU/L; Test Date: 20210907; Test Name: CK; Test Result: Inconclusive ; Result Unstructured Data: 87 IU/L; Test Date: 20210910; Test Name: CK; Test Result: Inconclusive ; Result Unstructured Data: 69 IU/L; Test Date: 20210906; Test Name: CKMB; Test Result: Inconclusive ; Result Unstructured Data: 1 IU/L; Test Date: 20210907; Test Name: CKMB; Test Result: Inconclusive ; Result Unstructured Data: 1 IU/L; Test Date: 20210910; Test Name: CKMB; Test Result: Inconclusive ; Result Unstructured Data: 2 IU/L; Test Date: 20210905; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: 38.0 degrees Celsius; Test Date: 20210906; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 1.94 mg/dl; Test Date: 20210907; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 3.26 mg/dl; Test Date: 20210910; Test Name: CRP; Test Result: Inconclusive ; Result Unstructured Data: 0.50 mg/dl; Test Date: 20210906; Test Name: Troponin; Test Result: Inconclusive ; Result Unstructured Data: 0.004ng/ml; Test Date: 20210907; Test Name: Troponin; Test Result: Inconclusive ; Result Unstructured Data: 0.005 ng/ml; Test Date: 20210910; Test Name: Troponin; Test Result: Inconclusive ; Result Unstructured Data: 0.005 ng/ml; Test Date: 20210906; Test Name: wbc; Test Result: Inconclusive ; Result Unstructured Data: 10,300/mcl; Test Date: 20210907; Test Name: wbc; Test Result: Inconclusive ; Result Unstructured Data: 4,600/mcl; Test Date: 20210910; Test Name: wbc; Test Result: Inconclusive ; Result Unstructured Data: 5,300/mcl
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Epicarditis; This case was received via Pharmaceutical Company(Reference number: 2021TJP095226) on 16-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority(Ref, i21103717). On an unknown date, the patient received 1st dose of the vaccine. On 04-Sep-2021, the patient received 2nd dose of the vaccine. On 05-Sep-2021, the patient experienced pyrexia of 38.0 degrees Celsius. Chest pain was noted at night. On 06-Sep-2021, the patient made an emergency outpatient visit and was hospitalized with a diagnosis of epicarditis. WBC 10,300/mcL, CRP 1.94 mg/dL, CK/CKoMB 98/1 IU/L, Trop T 0.004 ng/mL, coronavirus PCR test negative. On 07-Sep-2021, WBC 4,600/mcL, CRP 3.26 mg/dL, CK/CKoMB 87/1 IU/L, Trop T 0.005 ng/mL. On 10-Sep-2021, WBC 5,300/mcL, CRP 0.50 mg/dL, CK/CKoMB 69/2 IU/L, Trop T 0.005 ng/mL. On an unknown date, the symptom was resolving with oral medication. On 11-Sep-2021, the patient was discharged from the hospital. The outcome of epicarditis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. A cause of epicarditis is unknown. However, the diagnosis of epicarditis was made based on the symptoms and the clinical course. The event was considered to be possibly an adverse reaction of the vaccine.; Sender''s Comments: This case concerns a 19 year-old male patient with no reported medical history, who experienced the unexpected serious event of Pericarditis. The event occurred one day after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1743316 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FE8405 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Hyperpyrexia, Malaise, Myalgia, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:40.5 to 42 Centigrade; Comments: Fever: 40.5 to 42 degrees Celcius
CDC Split Type: NLPFIZER INC202101208843

Write-up: Fever: 40.5 to 42 degrees Celcius; Myalgia; Feeling unwell; Cold chills; Inflammatory reaction at reaction site: redness, pain; Fatigue; Reaction at or around the injection site: redness; Reaction at or around the injection site: pain; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority-WEB NL-LRB-00683682. A 31-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was FE8405, Expiration date was not reported) via unspecified route of administration on 05Sep2021, as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. The patient''s medical history included Suspected COVID-19 from 14Aug2021 to unknown date. Concomitant medications were not reported. There were quite disease symptoms of previous COVID-19 infection. On 05Sep2021, the patient experienced Feeling unwell, Cold chills, Inflammatory reaction at reaction site: redness, pain, Fatigue, Reaction at or around the injection site: redness, Reaction at or around the injection site: pain. on 06Sep2021, 1 day after first dose the patient experienced Fever: 40.5 to 42 degrees Celsius and Myalgia. There was no extensive swelling of the vaccinated limb. The patient underwent lab tests and medical procedure which included Body temperature on 06Sep2021, which showed result of Fever: 40.5 to 42 degrees Celsius. The clinical outcome of event fever: 40.5 to 42 degrees Celsius, cold chills was recovered on 08Sep2021. Outcome of event Feeling unwell was recovered on 09Sep2021, while outcome of other events was recovering. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Redness and Swelling Extensive swelling of vaccinated limb: no COVID19 Previous COVID-19 infection: disease symptoms: quite


VAERS ID: 1743341 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE423 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed mood, Discomfort, Gait inability, Hypoaesthesia, Impaired driving ability, Loss of personal independence in daily activities, Mental disorder, Muscular weakness, Pyrexia, Sensory disturbance, Suicidal ideation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Suicide/self-injury (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210949437

Write-up: AFFECTS DAILY LIFE; CAN NOT DRIVE; VERY UNCOMFORTABLE FEELING; PROBLEM TO PICK UP SMALL ITEMS WITH HIS FINGERS; NUMBNESS; TEMPERATURE/FEVER; SUICIDAL THOUGHTS; NOT FEELING WELL MENTALLY / I DID NOT FEEL MYSELF AFTER VACCINE; LOW MOOD; STRANGE FEELING IN HIS FINGERS-FEELS LIKE AFTER ELECTRIC SHOCK; PROBLEM TO WALK DOWN STAIRS; This spontaneous potential legal report received from a patient concerned a male of unspecified age, 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: XE423 and expiry: UNKNOWN) dose was not reported, 1 total administered on 05-SEP-2021 to right deltoid for prophylactic vaccination. No concomitant medications were reported. On 05-SEP-2021, overnight (vaccination night) the patient developed temperature (fever) and was not feeling well mentally, and stated as "I was not myself". On the same day the patient had experienced suicidal thoughts, very low mood, problem to walk down stairs and developed a strange feeling in his fingers, reported that it was very difficult to describe what was wrong with his finger tips it feels like after electric shock. The patient had the feeling in 4 fingers on the right hand and 2 fingers on the left hand and reported that it affects patient daily life (date unspecified). The patient also reported that (on an unspecified date), the patient can''t drive with both hands on the steering wheel, had problem to pick up small items with his fingers, and described that patient had to change his when using computer mouse, said not just numbness but strange and very uncomfortable feeling. The patient reported that the temperature resolved within 30 hours (06-SEP-2021), low mood and suicidal thoughts resolved within 24 hours (06-SEP-2021) but still suffers with the strange feeling in his fingers (fingertips most affected), and the problem affects him physically and mentally. It was also reported that the patient also went to the physician, however the physician prescribed only some sachets to dissolve but they does not help. The patient stated that he works as an electrician and needs his fingers to be precise, and stated that he may take the legal action if his health did not improve. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suicidal thoughts, low mood, and temperature/fever on 06-SEP-2021, and not feeling well mentally / I did not feel myself after vaccine on 08-SEP-2021, had not recovered from strange feeling in his fingers-feels like after electric shock, and the outcome of problem to walk down stairs, can''t drive, problem to pick up small items with his fingers, numbness, very uncomfortable feeling and affects daily life was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: Medical Assessment comment not required as per standard operating procedure for legal case.


VAERS ID: 1746065 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   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 FG4686 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101222580

Write-up: Dyspnea; Chest pain; body temperature increased; This is a spontaneous report from a contactable consumer downloaded from the regulatory agency-WEB. This is a report received from regulatory agency. Regulatory authority report number ES-AEMPS-993858 with Safety Report Unique Identifier ES-AEMPS-993858. A 15-years-old male patient received the second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 04Sep2021 (Lot Number: FG4686) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 05Sep2021 afternoon the patient has lack of air feeling on 05Sep2021, left chest is in pain on 05Sep2021, body temperature increased on 05Sep2021. The events outcome was unknown. No follow-up attempts are needed. No further information is expected


VAERS ID: 1746069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101222636

Write-up: Myocarditis; This is a spontaneous report received from a contactable physician downloaded from the regulatory agency-WEB, regulatory authority number ES-AEMPS-995686. A 14-year-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: FG7898) via an unknown route of administration on 03Sep2021 as DOSE 2, SINGLE and dose 1 (Lot Number: unknown) via an unknown route of administration on an unspecified date in Aug2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocarditis on 05Sep2021. The patient was hospitalized for myocarditis from 05Sep2021 to an unknown date. Outcome of event was unknown. No follow-up attempts are possible. Information about batch number cannot be obtained.


VAERS ID: 1746099 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
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: Myocarditis
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Myocarditis; This case was received via Regulatory Authority (Reference number: FI-FIMEA-20214622) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 26-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company Comment: This case concerns a 26 year-old, male patient with no relevant medical history, who experienced the serious expected adverse event of special interest of Myocarditis. The event occurred approximately 4 days after the first dose of Spikevax. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 26 year-old, male patient with no relevant medical history, who experienced the serious expected adverse event of special interest of Myocarditis. The event occurred approximately 4 days after the first dose of Spikevax. The rechallenge was unknown since the event occurred after the first dose and no information has been provided regarding second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1746104 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Computerised tomogram abdomen, Pancreatitis acute
SMQs:, Acute pancreatitis (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 09/07/2021; Test Name: native abdominal computed tomography; Result Unstructured Data: Test Result: Acute pancreatitis; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result: 182.
CDC Split Type: FIPFIZER INC202101222306

Write-up: This is a spontaneous report from a contactable physician, downloaded via the regulatory authority (report number: FI-FIMEA-20214643). A 15-year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FH0161), intramuscularly, in left arm, on Sep 2, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient experienced acute pancreatitis on Sep 5, 2021. The patient hospitalized for acute pancreatitis from Sep 6, 2021 to an unknown date. The clinical course as follows: Sep 2, 2021 Pfizer''s Comirnaty-vaccine (first dose). On Sep 4, 2021 he enjoyed half a bottle of clear alcohol (single use). Sep 5, 2021 upper abdominal pain. On Sep 6, 2021 to the hospital. P-tertiary amylphenol 473 and C-reactive protein 182. Sep 7, 2021 in native abdominal computed tomography suitable finding for acute pancreatitis. On Sep 9, 2021, patient recovering from acute pancreatitis. No follow-up attempts possible. No further information expected.


