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From the 11/19/2021 release of VAERS data:

Found 894,019 cases where Vaccine is COVID19 and Patient Did Not Die

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Onset Date)

This is page 471 out of 8,941

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VAERS ID: 1799542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Ear disorder, Fall, Immunisation, Off label use, SARS-CoV-2 test, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101316936

Write-up: vomiting; fall; heaviness in ears; Vertigo; dizziness; Off label use; BOOSTER; This is a spontaneous report from a contactable physician (patient) received from the Regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110041402254360-TUREM. Safety Report Unique Identifier is GB-MHRA-ADR 26033205 A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 26Sep2021 as DOSE 3 (BOOSTER DOSE), SINGLE for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient was not pregnant at the onset of event and at the time of vaccination. Patient was perfectly normal, active and healthy. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient experienced dizziness on an unspecified date with outcome of not recovered, vomiting on an unspecified date with outcome of not recovered, fall on an unspecified date with outcome of not recovered, vertigo on 04Oct2021 with outcome of not recovered, and heaviness in ears on an unspecified date with outcome of unknown; off label use and booster on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date, No - Negative COVID-19 test. Therapeutic measure was taken for dizziness, vomiting, fall, vertigo and heaviness in ears that included vertigo medication. The patient''s hospitalization was prolonged as a result of dizziness; events vomiting, fall, vertigo and heaviness in ears caused hospitalization. The events dizziness, vomiting, fall, vertigo and heaviness in ears were also assessed as medically significant, while the other events were assessed as non-serious. Case narrative: Severe vertigo, dizziness and vomiting , heaviness in ears on waking up. This is day 1 but not sure how many days this will continue with. Almost caused a severe fall and risk of major injury. Cost implication- unpaid time off from work as currently an agency worker. If I was not a doctor myself, I would have been in the A&E right now seeking urgent medical care. I may still need to do so if symptoms persist. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Vertigo medication. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1799546 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH8469 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Fatigue, Myalgia, Nausea, Off label use, Product use issue, Pruritus, Rash
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (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: CITALOPRAM; EVOREL CONTI; TRAZODONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Hormone replacement therapy; Immunisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101325328

Write-up: Burning sensation; fatigue; joint pain; nausea; itchy; Rash; Myalgia; Patient received bnt162b2 on 26Sep2021 and influenza vaccine on 26Sep2021; Patient received bnt162b2 on 26Sep2021 and influenza vaccine on 26Sep2021; This is a spontaneous report from a contactable pharmacist. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110041538055300-B4QVJ, Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 26033556. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration on 26Sep2021 (Lot Number: FH8469) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included depression, immunisation, hormone replacement therapy. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included influenza vaccine taken for immunisation from 26Sep2021 to 26Sep2021; citalopram taken for depression from Oct2011 to an unspecified stop date; estradiol, norethisterone acetate (EVOREL CONTI) taken for hormone replacement therapy from 2019 to an unspecified stop date; trazodone taken for depression from 2012 to an unspecified stop date. Patient received bnt162b2 on 26Sep2021 and influenza vaccine on 26Sep2021. On 28Sep2021, the patient experienced fatigue, joint pain, nausea, itchy, rash, myalgia. On 29Sep2021, burning sensation. Covid19 booster and flu vaccine given Sunday pm. Monday morning nausea, fatigue, muscle and joint pain. Monday evening rash appeared. Itchy and red blotches on neck and chest. Tuesday morning nausea, muscle and joint pain only mild now but fatigue and rash worse. Rash itchy and now hot and burning feeling and has spread over head and whole neck, chest and most of torso area, under breasts and groin. Wednesday and Thursday no change to rash & fatigue. Nausea and joint pain stopped. Friday rash and fatigue improved by end of day. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No report related to possible blood clots or low platelet counts. Outcome of fatigue, muscle pain was recovering, joint pain, nausea, itchy, burning sensation was recovered on an unspecified date, rash was recovered in 02Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1799684 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Immunisation, Malaise, Off label use, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: DTPA IPV HIB VACCINE; HYDROCORTISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sheehan''s syndrome; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101359396

Write-up: Muscular back pain; Off label use; Booster; Very strange back pain very severe/back pain; Vomiting; pain in feet; felt very unwell; pain in hand; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202110112018052440-K9BDY with Safety Report Unique Identifier GB-MHRA-ADR 26062310. A 54-year-old non-pregnant female patient received the third dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Unknown) via unspecified route of administration, on 26Sep2021 (at the age of 54-year-old) as a dose 3 (booster), single for COVID-19 immunization. The patient medical history included sheehan''s syndrome, Steroid therapy (Taking regular steroid treatment (orally or rectally)); both from an unknown date and unknown if ongoing. The concomitant medications included diphtheria vaccine toxoid, hib vaccine, pertussis vaccine, polio vaccine inact, tetanus vaccine toxoid (DTPA IPV HIB VACCINE) on an unspecified date as single dose for immunization and hydrocortisone (MANUFACTURER UNKNOWN) for Sheehan''s syndrome from 06Jan2021 and unknown if ongoing. The patient previously received first dose and second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: Unknown) via unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization and experienced headache and pain in arm with both doses. The patient had not tested positive for COVID-19 since having the vaccine. On 30Sep2021, the patient experienced muscular back pain. On an unspecified date of 2021 the patient experienced very strange back pain very severe/back pain, vomiting, pain in feet, felt very unwell and pain in hand. The clinical course was reported that patient had 2 doses of vaccination with not many side effects, slight headache and sore arm. After third booster vaccination, 2 weeks before, the patient had very strange back pain, very severe and felt very unwell, whole back was rigid with pain and had constant pain for the previous week, as though all nerves constantly switched on, pain in feet and hands too which was really painful. The events back pain, muscular back pain, vomiting, pain in feet and felt very unwell were reported as serious for being medically significant. On an unspecified date the patient underwent lab tests and procedures which included SARS-CoV-2 test (COVID-19 virus test): Negative COVID-19 test. The outcome for the reported events of very strange back pain very severe/back pain and vomiting was resolved on an unspecified date of 2021. The outcome for muscular back pain was not resolved. The outcome for pain in feet, felt very unwell and pain in hand was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101378645 Same pt, different events/doses


VAERS ID: 1799824 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6270 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paresis, Lip swelling, Pain in extremity, Paraesthesia, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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? 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: Anaphylactic shock (at 13 years old from peach and pollen.); Asthma; Grass allergy; Ischemic stroke (admitted to stroke unit at a hospital); Thrombolysis (admitted to stroke unit at a hospital)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101313736

Write-up: Swollen lips; Pain in leg; Facial paresis; Urticaria; night tingling left leg; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-792924. A 30-year-old female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection) intramuscular, administered in Arm Left on 26Sep2021 (at the age of 30 years old) (Lot Number: FG6270) as dose 1, single for COVID-19 immunization. Medical history included anaphylactic shock (at 13 years old from peach and pollen), allergy to grasses and allergy-related asthma; all from an unknown date and unknown if ongoing and transient Ischemic Attack with thrombolysis in 17Jul2021. The patient''s concomitant medications were not reported. On 26Sep2021 (45 minutes after vaccination), the patient experienced swollen lips, pain in leg, facial paresis and urticaria. Clinical course: After 45 minutes, urticaria, paresis left hemivolt (as reported), in the night tingling left leg. Upon awakening, desensitization left hemivolt (as reported), pain left leg, swollen lips since 26Sep2021. Impact on quality of life (8/10). The events were reported as serious (Disabling/Incapacitating). The outcome of the events was not recovered. Reporter''s comment: anaphylactic shock at age 13 from peach and pollen. Serious allergy to grasses. Allergy-related asthma. admitted to stroke unit at a hospital from 17Jul2021 for suspected Transient Ischemic Attack with thrombolysis. information provided at time of anamnesis with vaccinating physician. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: anaphylactic shock at age 13 from peach and pollen. Serious allergy to grasses. Allergy-related asthma. admitted to stroke unit at a hospital from 17Jul2021 for suspected Transient Ischemic Attack with thrombolysis. information provided at time of anamnesis with vaccinating physician.


VAERS ID: 1799916 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ5790 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Heart rate increased, Hypoaesthesia, Oxygen saturation, Peripheral coldness, Seizure
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SEDIEL; MIYA-BM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety symptoms NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: blood pressure / BP; Result Unstructured Data: Test Result:98/76; Comments: AT 09:30; Test Date: 20210926; Test Name: blood pressure / BP; Result Unstructured Data: Test Result:108/62; Comments: AT 09:35; Test Date: 20210926; Test Name: blood pressure / BP; Result Unstructured Data: Test Result:98/60; Comments: AT 09:50; Test Date: 20210926; Test Name: blood pressure / BP; Result Unstructured Data: Test Result:96/58; Comments: at 10:00; Test Date: 20210926; Test Name: body temperature; Result Unstructured Data: Test Result:36.00 Centigrade; Comments: before vaccination; Test Date: 20210926; Test Name: HR; Result Unstructured Data: Test Result:150; Comments: AT 09:30; Test Date: 20210926; Test Name: HR; Result Unstructured Data: Test Result:84; Comments: AT 09:35; Test Date: 20210926; Test Name: HR; Result Unstructured Data: Test Result:55; Comments: AT 09:50; Test Date: 20210926; Test Name: HR; Result Unstructured Data: Test Result:57; Comments: at 10:00; Test Date: 20210926; Test Name: Sao2; Test Result: 98 %; Comments: AT 09:30; Test Date: 20210926; Test Name: Sao2; Test Result: 100 %; Comments: AT 09:35; Test Date: 20210926; Test Name: Sao2; Test Result: 95 %; Comments: AT 09:50; Test Date: 20210926; Test Name: Sao2; Result Unstructured Data: Test Result:96-99 %; Comments: at 10:00
CDC Split Type: JPPFIZER INC202101313743

Write-up: Convulsion; Feels poorly; HR was 150; Cold extremities; numbness; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21128601. The patient was a 35-year female. Body temperature before vaccination was 36.00 degrees Centigrade. The patient had no family history. The patient had medical history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included Anxiety symptoms (Sediel, MIYA-BM orally taken) and during menstruation. Concomitant medication which included tandospirone citrate (SEDIEL) and clostridium butyricum (MIYA-BM); both on an unspecified date and indication. On 26Sep2021 at 09:12 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FJ5790, Expiration date 31Dec2021) at the age of 35-years-old, via intramuscular as dose 1, single for COVID-19 immunization. On 26Sep2021 at 10:30 (1hours and 18 minutes after the vaccination), the event started (as reported). On 26Sep2021 (the same day of the vaccination), the outcome of the event was recovered. The course of the event was as follows: At 09:12, intramuscular injection was performed, at 09:30, feels poorly, at that time, blood pressure was 98/76, HR was 150, Sao2 was 98, at 09:35, cold extremities, numbness and convulsion occurred, BP was 108/62, HR was 84, Sao2 was 100%, continued after that, at 09:50, BP 98/60 HR was 55, Sao2 was 95, symptoms recovering, at 10:00, became stable, BP 96/58, HR 57, Sao2 96-99. At 10:05 the patient walked home. The outcome of the events recovered on 26Sep2021. The reporting physician classified the event as non-serious and assessed that the event was unrelated to BNT162B2. The reporting physician commented as follows: it was considered the symptom was due to strong anxiety; Sender''s Comments: Based on the current information available and considering drug-event temporal association a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported events of Convulsion, Feeling abnormal, Heart rate increased, Cold extremities and Numbness. The case will be reassessed further upon receipt of additional information. 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: 1799928 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram head, Epilepsy, Fall, Hyperventilation, Loss of consciousness, Subcutaneous haematoma
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), 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), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Test Date: 20210926; Test Name: head CT; Result Unstructured Data: Test Result:No abnormality; Comments: No abnormality
CDC Split Type: JPPFIZER INC202101319854

Write-up: Loss of consciousness; epileptic seizures/ epilepsy; hyperpnoea; fall; subcutaneous haematoma in back of the head; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128703. A 19-year and 5-month-old male received the first dose of bnt162b2 (Comirnaty, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration on 26Sep2021 in the afternoon (the day of the vaccination), as a single dose for COVID-19 immunization. Body temperature before the vaccinations was 36.0 Centigrade. There were no points provided on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). The course of the event was as follows: After 3 minutes of vaccination, the patient experienced loss of consciousness and fall, subcutaneous haematoma in back of the head was found. Immediately after the fall (1-2minutes), Restoration of consciousness. Head CT was performed, no abnormality. It is unknown whether it was influenced by the vaccination or due to the epileptic seizures which was caused by hyperpnoea after vaccination. Event onset date was reported as on 26Sep2021 at 14:50 (the day of the vaccination). On 26Sep2021 (the same day of vaccination), the outcome of the event was reported as recovered and recovering. (as reported). The reporter classified the event as non-serious and assessed the causality between the event and the vaccines as unassessable. Other possible cause of the event such as any other diseases was: Epilepsy.


VAERS ID: 1801923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis, Palpitations, Sinus arrhythmia, Troponin increased
SMQs:, Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: troponin increased; Result Unstructured Data: Test Result:troponin increased
CDC Split Type: AUPFIZER INC202101318269

Write-up: Myocarditis; Chest pain; Palpitations; Sinus arrhythmia; Troponin increased; This is a spontaneous report from a contactable healthcare professional via the regulatory authority. The regulatory authority report number is 633367. A 13-year-old male patient received BNT162B2 (COMIRNATY, Lot unknown, unknown if first or second dose) solution for injection intramuscular on 22Sep2021 as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced chest pain; myocarditis; palpitations; sinus arrhythmia; troponin increased. The outcome of the events chest pain; myocarditis; palpitations; sinus arrhythmia; troponin increased was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1801925 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-26
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Myalgia, Nausea, Neck pain, Pericarditis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101318753

Write-up: Pericarditis; Headache; Lymphadenopathy; Myalgia; Nausea; Neck pain; This is a spontaneous report from a contactable other health professional via the (RA). Regulatory authority report number is 634552. A 27-year-old female patient received second dose of BNT162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 21Aug2021 (Batch/Lot number: not provided) as dose 2, single and first dose of BNT162b2 (COMIRNATY, solution for injection) via an unspecified route of administration on 31Jul2021 (Batch/Lot number: not provided) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced headache, lymphadenopathy, myalgia, nausea, neck pain, pericarditis. 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: 1802082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Blood test, Dermatitis allergic, Electrocardiogram, Fatigue, Heart rate, Hypertension, Oral dysaesthesia, Orthostatic hypotension, Oxygen saturation, Palpitations, Somnolence, Swollen tongue
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), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: blood pressure; Result Unstructured Data: Test Result:180/120; Test Date: 20210926; Test Name: blood pressure; Result Unstructured Data: Test Result:180/110; Test Date: 20210926; Test Name: Blood sampling; Result Unstructured Data: Test Result:unknown results; Test Date: 20210926; Test Name: electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 20210926; Test Name: pulse; Result Unstructured Data: Test Result:110-120; Test Date: 20210926; Test Name: pulse; Result Unstructured Data: Test Result:120; Test Date: 20210926; Test Name: oxygen measurements; Result Unstructured Data: Test Result:unknown results
CDC Split Type: DEPFIZER INC202101322988

Write-up: Anaphylaxis; Heart racing; Swelling of tongue; Hypotension orthostatic symptomatic; Hypertension; Drowsiness; Dysesthesia of tongue; Allergic rash; Exhaustion; This is a spontaneous report from a non-contactable consumer (patient) downloaded from the Regulatory Authority-WEB (regulatory authority number: DE-PEI-202100200853). An adult female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Sep2021 10:30 (Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced anaphylaxis, heart racing, swelling of tongue, hypotension orthostatic symptomatic, exhaustion, hypertension, allergic rash, drowsiness, dysesthesia of tongue on 26Sep2021. The clinical course was reported as follows: The patient was vaccinated on Sunday, 26Sep2021 around 10:30 am with bnt162b2. The vaccination was carried out by the PRIVACY health department. After the usual 15 minute follow-up time, she noticed a tingling sensation on her tongue and it swelled up, then a rash appeared as well as onset of numbness, racing heart, when she got up her legs kinked and she suffered from drowsiness. She was lying on a couch, her blood pressure was 180/110, and her pulse was 120. She got a catheter and cortisone and histamine were simultaneously injected and an infusion was attached. After a certain amount of time, the symptoms improved. And when the blood pressure and pulse values went somewhat towards normality (but were not in the normal range), she was released and then drove home. At home, she laid down immediately because she felt very sick. She slept for about 2-3 hours and woke up with a racing heart. Her blood pressure was 180/120 and her pulse was between 110 and 120, therefore she should have immediately calibrated it with her blood pressure monitor. She called the ambulance control center who recommended immediate hospitalization. She did this and went to the clinic (on the same date, 26Sep2021) wherein close monitoring was carried out: electrocardiogram, blood sampling, blood pressure measurements, oxygen measurements, infusion, etc. At the clinic, the doctor did not understand why she had not been admitted to the nearest hospital as she suffered an allergic reaction to the first bnt162b2 vaccination. She was monitored at the clinic for 24 hours. Diagnosis upon discharge: Anaphylaxis following the first bnt162b2 vaccination. Therapeutic measures were taken as a result of the adverse events. Outcome of the event exhaustion was not recovered, outcome of dysethesia of tongue was recovering, while outcome of the remaining events was recovered on an unspecified date. The regulatory authority assessed this report as serious (hospitalization). The patient was hospitalized for the events for 24 hours. Comirnaty/Heart racing, Swelling of tongue, Hypotension orthostatic symptomatic, Exhaustion, Hypertension, Allergic rash, Drowsiness, Anaphylaxis, Dysesthesia of tongue/Regulatory Authority/B. Indeterminate No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1802090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-09-26
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: 20210929; Test Name: covid; Test Result: Positive
CDC Split Type: DEPFIZER INC202101320193