VAERS ID: 1746406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   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 FE9174 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactoid reaction, Cardiovascular disorder, Chills, Erythema, Fatigue, Headache, Hypotension, Malaise, Pharyngeal swelling, Pyrexia, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tympanic membrane disorder (closing eardrum right)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101222296

Write-up: waking up at night due to tachycardia and anaphylactic symptoms (hypotension, swollen throat, redness all over the body); waking up at night due to tachycardia and anaphylactic symptoms; waking up at night due to tachycardia and anaphylactic symptoms (hypotension); waking up at night due to tachycardia and anaphylactic symptoms (swollen throat); waking up at night due to tachycardia and anaphylactic symptoms (redness all over the body); Shivering; Fever; Cardiovascular disorder; Malaise; Fatigue; Headache; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is BE-FAMHP-DHH-N2021-106441. A 15-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Sep2021 (Batch/Lot Number: FE9174) as dose 2, single for COVID-19 immunisation. The patient medical history included closing eardrum right on 01Jan2016. The patient''s concomitant medications were not reported. On 05Sep2021 the patient experienced waking up at night due to tachycardia and anaphylactic symptoms (hypotension, swollen throat, redness all over the body), shivering, fever, cardiovascular disorder, malaise, fatigue, headache. The events were reproted as serious , medically significant. The clinical outcome of the events tachycardia and anaphylactic symptoms (hypotension, swollen throat, redness all over the body), shivering, fever, cardiovascular disorder, malaise, fatigue, headache was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1746547 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Dyspepsia, SARS-CoV-2 test
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Other ischaemic heart disease (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 started and stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101211328

Write-up: dull pain in my heart; Heartburn; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109141523316440-PORKX, Safety Report Unique Identifier GB-MHRA-ADR 25939649. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 03Sep2021 (Lot Number: FE3380), as the second single dose, for COVID-19 immunization. Medical history included suspected COVID-19 from an unknown date (unsure when symptoms started and stopped). The patient''s concomitant medications were not reported. The patient experienced heartburn on 05Sep2021 with outcome of not recovered. The case was reported as non-serious. The patient underwent lab tests and procedures which included COVID-19 virus test: positive on an unspecified date. Additional information: Occasionally the patient felt a dull pain in his heart. The person who gave him the jab said that this would be a side effect that he should seek help for. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1746596 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Migraine, Muscle spasms, Neurological examination, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Neurological exam; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101217673

Write-up: migraine; Tremor; Tiredness; cramp pain in lower leg; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109151245497030-VSMHC with Safety Report Unique Identifier of GB-MHRA-ADR 25945438. A 36-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Sep2021(at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 05Sep2021, the patient experienced tremor, migraine, cramp pain in lower leg, and tiredness. The events migraine, tiredness and tremor were reported as serious for being medically significant. The clinical course was reported as follows: within 1hour of vaccine, the patient had tiredness, migraine, cramp pain in lower leg. Doctor discovered a tremor and was sent to neurology department. Relevant investigation conducted was neurological exam(unspecified results).The clinical outcome of the event tremor was not resolved while that of migraine, tiredness and cramp pain in lower leg was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746963 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Vital signs measurement; Result Unstructured Data: Test Result:Normal; Comments: all vital signs were normal
CDC Split Type: IEPFIZER INC202101237828

Write-up: FAINT; ALL VITAL SIGNS WERE NORMAL ALTHOUGH PATIENT WAS QUITE PALE; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-2021-083901. A 13-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Sep2021 (Lot Number: FG9019) at age of 13-year-old as dose 2, 0.3ML, single for COVID-19 immunisation. Medical history included food allergy. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), via an unspecified route of administration on 15Aug2021 as dose 1, 0.3ML, single for COVID-19 immunisation and the patient suffered a concussive injury at rugby training, and lost consciousness for about 1 minute on 04Sep2021. The patient was quite pale although all vital signs were normal and faint on 05Sep2021. The outcome of the events was recovered in Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747019 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Dyspnoea, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via European Medicines Agency (Reference number: IT-MINISAL02-785149) 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 ABDOMINAL PAIN (Il 4 fatto vaccino Moderna 2^ in a 38-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. No Medical History information was reported. On 04-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 05-Sep-2021, the patient experienced ABDOMINAL PAIN (Il 4 fatto vaccino Moderna 2^ dose.5 alle ore11 seriousness criterion life threatening), PYREXIA (Il 4 fatto vaccino Moderna 2^ dose.5 alle ore11 and DYSPNOEA ( At the time of the report, ABDOMINAL PAIN had resolved. No concomitant or treatment medication has been reported. This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected events of pyrexia, abdominal, consciousness and dyspnea. The events occurred 1 day after the first dose of mRNA-1273. The rechallenge was unknown as no information regarding the second dose was disclosed. Causality assessment for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness for assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were life-threatening. A temperature of 38 degrees Celsius is not considered serious er regulatory reporting requirement.; Reporter''s Comments: No; Sender''s Comments: This case concerns a patient of unknown age and gender with no reported medical history who experienced the unexpected events of pyrexia, abdominal, consciousness and dyspnea. The events occurred 1 day after the first dose of mRNA-1273. The rechallenge was unknown as no information regarding the second dose was disclosed. Causality assessment for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness for assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events were life-threatening. A temperature of 38 degrees Celsius is not considered serious er regulatory reporting requirement.


VAERS ID: 1747027 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-05
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Contraception NOS (In estrogen-progestogen therapy (Prevention of conception))
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101222836

Write-up: acute myopericarditis; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-785244. A 24-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: not reported, expiry date: not reported) intramuscularly on 29Jul2021 at 0.3 ml as dose 2, 0.3 ML single for covid-19 immunization. Medical history included estrogen-progestogen therapy (Prevention of conception) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 05Sep2021, the patient experienced acute myopericarditis (hospitalization). Clinical outcome of the event was reported as recovered on 10Sep2021. Reporter''s comments: In estrogen-progestogen therapy (Prevention of conception) Sender''s comments: Request to reporter for vaccine batch and expiry date. Request for clinical documentation referring to the suspected adverse reaction reported. On 13Sep2021 inserted the required clinical documentation. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1747219 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-09-05
   Days after vaccination:65
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: COVID-19, Drug ineffective
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: LTPFIZER INC202101221858

Write-up: COVID-19; drug ineffective; This is a spontaneous report from a contactable Consumer or other HCP downloaded from the Authority-WEB LT-SMCA-5942N.A 23-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation:Solution for injection, Batch/Lot Number: FD4555, Expiration date: 31Oct2021), via an unspecified route of administration on 02Jul2021 as Dose 2, Single for Covid-19 immunization. The patient medical and concomitant medications were not reported. On 05Sep2021, the patient had experienced covid-19 (drug ineffective) (medically significant). The duration and outcome of the events was unknown on an unspecified date. On PRD 18Sep2021 Product quality complaint: Information was provided from division site that includes Investigation on Dose 2, lot: FD4555, expiry date: 31Oct2021. Conclusion: 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 FD4555. 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. No follow-up attempts possible. No further information expected.


VAERS ID: 1747302 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-09-05
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Electrocardiogram, Magnetic resonance imaging, Myocarditis, Troponin T, Ultrasound scan
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:elevated; Test Name: ECG; Result Unstructured Data: Test Result:no results reported; Test Name: MRI; Result Unstructured Data: Test Result:no results reported; Test Name: troponin T; Result Unstructured Data: Test Result:elevated; Test Name: echography; Result Unstructured Data: Test Result:no results reported
CDC Split Type: NLPFIZER INC202101216276

Write-up: chest pain, elevated troponin T, CRP --$g dd: perimyocarditis; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority number is NL-LRB-00682460. A 46-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 23Jul2021 (Batch/Lot Number: FF4213) as dose 2, single for COVID-19 immunisation. Medical history included disease risk factor. The patient has no previous COVID-19 infection. The patient''s concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY), via an unspecified route of administration on 18Jun2021 (Batch/Lot Number was not reported) as dose 1, 0.3 mL single for COVID-19 immunisation (possible side effects are unknown). On 05Sep2021, (also reported as 1 month after start of vaccination), the patient experienced perimyocarditis. The event was considered serious (caused or prolonged hospitalization). The patient was treated with Carbasalate calcium (600 mg, 4x/day) and colchicine (0.5mg, 2x/day). A symptom of perimyocarditis was chest pain. Four days after onset of chest pain, the patient was hospitalised. A blood test showed elevated troponin T and CRP levels. Relevant tests included: blood test, troponin T: elevated; C-reactive protein (CRP): elevated), Magnetic resonance imaging (MRI) (no results reported), echography (no results reported), Electrocardiogram (ECG) (no results reported). The patient has not recovered from perimyocarditis 4 days after onset. Reporter comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 18Jun2021. Chest pain, elevated troponin T, CRP --$g dd: perimyocarditis. Hospitalization information: perimyocarditis. Additional information ADR: 4 days before hospital admission the side effects occurred: POB. Previous COVID-19 infection: No. Other: diagnostic procedures: MRI/echo/ecg and blood tests. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 18Jun2021. Chest pain, elevated troponin T, CRP --$g dd: perimyocarditis. Hospitalization information: perimyocarditis. Additional information ADR: 4 days before hospital admission the side effects occurred: POB. Previous COVID-19 infection: No. Other: diagnostic procedures: MRI/echo/ecg and blood tests.


VAERS ID: 1747346 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-09-05
   Days after vaccination:16
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: Arrhythmia, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101216112

Write-up: heart rhythm disorder; PERICARDITIS; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the regulatory authority-WEB NO-NOMAADVRE-PASRAPP-2021-Uxaenp. A 43-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 20Aug2021 13:40 (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. The patient experienced arrhythmia described as "heart rhythm disorder" on an unspecified date and pericarditis on 05Sep2021. The patient reported about being at a hospital for observation from 09:00 to 16:30 on 08Sep2021, due to arrhythmia and pericarditis. The patient was diagnosed with pericarditis. The events were also assessed as important medical events and resulted in physician office visit. Patient reported about getting a sick leave. The outcome of the event arrhythmia was unknown while pericarditis was not recovered. The Pharmacovigilance Center did not provide a causality assessment. Reporter Comment: Contact with healthcare professionals: Physician. Patient reports about being at a hospital for observation from 09:00 to 16:30 on 08Sep2021, due to ARRHYTHMIA. Patient was diagnosed with PARICARDITIS. Sender Comment: Patient reports about getting a sick leave. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Contact with healthcare professionals: Physician. Patient reports about being at a hospital for observation from 09:00 to 16:30 on 08Sep2021, due to ARRHYTHMIA. Patient was diagnosed with PARICARDITIS.


VAERS ID: 1750795 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
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: Cholecystitis acute
SMQs:, Infectious biliary disorders (narrow), Gallbladder related disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: RAMIPRIL; DEROXAT; KARDEGIC; ATORVASTATINE
Current Illness: Alzheimer''s disease; Arterial hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Aortocoronary bypass; Transient ischemic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Acute cholecystitis; This case was received via regulatory authority (Reference number: FR-AFSSAPS-PV20212730) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of CHOLECYSTITIS ACUTE (Acute cholecystitis) in an 88-year-old female patient who received mRNA-1273 (Spikevax) for Revaccination with different COVID-19 vaccine. Co-suspect product included non-company product FEBUXOSTAT (ADENURIC) for Hyperuricemia. The patient''s past medical history included Transient ischemic attack and Aortocoronary bypass. Concurrent medical conditions included Alzheimer''s disease and Arterial hypertension. Concomitant products included RAMIPRIL, PAROXETINE HYDROCHLORIDE (DEROXAT), ACETYLSALICYLATE LYSINE (KARDEGIC) and ATORVASTATINE for an unknown indication. In 2016, the patient started FEBUXOSTAT (ADENURIC) (Oral) unknown dosage. On 04-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 05-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced CHOLECYSTITIS ACUTE (Acute cholecystitis) (seriousness criteria hospitalization and medically significant). At the time of the report, CHOLECYSTITIS ACUTE (Acute cholecystitis) was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case concerns a 88 year-old female subject with no relevant medical history, who experienced the unexpected events of Cholecystitis Acute and revaccination with different COVID-19 vaccine was considered as an additional event. The event Cholecystitis Acute occurred one day after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. RA SD onset from the last dose was captured as 2 days instead of 1 day. RA SD coding was maintained. This case was linked to FR-AFSSAPS-PV20212698 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 28-Sep-2021. Dosage text for co-suspect was updated to unknown dosage.; Sender''s Comments: This case concerns a 88 year-old female subject with no relevant medical history, who experienced the unexpected events of Cholecystitis Acute and revaccination with different COVID-19 vaccine was considered as an additional event. The event Cholecystitis Acute occurred one day after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable, as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. RA SD onset from the last dose was captured as 2 days instead of 1 day. RA SD coding was maintained. FR-AFSSAPS-PV20212698:


VAERS ID: 1750947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram head, Headache, Inflammation, Investigation, Noninfective encephalitis, SARS-CoV-2 test, Vascular headache
SMQs:, Noninfectious encephalitis (narrow), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CERELLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Contraception; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: Blood tests; Result Unstructured Data: Test Result:Unknown results; Test Name: head CT scan; Result Unstructured Data: Test Result:Unknown results; Test Name: tests; Result Unstructured Data: Test Result:Unknown results; Comments: After several tests the doctor has prescribed steroid medication for a possible inflammation in the brain for 3 days.; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101225273

Write-up: inflammation; headache; Brain inflammation; Headache vascular; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109162007298570-88XWF, Safety Report Unique Identifier GB-MHRA-ADR 25955155. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2153), via an unspecified route of administration on 31Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included contraception. Patient has never been taking regular medications apart from contraceptive pill. Patient is healthy, don''t drink, don''t smoke or use any drugs. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included desogestrel (CERELLE) taken for contraception from 01Feb2019 to an unspecified stop date. The patient experienced brain inflammation on 13Sep2021 with outcome of not recovered, inflammation on an unspecified date with outcome of recovering, headache on an unspecified date with outcome of recovering, headache vascular on 05Sep2021 with outcome of not recovered. The patient underwent lab tests which included COVID-19 virus test: negative on an unspecified date, blood tests, tests and head CT scan, with unknown results on an unspecified date. Therapeutic measures were taken as result of the events. Patient has not tested positive for COVID-19 since having the vaccine. The events were reported as serious, caused hospitalization and medically significant. The clinical course was reported as follows: I have experienced severe headache on the left side of my head for 8 containing day and night when I have been told by the GP to go to the A&E. After several tests the doctor has prescribed steroid medication for a possible inflammation in the brain for 3 days. I currently have one more dose to take and it seems to help my headache and lessen the pain, although is hasn''t resolved it completely. Currently awaiting to be seen by a neurologist in the near future. Relevant investigations or tests conducted: "Related Blood tests and head CT scan has been performed in the hospital" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1751045 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhage, Inappropriate schedule of product administration, Intermenstrual bleeding, Muscle spasms, Nausea, Ovulation pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101227072

Write-up: cramps; bleeding; Intermenstrual bleeding; Intermenstrual pain; Fever; Nausea; Pain in arm; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109171726474710-DMDFS. Safety Report Unique Identifier: GB-MHRA-ADR 25960418. This is the first of 2 reports for the same patient reporting different doses A 26-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Sep2021 (Lot Number: FF2153) as single dose (at the age of 26) for covid-19 immunisation. First dose was received on 11Jul2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cramps on an unspecified date, bleeding on an unspecified date, intermenstrual bleeding on 05Sep2021, intermenstrual pain on 05Sep2021, fever on 05Sep2021, nausea on 05Sep2021, pain in arm on 05Sep2021, inappropriate schedule of vaccine administered on 05Sep2021. Pyrexia recovered on 08Sep2021, nausea recovered on 07Sep2021, pain in arm recovered on 11Sep2021. The outcome of inappropriate schedule of vaccine administered was unknown, of the other events was recovering. Text for relevant medical history and concurrent conditions: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient is not pregnant, patient is not currently breastfeeding. The intermenstrual bleeding was light but carried on until my next period. I am currently taking the Gederel Contraceptive Pill and the bleeding occurred even when I continued to take the medication. I also had slight cramps. This occurred after both doses. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101291827 same patient/different dose;GB-PFIZER INC-202101291827 same product/different dose


VAERS ID: 1751085 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; PROVERA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovary
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101227066

Write-up: Prolonged periods/ Long on off period/ Extremely heavy; This is a spontaneous report received from a contactable consumer. This is a report received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109172125295900-TM3WI Safety Report Unique Identifier GB-MHRA-ADR 25961567. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Sep2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient''s medical history included polycystic ovaries from unspecified date. Patient had not had symptoms associated with COVID-19. Concomitant medications included metformin and medroxyprogesterone acetate (PROVERA), both from unspecified date for polycystic ovaries. The patient experienced prolonged periods on 05Sep2021 reported as serious with medically significant criterion. It was also reported long on off period. Extremely heavy. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included COVID-19 virus test (negative, no - negative COVID-19 test) on unspecified date. The outcome of the events was not resolved. No follow-up attempts are possible, Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751253 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Lethargy, Nausea, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

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

Write-up: Fever; After second moderna dose; Lethargy; Headache; Fatigue; Nausea; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25975645) 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 PYREXIA (Fever), VOMITING (After second moderna dose), LETHARGY (Lethargy), HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Concomitant products included BECLOMETHASONE DIPROPIONATE MONOHYDRATE, FLUOXETINE and PROPRANOLOL for an unknown indication. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), VOMITING (After second moderna dose) (seriousness criterion medically significant) and LETHARGY (Lethargy) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), VOMITING (After second moderna dose) and LETHARGY (Lethargy) outcome was unknown and HEADACHE (Headache), FATIGUE (Fatigue) and NAUSEA (Nausea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported. After second moderna dose patient developed fatigue, fever, headache , lethargy. Post first dose patient had only tiredness. It was reported that patient had no symptoms associated with COVID-19 and was not enrolled in any clinical trials.Patient was not pregnant and was not breastfeeding at the time of reporting. Company Comment - This case concerns a 18-year-old, female patient with no relevant medical history on propranolol, who experienced the unexpected events of lethargy and the expected events of pyrexia, vomiting, headache, fatigue and nausea. The events occurred on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''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.; Sender''s Comments: This case concerns a 18-year-old, female patient with no relevant medical history on propranolol, who experienced the unexpected events of lethargy and the expected events of pyrexia, vomiting, headache, fatigue and nausea. The events occurred on the same day after the second dose of Moderna Covid-19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter''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: 1751366 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-05
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       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: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-786031) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS in a 26-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003655) for COVID-19 vaccination. No Medical History information was reported. On 13-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced FACIAL PARALYSIS (seriousness criterion medically significant). At the time of the report, FACIAL PARALYSIS had not resolved. No concomitant medications reported. No treatment information was provided. Patient had facial paralysis in the seventh sector on the right appeared which prevented him from closing his right eye and constantly lifting his lip on the same side. Company Comment: This case concerns a 26-year-old, male patient with no relevant medical history, who experienced the expected event of facial paralysis. The event facial paralysis occurred 23 days after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since only information about the this unknow dose number was disclosed. No product report assessment was given from the reporter. 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: Translation document received on 28 Sep 2021. Updated narrative with event details from event verbatim. Added sender''s comment.; Reporter''s Comments: September 14, 2021 Local Drug Safety Manager: batch no. and vaccination date obtained by the Regulatory Authority. Request to the hospital clinical documentation reporter. Awaiting reply.; Sender''s Comments: This case concerns a 26-year-old, male patient with no relevant medical history, who experienced the expected event of facial paralysis. The event facial paralysis occurred 23 days after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since only information about the this unknow dose number was disclosed. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1751377 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-09-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Application site joint swelling, Blood pressure increased, Blood pressure measurement, Extrasystoles, Feeling cold, Heart rate, Injection site pain, Injection site pruritus, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to antibiotic (Augmentin)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood pressure; Result Unstructured Data: 140/120; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: extrasystoles (160 bpm)
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site; This case was received (Reference number: IT-MINISAL02-786339) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of EXTRASYSTOLES (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), PARAESTHESIA (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), FEELING COLD (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), INJECTION SITE PRURITUS (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), INJECTION SITE PAIN (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), BLOOD PRESSURE INCREASED (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) and APPLICATION SITE JOINT SWELLING (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) in a 41-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Augmentin). On 29-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 500 microliter in total. On 05-Sep-2021, the patient experienced EXTRASYSTOLES (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization), PARAESTHESIA (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization), FEELING COLD (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization), INJECTION SITE PRURITUS (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization), INJECTION SITE PAIN (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization) and APPLICATION SITE JOINT SWELLING (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) (seriousness criterion hospitalization). At the time of the report, EXTRASYSTOLES (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), PARAESTHESIA (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), FEELING COLD (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), INJECTION SITE PRURITUS (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), INJECTION SITE PAIN (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site), BLOOD PRESSURE INCREASED (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) and APPLICATION SITE JOINT SWELLING (Legs and arms asleep, feeling of icy liquid that goes down from the trunk along the legs, high blood pressure (140/120), extrasystoles (160 bpm), swelling, itching and pain at the injection site) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Sep-2021, Blood pressure measurement: 140/120 (High) 140/120. On 05-Sep-2021, Heart rate: 160 bpm (abnormal) extrasystoles (160 bpm). The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. This case concerns a 41-year-old female patient with relevant medical history of Drug hypersensitivity, who experienced the unexpected serious, per reported severity events of Extrasystoles, Paraesthesia, Feeling cold, Injection site pruritus, Injection site pain, Blood pressure increased, Application site joint swelling. The events occurred approximately 8 days after first dose of Spikevax administration. The rechallenge was unknown as no information on the second dose available. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 28-Sep-2021 contains significant information - relevant history added. On 28-Sep-2021: Event added.; Sender''s Comments: This case concerns a 41-year-old female patient with relevant medical history of Drug hypersensitivity, who experienced the unexpected serious, per reported severity events of Extrasystoles, Paraesthesia, Feeling cold, Injection site pruritus, Injection site pain, Blood pressure increased, Application site joint swelling. The events occurred approximately 8 days after first dose of Spikevax administration. The rechallenge was unknown as no information on the second dose available. The benefit-risk relationship is not affected by this report.