Write-up: Vaccination failure/patient fell ill with fever and strep throat; COVID-19/patient fell ill with fever and strep throat; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100201046. An 84-year-old female patient received bnt162b2 (COMIRNATY) on 16Apr2021 (Lot Number: EW8904) as dose 2, single, and on 26Mar2021 (Lot Number: ER7812) as dose 1, single both via an unspecified route of administration for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure and covid-19. Clinical course details: patient fell ill with fever and strep throat on 26Sep2021. Testing as part of an outbreak investigation on 28Sep2021, and on 29Sep2021 Coronavirus SARS-CoV-2 PCR positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 29Sep2021. The outcome of the events was unknown. Assessment: Comirnaty/ COVID-19/ PEI: B. Indeterminate; Comirnaty/ Vaccination failure/ PEI: B. Indeterminate. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1802174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRP9 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Influenza like illness, 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? Yes
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: Myocarditis (had myocarditis years ago, before the vaccination with Comirnaty)
Allergies:
Diagnostic Lab Data: Test Name: Body temeprature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: DEPFIZER INC202101323056

Write-up: Myocarditis; Flu like symptoms; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021185718 and Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100200712. A 21-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Sep2021 (Batch/Lot Number: SCRP9) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of Comirnaty and experienced swollen nodes. Medical history included myocarditis years ago, before the vaccination with Comirnaty. The patient''s concomitant medications were not reported. On 26Sep2021 the patient experienced myocarditis, flu like symptoms. Everything was checked again by the cardiologist. after the symptoms arose, patient contacted family doctor. After my examination, he recommended the transfer to the hospital. First there was a fever 40 ?C, headache, fatigue and malaise. During the night, severe chest pain, muscle pain, vomiting, nausea, etc. occurred. Myocarditis has now been diagnosed in the hospital. The outcome of events was recovering. This report is serious - hospitalization. Result of assessment for Syncope convulsion /PEI / : D. Unclassifiable No follow-up attempts possible. No further information expected. ; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101348624 The same patient/ different events/ different doses


VAERS ID: 1802549 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Immunisation, Incorrect route of product administration, Off label use, Pain in extremity, Superficial vein thrombosis, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIRTAZAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mental disorder
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: Ultrasound scan; Result Unstructured Data: Test Result:Found to have a blood clot.
CDC Split Type: GBPFIZER INC202101367544

Write-up: Superficial thrombophlebitis; Leg pain; Blood clot/Thrombosis leg; Off-label use; Booster; COMIRNATY was administered via subcutaneous route of administration; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-EYC 00263086 with Safety Report Unique Identifier GB-MHRA-ADR 26059366. An 81-year-old female patient received third (booster) dose of BNT162b2 (COMIRNATY; Lot Number: FG3712) via subcutaneous route of administration on 26Sep2021 as a single dose for COVID-19 immunisation. Medical history included mental disorder. Concomitant medications included mirtazapine (MANUFACTURER UNKNOWN) taken for mental disorder from an unknown date in Feb2012 and unknown if ongoing. On an unknown date in Oct2021, the patient experienced thrombosis leg. On 02Oct2021, 6 days after the booster vaccination, the patient experienced leg pain. On 08Oct2021, 12 days after vaccination the patient experienced superficial thrombophlebitis; all the events were reported as serious for being medically significant. The clinical course was reported as follows: the patient had superficial thrombophlebitis and developed leg pains 6 days after receiving the booster vaccination - the patient attended her general practitioner who sent her to the thrombosis team at hospital. The patient was scanned via ultrasound on an unknown date in Oct2021 and was found to have a blood clot. Patient also provided medically significant details, possibly developed a thrombosis in her leg due to the vaccination booster. The clinical outcome of the event superficial thrombophlebitis was not recovered while that of thrombosis leg and leg pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1802626 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Heart rate increased, Immunisation, Influenza, Lethargy, Off label use, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test; Test Result: Negative ; Comments: not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC202101334273

Write-up: Flu symptoms; Off-label use; Booster; lethargic; achy bas chest; increased heart rate; high temp; 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-202109302319356080-DUJJR. Safety Report Unique Identifier GB-MHRA-ADR 26046586. A 42-year-old male patient received third dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Batch/Lot Number: Not known), via an unspecified route of administration on 26Sep2021 (at the age 42-years) as dose 3 (booster), single for COVID-19 immunization. Medical history included suspected covid-19 from 15Jun2021(Unsure when symptoms stopped). The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine on unspecified date in 2021. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unknown date (Batch/Lot Number: unknown) as dose 1, single and second dose via an unspecified route of administration on an unknown date (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunization. The patient experienced high temp lethargic, chest pain, heart rate increased on an unspecified date in 2021 and off label use, booster and flu symptoms (influenza) on 26Sep2021. Events were considered as serious (medically significant) except off label use and booster were non-serious. It was reported that high temp lethargic achy bas chest increased heart rate unable to exert much. The outcome of the event Flu symptoms was recovering and unknown for other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1802631 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autoimmune disorder, Fibromyalgia, Headache, Lethargy, Lichen sclerosus, Myalgia, Nausea, Premature menopause, SARS-CoV-2 test, Vaginal discharge, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Fertility disorders (narrow), Tendinopathies and ligament disorders (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLONIDINE; MEMANTINE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE; METHOTREXATE SODIUM; MIRENA; PALEXIA SR; SANDRENA; XELJANZ
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis; Anxiety; Asthma; Bursitis; Chronic pain; Degenerative disc disease; Diverticulitis; Fibromyalgia; HRT; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef); Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohns disease, ulcerative colitis)); Lichen sclerosus; Menopausal; Psoriasis; Psoriatic arthritis; Rheumatoid arthritis (Taking regular medicines for rheumatoid arthritis); Weight loss
Allergies:
Diagnostic Lab Data: Test Date: 20210307; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101334355

Write-up: Vaginal bleeding; Nausea; Fibromyalgia worsened; Muscle ache; Lethargy; Headache; menopause lnmp; autoimmune diseases; vaginal discharge; lichen sclerosus; This is a spontaneous report from a contactable consumer received from the United Kingdom''s Medicines and Healthcare products Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110010248141680-SFZHU,Safety Report Unique Identifier GB-MHRA-ADR 26046481. A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration, on 26Sep2021 (at the age of 48-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included rheumatoid arthritis, took regular medicines for rheumatoid arthritis (or other types of arthritis except osteoarthr , asthma , psoriatic arthritis, inflammatory bowel disease Taking medicines for inflammatory bowel disease (Crohnics disease, ulcerative colitis), immunodeficiency Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef, psoriasis, ankylosing spondylitis, degenerative disc disease, diverticulitis, fibromyalgia, bursitis, lichen sclerosus, menopausal, anxiety, weight loss and hrt. Patient had no symptoms associated with COVID-19, patient was not pregnant, 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 clonidine taken for anxiety from 2019 to an unspecified stop date; memantine hydrochloride taken for fibromyalgia from 16Sep2021 to an unspecified stop date; metformin hydrochloride taken for weight decreased from 16Sep2021 to an unspecified stop date; methotrexate sodium taken for psoriatic arthropathy from 2008 to 27Aug2021; levonorgestrel (MIRENA) taken for hormone replacement therapy from Nov2018 to an unspecified stop date; tapentadol hydrochloride (PALEXIA SR) taken for pain from Jun2021 to an unspecified stop date; estradiol (SANDRENA) taken for hormone replacement therapy from Jul2021 to an unspecified stop date; tofacitinib citrate (XELJANZ) taken for autoimmune arthritis from May2018 to 27Aug2021. The patient experienced menopause lnmp LNMP: Aug 2018, patient had multiple autoimmune diseases and was instructed to cease her JAK inhibitor and methotrexate prior to vaccination and post vaccination as per Rheumatology Association recommendations, heightened pain and bleeding along with a slight vaginal discharge that was pale pink, lichen sclerosus and reported inflammation on an unspecified date in 2021; headache, lethargy on 26Sep2021; nausea, fibromyalgia worsened, muscle ache on 27Sep2021; vaginal bleeding on 28Sep2021. The events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 07Mar2021. The clinical outcome of event vaginal bleeding, headache, fibromyalgia worsened and muscle ache was resolving; nausea was resolved on 29Sep2021, lethargy resolved on 30Sep2021 and other all events are resolved on unspecified dates in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1802694 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Blood pressure diastolic, Blood pressure increased, Blood pressure measurement, Chest X-ray, Chest discomfort, Chest pain, Discomfort, Dyspnoea, Electrocardiogram, Feeling abnormal, Gastrointestinal pain, Hypotension, Immunisation, Investigation, Neck pain, Nephrolithiasis, Off label use, Pain in extremity, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad), Hypokalaemia (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: Gallstones; HRT; Pain (Gall stones pain managed with diet); Renal stone
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:197/190; Test Date: 20211002; Test Name: Blood pressure; Result Unstructured Data: Test Result:very high; Comments: diastolic blood pressure; Test Name: Chest X-ray; Result Unstructured Data: Test Result:showed no abnormalities; Test Name: ECG; Result Unstructured Data: Test Result:showed no abnormalities; Test Name: low blood pressure; Result Unstructured Data: Test Result:ranging from 100/60 to 130/60; Test Name: cardiac bloods; Result Unstructured Data: Test Result:showed no abnormalities; Test Date: 20210902; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101325230

Write-up: Painful L arm; Painful shoulder; Neck pain; Still experiencing some discomfort; It was very uncomfortable; discomfort in my chest; Back pain; gall stones; low blood pressure; Breathlessness; Diastolic blood pressure; Raised BP; GI pain; Chest pain; Off label use; Booster; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202110051810071290-BBL4P and Safety Report Unique Identifier GB-MHRA-ADR 26039736. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 3 via an unspecified route of administration on 26Sep2021 (at the age of 59-years-old) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included renal stone, hormone replacement therapy and gall stones pain managed with diet from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced gall stones, low blood pressure, breathlessness, diastolic blood pressure, painful l arm, painful shoulder, neck pain, still experiencing some discomfort, it was very uncomfortable, discomfort in my chest and back pain. Raised bp, gi pain and chest pain on 30Sep2021, off label use and booster on 26Sep2021. Case narrative included that extremely painful L arm shoulder and neck initially. This came on immediately and was intense for three days following. Still experiencing some discomfort now day 9. On day 4 woke in the night with pain in my chest and back and pain in she L arm. Difficult to differentiate whether the pain in arms was the same or if there was an additional pain i was experiencing. I had gall stones which following discussion with my consultant had decided to treat conservatively with a low-fat diet. Have not had pain from this since following the new diet in january. she couldn''t determine whether the pain she was feeling in my chest was in fact pain from gallstones or a new pain. It was very uncomfortable. I took paracetamol and gaviscon and managed to get back to sleep. Patient checked my blood pressure the following saturday 02Oct2021 and noted a very high diastolic blood pressure. Patient checked it on several devices. Patient had always had a low blood pressure ranging from 100/60 to 130/60. she contacted my GP on monday 04Oct2021 and managed to get appointment for thursday 7Oct21 however she managed to get a same day appointment with the practice nurse for a blood pressure check. She was equally concerned about the sudden increase and given the pain she had and continued to experience in chest advised me to attend the A&E department. My BP was recorded at 197/190 in the A&E department. The ECG chest x-ray and cardiac bloods showed no abnormalities. Patient continue to feel discomfort in chest and some intermittant breathlessness. Patient BP was still recording very high. The patient underwent lab tests and procedures which included blood pressure measurement: 197/190 on an unspecified date, blood pressure measurement: very high on 02Oct2021 (diastolic blood pressure), chest x-ray: showed no abnormalities on an unspecified date, electrocardiogram: showed no abnormalities on an unspecified date, hypotension: ranging from 100/60 to 130/60 on an unspecified date, investigation (cardiac bloods): showed no abnormalities on an unspecified date, SARS-COV-2 test: negative on 02Sep2021 (No - Negative COVID-19 test). Therapeutic measures were taken as a result of gall stones, low blood pressure, breathlessness, diastolic blood pressure, raised bp, gi pain, chest pain, painful l arm, painful shoulder, neck pain, still experiencing some discomfort, it was very uncomfortable, discomfort in my chest, back pain and included treatment with paracetamol and gaviscon. The outcome of the events gall stones, low blood pressure, breathlessness, diastolic blood pressure and chest pain was recovering and 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: 1802819 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Fibrin D dimer, Pain in extremity, Platelet count, Platelet factor 4, SARS-CoV-2 test, Vascular pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown if $g4000; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown if <150 A- 109/L; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown if identified; Test Date: 20210305; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101334612

Write-up: sore fingers / Painful to touch and veins show and very sore to touch; sore fingers / Painful to touch and veins show and very sore to touch; Bruising of arm/Bruised 2 fingers of the arm that was jabbed/Bruised fingers; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202110062134523410-XZZJQ. Safety Report Unique Identifier GB-MHRA-ADR 26046137. A 37-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FF2153; expiration date not provided), via an unspecified route of administration (anatomical location: arm) on 23Sep2021 as DOSE 1, SINGLE for COVID-19 immunisation. Patient''s medical history included ''smoker'' from an unspecified date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. The patient has not had any previous reactions to medications, especially heparin or anticoagulants. The patient no confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient has no history or current malignancy. Patient has no current or recent intracranial infections. Patient has no recent surgical or medical interventions to the central nervous system (including lumbar puncture). Patient has no recent trauma/injury. Patient is not enrolled in clinical trial. The patient previously took heparin. The patient experienced ''Bruising of arm/Bruised 2 fingers of the arm that was jabbed/Bruised fingers'' on 26Sep2021 and ''sore fingers/Painful to touch and veins show and very sore to touch'' on an unspecified date. Patient''s clinical course was as follows: Patient experienced bruised 2 fingers of the arm that was jabbed. Painful to touch and veins show and very sore to touch. It was reported that patient had a doctor''s appointment. The details of the event were specified as ''bruised and sore fingers'' which was diagnosed by doctor. The events were assessed as serious (disability). Patient has not tested positive for COVID-19 since having the vaccine. Patient underwent lab tests and procedures which included D-dimer with result of ''Unknown if $g4000'', platelet count with result of ''Unknown if <150 A- 109/L'', and anti-PF4 antibodies with result of ''Unknown if identified'' on unspecified dates; COVID-19 virus test with result of ''Negative; No - Negative COVID-19 test'' on 05Mar2021. Outcome of the event ''Bruising of arm/Bruised 2 fingers of the arm that was jabbed/Bruised fingers'' was recovering; outcome of the event ''sore fingers/Painful to touch and veins show and very sore to touch'' was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1803069 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3739 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Headache, Malaise, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: body temperature; Result Unstructured Data: Test Result:low-grade fever
CDC Split Type: ITPFIZER INC202101332586

Write-up: low-grade fever; pain at the injection site; lightheadedness; headache; general malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-794627. A 38-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: FG3739; Expiration Date: 31Dec2021), intramuscular, administered in left arm (reported as left shoulder) on 25Sep2021 09:28 (at an unspecified age) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Lot Number: FG4493; Expiration Date: 30Nov2021), administered in left shoulder on 04Sep2021 (at an unspecified age) as dose 1, single for COVID-19 immunisation. On 26Sep2021, the patient experienced low-grade fever (medically significant), pain at the injection site (medically significant), lightheadedness (medically significant), headache (medically significant), general malaise (medically significant). Therapeutic measures were taken as a result of the events included anti-inflammatory, mucolytics, supplements. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1803738 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctivitis, Herpes ophthalmic
SMQs:, Severe cutaneous adverse reactions (broad), Conjunctival disorders (narrow), Ocular infections (narrow), Hypersensitivity (broad), Opportunistic infections (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: Herpes ocular; Liver transplantation
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority(Reference number: SE-MPA-2021-086943) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of HERPES OPHTHALMIC in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient''s past medical history included Herpes ocular in 1996 and Liver transplantation in 1996. On 21-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced HERPES OPHTHALMIC (seriousness criterion medically significant) and CONJUNCTIVITIS (seriousness criterion medically significant). At the time of the report, HERPES OPHTHALMIC and CONJUNCTIVITIS had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Batch number of the suspect product was unknown. The action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This case concerns a 57-year-old female patient with relevant medical history of Liver transplantation and previous Herpes ocular infection who experienced serious unexpected events of Herpes ophthalmic and Conjunctivitis. The events developed five days after the administration of the second dose of Spikevax. The events did not resolve at the time of the report and no further information was provided regarding the clinical course of these events. The rechallenge is not applicable as the events occurred after the second dose of the vaccine. The patient''s medical history of solid organ transplantation (liver transplantation) remains a confounder for the reported events having in mind that these patients are at higher risk of complications such as infections, which is also confirmed by a previous herpes ocular infection in medical history. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation received on 16 Oct 2021, included dosage text and event verbatim were updated.; Sender''s Comments: This case concerns a 57-year-old female patient with relevant medical history of Liver transplantation and previous Herpes ocular infection who experienced serious unexpected events of Herpes ophthalmic and Conjunctivitis. The events developed five days after the administration of the second dose of Spikevax. The events did not resolve at the time of the report and no further information was provided regarding the clinical course of these events. The rechallenge is not applicable as the events occurred after the second dose of the vaccine. The patient''s medical history of solid organ transplantation (liver transplantation) remains a confounder for the reported events having in mind that these patients are at higher risk of complications such as infections, which is also confirmed by a previous herpes ocular infection in medical history. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1804089 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest pain, Dyspepsia, Gastrooesophageal reflux disease, Heart rate increased, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Dehydration (broad)

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

Write-up: Chest pains beginning a few days after injection still persisting. Increased heart rate. Heartburn/acid reflux, unable to keep food down, vomiting.


VAERS ID: 1806029 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Fatigue, Gait disturbance, Malaise, Pallor, Pelvic pain, Peripheral swelling, Urinary tract infection bacterial, Urine analysis abnormal
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Tetralogy of Fallot (Waiting for a valve placement. He had surgery as a baby but still correcting a sequel.)
Allergies:
Diagnostic Lab Data: Test Name: urine test; Result Unstructured Data: Test Result:Detected bacteria
CDC Split Type: BRPFIZER INC202101341267

Write-up: Arm swollen; Tiredness; He is not feeling well; he is limp; urinary infection; he was pale; without strength; pelvic pain; very severe abdominal pain; This is a spontaneous report from a contactable consumer (patients mother). A 14 years old male patient received bnt162b2 (COMIRNATY Lot number was not reported) via an unspecified route of administration on 24Sep2021 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included fallot''s tetralogy - congenital heart disease, he is waiting for a valve placement. He had surgery as a baby but still correcting a sequel. The patient''s concomitant medications were not reported. The consumer reported that on 26Sep2021 in the morning, 07:00, he had very severe abdominal pain (woke up with the pain) - it was a pelvic pain, right below the navel. She gave medicine for gas and home remedies because she thought it was something he ate too. And he spent the normal Sunday. At 20:00 on Sunday (26Sep2021) the pain returned, he gave more medicine for gas and at 22:40 he couldn''t take it anymore, he was pale and without strength. Called the and the doctor applied medicine in the vein and did not do any exam. The pain stopped. On Monday (27Sep2021) he had no pain. On Tuesday (28Sep2021) she looked for another appointment and the doctor detected a urinary infection (detected bacteria and started taking antibiotics, which ends tomorrow). He no longer felt the pain. He is not the same anymore, he says he is limp, tired, he just wants to sleep. He is not feeling well. The consumer would like to know if it is an adverse reaction to vaccine. She read at the WHO, that there is "a thing written there that loses a lot of proteins through pee, a product (a substance in the vaccine) that causes a lot of protein to be lost through pee, some granules. She reiterates that he has never had anything before and within 48 hours it appeared. She informs that she takes great care of his son. She also informs that his arm was swollen/very swollen after the vaccination. He had never had any vaccine reaction and has already taken all the vaccines because he has comorbidity. He never had anything. The outcome of abdominal pain and pelvic pain was recovered. The outcome of the other events was unknown.


VAERS ID: 1806308 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E028A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Rash papular, Ultrasound scan, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Ultrasound; Result Unstructured Data: Test Result:thrombosis
CDC Split Type: DEPFIZER INC202101339727

Write-up: Leg venous thrombosis; extreme pains in leg; red raised area (approximately 5 cm diameter) on the leg; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority WEB. Regulatory authority number is DE-PEI-CADR2021186875. A 19-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Sep2021 (Lot Number: 1E028A, Expiry date not reported) as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. Medical history included seasonal allergy (hay fever). Concomitant medications were not reported. The patient experienced leg venous thrombosis on 26Sep2021 with outcome of recovering, extreme pains in leg on 26Sep2021 with outcome of unknown, and red raised area (approximately 5 cm diameter) on the leg on 26Sep2021 with outcome of unknown. The patient underwent lab tests and procedures which included ultrasound scan: thrombosis on 2021. Therapeutic measures were taken as a result of the events leg venous thrombosis and extreme pains in leg that included Clexane injections and for red raised area (approximately 5 cm diameter) on the leg that included wearing compression stockings. It was reported that the type of thrombosis must be monitored as it can move to the lung and cause pulmonary embolism. The events leg venous thrombosis and extreme pains in leg were reported as serious, medically significant by the health authority, while red raised area (approximately 5 cm diameter) on the leg was non-serious. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1806467 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Disease recurrence, Electrocardiogram, SARS-CoV-2 test
SMQs:, Supraventricular tachyarrhythmias (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COVID-19; Prostate cancer; Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation; Comments: AF at 110 bpm, fine QRS, no repolarization disturbances; Test Date: 20210820; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101339968

Write-up: AFib/recurrence with arrhythmia on the pulse; AFib/recurrence with arrhythmia on the pulse; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-NT20214524. A 68-year-old male patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 02Sep2021 (Batch/Lot Number: J07BX03) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included covid-19, prostate cancer, radiotherapy from 2019, and atrial fibrillation on 21Aug2021. The patient''s concomitant medications were not reported. The patient experienced Afib (atrial fibrillation) on 26Sep2021. The event was assessed as serious medially significant. The event resulted in emergency room visit. It was further reported that patient had complete arrhythmia by atrial fibrillation for 10 hours. Start at 3 p.m., taking a tablet of bisoprolol 5 mg at 3:30 p.m. Hospitalization for cardiological assessment. Discharged at 11 p.m. with prescription of bisoprolol 5 mg once a day and Eliquis 5 mg twice a day. Return to sinus rhythm during sleep between 0:30 and 1:45 a.m. A first attack of atrial fibrillation gave rise to a pharmacovigilance declaration after the first injection of Comirnaty vaccine with evolution as favorable. Appointment for cardiac ultrasound on 25Nov2021. Furthermore, it was reported that patient was diagnosed with atrial fibrillation on 21Aug2021 before the onset of palpitations which prompted a visit to the emergency room. Initiation of treatment with apixaban 5 mg morning and evening, not taken by the patient, because return to sinus rhythm (pulse taken regularly). On 26Sep2021, recurrence with arrhythmia on the pulse, taking 5 mg of bisoprolol. Faced with the persistence of palpitations, he consults. Electrocardiogram (ECG): atrial fibrillation (AF) at 110 bpm, fine QRS, no repolarization disturbances on 26Sep2021. Resumption of apixaban 5 mg and bisoprolol and start of amiodarone 200 mg on 11Oct2021. Conclusion: probably paroxysmal atrial fibrillation. Returned home on 26Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. On 27Sep2021, the patient recovered from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1806553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3712 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Immunisation, Off label use, Palpitations, SARS-CoV-2 test, X-ray
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN ANALGESIC; ATENOLOL; ATORVASTATIN; PREDNISOLONE; TACROLIMUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Brain cancer metastatic; Cancer; Kidney transplant; Morbid thoughts; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Comments: Unknown results; Test Date: 20200804; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test; Test Name: X-RAY; Result Unstructured Data: Test Result:Unknown results; Comments: Unknown results
CDC Split Type: GBPFIZER INC202101341709

Write-up: Off label use; Booster; Palpitations; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-APPCOVID-202110071910104740-C14MD, Safety Report Unique Identifier GB-MHRA-ADR 26050141. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: FG3712) via an unspecified route of administration on 25Sep2021 as dose 3(booster), single for COVID-19 immunization. The patient previously received first dose of historical vaccine BNT162B2 as dose 1, single on 24Jan2021 and second dose of historical vaccine BNT162B2 as dose 2, single on 04Mar2021 for COVID-19 immunization. Medical history included morbid thoughts, steroid therapy (Taking regular steroid treatment (e.g. orally or rectally) from an unknown date and unknown if ongoing and kidney transplant, neck cancer and head cancer from an unknown date and unknown if ongoing. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN ANALGESIC), atenolol (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), tacrolimus (MANUFACTURER UNKNOWN) taken for renal transplant from 28Jul2017 to an unspecified stop date; prednisolone (MANUFACTURER UNKNOWN) taken for renal transplant from 02Feb1977 to an unspecified stop date. The patient experienced palpitations (medically significant) on 26Sep2021; off label use and booster on an unspecified date. It was reported that the patient went for a walk, unable to continue walking due to heart palpitations. heart palpitations while sitting down recurring over several days. Patient has not tested positive for COVID-19 since having the vaccine; Patient is not enrolled in clinical trial. Details of any relevant investigations or tests conducted reported as went to A&E who did tests including ECG and X-Ray; referred to (name). On 04Aug2020he patient underwent lab tests and procedures which included SARS-COV-2 test (no - negative COVID-19 test) and on an unspecified date electrocardiogram (unknown results), and x-ray (unknown results). The outcome of the event palpitations was recovered on 04Oct2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1807027 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH3023 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, CSF test, Dizziness, Dysstasia, Investigation, Magnetic resonance imaging head, Muscular weakness, Nerve conduction studies, Neuropathy peripheral
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (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, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: blood test; Result Unstructured Data: Test Result:No abnormalities; Test Date: 20210925; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20211001; Test Name: Spinal fluid check; Result Unstructured Data: Test Result:protein cells without dissociation; Test Date: 20211001; Test Name: MMT; Result Unstructured Data: Test Result:3/3; Test Date: 20211007; Test Name: MMT; Result Unstructured Data: Test Result:5/5; Test Date: 20211001; Test Name: head MRI; Result Unstructured Data: Test Result:No abnormalities; Test Name: F wave of median nerve of both upper limbs; Result Unstructured Data: Test Result:30-40 %
CDC Split Type: JPPFIZER INC202101335287

Write-up: Peripheral nerve disorder NOS; Muscular weakness of limbs; Light-headed feeling; Astasia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128952. The patient was a 14-year and 0-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade on 25Sep2021. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 25Sep2021 at 13:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH3023, Expiration date 31Dec2021) at the age of 14-year-old, via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Sep2021 at 21:00 (1 day 7 hours 30 minutes after the vaccination), the patient experienced Peripheral nerve disorder NOS, Muscular weakness of limbs. On 01Oct2021 (6 days after the vaccination), the patient was admitted to the hospital and discharged on 07Oct2021. On 07Oct2021, the outcome of the event was recovering. The course of the event was as follows: "On 26Sep2021 from night, the patient experienced Muscular weakness of both upper and lower limbs (Smartphone dropped, Light-headed feeling when walking, Astasia). After that, the symptoms worsened, and the patient went to hospital for consultation. On 01Oct2021, No abnormalities in blood test, head MRI. On 01Oct2021, for intensive investigation, the patient was introduced to this hospital. At the time of consultation, the cranial nerve system and sensory nerves were normal. The Muscular weakness was low at the level of MMT3/3, Biceps and knee tendon reflex normal. Spinal fluid check resulted in protein cells without dissociation. No decrease in nerve conduction velocity in upper and lower limbs. Judgment was Peripheral nerve disorder NOS. 2 days after hospitalization, Muscular improvement tendency. On 07Oct2021, Limbs MMT5/5, made sure it had no impact on daily life, Discharged." The outcome of events Light-headed feeling, astasia was recovering. The reporting physician classified the event as serious (hospitalization from 01Oct2021 to 07Oct2021), and the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Only the frequency of occurrence of F wave of median nerve of both upper limbs was 30-40%, so the patient planned to revisit as outpatient.


VAERS ID: 1807291 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-09-26
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Hypoglycaemia (broad)

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

Write-up: Nausea; Syncope; On July 2, 2021, the patient received Cov_Moderna vaccine, and 87 days have passed since then. On September 26, 2021, the patient received Cov_Moderna vaccine, and one day has passed since then.; This regulatory authority case was reported by a pharmacist and describes the occurrence of SYNCOPE (Syncope) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On July 2, 2021, the patient received Cov_Moderna vaccine, and 87 days have passed since then. On September 26, 2021, the patient received Cov_Moderna vaccine, and one day has passed since then.). On 27-Sep-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant). On an unknown date, the patient experienced NAUSEA (Nausea). The patient was treated with PIROXICAM for Adverse event, at an unspecified dose and frequency; METOCLOPRAMIDE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE for Adverse event, at an unspecified dose and frequency and NORMAL SALINE for Adverse event, at an unspecified dose and frequency. On 26-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On July 2, 2021, the patient received Cov_Moderna vaccine, and 87 days have passed since then. On September 26, 2021, the patient received Cov_Moderna vaccine, and one day has passed since then.) had resolved. At the time of the report, SYNCOPE (Syncope) and NAUSEA (Nausea) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. Patient denied any systemic disease, suffered from sudden dizziness at 1:00 p.m., accompanied with dizziness without spinning sensation while suddenly standing up and mild nausea. He also denied blurred vision, focal weakness, facial palsy, slurred speech or chest pain. His gait, muscle power and balance were ok. He had similar condition before. Company comment: This case concerns a 78-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of syncope. The event occurred approximately 1 day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report.; Sender''s Comments: This case concerns a 78-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of syncope. The event occurred approximately 1 day after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report.