VAERS ID: 1751384 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-05
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumothorax
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101228736

Write-up: RIght pneumothorax; This is a spontaneous report from a contactable physician downloaded from the regulatory authority.-WEB, regulatory authority number IT-MINISAL02-787035. A 54-years-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FF0688, Expiration Date: 31Oct2021), intramuscular, administered in deltoid left on 15Jul2021 as 0.3 ML single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (COMIRNATY), on 10Jun2021 for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced pneumothorax and hospitalization on 05Sep2021. Therapeutic measures were taken as a result of pneumothorax. The outcome of the event was recovering. No follow-up attempts are possible. No further information expected.


VAERS ID: 1751649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Myalgia, SARS-CoV-2 test, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Body temperature; Result Unstructured Data: 37 C; Test Date: 20210907; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: SIJNJFOC20210956570

Write-up: Vaccination failure; Myalgia; Body temperature increased; This spontaneous report received from a physician via regulatory authority (SI-JAZMP-NCPHV-2021SI0896_0896) on 29-SEP-2021 concerned a 37 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: XD974 expiry: 28-FEB-2023) 1 dosage forms, 01 total, administered on 02-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 05-SEP-2021, the patient had body temperature increased, and myalgia. Laboratory data included: Body temperature (NR: not provided) 37 celsius (C). On 07-SEP-2021, the patient experienced vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) resulted positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body temperature increased, vaccination failure, and myalgia. This report was serious (Other Medically Important Condition).


VAERS ID: 1754674 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   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 FE4728 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Vulval ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alexia; COVID-19; Dyslexia; Mixed anxiety and depressive disorder; Vulval ulceration (present painful vulvar ulcers with the disease covid19)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101229415

Write-up: Vulval ulceration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number ES-AEMPS-1003184. A 15-year-old female patient received the first dose of bnt162b2, intramuscular on 03Sep2021 (Batch/Lot Number: FE4728) as 0.3 ml, single for covid-19 immunisation. Medical history included COVID-19 from 11Apr2021 to 21Apr2021, vulval ulceration in Apr2021 present painful vulvar ulcers with the disease covid19, major depressive and anxiety disorder, dyslexia, and alexia. Concomitant medications included escitalopram and diazepam both taken for major depressive and anxiety disorder. On 05Sep2021, the patient experienced vulval ulceration. Clinical course was reported as follows. The patient with major depressive and anxiety disorder, dyslexia and alexia. In treatment with escitalopram, diazepam. Patient who passed covid19 between 11Apr2021 and 21Apr2021. Refers to present painful vulvar ulcers with the disease covid19 and also after vaccination BNT162B2 03Sep2021. Outcome the event was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1754677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   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 FG9428 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101229372

Write-up: This is a spontaneous report from a contactable physician, downloaded via the regulatory authority (ES-AEMPS-1003868). A 12-year-old female patient received unknown dose number of BNT162B2 (Comirnaty, solution for injection, batch/lot# FG9428; expiration date: Dec 21, 2021), via an unspecified route of administration, on Sep 1, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. On Sep 5, 2021, patient experienced facial droop (pure, uncomplicated, complete peripheral facial paralysis). Patient received treatment with corticosteroids and eye lubricants as a result of facial droop. Control at 48-hours from the start of the treatment. She is now stable. At the time of this report, the outcome of event: not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1755151 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Cold sweat, Myocarditis, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210917; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: fever; chest pain; cold sweats; Myocarditis; This case was received via the regulatory authority (Reference number: GB-MHRA-ADR 25985145) 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 PYREXIA (fever), CHEST PAIN (chest pain), COLD SWEAT (cold sweats) and MYOCARDITIS (Myocarditis) in a 20-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Patient has not had symptoms associated with COVID-19. On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant) and COLD SWEAT (cold sweats) (seriousness criterion medically significant). At the time of the report, PYREXIA (fever), CHEST PAIN (chest pain) and COLD SWEAT (cold sweats) outcome was unknown and MYOCARDITIS (Myocarditis) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. The patient experienced Chest pain every morning got a few days in a row. Cold sweats and a fever. Also thumping heart beat and also what felt like a quick heart beat than then slowed down again. No treatment information was provided. Company Comment: This case concerns a 20 year-old, male subject with no relevant medical history, who experienced the unexpected events of myocarditis, pyrexia, chest pain, and cold sweat. The event occurred approximately 2 days after the unknown dosage of Moderna covid -19 vaccine. The benefit-risk relationship of drug x in not affected by this report.; Sender''s Comments: This case concerns a 20 year-old, male subject with no relevant medical history, who experienced the unexpected events of myocarditis, pyrexia, chest pain, and cold sweat. The event occurred approximately 2 days after the unknown dosage of Moderna covid -19 vaccine. The benefit-risk relationship of drug x in not affected by this report


VAERS ID: 1755436 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19
SMQs:, 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:
CDC Split Type: JPPFIZER INC202101236348

Write-up: COVID-19 occurred; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative via medical information team. A patient of unknown age and gender received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration on 25Aug2021 (the day of vaccination) as Dose 1, Single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced COVID-19. The detail of the reaction was reported as follow: About CMT. There was a patient who received the first dose of vaccination on 25Aug2021. On 05Sep2021, COVID-19 occurred. Then antibody cocktail therapy was performed, and the patient was recovered on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Covid -19 The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1755554 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Dyspnoea, Nasopharyngitis, Oropharyngeal pain, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (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? 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: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 38 C; Test Date: 20210914; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive; Test Date: 20210915; Test Name: Oxygen saturation; Result Unstructured Data: 94 %, decreased
CDC Split Type: PHJNJFOC20210959841

Write-up: DIFFICULTY BREATHING; OXYGEN SATURATION DECREASED; RTPCR (+); CONFIRMED CLINICAL VACCINATION FAILURE; FEVER; SORE THROAT; COLDS; DRY COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300107765] concerned a 47-year-old male patient 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 was not reported) dose was not reported, 1 total, administered on 25-JUL-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 05-SEP-2021, the patient experienced dry cough and colds. On 08-SEP-2021, still with previous signs and symptoms the patient experienced sore throat, fever. Laboratory data included: Body temperature (NR: not provided) 38 C. On 14-SEP-2021, still with previous signs and symptoms, the patient underwent SARS-CoV-2 RT-PCR test and result came positive (COVID-19, confirmed clinical vaccination failure). On same day, in the afternoon, patient was consulted at hospital. On 15-SEP-2021, the patient experienced difficulty breathing, progression of cough, oxygen saturation decreased. Laboratory data included: Oxygen saturation (NR: not provided) 94 percent. On 15-SEP-2021, 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 difficulty breathing, was recovering from dry cough, fever, colds, sore throat, oxygen saturation decreased, and COVID-19, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint.; Sender''s Comments: V0: 20210959841-COVID-19 VACCINE AD26.COV2.S -difficulty breathing, dry cough, fever, colds, sore throat, oxygen saturation decreased, and COVID-19. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210959841-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1758032 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatic cytolysis, Influenza like illness
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (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:
Current Illness: Arthritis rheumatoid; Hypertension; Osteoarthritis; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Spondylodiscitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Hepatic cytolysis; Influenza like illness; This case was received via Regulatory Agency (Reference number: FR-AFSSAPS-BX20218660) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of HEPATIC CYTOLYSIS (Hepatic cytolysis) and INFLUENZA LIKE ILLNESS (Influenza like illness) in an 81-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Spondylodiscitis and COVID-19. Concurrent medical conditions included Osteoarthritis, Hypertension, Type 2 diabetes mellitus and Arthritis rheumatoid. On 04-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 05-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced INFLUENZA LIKE ILLNESS (Influenza like illness) (seriousness criterion hospitalization). On 06-Sep-2021, the patient experienced HEPATIC CYTOLYSIS (Hepatic cytolysis) (seriousness criteria hospitalization and medically significant). At the time of the report, HEPATIC CYTOLYSIS (Hepatic cytolysis) was resolving and INFLUENZA LIKE ILLNESS (Influenza like illness) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details was reported. This case concerns an 81 year old female with no relevant medical history who experienced the serious (hospitalization) events of Influenza like illness and Hepatic cytolysis. The events occurred one day and two days after Spikevax respectively. Re-challenge is not applicable as this was first dose. Benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation Document received on 29-SEP-2021, contain no new information; Sender''s Comments: This case concerns an 81 year old female with no relevant medical history who experienced the serious (hospitalization) events of Influenza like illness and Hepatic cytolysis. The events occurred one day and two days after Spikevax respectively. Re-challenge is not applicable as this was first dose. Benefit-risk relationship is not affected by this report.


VAERS ID: 1758244 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-09-05
   Days after vaccination:188
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, COVID-19, COVID-19 pneumonia, Computerised tomogram, Drug ineffective, Fibrin D dimer, Fraction of inspired oxygen, Hypoxia, Investigation, Oxygen saturation, SARS-CoV-2 test
SMQs:, Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PLAVIX; LOXEN L P; TADENAN; DIPROSONE G; LEVOTYROXIN NYCOMED; RACECADOTRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma lung; Arterial disorder (Non-stented stage II Obliterating arterial disease of the lower limbs); Benign prostatic hyperplasia; COPD (Moderate post-smoking Chronic obstructive pulmonary disease;(diffuse emphysema)); Depressive state; Dysuria; Ex-smoker (Smoking for 50 years, cessation since 2018); Hypertension (for $g 10 years); Hypothyroidism; Lung lobectomy; Pancreatic insufficiency; Peripheral arterial occlusive disease; Rectal bleeding; Rectorrhagia (on possible bleeding from a diverticulosis); Renal insufficiency; Thyroid disorder
Allergies:
Diagnostic Lab Data: Test Name: auscultation; Result Unstructured Data: Test Result:bilateral bronchial rales; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Name: thoracic CT scan; Result Unstructured Data: Test Result:does not reveal a pulmonary embolism; Comments: Evidence of a known major diffuse bullous emphysema. Parenchymatous damage in ground-glass areas estimated at about 25%, associated with bronchial fillings of the right basal pyramid.; Test Name: fibrin d-dimer; Result Unstructured Data: Test Result:increased; Comments: slightly increased D-dimer; Test Date: 20210915; Test Name: fraction of inspired oxygen; Test Result: 100 %; Test Name: hypoxemia; Result Unstructured Data: Test Result:8.6 kPa; Test Name: hypoxemia; Result Unstructured Data: Test Result:8.6; Test Name: Biological work-up; Result Unstructured Data: Test Result:no inflammatory syndrome; Test Date: 20210910; Test Name: Saturation; Test Result: 87 %; Test Date: 20210915; Test Name: Saturation; Test Result: 90 %; Test Date: 20210907; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 20210914; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101232768

Write-up: Drug ineffective; COVID-19 confirmed by positive COVID-19 test; SARS CoV2 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-NT20214021. A 69-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: Unknown), via intramuscular on an unspecified date in Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included lung lobectomy, peripheral arterial occlusive disease, hypertension (for $g 10 years), pancreatic failure, depressive state, benign prostatic hyperplasia, dysuria, rectal bleeding, right lower lobar bronchial adenocarcinoma, thyroid disorder, hypothyroidism, renal insufficiency, chronic obstructive pulmonary disease (Moderate post-smoking Chronic obstructive pulmonary disease;[diffuse emphysema]), obliterating arterial disease of the lower limbs (Non-stented stage II Obliterating arterial disease of the lower limbs); all from an unknown date and unknown if ongoing, rectorrhagia (on possible bleeding from a diverticulosis) from 2016 and unknown if ongoing, Lobectomy of the lower right lobe from Jan2019 and unknown if ongoing, ex-smoker (Smoking for 50 years, cessation since 2018) from an unknown date and stopped on 2018. Concomitant medications included clopidogrel bisulfate (PLAVIX), nicardipine hydrochloride (LOXEN L P), prunus africana extract (TADENAN), betamethasone dipropionate, gentamicin sulfate (DIPROSONE G), levothyroxine sodium (LEVOTYROXIN NYCOMED); all taken for an unspecified indication, start and stop date were not reported, racecadotril (RACECADOTRIL) taken for diarrhoea, start and stop date were not reported. On 05Sep2021, the patient experienced symptoms associating asthenia and progressive dyspnea. On 07Sep2021, the patient has Covid PCR test positive. On 10Sep2021, in the morning, the patient had increased of the dyspnea, desaturation at 87% and was transferred to the emergency room for acute respiratory distress. Polypneic with signs of struggle associated with coughing fits and fever to 39?. On auscultation bilateral bronchial rales, put on a high concentration mask at 15L/min on arrival. Biologically, no inflammatory syndrome, slightly increased D-dimer, hypoxemia at 8.6 kPa gas. Treatment with Dexamethasone was started. The pulmonary adenocarcinoma is in very good progression of lung cancer, excellent response to immunotherapy, disease almost no longer measurable. In view of the severity of the initial picture and in order to eliminate a pulmonary embolism, a thoracic CT scan with I.V. is performed in the emergency room, which does not reveal a pulmonary embolism. Evidence of a known major diffuse bullous emphysema. Parenchymatous damage in ground-glass areas estimated at about 25%, associated with bronchial fillings of the right basal pyramid. Transfer for further management of hypoxemic SARS CoV2 pneumonia. In total, acute respiratory distress of a hypoxemic Sars Cov2 lung disease in a 69 year old patient under immunotherapy in 2nd line of treatment of a bronchial adenocarcinoma with very good oncological response and history of emphysematous post-smoking COPD with little follow-up. Eupnea under Venturi mask 31%. Continuation of corticosteroid therapy with Dexamethasone 6 mg associated with 1 injection of tocilizumab and reinforced Lovenox. Evolution: On 15Sep2021, discontinuation of curares. Saturation at 90% under Fio2 100%. Increased sedation. Note: Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal procedures. Therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 39 centigrade, computerised tomogram: does not reveal a pulmonary embolism (Evidence of a known major diffuse bullous emphysema. Parenchymatous damage in ground-glass areas estimated at about 25%, associated with bronchial fillings of the right basal pyramid), fibrin d dimer: increased, hypoxia: 8.6 kpa, investigation: no inflammatory syndrome on an unspecified date, oxygen saturation: 87 % on 10Sep2021 and 90 % on 15Sep2021, sars-cov-2 test: positive on 07Sep2021 and negative on 14Sep2021. The outcome of the events was not recovered.


VAERS ID: 1758302 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Emotional distress, Hormone level abnormal, Musculoskeletal stiffness, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRAN [COD-LIVER OIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; In vitro fertilisation; Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101229033

Write-up: gone really deep in psyche; sore hand; Hormonal imbalance; dots on face/tingling hands/face/some kind of dots on face and hands; Stiff in the arm; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the Regulatory Agency-WEB, regulatory authority number NO-NOMAADVRE-PASRAPP-2021-Uxaegy. Safety Report Unique Identifier is NO-NOMAADVRE-E2B_00050084. A 34-year-old female patient received 1st dose of BNT162B2 (COMIRNATY) at single dose intramuscular in left arm on the 01Sep2021 08:00 for COVID-19 immunisation. Medical history included abstains from alcohol and non-smoker. The patient also reported to have been through a long process of in vitro fertilisation and lots of medications a year ago. Concomitant medication included cod-liver oil (TRAN). Serious events were reported as gone really deep in psyche, and sore hand with unknown date; dots on face, stiff in the arm, and hormonal imbalance with onset date of 05Sep2021; all with seriousness criteria of hospitalization. The clinical course was reported as follows: The patient reported that the vaccination had caused mental distress and hormonal imbalance ("pushing with the hormones"). She was still not working optimal. The patient also developed stiffness arm, painful hand and tingling hands/face. It was unclear if the patient meant tingling face/hands or some kind of dots on face and hands. For events "pushing with the hormones", stiffness arm, tingling face/hands and painful hand, Sunday was worst. The hand hurt for 2 days after the injection. The event required Physician Office Visit. Outcome of stiff in the arm and hormonal imbalance was not resolved. Outcome of the other events was unknown. The reactions/case was considered to be serious due to hospitalization required. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1758304 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Dyspnoea, Nasopharyngitis, Oropharyngeal pain, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: 38 C; Comments: 38 C; Test Date: 20210914; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive; Test Date: 20210915; Test Name: Oxygen saturation; Result Unstructured Data: 94 %, decreased
CDC Split Type: PHJNJFOC20210959364

Write-up: DIFFICULTY BREATHING; DECREASED OXYGEN; CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; FEVER; SORE THROAT; DRY COUGH; COLDS; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107762] concerned a 47-year-old male patient 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: unknown and expiry: unknown) dose was not reported, 1 total, administered on 25-JUL-2021 for an unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-SEP-2021, the patient experienced dry cough and colds. On 08-SEP-2021, still with above signs and symptoms the patient experienced sore throat, fever and patient body temperature was 38 degree celsius (C). On 14-SEP-2021, still with above signs and symptoms, the patient underwent SARS-CoV-2 RT-PCR test and result came positive (confirmed covid-19 infection, confirmed clinical vaccination failure). On same day in the afternoon patient was consulted at hospital. On 15-SEP-2021, the patient experienced difficulty breathing, progression of cough, decreased oxygen saturation which was 94%, On same day the patient was hospitalized (days and dates unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, colds, sore throat, difficulty breathing, decreased oxygen, and dry cough, and the outcome of confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000195612; Sender''s Comments: V0: 20210959364-COVID-19 VACCINE AD26.COV2.S-Confirmed Clinical Vaccination Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS 20210959364-COVID-19 VACCINE AD26.COV2.S-Confirmed Covid-19 Infection, Dry cough, Cold, Sore throat, Difficulty breathing, Oxygen saturation decreased, Fever. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1759841 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-05
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101242598

Write-up: Pericarditis; Troponin increased; This is a spontaneous report from a contactable other health professional via the Regulatory Agency. Regulatory authority report number is 623010. A 21-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Aug2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced pericarditis and troponin increased. Onset latency from vaccination was reported as 20 days. The patient recovered from the events on unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1759849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Malaise, Myalgia, Neuralgia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), 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: BEPFIZER INC202101228634

Write-up: Myalgia; Shivering; Feeling unwell; joint pain; I''ve had a really annoying kind of nerve pain in the forearm for a whole week now; Injection site reaction; This is a spontaneous report from a contactable consumer or other non-HCP from the regulatory authority number BE-FAMHP-DHH-N2021-106569. A 41-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced myalgia, shivering, feeling unwell, joint pain, I''ve had a really annoying kind of nerve pain in the forearm for a whole week now, injection site reaction. Time interval between beginning of drug administration and start of reaction/event was 12 hours. Verbatim: [BE-FAMHP-DHH-N2021-106569]. Spontaneous COVID-19 report received by the regulatory authorities on 10Sep2021. This female patient was vaccinated on 04Sep2021 with Comirnaty (second dose administered). Reported ADRs: Injection site reaction, Malaise, Shivering, Arthralgia, Myalgia, Nerve pain. Myalgia, Shivering, Malaise, Injection site reaction Stop date: 07Sep2021. Dosage text: Second dose administered There is no end date as the complaint is still present. The events were considered as serious (Disability). Outcome of vaccination site pain was recovered on 07Sep2021 and rest all the events was not recovered. Reporter Comment: Treatment: No. Evolution of the adverse drug reaction - No Improvement. Conditions - Other: vaccine itself. Adverse drug reaction description - The ticked side effects were gone after 48 hours (and only started +/- 12 hours after vaccination 2). But I have been experiencing an incredibly annoying kind of nerve pain in the forearm for a whole week now. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Treatment: No. Evolution of the adverse drug reaction - No Improvement. Conditions - Other: vaccine itself. Adverse drug reaction description - The ticked side effects were gone after 48 hours (and only started +/- 12 hours after vaccination 2). But I have been experiencing an incredibly annoying kind of nerve pain in the forearm for a whole week now.