VAERS ID: 1807295 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dysstasia, Gait disturbance, Muscular weakness, Oxygen saturation, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebrovascular accident; Heart disease, unspecified (heart stent*2); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Oxygen saturation; Result Unstructured Data: 91%
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Fever; sudden weakness of the right limbs; the patient was suddenly limp; unable to stand up; Weakness; This regulatory authority case was reported by an other health care professional and describes the occurrence of ASTHENIA (Weakness), PYREXIA (Fever), MUSCULAR WEAKNESS (sudden weakness of the right limbs), GAIT DISTURBANCE (the patient was suddenly limp) and DYSSTASIA (unable to stand up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified (heart stent*2), Hypertension and Cerebrovascular accident since July 2021. On 25-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced ASTHENIA (Weakness) (seriousness criteria hospitalization and medically significant), MUSCULAR WEAKNESS (sudden weakness of the right limbs) (seriousness criterion hospitalization), GAIT DISTURBANCE (the patient was suddenly limp) (seriousness criterion hospitalization) and DYSSTASIA (unable to stand up) (seriousness criterion hospitalization). On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criteria hospitalization and medically significant). At the time of the report, ASTHENIA (Weakness), PYREXIA (Fever), MUSCULAR WEAKNESS (sudden weakness of the right limbs), GAIT DISTURBANCE (the patient was suddenly limp) and DYSSTASIA (unable to stand up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: abnormal (abnormal) 91%. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. On examination patient had a Clear consciousness; GCS: E4V5M6; smooth breathing; warm limbs, skin: intact; MP: limbs: 3-4 points Company Comment: This case concerns a 81-year-old, male patient with previous relevant medical history of Hypertension and Cerebrovascular accident , who experienced the serious events of pyrexia, asthenia, muscular weakness, Gait disturbance and Dysstasia. The event of pyrexia is unexpected as it is retained as serious per the source document Authority reporting. The events muscular weakness, gait disturbance, dysstasia, and asthenia occurred 1 day after the dose of Spikevax. For the event pyrexia, the time to onset from vaccination was not reported. The rechallenge was not applicable, as the dose number was not reported. The medical history of hypertension and cerebrovascular accident remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 81-year-old, male patient with previous relevant medical history of Hypertension and Cerebrovascular accident , who experienced the serious events of pyrexia, asthenia, muscular weakness, Gait disturbance and Dysstasia. The event of pyrexia is unexpected as it is retained as serious per the source document Authority reporting. The events muscular weakness, gait disturbance, dysstasia, and asthenia occurred 1 day after the dose of Spikevax. For the event pyrexia, the time to onset from vaccination was not reported. The rechallenge was not applicable, as the dose number was not reported. The medical history of hypertension and cerebrovascular accident remains a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1808739 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy, Blood test, Fatigue, Haematemesis, Headache, Internal haemorrhage, Nausea, Pyrexia, Somnolence, Vaginal haemorrhage, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal haemorrhage (narrow), 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)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer; Chemotherapy
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Biopsie; Result Unstructured Data: Test Result:Pending; Comments: Operation planned to remove the matrix; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:- Hemoglobin: 5 g; Comments: - Hemoglobin: 8 g (after infusion of 3 blood bags, 7 g of Iron)
CDC Split Type: BEPFIZER INC202101384482

Write-up: Fever; Vaginal bleeding; Vomiting; Somnolence; Internal haemorrhage; Fatigue; Nausea; Headache; vomiting with blood; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107594. A 46-year-old female patient received bnt162b2 (COMIRNATY), dose 3 via an unspecified route of administration on 25Sep2021 (Batch/Lot Number: Unknown) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included neoplasm malignant, chemotherapy from an unknown date and unknown if ongoing. Concomitant medication included paracetamol (PARACETAMOL) taken for an unspecified indication, start and stop date were not reported. The patient experienced fever, vaginal bleeding, vomiting, somnolence, internal haemorrhage, fatigue, nausea, headache, all on 26Sep2021 with outcome of recovering. It was reported that there was somnolence the next 3 days (also being reported as on 26Sep2021), then vomiting with blood, followed by 3 days of vaginal bleeding with entrainment of internal bleeding, followed by hospitalization for one week, more than 5 g of hemoglobin, infusion of 3 bags of blood, 7g of Iron, 8g of whatever (forgot the name) to stop the bleeding. Current rate raised to only 8 gr of hemoglobin, it was excluded that patient make a 4th dose with chemotherapy of Kadcyla. Therapeutic measures were taken as a result of all events. The events were reported as serious, life threatening and serious for hospitalization. Reporter''s comments: Treatment: Blood transfusion + Iron + Product to stop the bleeding Evolution of the ADR: In progress Situations: Other: I don''t know Examinations: - Hemoglobin level 5 - Biopsy performed in the matrix: result on the 23rd, with operation planned to remove the matrix No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Treatment: Blood transfusion + Iron + Product to stop the bleeding Evolution of the ADR: In progress Situations: Other: I don''t know Examinations: - Hemoglobin level 5 - Biopsy performed in the matrix: result on the 23rd, with operation planned to remove the matrix


VAERS ID: 1808923 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-09-26
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-10-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002334 / 2 - / OT

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

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

Write-up: COVID-19; This case was received via regulatory authority (Reference number: DE-PEI-202100203264) on 14-Oct-2021 and was forwarded to Moderna on 14-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002334) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Vaxzevria (Batch number: ABV 5443) on 28-Mar-2021. Past adverse reactions to the above products included No adverse event with Vaxzevria. On 01-Jun-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19) outcome was unknown. Treatment information was not provided by the reporter. Patient had PCR assay from 27 Sep 2021, result were positive, CT values 19.0. Patients symptoms includes runny nose, cough. Company Comment: This case of Interchange of vaccine products concerns a 40-year-old, female patient with relevant medical history of vaccination with COVID-19 Vaccine Astrazeneca , who experienced the unexpected AESI event of COVID-19. The event occurred approximately 3 months after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable since the first dose was a different vaccine product. The patient''s medical history of vaccination with COVID-19 Vaccine Astrazeneca remain as a confounder for the occurrence of the event. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation document received on 17-Oct-2021: senders comment added in I narrative; Sender''s Comments: This case of Interchange of vaccine products concerns a 40-year-old, female patient with relevant medical history of vaccination with COVID-19 Vaccine Astrazeneca , who experienced the unexpected AESI event of COVID-19. The event occurred approximately 3 months after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was not applicable since the first dose was a different vaccine product. The patient''s medical history of vaccination with COVID-19 Vaccine Astrazeneca remain as a confounder for the occurrence of the event. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.


VAERS ID: 1809455 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PP3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Guillain-Barre syndrome, Magnetic resonance imaging, Nervous system disorder, Neurological examination, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: neuro investigations; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101351134

Write-up: Nervous system disorder; Guillain Barre syndrome; This is a spontaneous report from a contactable Other HCP downloaded from the regulatory authority-WEB. Regulatory authority report number [GB-MHRA-WEBCOVID-202110041647479790-RFBLS]. Safety Report Unique Identifier [GB-MHRA-ADR 26033779]. A 24-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Pp3319), via an unspecified route of administration on 26Sep2021 (at the age of 24-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with covid-19. Patient was not currently breastfeeding. Patient had not tested positive for covid-19 since having the vaccine. The patient was not pregnant at the time of vaccination. Patient was not enrolled in clinical trial. Last menstrual period date was 03Oct2021. On an unspecified date in 2021, the patient experienced guillain barre syndrome and nervous system disorder on 26Sep2021. The events were assessed as serious (hospitalization and medically significant) by the health authority. The patient underwent lab tests and procedures on an unspecified date which included MRI, blood work, neuro investigations: unknown results, sars-cov-2 test: no - negative covid-19 test. The outcome of event guillain barre syndrome was unknown while for nervous system disorder was not recovered . No follow-up attempts are possible. No further information is expected.


VAERS ID: 1809465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-09-26
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, SARS-CoV-2 test, Scan
SMQs:, Termination of pregnancy and risk of abortion (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: FOLIC ACID; INFANRIX IPV HIB
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Hay fever; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:Foetal abnormalities were found including facial; Comments: Foetal abnormalities were found including facial cleft, cleft lip, cleft palate, underdeveloped eye
CDC Split Type: GBPFIZER INC202101341902

Write-up: loss of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202110071735531460-SFBTE. Safety Report Unique Identifier is GB-MHRA-ADR 26049745. This consumer reported information for both mother and fetus. This is the maternal report. A 32-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW3143) as dose 1, single and via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FD8813) as dose 2, single for Covid-19 immunisation . Medical history included allergy, pregnancy from an unknown date and unknown if ongoing (patient no longer pregnant at the time of reporting), and hayfever. Patient was medically fit and well. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included folic acid taken for folic acid supplementation, start and stop date were not reported; diphtheria vaccine toxoid, hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX IPV HIB) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and experienced allergy. The patient experienced loss of pregnancy on 26Sep2021 with outcome of unknown. The patient underwent lab test and procedures which included Covid-19 virus test: no-Covid-19 test on unknown date, scans: foetal abnormalities were found including facial on unknown date. Foetal abnormalities were found including facial cleft, cleft lip, cleft palate, underdeveloped eye. pregnancy was subsequently lost in the second trimester. Patient has not tested positive for COVID-19 since having the vaccine. Additional information: I had the vaccines during the first trimester and a foetal abnormality (resulting in loss of pregnancy) was found. I am concerned it was a result of having the vaccine at such a sensitive time in the pregnancy. An autopsy is being carried out.Did the medicine have an adverse effect on any aspect of the pregnancy: Yes. Pregnancy adverse effects details: Foetal abnormality, potentially related. Details of previous pregnancies: Previous healthy baby boy, born at term. This pregnancy was very restful, but abnormality was found and pregnancy was subsequently lost in the second trimester. Patient was exposed to the medicine first-trimester (1-12 weeks). Details of scans or investigations: Foetal abnormalities were found including facial cleft, cleft lip, cleft palate, underdeveloped eye, more results pending, and will follow after autopsy. Relevant investigations or tests conducted: "Autopsy of foetus will occur but results have not yet been given." No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101355068 babycase


VAERS ID: 1809490 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disturbance in attention, Dizziness, Immunisation, Nausea, Off label use, SARS-CoV-2 test, Vertigo positional
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101342545

Write-up: nausea; Vertigo positional; dizzy; unable to focus; off label use; booster; This is a spontaneous report from a contactable consumer (patient). This is the report received from the Regulatory authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202110081545320080-RCABO. Safety Report Unique Identifier is GB-MHRA-ADR 26050683. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 26Sep2021 (at the age of 82 years old) as dose 3 (booster), single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 28Sep2021, the patient experienced nausea, vertigo positional, dizzy, and unable to focus. The events were reported as serious per other medically important condition. The patient also experienced off label use and booster on 26Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 26Sep2021. The clinical course was reported as follows: 48 hours (2 days) after receiving booster, the patient woke up to find herself dizzy, with nausea, unable to focus. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event vertigo positional was recovering, while outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1809707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101350751

Write-up: Urticarial rash all over with circular lesions consistent with a dx of erythema multiforme; Urticarial rash all over with circular lesions consistent with a dx of erythema multiforme; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received IE HPRA Regulatory authority report number IE-HPRA-2021-085005 with Safety Report Unique Identifier IE-HPRA-2021-085005. A 12-year-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot Number: FG9019), dose 2 via an unspecified route of administration on 23Sep2021 as DOSE 2, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Formulation: solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 26Aug2021 as DOSE 1, 0.3 ML SINGLE for COVID-19 immunization. 3 days later on 26Sep2021, the patient experienced urticarial rash all over with circular lesions consistent with a dx of erythema multiforme. Therapeutic measures were taken as a result of the events with an unspecified antihistamine on the day of rash. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1809712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG9019 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Heart rate increased, Odynophagia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIENOGEST; LEVOTHYROXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101350590

Write-up: Pulse acceleration; Swallow unconfortable; Chest unconfortable; This is a spontaneous from a contactable consumer or other non-health care professional downloaded from the regulatory authority-WEB. This is a report received [RA} Regulatory authority report number [IE-HPRA-CVARR2021100422179] with Safety Report Unique Identifier [IE-HPRA-2021-085191]. A 40-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch Number: FG9019), via an unspecified route of administration as dose 1, single on 24Sep2021 for Covid-19 immunization. Medical history included endometriosis and hypothyroidism. Concomitant medication included dienogest taken for endometriosis from 04Oct2018 to an unspecified stop date and levothyroxine daily (37 daily) taken for hypothyroidism. On 26Sep2021, 2 days after vaccination the patient experienced pulse acceleration, swallow uncomfortable and chest uncomfortable. Patient said it was the heart and they did not know the consequences, the patient reported that they did not have a doctor yet. All events were assessed as medically significant. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1809797 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 049283017 - 300 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hemiparaesthesia, Hypoaesthesia, Insomnia, Malaise
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Sexual dysfunction (broad)

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

Write-up: Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise; Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise; Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise; Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise; Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-796788) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEMIPARAESTHESIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 049283017 - 3005294) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced HEMIPARAESTHESIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise) (seriousness criterion medically significant), HYPOAESTHESIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise), INSOMNIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise), MALAISE (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise) and HEADACHE (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise). At the time of the report, HEMIPARAESTHESIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise), HYPOAESTHESIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise), INSOMNIA (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise), MALAISE (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise) and HEADACHE (Tingling and aching of the left leg - headache - increase in standard blood pressure values - Insomnia - Malaise) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medication were not provided. Treatment medication were not provided. Company comment: This case concerns a 58-year-old, male patient with no relevant medical history, who experienced the unexpected event of Hemiparaesthesia. The event occurred approximately 5 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Translated document received on 18-Oct-21 and it contains translated events verbatim.; Reporter''s Comments: Concomitant conditions: NONE - Reaction Time:07:00 - Sent by VigiCovid19-scheda; Sender''s Comments: This case concerns a 58-year-old, male patient with no relevant medical history, who experienced the unexpected event of Hemiparaesthesia. The event occurred approximately 5 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report


VAERS ID: 1809799 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / 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: ITMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received (Reference number: IT-MINISAL02-796946) on 15-Oct-2021 and was forwarded to Moderna on 15-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 19-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 immunisation. No Medical History information was reported. On 20-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 26-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. Concomitant medications were not reported. Treatment medications were not reported. Vaccine administered at 09:49 a.m.; first vaccine dose batch 3004499 administered on 19-Aug-2021 at 12:58 p.m. onset of symptoms after 6 days. Company comment: This case concerns a 19-year-old male patient with no relevant medical history who experienced serious expected event of Myocarditis. The event occurred 7 days following the vaccination with the second dose of Spikevax. Details of clinical presentation, diagnostic criteria, treatment, and clinical course were not provided. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: Translation received on 18 Oct 2021 non significant information received Include event verbatim and Sender''s comments updated; Sender''s Comments: This case concerns a 19-year-old male patient with no relevant medical history who experienced serious expected event of Myocarditis. The event occurred 7 days following the vaccination with the second dose of Spikevax. Details of clinical presentation, diagnostic criteria, treatment, and clinical course were not provided. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1809863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperthermia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37.4-37.9 Centigrade; Test Name: Body temperature; Result Unstructured Data: Test Result:37.4-37.6 Centigrade; Comments: from last week; Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:around 40 Centigrade
CDC Split Type: JPPFIZER INC202101376279

Write-up: pyrexia; Hyperthermia around 40 degrees centigrade persisted for 5 days; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 14-year-old female patient received bnt162b2 (COMIRNATY; Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 25Sep2021 (as reported) (the day of vaccination) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY; Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 31Aug2021 at dose 1, single for covid-19 immunization and experienced pyrexia, hyperthermia and headache. The patient experienced hyperthermia around 40 degrees centigrade persisted for 5 days (medically significant) on 26Sep2021, which was 15 hours later; had pyrexia on an unspecified date. It was reported that second dose was on 25Sep2021. From the next day, hyperthermia of 40 degrees centigrade persisted for 5 days. Then it was from 37.4-37.9 degrees centigrade, it went down and up. From last week, pyrexia of 37.4-37.6 degrees centigrade persisted. But basically, Hyperthermia persisted. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Hyperthermia, and Pyrexia cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1809976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH4092 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: ADAMTS13 activity assay, Antiphospholipid antibodies, Foetal death, Investigation, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Termination of pregnancy and risk of abortion (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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: Hypothyreosis; Spontaneous abortion (3 former spontaneous abortions in 1 trimester); Vitiligo
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: ADAMTS13 activity assay; Result Unstructured Data: Test Result:Severly reduced; Comments: Severly reduced ADAMTS13 activity, diagnostic for thrombotic thrombocytopenic purpura.; Test Date: 2021; Test Name: Antiphospholipid antibodies; Result Unstructured Data: Test Result:Negative; Test Date: 20210926; Test Name: Investigation; Result Unstructured Data: Test Result:had debut of neurological symptoms; Comments: the same day as intrauterine death was established
CDC Split Type: NOPFIZER INC202101384632

Write-up: DEATH INTRAUTERINE (22+3 WEEKS); THROMBOTIC THROMBOCYTOPENIC PURPURA; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number [NO-NOMAADVRE-FHI-2021-Uwjngg] and [NO-NOMAADVRE-E2B_00054246]. A 35-year-old pregnant female patient received bnt162b2 (COMIRNATY), intramuscular on 16Sep2021 (Lot Number: FH4092) as dose number unknown, single for COVID-19 immunization. Medical history included vitiligo, hypothyreosis and spontaneous abortion (three former spontaneous abortions in 1 trimester, but the patient had no history of illness in conjunction with these). The patient''s concomitant medications were not reported. On 26Sep2021, the patient developed thrombotic thrombocytopenic purpura and death intrauterine. The mother reported she became pregnant while taking bnt162b2. The mother was 22 Weeks pregnant at the onset of the event. The fetal outcome is intrauterine death. Course of events: The patient had experienced signs of reduced foetal life a few days after vaccination. Contacted gynecologist which stated that foetal heart action was ok. patient again contacted gynecologist due to lack of foetal signs of life. The gynecologist determined intrauterine foetal death, week 22+3. Investigation on 26Sep2021: the patient had debut of neurological symptoms the same day as intrauterine death was established. Established intravascular haemolysis and severe thrombocytopenia. On 26Sep2021, severely reduced ADAMTS13 activity, diagnostic for thrombotic thrombocytopenic purpura. Negative for antiphospholipid syndrome on unspecified date in 2021. The reported events resulted in Physician office visit. Therapeutic measure was taken as a result of thrombotic thrombocytopenic purpura which included daily plasmapheresis, high-dose steroids, rituximab. The outcome of the events was not recovered. The events were considered serious (Life Threatening, Other Serious (Important Medical Events)). The RA assessed the causality of the events with bnt162b2 (COMIRNATY) as possible. Reporter comments: The patient was started on treatment for thrombotic thrombocytopenic purpura from the day of the admission with daily plasmapheresis, high-dose steroids, rituximab. The situation for the patient was still critical at day 9 of the treatment. 08Oct2021 and 12Oct2021, RA: Additional information received from hospital by phone. They consider it likely that thrombotic thrombocytopenic purpura has been triggered by the pregnancy in itself, and that it is unlikely to be caused by vaccination. However, due to temporal relationship, they decided to report it. The patient was still in hospital on 12Oct2021. An autopsy will be performed on the foetus. 13Oct2021 RA: requested additional information. If new medical information is received, report will be updated. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Summary of Reporter Comment: The patient was started on treatment for thrombotic thrombocytopenic purpura from the day of the admission with daily plasmapheresis, high-dose steroids, rituximab. The situation for the patient was still critical at day 9 of the treatment.


VAERS ID: 1815639 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Back pain, Fatigue, Flank pain, Headache, Lymphadenopathy, Musculoskeletal stiffness, Swelling, Vaccination site pain, Vaccination site reaction
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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: Medical History/Concurrent Conditions: Pneumonia (With hospitalization)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101350237

Write-up: Headache; Injection site reaction; Axillary lymph nodes enlarged/ swelling of the lymph nodes under the armpits; Fatigue; Backache; Injection site muscle pain; Local swelling/ swelling on the side of the torso up to the hip; Stiff arm; pain in the left armpit and left flank; pain in the left armpit and left flank; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number BE-FAMHP-DHH-N2021-107175. A 12-year-old male patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 25Sep2021 as single dose for covid-19 immunisation. Medical history included pneumonia from Jul2017 (with hospitalization). The patient''s concomitant medications were not reported. On 26Sep2021, patient experienced injection site reaction, fatigue, injection site muscle pain, headache, axillary lymph nodes enlarged, local swelling and backache. Besides the stiff arm, headache and fatigue, especially swelling of the lymph nodes under the armpits, especially the left armpit (closest to the injection site) where a thick lump developed which also hurt quite a bit. Swelling was also noticeable lower on the left flank, and complaints of back pain in one line near the ''sagged swelling''. The patient woke up with these complaints in both armpits, especially on the left side, the day after the vaccination. A large oval bulge measuring about 10 cm had formed in the armpit by the evening, and also swelling on the side of the torso up to the hip, and besides the pain in the left armpit and left flank, he also complained about back pain. Everything was still swollen and painful, but the headache had improved, on Monday morning 27Sep2021. After a telephone consult with the general practitioner, he went to school without participating in physical education classes. Today, Tuesday 28Sep2021, notice a decreased but still visible swelling on the left side, but no more back pain or headache. It seemed to subside. After a telephone consult with the general practitioner, went to school and was advised not exert himself for the rest of the week. The seriousness criteria was reported as disability. Patient received treatment paracetamol against the pain. No treatment with regard to the swelling. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1816088 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased
CDC Split Type: ESPFIZER INC202101350998

Write-up: Oxygen saturation decreased; Dyspnoea; Tachypnoea; This is a spontaneous report from a contactable Other HCP downloaded from the regulatory agency-WEB [ES-AEMPS-1023337]. A 79-year-old female patient received the third (BOOSTER) BNT162B2 (COMIRNATY, Lot Number: FE4721) via intramuscular at 0.3 ml single in Sep2021 for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced decreased, dyspnoea and tachypnoea on 26Sep2021 with seriousness criteria medically significant. It reported that after receiving the third dose COMIRNATY vaccine, was treated in the hospital emergency room for dyspnea, tachypnea and desaturation. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1816156 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-26
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Angina pectoris, Angiogram, Blood electrolytes, Body temperature, C-reactive protein, Cardiac telemetry, Chest discomfort, Chest pain, Echocardiogram, Electrocardiogram, Fatigue, Fibrin D dimer, Full blood count, Lymph node pain, Migraine, Myocarditis, Oropharyngeal pain, Pyrexia, Troponin T, Troponin T increased, Viral infection
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PROGESTOGENS NOS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease (patient''s father died at the age of 59 of coronary heart disease.); Tobacco user ((snuff); nonsmoker)
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: angiography; Result Unstructured Data: Test Result:uncompressed smooth-walled coronary arteries; Test Date: 20210926; Test Name: Electrolytes; Result Unstructured Data: Test Result:in reference values; Test Date: 20210926; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8; Test Date: 20210928; Test Name: telemetry; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210926; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Less than 1; Test Date: 20210927; Test Name: Echocardiogram; Result Unstructured Data: Test Result:normal finding; Test Date: 20210926; Test Name: electrocardiogram; Result Unstructured Data: Test Result:No changes; Test Date: 20210927; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:idea of myocarditis; Test Date: 20210928; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Neat; Test Date: 20210927; Test Name: Fibrin D-Dimer; Result Unstructured Data: Test Result:0.2; Test Date: 20210926; Test Name: complete blood count; Result Unstructured Data: Test Result:neat; Test Date: 20210926; Test Name: Troponin-T; Result Unstructured Data: Test Result:high; Test Date: 20210927; Test Name: Troponin-T; Result Unstructured Data: Test Result:higher on 90; Test Date: 20210928; Test Name: Troponin-T; Result Unstructured Data: Test Result:decreased to 45
CDC Split Type: FIPFIZER INC202101350335

Write-up: Myocarditis / troponin t: higher; angina pectoris; Body temperature 37.8; migraine; heavy feeling in the chest; chest pain; troponin-T is elevated / Troponin-T has been high; band-like squeezing upper abdominal pain; abnormal fatigue; sore throat; neck lymph tenderness; viral infection; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority number FI-FIMEA-20215389. A 32-year-old female patient received an unknown dose of BNT162B2 (COMIRNATY) via intramuscular on 16Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included snuff (nonsmoker) and unknown if ongoing. The patient''s father died at the age of 59 of coronary heart disease. Concomitant medication included progestogens nos and no other medication. On 26Sep2021, the patient experienced myocarditis, band-like squeezing upper abdominal pain and troponin-t is elevated. On 27Sep2021, the patient experienced heavy feeling in the chest and chest pain. On 29Sep2021, the patient experienced migraine. In 2021, the patient experienced abnormal fatigue, sore throat, neck lymph tenderness and viral infection. The patient underwent lab tests and procedures which included angiogram: uncompressed smooth-walled coronary arteries on 28Sep2021, blood electrolytes: in reference values on 26Sep2021, body temperature: 37.8 on 26Sep2021, cardiac telemetry: no abnormality on 28Sep2021, c-reactive protein: less than 1 on 26Sep2021, echocardiogram: normal finding on 27Sep2021, electrocardiogram: no changes on 26Sep2021, electrocardiogram: idea of myocarditis on 27Sep2021, electrocardiogram: neat on 28Sep2021, fibrin d dimer: 0.2 on 27Sep2021, full blood count: neat on 26Sep2021, troponin t: high on 26Sep2021, troponin t: higher on 90 on 27Sep2021, troponin t: decreased to 45 on 28Sep2021. Therapeutic measures were taken as a result of myocarditis. On 26Sep2021 to emergency room. Has rested on the couch after work and felt a few times a band-like squeezing upper abdominal pain, short in duration. Repeated three times. Once during the scene when walking up the stairs, had to stop. Pain reduced when crouching. No fever, stomach functioning normally, no nausea or vomiting. Body temperature 37.8. Brought to the emergency room, no changes in electrocardiogram, complete blood count neat, C-reactive protein less than 1, Electrolytes in reference values. No pain and was discharged. Troponin-T has been high, therefore for check up on 27Sep2021. The refined history describes a week of abnormal fatigue during a CrossFit-type workout and a week earlier briefly a sore throat and neck lymph tenderness referring to viral infection. Still a heavy feeling in the chest. In the emergency room, Troponin-T higher on 90, Fibrin D-Dimer 0.2, no suspicion of pulmonary embolism or aortic pathology. Consulted cardiology, made echocardiogram in the emergency room, normal finding. Electrocardiogram calm, taken to the cardiac ward for follow-up with the idea of myocarditis. In the morning, when resting asymptomatic, telemetry has no abnormality, morning electrocardiogram neat and troponin-T decreased to 45. I was walking stairs, when feeling of heavy chest appeared as the day before. End up doing a diagnostic angiography, which shows uncompressed smooth-walled coronary arteries. The patient has chest pain and troponin-T is elevated, is now being treated for myocarditis, with a background of possible viral infection. Due to angina pectoris, coronary artery disease excluded and echocardiogram was neat. Non-steroidal anti-inflammatory drugs to treat myocarditis, laboratory control in a week, when normalization of troponin-T is seen, electrocardiogram is also checked. Guided to move calmly and to restrain from sports for a month. The outcome of Myocarditis 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: 1816286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-09-26
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pelvic pain, Postmenopausal haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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: Medical History/Concurrent Conditions: Biopsy vulva; Bipolar disorder (with no current treatment)
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101349146

Write-up: Postmenopausal bleeding; Pelvic pain female; Fatigue; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority. The regulatory authority number is FR-AFSSAPS-PV20212907. A 51-year-old female patient received BNT162b2 (COMIRNATY), intramuscular on 18Aug2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml, single for COVID-19 immunisation. Medical history included bipolar disorder with no current treatment and vulvar biopsy in 2021. The patient''s concomitant medications were not reported. On 26Sep2021, the patient experienced occurrence of postmenopausal bleeding, pelvic pain female, and fatigue. Additional examinations included SARS-CoV-2 test: negative on an unspecified date. The outcome of the events was recovering/resolving. Note: Imputability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. Therapie 1985; 40: 111-8. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1816408 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Pain, Paraesthesia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101342664

Write-up: pins and needles; Aching joints; Pain dull/Pain/dull aching all over; moderate pain in the arm vaccine was given; 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-202110082158366200-HPQFJ, Safety Report Unique Identifier GB-MHRA-ADR 26055834. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 26Sep2021 (Batch/Lot number was not known) (at the age of 30-year-old) as dose 3 (booster), single for COVID-19 immunisation. The patient''s medical history was not reported. 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 patient''s concomitant medications were not reported. The patient experienced pain and pins and needles on an unspecified date; and aching joints and pain dull on 26Sep2021. Clinical course details: since the evening of the vaccine (26Sep2021), she had been experiencing dull aching all over and moderate pain in the arm vaccine was given. It was many weeks later now and aching and pain persisted. She had also experienced intermittent pins and needles in the face since the evening of the vaccine (26Sep2021). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events pins and needles was recovering; and aching joints, pain dull/pain/dull aching all over, and moderate pain in the arm vaccine was given was not recovered. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1816719 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Myopericarditis; Guillain Barre syndrome; This case was received via regulatory authority (Reference number: FR-AFSSAPS-BR20213664) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myopericarditis) and GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) in a 63-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Atrial fibrillation. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization and medically significant) and GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myopericarditis) had resolved and GUILLAIN-BARRE SYNDROME (Guillain Barre syndrome) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were reported. Company Comment: This case concerns a 63-year-old, male patient with a previous relevant medical history of Atrial fibrillation, who experienced the serious unexpected event (AESI) of Guillain-Barre syndrome and serious expected event (AESI) of Myocarditis. The events occurred 10 days after the first dose of mRNA-1273. No lab data was provided to support the diagnosis of the events. The medical history of Atrial fibrillation remains a confounder The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Translation Document received on 19-OCT-2021.Drug Information (Substance / Specified Substance Name) updated.(Non-significant information); Sender''s Comments: This case concerns a 63-year-old, male patient with a previous relevant medical history of Atrial fibrillation, who experienced the serious unexpected event (AESI) of Guillain-Barre syndrome and serious expected event (AESI) of Myocarditis. The events occurred 10 days after the first dose of mRNA-1273. No lab data was provided to support the diagnosis of the events. The medical history of Atrial fibrillation remains a confounder The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1816724 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214005 / UNK - / OT

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

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

Write-up: Reactogenicity event; Syncope vasovagal; Headache; This case was received via the regulatory authority (Reference number: FR-AFSSAPS-PV20212881) on 18-Oct-2021 and was forwarded to Moderna on 18-Oct-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of REACTOGENICITY EVENT (Reactogenicity event), SYNCOPE (Syncope vasovagal) and HEADACHE (Headache) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214005) for COVID-19 vaccination. No Medical History information was reported. On 25-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 26-Sep-2021, the patient experienced REACTOGENICITY EVENT (Reactogenicity event) (seriousness criterion medically significant), SYNCOPE (Syncope vasovagal) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, REACTOGENICITY EVENT (Reactogenicity event), SYNCOPE (Syncope vasovagal) and HEADACHE (Headache) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company Comment: This case concerns a 35-year-old male patient with no relevant medical history, who experienced the serious unexpected events of reactogenicity event, syncope and headache. The events occurred next day after receiving the mRNA-1273-vaccine. The re-challenge was not applicable as there is no clear information regarding the vaccine doses. The benefit-risk relationship of vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Translation document received on 19-Oct-2021 and included no new information.; Sender''s Comments: This case concerns a 35-year-old male patient with no relevant medical history, who experienced the serious unexpected events of reactogenicity event, syncope and headache. The events occurred next day after receiving the mRNA-1273-vaccine. The re-challenge was not applicable as there is no clear information regarding the vaccine doses. The benefit-risk relationship of vaccine is not affected by this report.


VAERS ID: 1816830 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005700 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Magnetic resonance imaging, Multiple sclerosis relapse
SMQs:, Optic nerve disorders (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Secondary progressive multiple sclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210930; Test Name: Magnetic resonance imaging; Result Unstructured Data: MRI showed a new recurrent lesion in the ventral midbrain, suggesting recurrence of multiple sclerosis.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Recurrence of multiple sclerosis; This case was received via Pharmaceuticals (Reference number: 2021TJP108518) on 15-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This case, initially reported to the Agency by a (physician), was received via the Agency (Ref, v21130005). The patient visited the reporting hospital regularly for multiple sclerosis with onset in 2007. After the recurrence in 2016, there was no clinical recurrence, but there was the recurrence and extension of the lesion in image findings, and it was the situation in which the symptom shifted to the secondary progressive multiple sclerosis. On 15-Sep-2021, the patient received the 1st dose of this vaccine. On 26-Sep-2021, headache and dizziness developed. On 30-Sep-2021, MRI showed a new recurrent lesion in the ventral midbrain, suggesting recurrence of multiple sclerosis. On 01-Oct-2021, the patient was hospitalized. On 08-Oct-2021, the symptoms were resolving spontaneously, and the patient was discharged from the hospital. The outcome of recurrence of multiple sclerosis 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: Another factor is multiple sclerosis, for which the patient visited the reporting department regularly. The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 39-year-old, male patient with medical history of Secondary progressive multiple sclerosis, who experienced the unexpected serious adverse event of special interest of multiple sclerosis relapse. The event occurred approximately 12 days after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the event occurred after the first dose and there is no information about the second dose. The event was considered related to the vaccine per the reporter''s assessment. The medical history of underlying secondary progressive multiple sclerosis remains as a relevant confounder. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.


VAERS ID: 1817681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Myocarditis, Thrombocytopenia, Troponin, Troponin increased
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:increased; Test Date: 20210926; Test Name: Troponin; Result Unstructured Data: Test Result:increased
CDC Split Type: AUPFIZER INC202101360713

Write-up: Myocarditis; Thrombocytopenia; Troponin increased; Fibrin D dimer increased; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 636770. A 16-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced Fibrin D dimer increased; Myocarditis (medically significant); Thrombocytopenia (medically significant); Troponin increased. The patient under went lab test and procedures which includes Fibrin D dimer and result was increased, Troponin and result was increased on 26Sep2021. Outcome of all 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: 1817753 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Communication disorder, Feeling cold, Headache, Heart rate increased, Nausea, Pain, Syncope, Tremor, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361660

Write-up: Syncope; Abdominal pain upper; Communication disorder; Feeling cold; Headache; Heart rate increased; Nausea; Pain; Tremor; Visual impairment; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 639292. A 13-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation; lisdexamfetamine mesilate (VYVANSE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for an unspecified indication. The patient''s medical history and concomitant medications were not reported. On 26Sep2021, the patient experienced syncope, abdominal pain upper, communication disorder, feeling cold, headache, heart rate increased, nausea, pain, tremor and visual impairment. Outcome of the events were recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.]