VAERS ID: 1759926 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-09-05
   Days after vaccination:79
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 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? 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: 20210909; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC202101239772

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the REGULATORY AUTHORITY-WEB EE-SAM-50602109095. A 45-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10May2021 (Batch/Lot Number: EW6126; Expiration Date: 31Jul2021) as dose 1, 0.3 mL, single and intramuscular on 18Jun2021 (Batch/Lot Number: FC1526; Expiration Date: 30Sep2021) as dose 2, 0.3 mL, single, for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure and covid-19 on 05Sep2021. On 05Sep2021, the patient developed COVID-19 infection. SARS-CoV-2 PCR test was positive on 09Sep2021. The course of the disease was mild, and the patient recovered completely by 09Sep2021. The outcome of the events was recovered on 09Sep2021. The causal relationship is considered possible. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW6126. A complaint sample was not returned. No related quality issues were identified during the investigation. There 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 process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation 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 FC1526. 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 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. Senders comments: Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1760057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Angiogram cerebral, Asthenia, Blood electrolytes, Blood thyroid stimulating hormone, Blood triglycerides, C-reactive protein, Coagulation test, Dysarthria, Electrocardiogram, Electrophoresis protein, Facial paralysis, Full blood count, Glomerular filtration rate, Glycosylated haemoglobin, Hemiparesis, Hypertriglyceridaemia, Hypogammaglobulinaemia, Investigation, Ischaemic stroke, Limb discomfort, Lipase, Liver function test, Low density lipoprotein, Low density lipoprotein increased, NIH stroke scale, Neurological examination, Renal function test, SARS-CoV-2 test, Speech disorder, Troponin, Ultrasound Doppler
SMQs:, Dyslipidaemia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (broad), Lipodystrophy (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LERCANIDIPINE; CORTANCYL; UVEDOSE; PARIET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis rheumatoid; Cataract bilateral NOS; Cholecystectomy (on calculi); Hip fracture; Hypertension arterial; Umbilical hernia repair; Uterine fibroid
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Computerized tomography angiogram of the brain; Result Unstructured Data: Test Result:Discussion of a right lateral pontine hypodense ga; Comments: Discussion of a right lateral pontine hypodense gap possibly of an ischemic nature; Test Date: 20210907; Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: thyroid stimulating hormone; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: tryglicerides; Result Unstructured Data: Test Result:1.72 g/l; Comments: moderate hypertriglyceridemia; Test Date: 20210908; Test Name: coagulation; Result Unstructured Data: Test Result:normal; Test Date: 20210907; Test Name: C-reactive protein; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: C-reactive protein; Result Unstructured Data: Test Result:cold; Test Date: 20210907; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:regular sinus rhythm without repolarization proble; Comments: regular sinus rhythm without repolarization problems; Test Date: 20210908; Test Name: electrophoresis of serum proteins; Result Unstructured Data: Test Result:moderate hypogammaglobulinemia; Test Date: 20210907; Test Name: complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: complete blood count; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210908; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:79 ml/min; Test Date: 20210908; Test Name: Glycated hemoglobin; Test Result: 6.3 %; Comments: normal for age; Test Date: 20210908; Test Name: rest of the clinical examination; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210907; Test Name: lipasemia; Result Unstructured Data: Test Result:normal; Test Date: 20210907; Test Name: hepatic assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: hepatic assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: low density lipoprotein; Result Unstructured Data: Test Result:1.63 g/l; Comments: high; Test Date: 20210907; Test Name: neurological examination; Result Unstructured Data: Test Result:did not substantiate a sensory-motor deficit, nor; Comments: did not substantiate a sensory-motor deficit, nor any sign of focusing; Test Date: 20210908; Test Name: National Institutes of Health Stroke Scale; Result Unstructured Data: Test Result:3; Test Date: 20210907; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: renal function; Result Unstructured Data: Test Result:good; Comments: good renal function with glomerular filtration rate at 79 ml/minute; Test Date: 20210908; Test Name: coronavirus 2 Polymerase Chain Reaction; Test Result: Negative ; Test Date: 20210907; Test Name: troponin; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: Doppler ultrasound of supra-aortic trunks; Result Unstructured Data: Test Result:without hemodynamically significant abnormalities; Test Date: 202109; Test Name: etiological assessment; Result Unstructured Data: Test Result:does not highlight any particular mechanism at the; Comments: does not highlight any particular mechanism at the moment
CDC Split Type: FRPFIZER INC202101239816

Write-up: Ischemic stroke; dysarthria; hypertriglyceridemia; high low density lipoprotein; left facial paralysis; hypogammaglobulinemia; Serious Acute Respiratory Syndrome; Asthenia; speech disorder; heaviness of the left arm; left hemiparesis; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-SE20212457. A 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 03Sep2021 (Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Cholecystectomy, Hypertension arterial, Cataract bilateral NOS, Arthritis rheumatoid, Umbilical hernia repair, Left hip fracture, Uterine fibroid. Patient had no COVID-19 in previously, has not been tested COVID-19. Concomitant medications included lercanidipine; prednisone (CORTANCYL); colecalciferol (UVEDOSE); rabeprazole sodium (PARIET) all taken for an unspecified indication, start and stop date were not reported. The patient experienced ischemic stroke (hospitalization, medically significant) on 05Sep2021 with outcome of recovering, left hemiparesis (medically significant) on 05Sep2021 with outcome of unknown, left facial paralysis (medically significant) on 08Sep2021 with outcome of unknown, hypogammaglobulinemia (medically significant) on 08Sep2021 with outcome of unknown, serious acute respiratory syndrome (medically significant) on 08Sep2021 with outcome of unknown, asthenia (non-serious) on 05Sep2021 with outcome of unknown, speech disorder (non-serious) on 05Sep2021 with outcome of unknown, heaviness of the left arm (non-serious) on 05Sep2021 with outcome of unknown, dysarthria (non-serious) on 08Sep2021 with outcome of unknown, hypertriglyceridemia (non-serious) on 08Sep2021 with outcome of unknown, high low density lipoprotein (non-serious) on 08Sep2021 with outcome of unknown. Clinical course reported that patient experienced Asthenia and speech disorder and left hemiparesis and heaviness of the left arm on 05Sep2021. Medical care: Consultation in the emergency department on 07Sep2021: The neurological examination did not substantiate a sensory-motor deficit, nor any sign of focusing. Electrocardiogram in regular sinus rhythm without repolarization problems. Blood test (complete blood count, C-reactive protein, hepatic assessment, electrolytes, renal function, lipasemia, troponins) normal. Returned home the same day. Patient redirected on 08Sep2021 to the emergency department. National Institutes of Health Stroke Scale score of 3 on left facial paralysis and dysarthria, rest of the clinical examination unremarkable. Computerized tomography angiogram of the brain: Discussion of a right lateral pontine hypodense gap possibly of an ischemic nature. Introduction KARDEGIC 75 mg and preventive LOVENOX. Hospitalization on 12Sep2021. Differential diagnosis on 08Sep2021 included Serious Acute Respiratory Syndrome coronavirus 2 Polymerase Chain Reaction on 08Sep2021 negative. Doppler ultrasound of supra-aortic trunks without hemodynamically significant abnormalities. Normal electrolytes, good renal function with glomerular filtration rate at 79 ml/minute, normal hepatic assessment, lipid assessment found moderate hypertriglyceridemia at 1.72 g/L, and a high low density lipoprotein at 1.63 g/L, the C-reactive protein is cold, thyroid stimulating hormone is normal, the electrophoresis of serum proteins finds a moderate hypogammaglobulinemia. Glycated hemoglobin is 6.3% therefore normal for age, unremarkable complete blood count, normal coagulation assessment. Patient discharged from the hospital in Sep2021. Magnetic Resonance Imaging of the brain and trans-thoracic echocardiography pending. Holter electrocardiogram and blood pressure scheduled for 02Nov2021 and 03Nov2021. Conclusion was ischemic stroke discovered on left facial paralysis and on dysarthria, evolving favorably in an 89-year-old patient, 2 days after 2nd dose of COMIRNATY, etiological assessment does not highlight any particular mechanism at the moment in Sep2021. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1760421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood alkaline phosphatase, Electrocardiogram, Myocarditis, Troponin
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:high values; Test Name: ECG; Result Unstructured Data: Test Result:unremarkable; Test Name: Troponin; Result Unstructured Data: Test Result:high values
CDC Split Type: DEPFIZER INC202101239322

Write-up: Myocarditis, after vaccination with Comirnaty/ Arrhythmia; Myocarditis/ high troponin and alkaline phosphatase values; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021179362; Safety Report Unique Identifier is DE-PEI-202100189967. A 17-year-old male patient (weight: 69 kg, height: 172 cm) received the second dose of bnt162b2 (COMIRNATY, mRNA TOZINAMERAN, strength: 0.3ml, Batch/Lot Number: UNKNOWN), intramuscular on 04Sep2021 (unknown age at time of vaccination) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "myocarditis, after vaccination with comirnaty/ arrhythmia" on 05Sep2021. Case narrative: This report is serious - hospitalization. On 05Sep2021 the patient experienced arrhythmia. Hospitalisation for high troponin and alkaline phosphatase values, ECG was unremarkable. The outcome of arrhythmia was recovering; outcome of "myocarditis/ high troponin and alkaline phosphatase values" was unknown. No follow-up attempts possible; information about lot/batch number cannot be obtained.


VAERS ID: 1760728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-09-05
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 or stopped).
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202101242712

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109200906283970-B4ERB; safety report unique identifier: GB-MHRA-ADR 25967271). A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FD8813), via an unspecified route of administration, on Jul 22, 2021, single dose, for COVID-19 immunisation. Medical history included suspected COVID-19 (unsure when symptoms started or stopped). The patient''s concomitant medications not reported. The patient experienced prolonged periods (medically significant) on Sep 5, 2021. Her period was always 3 days. Now after her second jab, one week. The patient underwent lab tests and procedures, which included COVID-19 virus test: negative on an unspecified date. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The outcome of the event recovered on Sep 10, 2021. No follow-up attempts needed. No further information expected.


VAERS ID: 1760809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Malaise, SARS-CoV-2 test, Vertigo
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (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 INC202101242844

Write-up: vertigo sick feeling; vertigo sick feeling; Dizzy spells; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109202016337080-A8LH2, Safety Report Unique Identifier GB-MHRA-ADR 25970503. A 24-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection), dose 2 via an unspecified route of administration on 30Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on unspecified date (Batch/Lot Number: not reported) as for covid-19 immunization. None Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 05Sep2021, the patient experienced dizzy spells (medically significant). On an unspecified date patient had vertigo sick feeling (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified (No - Negative COVID-19 test). Any relevant investigations or tests conducted reported as it seems to prescribe medication. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1760887 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (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:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: This case was received via the Regulatory Authority (Reference number: DE-PEI-202100187119) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA and SYNCOPE in a 38-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 04-Sep-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 first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Sep-2021, the patient experienced ARRHYTHMIA (seriousness criteria hospitalization and medically significant). On 13-Sep-2021, the patient experienced SYNCOPE (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 05-Sep-2021 to 05-Sep-2021 due to ARRHYTHMIA and SYNCOPE. At the time of the report, ARRHYTHMIA had resolved and SYNCOPE had resolved with sequelae. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Patient had very slow resting pulse without symptoms. Sometimes had a heart rate of 35 (yes, that''s not a typo). His heart was last examined in February, and there was no evidence of disease. The resting pulse is normal for him. But he don''t know how this is compatible with the vaccine. He was brought to the hospital by ambulance. There, ECG and blood values were checked non-HDL Cholesterol 150 mg/dL, Leukocytes 11.0/nL, LDL Cholesterol 137 mg/dL, INR 1.04, PTT 23.5 sec. Most recent FOLLOW-UP information incorporated above includes on 27-Sep-2021 translation received on 29-Sep-2021 updated medical history, lab data, and new events in I-narrative supplement and hospitalization start date and stop date in events tab. This case concerns a 38 year old male patient with medical history of bradycardia, who experienced serious unexpected events of arrhythmia and syncope after second dose of mRNA1273. The events occurred the next day after vaccination. The rechallenge is not applicable. Patient''s medical history remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1760954 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 FG9019 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye contusion, Facial paralysis, Hypoaesthesia, Maternal exposure during breast feeding, Off label use, Product use issue, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hearing impairment (broad), Neonatal exposures via breast milk (narrow), Hypersensitivity (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Colecalciferol
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dairy free diet
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101278958