VAERS ID: 1817760 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101361720

Write-up: Appendicitis; This is a spontaneous report from a contactable healthcare professional via the Regulatory Authority. Regulatory authority report number is 639584. A 17-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced appendicitis on 26Sep2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1819425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LUCETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Period pains; Comments: Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101373888

Write-up: Prolonged periods; it''s been over 2 weeks now/ feelings of weakness; This is a spontaneous report from a contactable consumer (the patient) received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110132012423960-MYUXH. Safety Report Unique Identifier GB-MHRA-ADR 26073631. A 27-year-old non-pregnant female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number was not known), via an unspecified route of administration, on 23Sep2021, as Dose 2, Single for COVID-19 immunization. Medical history included period pains. The patient has not had symptoms associated with COVID-19.The patient was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial.Concomitant medication included drospirenone, ethinylestradiol (LUCETTE) taken for period pains from 01Mar2021.The patient experienced prolonged periods on 26Sep2021 (3 days after the second dose) and it''s been over 2 weeks now/ feelings of weakness on an unspecified date in 2021. Despite being on the pill, patient''s period started a few days after the second vaccine and hasn''t stopped since. It''s been over 2 weeks now, almost 3. The seriousness criteria for the events were reported as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was negative (No - Negative COVID-19 test) on an unspecified date. The clinical outcome of the event feelings of weakness was recovering while the outcome of the event prolonged periods was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1819722 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9944 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Eye pain, Fatigue, Hypokinesia, Muscular weakness, Myalgia, Nausea, Pain in extremity, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ALVESCO; RUPAFIN; ZINC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Duodenal ulcer
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: Blood pressure; Result Unstructured Data: Test Result:above 170; Comments: at 18:30
CDC Split Type: JPPFIZER INC202101361361

Write-up: Tachycardia; Blood pressure increased (above 170); Muscular weakness; myalgia; pain in extremity; hypokinesia; nausea; Eye pain; Fatiguability; This is a spontaneous report from a contactable other healthcare professional received via regulatory authority. A non-pregnant 57-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FF9944; Expiration Date: 30Nov2021), via an unspecified route of administration, administered in left arm on 22Sep2021 at 11:00 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included asthma bronchial and duodenal ulcer. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included ciclesonide (ALVESCO), rupatadine fumarate (RUPAFIN) and zinc, all taken for an unspecified indication, start and stop date were not reported. On 26Sep2021 at 18:30 (4 days 7 hrs 30 min after the vaccination), the patient experienced tachycardia, blood pressure increased (above 170), muscular weakness, myalgia, pain in extremity, hypokinesia, nausea, eye pain, fatiguability. The outcome of the events was not recovered with treatment including drip infusion and stomach medicine. The reporter stated the events result in doctor or other healthcare professional office/clinic visit and in Emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. No follow up attempts are possible. No further information is expected.; Sender''s Comments: The events was considered related to suspect drug based on strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1820255 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Chest discomfort
SMQs:, Anaphylactic reaction (broad), Other ischaemic heart disease (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: TWPFIZER INC202101424447

Write-up: CHEST TIGHTNESS; HEART STINGING; This is a spontaneous report from a non-contactable other health professional via Regulatory Authority (Regulatory authority report number: TW-TFDA-TVS-1100008517), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003896), license party for bnt162b2(COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008517. A 15-year-old female patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via intramuscular at unspecified dosage regimen for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced chest tightness and heart stinging on 26-Sep-2021. On 26-Sep-2021, the patient developed chest tightness combined with heart stinging. On 27-Sep-2021, the patient and her patient went to a hospital for an emergency examination. It was reported that "On 29-Sep-2021, cases study in a school". Chest tightness and heart stinging met the seriousness criterion of hospitalization. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment for COMIRNATY with events chest tightness and heart stinging was both possible per Reporter and per Company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820296 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Chest pain, Electrocardiogram, X-ray
SMQs:, Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210930; Test Name: Blood test; Result Unstructured Data: Test Result:normal; Test Date: 20210930; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210930; Test Name: X-ray; Result Unstructured Data: Test Result:normal
CDC Split Type: TWPFIZER INC202101419333

Write-up: CHEST TIGHTNESS; CHEST PAIN; This is a spontaneous report from a non-contactable healthcare professional via the RA (Regulatory authority report number: TW-TFDA-TVS-1100008789), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004045), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the RA. The regulatory authority report number is TW-TFDA-TVS-1100008789. A 15-year-old male patient started to receive an unknown dose of Tozinameran (COMIRNATY) (batch number:unknown ) on 23-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Concomitant medication(s) and past product were not reported. The patient experienced chest tightness, chest pain on 26-Sep-2021. 1. Use medication disease / symptoms: to receive vaccination 2. Time, symptom, and part of the adverse reaction: On 26-Sep-2021, the patient experienced chest tightness, chest pain. 3. History, diagnostic results, severity and disposal: The first agent BNT vaccine was taken at 23-Sep-2021. At the beginning of the 26-Sep-2021 sunday,the patient felt that the slight chest tightness, the stab thorn is uncomfortable, and the frequency increased on the 29-Sep-2021, today (30-Sep-2021) went to heart department. On 30-Sep-2021 electrocardiogram, blood draw, X-ray examination was normal. 4. Document source: Imitation list . The following was tracking care. Chest tightness, chest pain met the seriousness criterion of other medically important condition . The actions taken for Tozinameran (COMIRNATY) regarding the hest tightness, chest pain were not applicable. At the time of the report, the outcomes of hest tightnessand chest pain were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible Causality assessment Chest tightness; Chest pain Per Reporter=Possible Per Company=Possible No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101409788

Write-up: CHEST PAIN; DYSPNEA; This is a spontaneous report from a non-contactable other health care professional via the regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008631), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004061), license party for BNT162b2 (COMIRNATY). A male patient of an unspecified age received bnt162b2 (COMIRNATY, Tozinameran, Formulation: solution for injection, Lot number: unknown) via an unspecified route of administration on 26Sep2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced dyspnea on 26Sep2021 and chest pain on 27Sep2021. Chest pain and dyspnea were considered as other medically important condition. Causality assessment for events dyspnea and chest pain with comirnaty was possible as per reporter and company (BioNtech SE). At the time of the report, the outcomes of chest pain and dyspnea were unknown. Follow-up closed; no further information is possible.


VAERS ID: 1820340 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Muscular weakness, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424648

Write-up: PARALYZED; LIMBS NUMBNESS; LIMB WEAKNESS; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority report number:TW-TFDA-TVS-1100008211), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004127), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority report number is TW-TFDA-TVS-1100008211. A 22-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number was unspecified) on 25-Sep-2021 via intramuscular at unknown dose with unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced limbs numbness, limb weakness and paralyzed on 26-Sep-2021. On 26-Sep-2021, after the BNT vaccination, the left half of the body was paralyzed. Paralyzed met the seriousness criterion of other medically important condition. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment for bnt162b2 for events paralyzed, limbs numbness and limb weakness was possible as per Reporter and per Company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1820341 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest discomfort, Chest pain, Pain, Pyrexia, Rash
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWPFIZER INC202101424677

Write-up: CHEST PAIN; CHEST TIGHTNESS; MILD FEVER; SKIN RASH ON TRUNK; GENERAL WEAKNESS; SORENESS; This is a spontaneous report from a non-contactable healthcare professional via the regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008225), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS004133), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008225. A 12-year-old male patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. Medical history, concomitant medications and past product were not reported. The patient experienced chest pain, chest tightness, mild fever, skin rash on trunk, general weakness and soreness on 26-Sep-2021. The patient had chest pain, chest tightness for 2 days after vaccination, with mild fever, skin rash on trunk, general weakness and soreness, no sobbing. Chest pain, chest tightness, mild fever, skin rash on trunk, general weakness and soreness met the seriousness criterion of hospitalization. The action(s) taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Events of '' Chest pain, Chest tightness, Fever, Rash trunk, Weakness generalized, General body pain'' was possibly related to COMIRNATY as per reporter and Company (BioNTech SE). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822075 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Lethargy, Pallor, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), 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: AUPFIZER INC202101361711

Write-up: Syncope; Lethargy; Pallor; Presyncope; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 639542. As per source: A 15-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, for covid-19 immunization. Medical history and concomitant medications were not reported. On 26ep2021, the patient experienced Lethargy; Pallor; Presyncope; Syncope. The outcome of the events was recovered on an unspecifed date. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822510 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-26
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Embolism, Pyelonephritis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cystitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101370445

Write-up: Pyelonephritis; Suspicion of a mobile clot; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB with regulatory authority report number FR-AFSSAPS-LY202111498. A 20-year-old female patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, lot number/expiry date unknown), intramuscular on 16Sep2021 as dose 2, single for covid-19 immunisation. Medical history included recurrent cystitis. The patient has no history of covid-19. Concomitant medications were not reported. On 26Sep2021 onset of pyelonephritis with pain and fever and suspicion of a mobile clot. The events resulted in emergency consultation (emergency room visit) and the patient was then put on antibiotic treatment (Oflocet 200 twice a day 10 days) + Nefopam. There were no exams available. The patient recovered from the events on 05Oct2021. No follow-up attempts are needed; information on the lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1822892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0161 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Impaired quality of life, Insomnia, Loss of personal independence in daily activities, Pyrexia, Quality of life decreased
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder disorder (bladder surgery for vesico-ureteric reflux); Cardiac ablation (due to paroxysmal tachycardias); Hashimoto''s thyroiditis; Hypothyroidism; Kidney disorder; Tachycardia paroxysmal
Allergies:
Diagnostic Lab Data: Test Name: Impact on quality of life; Result Unstructured Data: Test Result:8/10; Comments: decreased
CDC Split Type: ITPFIZER INC202101405901

Write-up: stopping me from sleeping; Impact on quality of life (8/10; Headache; joint pain; High fever; Following the PFIZER vaccination I was in bed for several days; This is a spontaneous report from a contactable consumer or other non healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-799600. A 48-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 24Sep2021 (Lot Number: FH0161) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism Hashimoto''s, hypothyroidism, hypertrophy in one kidney, cardiac ablation due to paroxysmal tachycardias and past surgery included bladder surgery (bladder surgery for vesico-ureteric reflux). Patient''s height was 173 cm and weight 71 kg. The patient''s concomitant medications were not reported. Following the PFIZER vaccination patient was in bed for several days with a high fever, headache, joint pain on 26Sep2021. After 3 weeks, the fever has faded. In the evening, headache reappeared, which patient has never suffered from before. Continued strong joint pains stopping her from sleeping. The patient experienced impaired quality of life on an unspecified date. Outcome for high fever was recovered, for headache, arthralgia, loss of personal independence in daily activities, insomnia, impaired quality of life was unknown. As indicated by doctor, patient has alternated between tachipirina 1000 and nurofen. The patient underwent lab tests and procedures which included quality of life showed: 8/10, decreased. Reporter comment: hypothyroidism Hashimoto''s thyroiditis hypertrophy in one kidney following bladder surgery for vesico-ureteric reflux cardiac ablation due to paroxysmal tachycardias. Sender comment: The seriousness of the report was not provide. No follow-up attempts are possible, No further information is expected.; Reporter''s Comments: hypothyroidism Hashimoto''s thyroiditis hypertrophy in one kidney following bladder surgery for vesico-ureteric reflux cardiac ablation due to paroxysmal tachycardias.


VAERS ID: 1823095 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-26
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210926; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Asymptomatic COVID-19 Confirmed
CDC Split Type: PHPFIZER INC202101375099

Write-up: Asymptomatic COVID-19; Asymptomatic COVID-19; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority (RA). The regulatory authority report number PH-PHFDA-300109673. A 24-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, on 16Jul2021 (Batch/Lot Number: FD5996), at age 24 years old, as dose number unknown, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On 26Sep2021 08:00, the patient experienced drug ineffective and asymptomatic COVID-19. "Asymptomatic COVID-19 Confirmed" was reported. The patient recovered from the events on an unspecified date. The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FD5996. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blindness transient, Diarrhoea, Dizziness, Presyncope, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101370057

Write-up: Temporary vision loss; Near fainting; feeling faint; Tremor limb; heavy belly ache; Diarrhea; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority report number is PT-INFARMED-B202109-2737. A 15-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular on 25Sep2021 (Batch Number: FG6273, CAUL: 48421) as dose 2, 0.3 mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were unknown. The patient previously received BNT162B2 on an unspecified date (Lot/Batch number was not reported) as dose 1, 0.3 mL single for COVID-19 immunisation and experienced no adverse events. Adverse drug reactions (ADR) started on the day following the administration of the second dose. On 26Sep2021, the patient experienced temporary vision loss, near fainting (also reported as feeling faint), tremor limb (also reported as left leg trembling), heavy belly ache, and diarrhea. The events were reported as serious - disability. There was no treatment to reverse ADRs, only water intake was mentioned. The patient was recovering from the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1823170 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-09-26
   Days after vaccination:228
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Positivo Iu international unit(s)
CDC Split Type: PTPFIZER INC202101388262

Write-up: COVID-19; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number PT-INFARMED-B202110-613. A 49-year-old female patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EL0725), via intramuscular on 10Feb2021 as dose 2, 0.3 ml single and received first dose bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: EL1491), via intramuscular on 20Jan2021 as dose 1, 0.3 ml single both doses for covid-19 immunization. The patient medical history was not reported. There were no concomitant medications. On 26Sep2021, the patient had myalgias and fatigue. It was reported that seven months after completing the Comirnaty vaccine scheduled, on 27Sep2021 the patient presented with COVID-19 and vaccination failure confirmed by a positive PCR test for SARS-CoV-2 infection. One day before the diagnosis was confirmed, the patient manifested symptoms associated with COVID-19, namely myalgia and fatigue. The patient underwent lab tests and procedures which included sars-cov-2 test with positive (Positivo Iu international unit(s)) on 27Sep2021. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-First dose: Comirnaty, 20Jan2021, Lot EL1491. Second dose: Comirnaty, 10Feb2021, Lot EL0725. Onset of symptoms on 26Sep2021: myalgias and fatigue. Positive PCR test a to 27Sep2021


VAERS ID: 1823264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Chest discomfort, Chest pain, Investigation, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Auscultation; Result Unstructured Data: Test Result: no gallop rhythm, no distant heart sound; Test Date: 20210927; Test Name: capillary refilling time; Result Unstructured Data: Test Result:< 2 seconds.
CDC Split Type: TWPFIZER INC202101424794

Write-up: CHEST TIGHTNESS; CHEST PAIN; FEVER; This is a spontaneous report from a non-contactable healthcare professional via the Regulatory Authority- (regulatory authority number: TW-TFDA-TVS-1100008243), based on information received by Pfizer from BioNTech SE (manufacturer control number TW-Fosun-2021FOS003882), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via the Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008243. A 16-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (lot number: 1G042A-CDC, expiry date not reported) on 23Sep2021 16:00 via intramuscular as DOSE 1, SINGLE for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced chest tightness, chest pain on 26Sep2021. At 16:00 of 23Sep2021, the patient receive the 1st dose of BNT vaccine. At 12:00pm of 26Sep2021, the patient experienced chest tightness, chest pain and once fever at home, no cough, no rhinorrhea, no vomiting, no diarrhea, denied trauma condition, no dyspnea, no cold sweating, no skin rash, no wound, LMP: 2 weeks ago, denied possibility of pregnancy, no family sick no obvious contact history, no cluster history, denied travelling history, denied oversea travelling history, denied Foreign contact history, denied other counties and cities travel history, denied COVID-19 Home isolation and home inspection independent management contact history, denied Hot spot exposure history, denied received cell newsletter. At 22:20 of 26Sep2021, no chest pain, no chest tightness, walking well. At 01:46 of 27Sep2021, fever subsided, no vomiting, no abdominal pain, soft abdomen, no muscle guarding, no rebounding pain, no tachypnea. no chest wall retraction, no gallop rhythm, no distant heart sound, capillary refilling time < 2 secs, conscious alert and clear, no meningeal signs, no limbs weakness, intake and urine output ok, no decreased activity, walking well, the patient was discharged (hospitalization end date on 27Sep2021). Chest tightness, chest pain and fever met the seriousness criterion of Caused / Prolonged Hospitalisation. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13Oct2021. Follow-up closed, no further information is possible. Causality assessment: Events Chest tightness, Chest pain, Fever were assessed as serious (hospitalization) and possibly related to Comirnaty per reporter and company (BioNTech SE).