Write-up: LIFT DROOPING; NUMBNESS FEELING / FEELING NUMBNESS IN FACE; BRUISING UNDER EYE; FACIAL SWELLING IN LEFT SIDE OF FACE / CHEEK SWOLLEN; MATERNAL EXPOSURE DURING BREAST FEEDING; Off-label use; Drug use in unapproved population; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number IE-HPRA-2021-084103, Sender''s (Case) Safety Report Unique Identifier-IE-HPRA-2021-084103. A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Sep2021 (at the age of 29 years) (Batch/Lot Number: FG9019) as dose 1, single for COVID-19 immunization. Medical history included cows milk free diet. Concomitant medication included calcium carbonate, colecalciferol 1250 mg taken for cows milk free diet from 01Sep2020 to 09Sep2021. On 05Sep2021, the patient experienced lift drooping, maternal exposure during breast feeding, numbness feeling/ feeling numbness in face, bruising under eye, facial swelling in left side of face/ cheek swollen. It was reported that patient was breastfeeding. It was reported that the patient consulted their doctor, who advised them that their symptoms were probably a reaction to vaccination. At the time of reporting, the patient''s symptom of swelling persisted for twenty-four hour and their symptom of facial numbness was not recovered. The outcome of the event facial swelling in left side of face/ cheek swollen was recovered on an unspecified date in 2021 while for the other events was not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-PFIZER INC-202101286901 baby case


VAERS ID: 1761136 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
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: Bell's palsy
SMQs:, 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: AUPFIZER INC202101243867

Write-up: Bell''s palsy; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 625890. A 28-years-old female patient received BNT162B2 (COMIRNATY, solution for injection, Batch/lot number and expiry date were not reported) via an unknown route of administration on an unknown date as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced Bell''s palsy. The outcome of the event was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1761157 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
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: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101244437

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 627209. A 46-year-old male patient received bnt162b2 (COMIRNATY; Solution for injection; Lot number: Unknown), via an unspecified route of administration as dose number unknown, single on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Sep2021, the patient experienced pulmonary embolism. At the time of this report, the outcome of event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1762394 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   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 UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Basophil count, Blood pressure measurement, Body temperature, C-reactive protein, Dyspnoea, Eosinophil count, Erythema, Heart rate, Influenza virus test, Laryngospasm, Lymphocyte count, Neutrophil count, Oxygen saturation, SARS-CoV-2 test, Suffocation feeling, Swelling face, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
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: EUTHYROX; ZALDIAR; CITALEC; MONTELAR [MONTELUKAST SODIUM]; TEZEO; BUVENTOL; KAPIDIN; XADOS
Current Illness: Asthma bronchial (difficult to treat); Cervicocranial syndrome; Dust allergy; Factor V Leiden heterozygote (thrombophilic state); Hypertension arterial; Hypothyreosis; Penicillin allergy; Pollen allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Backache; Syncope (repeated syncope)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Basophil count; Result Unstructured Data: Test Result:0.01 x10 9/l; Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/100 mmHg; Test Date: 20210905; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Test Date: 202109; Test Name: C-reactive protein; Result Unstructured Data: Test Result:28 mg/l; Test Date: 202109; Test Name: C-reactive protein; Result Unstructured Data: Test Result:15.3 mg/l; Test Date: 20210905; Test Name: Eosinophil count; Result Unstructured Data: Test Result:0 x10 9/l; Test Date: 20210905; Test Name: Heart rate; Result Unstructured Data: Test Result:84; Comments: per min; Test Date: 20210905; Test Name: Influenza virus test; Test Result: Negative ; Comments: Influenza A, B; Test Date: 20210905; Test Name: Absolute lymphocyte count; Result Unstructured Data: Test Result:1.01 x10 9/l; Test Date: 20210905; Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:11.15 x10 9/l; Test Date: 20210905; Test Name: Oxygen saturation; Test Result: 96 %; Comments: with mask (oxygen 3 l/min); Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210905; Test Name: White blood cell count; Result Unstructured Data: Test Result:12.4 x10 9/l
CDC Split Type: CZPFIZER INC202101278625

Write-up: Laryngospasm; Anaphylactic reaction to vaccine; Difficulty breathing; Redness facial; Swelling face; mildly suffocating; This is a spontaneous report from a contactable consumer and other healthcare professional downloaded from the regulatory authority number CZ-CZSUKL-21010741. A 40-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY, Batch/Lot Number unknown), via intramuscular on 05Sep2021 (at the age of 40-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing hypertension arterial, ongoing cervicocranial syndrome, ongoing dust allergy, ongoing pollen allergy, ongoing factor V leiden heterozygote (thrombophilic state), ongoing asthma bronchial (difficult to treat), ongoing hypothyreosis, repeated syncope, ongoing penicillin allergy, and backache. Concomitant medications included levothyroxine sodium (EUTHYROX, Tablet); paracetamol, tramadol hydrochloride (ZALDIAR) taken for back pain; citalopram hydrobromide (CITALEC); montelukast sodium (MONTELAR); telmisartan (TEZEO); salbutamol sulfate (BUVENTOL); lercanidipine hydrochloride (KAPIDIN); and bilastine (XADOS). The patient previously took diclofenac sodium (DOLMINA), and experienced drug allergy. The patient previously received 1st single dose of BNT162B2 (COMIRNATY, Batch/Lot Number unknown) via intramuscular in 2021 for COVID-19 immunisation. The patient had difficulty breathing and a recurrent anaphylactic reaction to vaccine (throat contraction) up to 5 minutes after vaccination with COMIRNATY vaccine on 05Sep2021. The patient was hospitalized, at admission to the hospital, she was mildly suffocating, swelling in the face, and red. Adrenaline 0.5 mg intramuscularly was administered, her condition improved. During hospitalization at the intensive care unit, anaphylactic attacked with laryngospasm were repeated several times, always with a good response to Adrenaline therapy. Antihistamines and corticotherapy were also given. The patient was hospitalized for all AEs until 13Sep2021. The events Laryngospasm, Anaphylactic reaction to vaccine and Difficulty breathing were also reported as serious (Life-threatening). The patient underwent lab tests and procedures which included basophil count: 0.01 x10 9/l on 05Sep2021, blood pressure measurement: 140/100 mmHg on 05Sep2021, body temperature: 36.8 centigrade on 05Sep2021, C-reactive protein: 28 mg/l in Sep2021, 15.3 mg/l in Sep2021, eosinophil count: 0 x10 9/l on 05Sep2021, heart rate: 84 per min on 05Sep2021, influenza virus test: negative on 05Sep2021 (Influenza A, B), lymphocyte count: 1.01 x10 9/l on 05Sep2021, neutrophil count: 11.15 x10 9/l on 05Sep2021, oxygen saturation with mask (oxygen 3 l/min): 96 % on 05Sep2021, SARS-COV-2 test: negative on 05Sep2021, white blood cell count: 12.4 x10 9/l on 05Sep2021. The outcome of the events was recovered on an unspecified date. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1763174 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: 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: IEPFIZER INC202101256712

Write-up: Large swelling of lymph node on left armpit. Arm where injection was administered.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number IE-HPRA-2021-083951. Safety Report Unique Identifier IE-HPRA-2021-083951. Initial report received by the RA on 06Sep2021 from a member of the public. A 12-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG9019), dose 2 via an unspecified route of administration, administered in Arm Left on 05Sep2021 (at 12-years age) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Information regarding the patients medical history/concurrent conditions was not included in the report. On 15Aug2021, the patient was vaccinated with his first dose of Comirnaty (batch details FE7053). The patient experienced large swelling of lymph node on left armpit. arm where injection was administered on 05Sep2021, 12 hours after vaccination. At the time of reporting the patient symptoms were continuing. Seriousness for the event was reported as medically significant. The outcome of the event was not resolved. No Follow-up attempts are possible. No further information is expected.


VAERS ID: 1766067 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Delirium, Dyspnoea, Hypotension, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization (3 weeks from birth due to mother''s twin pregnancy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101256901

Write-up: Consciousness loss; Delirium; Asthenia; Hypotension; Shortness of breath; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is FR-AFSSAPS-PC20213773. A 17-year-old male patient received the first dose of BNT162B2 (COMIRNATY solution for injection; lot number: FG7387), via intramuscular on 05Sep2021 (at the age of 17-years-old) at dose 1, 0.3 ml single in the left arm for COVID-19 immunisation. Medical history included hospitalization (3 weeks from birth due to mother''s twin pregnancy). The patient''s concomitant medications were reported as none. On 05Sep2021, the patient experienced consciousness loss for 10 minutes, delirium, asthenia, hypotension, and shortness of breath. The events consciousness loss and delirium were reported as serious, medically significant. Outcome of the events consciousness loss and delirium was recovered on 05Sep2021, and for other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1766735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (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: Colonic polyp; Dyslipidemia; Neoplasm of unspecified nature of digestive system; Overweight; Tobacco abuse
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20211007053

Write-up: Vaccination failure; This spontaneous report received from a health care professional via regulatory authority (EVHUMAN Vaccines, PT-INFARMED-T202109-1459) was received on 05-OCT-2021 and concerned a 52 year old male with unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: colonic polyp, neoplasm of unspecified nature of digestive system, overweight, dyslipidemia, and tobacco abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD986 expiry: UNKNOWN) 0.5 ml, 1 total administered on 04-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 05-SEP-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information: COVID-19 INFECTION 08-Sep-2021; ALTERATION OF LIPIDS 06-Apr-2021; BENIGENT / NON-SPECIFIC NEOPLASY OF THE DIGESTIVE SYSTEM; COLON POSLIP AT with SBD 25-Jun-2020; OVERWEIGHT 22-Apr-2019; ABUSE OF TOBACCO


VAERS ID: 1770122 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 209C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Pyrexia, Rhinitis
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211012121

Write-up: COUGH; DIFFICULTY BREATHING; FEVER; COLDS; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300108683] concerned a 45 year old male 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: 209C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 31-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 05-SEP-2021, the patient experienced cough, colds, difficulty breathing, fever and was hospitalized (date unspecified). The number of days hospitalized was unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough, colds, difficulty breathing, and fever. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20211012121-COVID-19 VACCINE AD26.COV2.S -cough and difficulty breathing. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20211012121-COVID-19 VACCINE AD26.COV2.S -fever. This event is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1772532 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
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: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Migraine; Obesity
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211011244

Write-up: Vaccination failure; This spontaneous report received from a pharmacist via Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-GR20214295) on 06-OCT-2021 and concerned a 57 year old female. The patient''s weight was 104 kilograms and height was 164 centimeters. The patient''s concurrent conditions included: obesity, migraine and hypertension arterial. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) .5 ml, 1 total, administered on MAY-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 05-SEP-2021, the patient experienced vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vaccination failure. This report was serious (Life Threatening). This report was associated with product quality complaint.