VAERS ID: 1823265 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Nausea, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
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: 20210927; Test Name: body temperature; Result Unstructured Data: Test Result:35.7
CDC Split Type: TWPFIZER INC202101424450

Write-up: SYNCOPE; NAUSEA; VOMIT; dizziness; This is a spontaneous report from a non-contactable other health professional via Regulatory Authority (Regulatory authority report number: TW-TFDA-TVS-1100008497), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003883), license party for bnt162b2(COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is TW-TFDA-TVS-1100008497. A 12-year-old male patient started to receive 1st dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 23-Sep-2021 at unspecified dosage frequency for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced nausea, vomit and syncope on 26-Sep-2021. On 26-Sep-2021, after inoculation, the patient developed dizziness and nausea. On 27-Sep-2021, the dizziness and nausea has not disappeared, the patient''s body temperature was 35.7. On 27-Sep-2021 night, the patient went to a otolaryngology department, and the physician said that the patient''s throat had no special situation. The patient was given enzymes and antipyretic drug to relieve symptom. The physician advised the patient to drink plenty of water and rest. On 28-Sep-2021, the patient''s mother said that the patient had no fever, dizziness, disgical relief (unspecified). Syncope was considered as Important Medical Event. The actions taken for Tozinameran (COMIRNATY) regarding the events were not applicable. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. COMIRNATY: Causality Assessments: Nausea, Vomiting, Syncope: Per Reporter and Per Company was possible and not reported for dizziness. Follow-up closed, no further information is possible.


VAERS ID: 1823266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1G042A-CDC / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Abdominal pain upper
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: abdomen routine; Result Unstructured Data: Test Result:A density superimposed with right iliac wing. Some; Comments: A density superimposed with right iliac wing. Some bowel loops with gas content in abdomen.
CDC Split Type: TWPFIZER INC202101424676

Write-up: STOMACH ACHE; This is a spontaneous report from a non-contactable healthcare professional via Taiwan Center for Disease Control (regulatory authority number: TW-TFDA-TVS-1100008246), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003884), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via Taiwan Center for Disease Control. The regulatory authority report number is TW-TFDA-TVS-1100008246. A 17-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: 1G042A-CDC) on 24-Sep-2021 (pending clarification) via intramuscular at an unknow dose with unspecified dosing frequency for COVID-19 immunization. Medical history included past medical history: acne. It was reported that other past diseases included bilateral lacrimal glazing eye disease and unfair. Concomitant medication(s) and past product were not reported. The patient experienced stomachache on 26-Sep-2021. At 14:00 of 25-Sep-2021, the patient received the 1st dose (pending clarification) of BNT Vaccine. At 16:00 of 26-Sep-2021, the patient experienced left epigastric abdominal, no vomiting, no diarrhea, no cough, no rhinorrhea, no fever, denied trauma condition, last stool passage: yesterday, yellowish, no bloody tinged LMP: 4-5th day, no chest pain, no chest tightness, no cold sweating, no family sick, no obvious contact history, no cluster history, denied travelling history, denied oversea travelling history, denied a history of exposure to foreign twin, denied the north, Ilan, outside the county tourism History, denied Covid-19 Home Isolated Residential Autonomous Management Contact History, denied Hotspot Exposure, denied received cell newsletter. At 26-Sep-2021, it was reported that abdomen routine [Standing View] showed: increased density in abdomen. A density superimposed with right iliac wing. Some bowel loops with gas content in abdomen. Stomachache met the seriousness criterion of Other Medically Important Condition. The action taken for Tozinameran (COMIRNATY) regarding the event was not applicable. At the time of the report, the outcome of the event was unknown. Initial report was received on 13-Oct-2021. Comirnaty: Causality Assessment: Stomach ache: Per Reporter and per company (BioNTech SE) was possible. Follow-up closed, no further information is possible.


VAERS ID: 1823278 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest discomfort, Decreased appetite, Dizziness, Electrocardiogram, Heart rate, Hypertension, Myocardial necrosis marker, Oxygen saturation, Respiratory rate, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: Blood pressure; Result Unstructured Data: Test Result:141 / 85-$g 130 / 80-$g 125 / 94 mmHg; Test Date: 20210927; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9; Test Date: 20210928; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result:100; Comments: Unit: times/min; Test Date: 20210928; Test Name: Cardiac enzymes; Result Unstructured Data: Test Result:normal; Test Date: 20210927; Test Name: O2 saturation; Result Unstructured Data: Test Result:99-100 %; Test Date: 20210927; Test Name: Respiratory rate; Result Unstructured Data: Test Result:18; Comments: Unit: times/min
CDC Split Type: TWPFIZER INC202101424722

Write-up: CHEST TIGHTNESS; HIGH BLOOD PRESSURE; VOMIT; LOSS OF APPETITE; DIZZINESS; This is a spontaneous report from a non-contactable healthcare professional via regulatory agency (Regulatory authority report number: TW-TFDA-TVS-1100008426), based on information received by Pfizer from BioNTech SE (manufacturer control number: TW-Fosun-2021FOS003929), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory agency. The regulatory authority report number is TW-TFDA-TVS-1100008426. A 13-year-old female patient started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 23-Sep-2021 via Intramuscular as DOSE NUMBER UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. The patient experienced vomit, loss of appetite, dizziness, high blood pressure and chest tightness on 26-Sep-2021. On 23-Sep-2021, the patient given a dose of vaccination. At noon (12:00) of 26-Sep-2021, the patient developed intermittent chest tightness and did not inform her parents. In the morning of 27-Sep-2021, the symptom occurred again. At 16:08, the patient was accompanied by classmates to the school health center with clearly conscious and complained congestive and chest tightness. The patient underwent some test: Body temperature was 36.9, heartbeat was 100 times / min, breathing was 18 times / min, blood pressure was 141 / 85-$g 130 / 80-$g 125 / 94 mmHg, oxygen was 99-100%. Then her parents were informed to pick up to the doctor and reminded them to go directly to the major hospital for emergency treatment. It was reported that "On 27-Sep-2021 calls Parents, a case of parents said that the family is currently waiting for medical treatment, and the family means that the current case is still incomplete, inquiry, indicating that the family will refuse to notify the VAERS system, have been informed of health The case still continues to call a case, and the family is consent, and it is not convenient to call the phone, and I will tell the case of the case, and the family is agreed." On 28-Sep-2021 09:50, the patient''s ECG was normal, heart enzyme was normal, myocarditis was excluded temporarily, and the doctor recommended to monitor blood pressure in morning and evening due to high blood pressure. The patient was still not suitable and returned to school. It was reported that "On 28-Sep-2021 1130 call, transfer to voicemail". It was reported that "On 28-Sep-2021 16:15 Calling the Master said that the case is the case, can''t eat, eat it, I have to go to school today, I am uncomfortable in the afternoon, please go home, I expected a long way to see the heart department, inquiry Post-case parent hopes to return the system". Vomit, loss of appetite, dizziness, high blood pressure and chest tightness met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were unknown. Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Causality Assessment: Events High blood pressure, Chest tightness, Dizziness, Loss of appetite, Vomit were assessed as serious and possibly related to Comirnaty per reporter and company (BioNTech SE).


VAERS ID: 1823282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Respiration abnormal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Respiratory failure (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: TWPFIZER INC202101424699

Write-up: BREATHING; CHEST TIGHTNESS; This is a spontaneous report from a non-contactable healthcare professional via regulatory authority (regulatory authority number: TW-TFDA-TVS-1100008490) based on information received by Pfizer from BioNtech (manufacturer control number: TW-Fosun-2021FOS003939), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from a non-contactable HCP received via regulatory authority. The regulatory authority report number is TW-TFDA-TVS-1100008490. A male patient with unknown age started to receive a dose of Tozinameran (COMIRNATY) (batch number: unknown) on 24-Sep-2021 via unknown route at unspecified dose/unspecified dosing frequency for COVID-19 immunization. No medical history was reported. Concomitant medication(s) and past product were not reported. The patient experienced breathing and chest tightness on 26-Sep-2021. It was reported that "the symptoms of the emergency treatment will improve the treatment of the hospital". Breathing and chest tightness met the seriousness criterion of Other Medically Important Condition. At the time of the report, the outcomes of the events were unknown . Initial report was received on 13-Oct-2021. Follow-up closed, no further information is possible. Comirnaty: Causality Assessment: breathing and chest tightness: Per reporter and per Company (BioNTech) was possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1824767 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Oxygen saturation, Suspected 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient was not on any other medication at the time adverse event started.The patient had no illness at the time of vaccination, had no past history of similar event, had no adverse event after any previous vaccination, had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, had no family history of any disease (relevant to vaccination) or allergy.
Allergies:
Diagnostic Lab Data: Test Date: 202110; Test Name: Oxygen saturation; Result Unstructured Data: 88; Test Date: 202110; Test Name: Body temperature; Result Unstructured Data: 40 deg
CDC Split Type: VEJNJFOC20211041938

Write-up: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 66 year old elderly male.The patient''s weight was 95 kilograms, and height was 182 centimeters. The patient was not on any other medication at the time adverse event started. The patient had no illness at the time of vaccination, had no past history of similar event, had no adverse event after any previous vaccination, had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, had no family history of any disease (relevant to vaccination) or allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 20XA2UA expiry: unknown) dose was not reported, frequency time 1 total administered on 14-JUN-2021 to right side for prophylactic vaccination. No concomitant medications were reported. On 26-SEP-2021, the patient experienced suspected covid-19 infection. In OCT-2021, the patient had suspected clinical vaccination failure. He consulted with physician on phone. The patient had fever, temperature up to 40 degrees, oxygenation 88 and dry cough. The patient was administered treatment at home, which included remdesivir and Arudil (rivaroxaban) and an oxygen concentrator of 5 liters per second. He was on the same treatment for 15 days The patient reported that he was covid-19 negative already. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection on 10-OCT-2021, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition) This report was associated with product quality complaint: 90000198159. This case is a duplicate of 20211032467. Following receipt of additional information, it was determined that nullification was required for the case 20211032467. The information indicated that the case 20211032467 originated in one country and not the country previously reported. Therefore, this case was created to correct country of Primary source. All relevant information will be submitted under the case 20211041938.; Sender''s Comments: V0: 20211041938-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS 20211041938-covid-19 vaccine ad26.cov2.s- suspected covid-19 infection. 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: 1826258 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / 3 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Osteoporosis, Pelvic pain, Scan, Spinal disorder
SMQs:, Retroperitoneal fibrosis (broad), Osteoporosis/osteopenia (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Radiography; Result Unstructured Data: Test Result:revealed a vertebral compression with osteoporosis
CDC Split Type: FRPFIZER INC202101379417

Write-up: Loin pain/excruciating and unbearable pain in the pelvis and lower back/intense lumbar pain; excruciating and unbearable pain in the pelvis and lower back; Radiography revealed a vertebral compression with osteoporosis; Radiography revealed a vertebral compression with osteoporosis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20214718. A 91-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 24Sep2021 (Batch/Lot Number: FF2834) as dose 3 (booster), single for COVID-19 immunization. Medical history included hypertension from an unknown date. The patient''s concomitant medications were not reported. The patient previously received Comirnaty on 10Feb2021 (Batch/Lot number: EJ6789) as dose 1, left arm, intramuscular and on 15Mar2021 (Batch/Lot number: ET3620) as dose 2, left arm, intramuscular for COVID-19 immunization. The patient previously took lamaline and experienced not tolerated by the patient. On 26Sep2021, the patient experienced loin pain/excruciating and unbearable pain in the pelvis and lower back/intense lumbar pain. The patient had consult with telemedicine doctor who prescribed tramadol and a switch to Lamaline (not tolerated by the patient). Radiography performed a few days later on an unspecified date in 2021 revealed a vertebral compression with osteoporosis. The pain progressed favorably with paracetamol. The events were considered medically significant. The outcome of the events loin pain/excruciating and unbearable pain in the pelvis and lower back/intense lumbar pain was recovering while for the rest of the events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826513 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Immunisation, Off label use, Oropharyngeal pain, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Negative ; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: Lateral flow; Test Result: Negative
CDC Split Type: GBPFIZER INC202101380872

Write-up: Breathlessness; Cough; Sore throat; booster; off label use; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202110141643305190-YBQKU, Safety Report Unique Identifier GB-MHRA-ADR 26079494. A 29-year-old non-pregnant female patient received third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Dose 3a), via an unspecified route of administration on 26Sep2021 (Batch/Lot Number: FF2153, age at the vaccination: 29-year-old) as dose 3 (booster), single for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient previously received dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date for COVID-19 immunisation. The patient''s concomitant medications were not reported. On 26Sep2021, patient had booster and off label use. On 03Oct2021, patient started with a sore throat and after a day it evolved to a cough and severe breathlessness. Something that had never felt before. It all went away suddenly. All events was considered as serious (medically significant). Patient underwent SARS-CoV-2 test, PCR and lateral flows were done and everything was negative so not COVID on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The clinical outcome of sore throat was recovered on 04Oct2021. The clinical outcome of breathlessness, cough was recovered on 06Oct2021. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "PCR; Lateral flow." No follow-up attempts are needed. No further information is expected.


VAERS ID: 1826688 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain lower, Body temperature, Headache, Inflammatory marker test, Lymphadenitis, Migraine, Ultrasound abdomen, Visual impairment
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: Body temperature; Result Unstructured Data: Test Result: afebrile; Test Date: 202109; Test Name: Inflammatory marker test; Result Unstructured Data: Test Result: Normal; Test Date: 202109; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result: Normal except for finding of mesenteric adenitis.
CDC Split Type: IEPFIZER INC202101379331

Write-up: abdominal pain; Headache / Developed headache with visual symptoms Migraine like; Headache with visual sysmtoms Migraine like; ABDO us normal except for finding of mesenteric adenitis; Ongoing abdominal pain / ongoing rif pain; Heacdache with visual symptoms Migraine like; lymphadenitis; abdominal pain lower; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory authority report number IE-HPRA-CVARR2021092922146, Safety Report Unique Identifier IE-HPRA-2021-085071. A 13-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on 21Sep2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not taking any concomitant medication. On 26Sep2021, the patient experienced headache/developed headache with visual symptoms migraine like, abdominal us normal except for finding of mesenteric adenitis, ongoing abdominal pain, ongoing pain, heacdache with visual symptoms migraine like. On an unspecified date, abdominal pain, lymphadenitis, abdominal pain lower. It was reported that, five days later on 26Sep2021, the patient was admitted to hospital with ongoing abdominal pain and headaches. It was reported that the patient experienced ongoing right iliac fossa pain with normal inflammatory markers. It was reported that the patient was afebrile. The patient developed headache with visual symptoms which were described as migraine like and responded to paracetamol (brand unspecified). At the time of reporting the patient symptoms were continuing. The patient underwent lab tests and procedures which included body temperature afebrile, inflammatory marker test normal, and ultrasound abdomen normal except for finding of mesenteric adenitis on Sep2021. Therapeutic measures were taken as a result of headache/developed headache with visual symptoms migraine like, headache with visual sysmtoms migraine like, headache with visual symptoms migraine like. The outcome of Headache with visual symptoms Migraine like, headache with visual symptoms Migraine like, Abdominal us normal except for finding of mesenteric adenitis, Ongoing abdominal pain, Headache with visual symptoms Migraine like was not recovered. Outcome of abdominal pain, abdominal pain lower, lymphadenitis was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1826817 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Oculomucocutaneous syndrome, Pyrexia, Rash
SMQs:, Severe cutaneous adverse reactions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210925; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101376415

Write-up: Oculomucocutaneous syndrome; pyrexia; skin eruption; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21129333. A 16-year-old male patient received BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: FH0151; Expiration Date: 31Dec2021), via an unspecified route of administration on 25Sep2021 at 15:05 (the day of the vaccination), (Age at vaccination: 16-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Body temperature before vaccination was 36.8 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that, the patient received first dose of COMIRNATY. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (COMIRANTY; Solution for injection; Batch/Lot Number: FE8162, Expiration date 30Nov2021) via an unspecified route of administration as dose 1, single on 04Sep2021 for COVID-19 immunization. On 26Sep2021 at unknown time (1 day after the vaccination), the patient experienced Oculomucocutaneous syndrome. The course of the event was as follows: on the following day of the vaccination, the patient had pyrexia and skin eruption, after took antipyretic the patient got rid of fever. Because of the skin eruption was persisted, the patient received consultation in our hospital on 27Sep2021. The patient received prescription including rinderon ointment and rinderon lotion. After that the symptoms were not recovering, on 11Oct2021 the patient received consultation again, the patient was introduced to dermatology of nearby hospital. The patient underwent lab tests and procedures which included body temperature: 36.8 centigrade on before the vaccination 25Sep2021. On 11Oct2021 (13 days after the vaccination), the outcome of the event was not recovered. The reporting physician classified the event as non-serious. The causality between the event and bnt162b2 as unassessable. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1827019 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-09-26
   Days after vaccination:228
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Positive Iu international unit(s)
CDC Split Type: PTPFIZER INC202101388085

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. This is a report received from the regulatory authority-WEB, regulatory authority number PT-INFARMED-B202110-578. A 47-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL1491, Expiration Date: Not reported), via intramuscular route of administration on 20Jan2021 as dose 1, 0.3 ml, single and received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: EL0725, Expiration Date: Not reported), via intramuscular route of administration on 10Feb2021 as dose 2, 0.3 ml, single for COVID-19 immunization. An interval of 21 days between each dose. The patient''s medical history and concomitant medications were not reported. No information about previous reactions to other drugs, or allergies. Information on previous infection with the SARS-CoV-2 virus was unknown. The vaccine failure was identified about 228 days after the second inoculation. On 23Sep2021, symptoms like cough, dyspnea, diarrhea started. On 26Sep2021, the patient had vaccination failure and COVID-19. The events were assessed as medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 PCR test: positive Iu (international unit) on 26Sep2021. Health Authority Comment: First dose Comirnaty 20Jan2021, Lot:EL1491. Second dose: 10Feb2021, Lot EL1491. Symptoms started on 23Sep2021: cough, dyspnea, diarrhea. Covid test (PCR): Positive on 26Sep2021 No follow-up attempts are possible. No further information is expected.