VAERS ID: 1773276 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysarthria
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20211012113

Write-up: SLURRED SPEECH; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [regulatory authority, PH-PHFDA-300108695] concerned a 62 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: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 05-SEP-2021, the patient had dizziness and slurred speech. Patient was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and was recovering from slurred speech. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20211012113-covid-19 vaccine ad26.cov2.s-slurred speech. 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).


VAERS ID: 1776225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-11
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: ATJNJFOC20211016581

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (AT-BASGAGES-2021-047640) on 08-OCT-2021 and concerned a 38 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: XD975 expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 28-MAY-2021 for an unspecified indication. No concomitant medications were reported. On 05-SEP-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: 1778223 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hypersomnia, Loss of personal independence in daily activities, Pain
SMQs:, Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101278973

Write-up: Slept for 18hrs; Finding it hard to function as he is so tired and slept for 18hrs; Aches, pains; Headache; Extreme tiredness; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number IE-HPRA-CVARR2021091220840 and Safety Report Unique Identifier IE-HPRA-2021-084228. A 15-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an un-specified route of administration on 05Sep2021 (age at the time of vaccination was 15-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient did not have any relevant medical history or concurrent conditions. The patient concomitant medications were not reported. The patient previously took first dose of bnt162b2 via an unspecified route of administration, on 15Aug2021 (Batch/Lot Number: not reported) for covid-19 immunization. Seven hours later, on 05Sep2021, the patient experienced aches, pains, headache, extreme tiredness, loss of personal independence in daily activities and hypersomnia. The patient was finding it hard to function as he was so tired and he slept for 18 hours. All the events were assessed as serious (disability). The patient was treated with paracetamol (brand unspecified). At the time of reporting, the patient symptoms were persisting. It was then 7 days later and he still had the extreme tiredness. The outcome of events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1778228 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Disturbance in attention, Dizziness postural, Dyspnoea, Fatigue, Headache, Irritability, Pain in extremity, Palpitations, Sleep disorder
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic fatigue (Patient concerned that the effects of the vaccine may increase her chronic fatigue)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101279037

Write-up: Light headed and dizzy when standing or moving around; Lack of concentration; Extreme fatigue; Feeling of breathlessness; Irritable; Lack of appetite; Very sore arm; Headache; Very fitful broken sleep/broken sleep; Heart racing/pounding in chest; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number IE-HPRA-2021-084248, Safety Report Unique Identifier IE-HPRA-2021-084248. A 15-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for Injection, Lot Number: FG9019) dose 2 via an unspecified route of administration on 05Sep2021 (at the age of 15-year-old) as dose 2, single for COVID-19 immunisation. Medical history included chronic fatigue (Patient concerned that the effects of the vaccine may increase her chronic fatigue) from an unknown date and unknown if ongoing. The patient was not taking any concomitant medication. Historical vaccine included Comirnaty dose 1, lot no: FE7053 via an unspecified route of administration received on 15Aug2021 for COVID-19 immunisation. On 05Sep2021, the patient experienced a very fitful, broken sleep. Her heart was racing, and she experienced pounding in her chest. The patient also experienced a headache and a very sore arm. On 06Sep2021, the patient experienced extreme fatigue, broken sleep, heart racing and the feeling of breathlessness. The patient outlined that she was lightheaded and dizzy when standing or moving around. She experienced a lack of concentration, a lack of appetite and described feeling irritable. The patient noted in the report that she was concerned that the effects of the vaccine may increase her chronic fatigue. The events were medically significant. Therapeutic measures were taken as a result of lightheaded and dizzy when standing or moving around, extreme fatigue, feeling of breathlessness, very sore arm, headache, very fitful broken sleep/broken sleep, heart racing/pounding in chest, lack of appetite. The patient was treated with paracetamol, magnesium glycinate, water and rest. It was outlined in the report that on 06Sep2021, the patient attended her general practitioner (GP) and on 08Sep2021 the patient attended the Accident and Emergency department (A and E). At the time of reporting the patient''s symptoms were continuing. The outcome of all events was reported as not recovered. No causality was provided for dizziness postural, disturbance in attention, fatigue, dyspnoea, irritability, pain in extremity, headache, sleep disorder, decreased appetite and palpitations. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1780070 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-09-05
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19 vaccination; Pericarditis; Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075132110FRA001551

Write-up: Pericarditis; Information has been downloaded from regulatory authority (FR-AFSSAPS-2021134971). This spontaneous report was received from a pharmacist referring to a 16-year-old female patient. The patient''s concurrent condition included pericarditis. The patient''s medical history and concomitant medications and drug reactions/allergies were not reported. On 02-AUG-2021, the patient was vaccinated with hpv rl 1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 5 milliliter (ml) via intramuscular route, for prophylactic vaccination. On 17-AUG-2021, the patient was vaccinated with tozinameran (COMIRNATY), at a dose of 0.3 ml via intramuscular route for corona virus disease (COVID-19) vaccination. For both the suspect vaccines, batch/lot # reported as unknown, and formulation, strength, frequency and expiration date were not reported). On 05-SEP-2021 (35 days after vaccination with hpv rl 1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and 20 days after vaccination with tozinameran (COMIRNATY)), the patient developed pericarditis. Approximately on an unknown date in September 2021, the patient was hospitalized due to the event. Action taken with the suspect vaccines were reported as withdrawn. On 10-SEP-2021, the event resolved. The relatedness between the event and suspect vaccines was not reported.


VAERS ID: 1780201 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 - / 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? 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: FRPFIZER INC202101278906

Write-up: Early miscarriage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency (RA)-WEB. The regulatory authority report number is FR-AFSSAPS-MP20217643. A 38-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FG7387), via intramuscular, on 28Aug2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient has not had COVID-19, and has not been tested. On 05Sep2021, it was reported that the patient experienced an occurrence of early miscarriage (medically significant), around 6 WA (as reported). "Concept" of loss of a baby at a more advanced term than the one concerned in this report. The outcome of the event was recovered on unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1780543 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-09-05
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Hypersensitivity, Rash erythematous, Rash macular, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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; Test Name: temperature; Result Unstructured Data: Test Result:increased
CDC Split Type: GBPFIZER INC202101294578

Write-up: blotchy red rash all over my body; blotchy red rash all over my body; allergic; The rash is so strong it gives me a temperature (increased); Hives; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109291046026160-JMBPV, Safety Report Unique Identifier GB-MHRA-ADR 26008661. A 21-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history included suspected COVID-19 (unsure when symptoms started and unsure when symptoms stopped). The patient''s concomitant medications were not reported. On 05Sep2021, the patient experienced hives. On an unknown date, the patient experienced blotchy red rash all over body and have never been allergic to anything and nothing in household has been changed to cause this apart from the vaccine he had. The rash was so strong it gave him a temperature (increased) and it was never ending. The outcome of the event hives was not recovered while the outcome of the remaining events was unknown. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included negative COVID-19 test on an unspecified date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1786713 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-05
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cough, Headache, Nausea, Pyrexia, Vaccination failure, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ITJNJFOC20211022681

Write-up: Vaccination failure; Losing wt; Cough; Headache; Fever; COVID-19 respiratory infection; Nausea; Asthenia; This spontaneous report received from a consumer via a Regulatory authority (regulatory authority, IT-MINISAL02-795552) on 12-OCT-2021 and concerned a 71 year old male. The patient''s weight was 76 kilograms, and height was 185 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: XD974 expiry: unknown) 0.5 ml, 1 total administered on 20-AUG-2021 for covid-19 vaccination. No concomitant medications were reported. On 05-SEP-2021, the patient experienced vaccination failure, losing wt, cough, headache, fever, covid-19 respiratory infection, nausea and asthenia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccination failure, losing wt, cough, headache, fever, covid-19 respiratory infection, nausea, and asthenia. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.; Reporter''s Comments: None


VAERS ID: 1671901 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Palpitations, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Effexor 150mg ER 1 PO at night
Current Illness: Covid-delta
Preexisting Conditions: SVT, DVT,A-FIB
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Palpitations, headache, shaky vision in both eyes


VAERS ID: 1674319 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Body temperature increased, Chills, Feeling cold, Headache, Hyperhidrosis, Pain, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (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: N/a
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: N/a
Diagnostic Lab Data:
CDC Split Type:

Write-up: Woke up around 12:30 am feeling body aches, couldn?t go back to sleep, started rigoring, took temp of 100.2 . Took Tylenol before I went to sleep around 9:00 pm and then again at 3:00 am - started sweating and got a couple more hours of sleep. Woke up freezing again with a headache


VAERS ID: 1674477 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Pruritus, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Not known
Current Illness: Not known
Preexisting Conditions: Not known
Allergies: Not known
Diagnostic Lab Data: Not known
CDC Split Type:

Write-up: Patient called the day after getting the vaccine stating his back is itchy and full of hives and he is short of breath.


VAERS ID: 1674530 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3181 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Epistaxis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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

Write-up: Patient had a bloody nose used proper procedures to stop the bleeding and took vitals those appeared normal for this patient.


VAERS ID: 1674532 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3/84 / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Seizure
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), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Seizure when I woke up to use the bathroom, I fell to the floor and was unconscious then regained conscious. It took about 5 minutes.


VAERS ID: 1674534 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None.
Current Illness: Diagnosed with Gastritis on 8/31/2021.
Preexisting Conditions: Diagnosed with Gastritis on 8/31/2021.
Allergies: Lactose intolerant. Allergic to plastic, latext.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Strong and sustained abdominal pain experienced beginning at 12:30 am on 9/4/2021.


VAERS ID: 1674538 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Immediate post-injection reaction, Muscle twitching, Seizure like phenomena, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NOT KNOWN; PATIENT DID NOT REPORT ANY MEDICATIONS TAKEN
Current Illness: NO PRIOR ILLNESS REPORTED BY PATIENT
Preexisting Conditions: PRIOR HISTORY OF SEIZURES; LAST SEIZURE IN 2008
Allergies: NO KNOWN REPORTED PATIENT ALLERGIES.
Diagnostic Lab Data: NOTIFIED EMS AND PATIENT WAS TAKEN BY PARAMEDICS FOR FURTHER EVALUATION AND OBSERVATION.
CDC Split Type:

Write-up: ADMINISTERED SINGLE DOSE OF JANSSEN COVID-19 VACCINATION; PATIENT IMMEDIATELY POST INJECTION FAINTED AND EXHIBITED SEIZURE LIKE SYMPTOMS; BODILY TWITCHING, ETC.


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