VAERS ID: 1828353 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Angioedema, Hypoaesthesia, Menstruation delayed, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Oropharyngeal allergic conditions (narrow), Guillain-Barre syndrome (broad), Fertility disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLLITROPIN ALFA; MENOPUR; LUTEINISING HORMONE (HUMAN); FOLLICLE-STIMULATING HORMONE, HUMAN
Current Illness: In vitro fertilisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: numbness was on left side of body; Delayed period; Giant urticaria; Numbness; This case was received via Regulatory Authority RA (Reference number: -MHRA-ADR 26104935) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MENSTRUATION DELAYED (Delayed period), HYPOAESTHESIA (numbness was on left side of body), HYPOAESTHESIA (Numbness) and ANGIOEDEMA (Giant urticaria) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included In vitro fertilisation since an unknown date. Previously administered products included for Product used for unknown indication: Adalimumab (Have taken adalimumab sept 2020 x2 doses) in September 2020. Past adverse reactions to the above products included No adverse event with Adalimumab. Concomitant products included FOLLITROPIN ALFA from 23-Sep-2021 to 28-Sep-2021, MENOTROPHIN (MENOPUR) from 23-Sep-2021 to 28-Sep-2021, LUTEINISING HORMONE (HUMAN) and FOLLICLE-STIMULATING HORMONE, HUMAN for an unknown indication. On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant). On 01-Oct-2021, the patient experienced ANGIOEDEMA (Giant urticaria) (seriousness criterion medically significant). On 11-Oct-2021, the patient experienced MENSTRUATION DELAYED (Delayed period) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOAESTHESIA (numbness was on left side of body) (seriousness criterion medically significant). On 28-Sep-2021, HYPOAESTHESIA (Numbness) had resolved. On 07-Oct-2021, ANGIOEDEMA (Giant urticaria) had resolved. At the time of the report, MENSTRUATION DELAYED (Delayed period) had not resolved and HYPOAESTHESIA (numbness was on left side of body) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. The patient took high doses of steroids for 10 days at a time on aug and Dec 2020, june 2021. The patient had numbness was on LEFT side of body, more so on face - same side as jabbed arm, Delayed period ongoing, Delayed onset very raised itchy painful area around jabbed site, about 4 x3 inches, lasting 1 week. Company Comment: This case concerns a female patient with previous relevant medical history of invitro fertilisation, who experienced the unexpected serious events of menstruation delayed, hypoaesthesia (reported as "numbness was on left side of body" and "numbness"), and angioedema. The event hypoaesthesia ("numbness") occurred 1 days after the first dose of Spikevax. The event angioedema occurred 6 days after the first dose of Spikevax. The event menstruation delay occurred 16 days after the first dose of Spikevax. For the event hypoaesthesia ("numbness was on left side of body") the time to onset from vaccination was not reported. The rechallenge was unknown as per RA reporting. The medical history of in vitro fertilisation, could be confounder for menstruation delay. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.; Sender''s Comments: This case concerns a female patient with previous relevant medical history of invitro fertilisation, who experienced the unexpected serious events of menstruation delayed, hypoaesthesia (reported as "numbness was on left side of body" and "numbness"), and angioedema. The event hypoaesthesia ("numbness") occurred 1 days after the first dose of Spikevax. The event angioedema occurred 6 days after the first dose of Spikevax. The event menstruation delay occurred 16 days after the first dose of Spikevax. For the event hypoaesthesia ("numbness was on left side of body") the time to onset from vaccination was not reported. The rechallenge was unknown as per RA reporting. The medical history of in vitro fertilisation, could be confounder for menstruation delay. The benefit-risk relationship of Spikevax is not affected by this report. Events term, onset date, outcome and seriousness captured per SD from Regulatory Authority reporting.


VAERS ID: 1830355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8288 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Anxiety, Chest discomfort, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (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: Medical History/Concurrent Conditions: Allergy (Allergic to Oky); Drug allergy; Nervous breakdown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101395099

Write-up: Anxiety and agitation/ It''s like you have heavy chest; I have difficulty breathing; Anxiety and agitation/ It''s like you have heavy chest; Anxiety and agitation/ It''s like you have heavy chest; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-799140. A 38-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FF8288; Expiration Date: Unknown) via intramuscular route administered in Arm Right on 26Sep2021 as dose 1, 0.3 ml single for covid-19 immunization. The patient''s medical history included drug allergy, allergic to oky and nervous breakdowns. The patient''s concomitant medications were not reported. On 26Sep2021, the patient experienced since, unfortunately, i have taken the first dose, i have difficulty breathing and consequently anxiety and agitation. it''s like you have heavy chest. i''ve made sure it''s not stress. Impact on quality of life was reported as 10/10. Therapeutic measures were taken as a result of events. The outcome of events was not recovered. Reporter Comment: Allergic to Oky, sensitive to drugs and with two nervous breakdowns behind her.; Reporter''s Comments: Allergic to Oky, sensitive to drugs and with two nervous breakdowns behind her.


VAERS ID: 1830366 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Iliac artery occlusion, Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

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

Write-up: Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.; Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.; This case was received via European Medicines Agency (Reference number: IT-MINISAL02-799682) on 22-Oct-2021 and was forwarded to Moderna on 22-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE (Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.) and ILIAC ARTERY OCCLUSION (Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.) in a 57-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced ISCHAEMIC STROKE (Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.) (seriousness criteria disability and medically significant) and ILIAC ARTERY OCCLUSION (Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.) (seriousness criterion disability). At the time of the report, ISCHAEMIC STROKE (Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.) and ILIAC ARTERY OCCLUSION (Arterial occlusion of the left side and common iliac vessel subjected to the revascularization operation. Ischemic stroke on 03/10/2021.) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment information was not provided. Company''s comment: This case concerns a 57-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Ischaemic stroke and Iliac artery occlusion. The events occurred unspecified time after the first dose of Spikevax. Rechallenge was not applicable as information regarding the second dose and events not reported. The benefit risk relation of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Translation received on 26-OCT-21, Event verbatim updated; Sender''s Comments: This case concerns a 57-year-old female patient, with no relevant medical history, who experienced the serious unexpected events of Ischaemic stroke and Iliac artery occlusion. The events occurred unspecified time after the first dose of Spikevax. Rechallenge was not applicable as information regarding the second dose and events not reported. The benefit risk relation of Spikevax is not affected by this report.


VAERS ID: 1830559 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005697 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Eosinophilic pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Fever
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20213

Write-up: MUSCLE PAIN; HEAVY, PROLONGED PERIOD; This case was received via regulatory authority (Reference number: SE-MPA-2021-089366) on 21-Oct-2021 and was forwarded to Moderna on 21-Oct-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (HEAVY, PROLONGED PERIOD) and MYALGIA (MUSCLE PAIN) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005697) for COVID-19 vaccination. The patient''s past medical history included COVID-19. Concurrent medical conditions included Fever. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (HEAVY, PROLONGED PERIOD) (seriousness criteria hospitalization and disability). On 01-Oct-2021, the patient experienced MYALGIA (MUSCLE PAIN) (seriousness criteria hospitalization and disability). At the time of the report, HEAVY MENSTRUAL BLEEDING (HEAVY, PROLONGED PERIOD) and MYALGIA (MUSCLE PAIN) had not resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Company Comment: This case concerns a 32 year-old, female with no relevant history reported, who experienced the serious unexpected events of Heavy menstrual bleeding and Myalgia. The events started approximately two weeks after the first dose of Spikevax. At the time of the report the events were Not recovered/Not resolved. The rechallenge is unknown as the events happened after the first dose of Spikevax and since no information from the second dose is provided. The benefit risk relationship of vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Translation Document received on 22-OCT-2021 contains no new information.; Sender''s Comments: This case concerns a 32 year-old, female with no relevant history reported, who experienced the serious unexpected events of Heavy menstrual bleeding and Myalgia. The events started approximately two weeks after the first dose of Spikevax. At the time of the report the events were Not recovered/Not resolved. The rechallenge is unknown as the events happened after the first dose of Spikevax and since no information from the second dose is provided. The benefit risk relationship of vaccine is not affected by this report.


VAERS ID: 1832585 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-25
Onset:2021-09-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214027 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Presyncope, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (PRIOR EPILEPSY SYNDROME)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: PRESYNCOPE AND FEVER; PRESYNCOPE AND FEVER; This case was received via Regulatory Authority (Reference number: IT-MINISAL02-799581) on 25-Oct-2021 and was forwarded to Moderna on 25-Oct-2021. This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA (PRESYNCOPE AND FEVER) and PRESYNCOPE (PRESYNCOPE AND FEVER) in a 19-year-old male patient who received mRNA-1273 (batch no. 214027) for COVID-19 vaccination. The patient''s past medical history included Epilepsy (PRIOR EPILEPSY SYNDROME). On 25-Sep-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced PYREXIA (PRESYNCOPE AND FEVER) (seriousness criterion medically significant) and PRESYNCOPE (PRESYNCOPE AND FEVER) (seriousness criterion medically significant). At the time of the report, PYREXIA (PRESYNCOPE AND FEVER) and PRESYNCOPE (PRESYNCOPE AND FEVER) was resolving. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Company Comment: This authority report concerns a 19 year old male patient with medical history of epilepsy who experienced serious unexpected events of pyrexia and pre-syncope. The events occurred one day after receiving the first dose of mRNA-1273 vaccine. Re-challenge was not applicable as the events occurred after the first dose of the vaccine. The outcome of the events were reported to be resolving. The event of pyrexia is unexpected as it is retained as serious per the source document authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Translation document received on 26-OCT-2021 include medical history comments, translated verbatim.; Sender''s Comments: This authority report concerns a 19 year old male patient with medical history of epilepsy who experienced serious unexpected events of pyrexia and pre-syncope. The events occurred one day after receiving the first dose of mRNA-1273 vaccine. Re-challenge was not applicable as the events occurred after the first dose of the vaccine. The outcome of the events were reported to be resolving. The event of pyrexia is unexpected as it is retained as serious per the source document authority reporting. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1834432 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Blood pressure abnormal, Blood pressure measurement, Body temperature, Bradycardia, Computerised tomogram, Diagnostic procedure, Dilatation atrial, Dysarthria, Electrocardiogram, Facial paralysis, Haemoglobin, Heart rate, Heart sounds abnormal, Ischaemic stroke, Magnetic resonance imaging head, Neurological examination, Oxygen saturation, Physical examination, Sinus bradycardia, Specialist consultation, Ultrasound Doppler, Ultrasound scan, White blood cell disorder
SMQs:, Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Disorders of sinus node function (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cranial arteritis; Horton''s disease; Hypertension arterial; Ischaemic stroke NOS; Ischemic stroke; Sinus arrhythmia; Stenosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:209/105; Test Date: 20210926; Test Name: blood pressure; Result Unstructured Data: Test Result:174/113; Test Date: 20210926; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210926; Test Name: Cerebral computed tomography with injection; Result Unstructured Data: Test Result:no intra or peri-cerebral haemorrhage; Comments: No intracranial expansive process. Leukopathy with little vasculo-degenerative appearance. No systematised cortico-subcortical dedifferentiation zone in favour of territorial ischemia. Ventricles and sulci of appropriate size for age, without morphological abnormalities. Permeability of the supra-aortic trunks without significant stenosis. Calcified atheromatous infiltration of the carotid bulbs. Permeability of the polygon of Willis.; Test Date: 2021; Test Name: Respiratory examination; Result Unstructured Data: Test Result:clear and symmetrical vesicular murmur; Comments: discrete subcrepitant at the bases, saturation 98%.; Test Date: 20210926; Test Name: Electrocardiogram (ECG):; Result Unstructured Data: Test Result:sinus bradycardia, no signs of ischaemia; Comments: End-Systolic Area and End-Systolic Volume.; Test Date: 20210926; Test Name: haemoglucotest; Result Unstructured Data: Test Result:6.2; Test Date: 2021; Test Name: pulse; Result Unstructured Data: Test Result:88; Test Date: 20210926; Test Name: pulse; Result Unstructured Data: Test Result:79; Test Date: 2021; Test Name: Brain magnetic resonance imaging (MRI); Result Unstructured Data: Test Result:deep diffusion restriction; Comments: related to recent ischemic damage, visible in FLAIR. There is moderate to marked vasculo-degenerative leukopathy, with several bilateral deep lacunae. The magnetic susceptibility sequence shows no haematoma, microbleeds or thrombus. Permeable ventricular branch. Permeable polygon of Willis artery, with irregular basilar trunk appearance, terminating in superior cerebellar artery bilaterally.; Test Date: 2021; Test Name: Neurological examination; Result Unstructured Data: Test Result:oriented, dysarthria; Comments: no lack of words or comprehension problems, no sensory-motor deficits, osteo-tendinous reflexes present and symmetrical, plantar skin reflex in flexion, no epileptoid trepidation, no swallowing problems, normal gag reflex; Test Date: 2021; Test Name: saturation; Test Result: 98 %; Test Date: 20210926; Test Name: physical examination; Result Unstructured Data: Test Result:presence of dysarthria without aphasia; Comments: no motor deficit, no sensory disturbance, no lateral homonymous hemianopia, no oculomotor disturbance, no facial paralysis; Test Date: 2021; Test Name: Cardiologist examination; Result Unstructured Data: Test Result:irregular heart sounds (known); Comments: no murmur, pulse +/+, no signs of cardiac insufficiency.; Test Date: 2021; Test Name: Doppler of the supra-aortic trunks; Result Unstructured Data: Test Result:moderate bi-carotid atheroma; Comments: without haemodynamic repercussions; Test Date: 2021; Test Name: Trans thoracic ultrasound; Result Unstructured Data: Test Result:moderate dilatation of the left atrium; Comments: No other anomalies
CDC Split Type: FRPFIZER INC202101391498

Write-up: Ischemic stroke; sinus bradycardia; facial paralysis /right facial paralysis during the journey to the emergency room; blood pressure 174/113/209/105 / Blood pressure 209/105; bradycardia; sudden onset of language problems; Leukopathy with little vasculo-degenerative appearance; Calcified atheromatous infiltration/bi-carotid atheroma; irregular heart sounds; moderate dilatation of the left atrium; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213706. An 83-year-old male patient received the third dose of BNT162B2 (COMIRNATY) via intramuscular on 02Sep2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included cranial arteritis, sinus arrhythmia, ischemic stroke, hypertension arterial, type 2 diabetes mellitus, histologically proven horton''s from Sep2019, bilateral cerebellar ischaemic strokes and bilateral spinal stenoses, all unknown ongoing. Concomitant medication was not reported. The patient previously received corticosteroid therapy from Sep20219 to Feb2021. The patient previously received the second dose and the first dose of BNT162B2, the second dose on Feb2021, the first dose on Jan2021, both via an unspecified route of administration as single dose for COVID-19 immunization. On 26Sep2021, the patient experienced ischemic stroke, facial paralysis /right facial paralysis during the journey to the emergency room, blood pressure 174/113/209/105, bradycardia, sudden onset of language problems (dysarthria), leukopathy and calcified atheromatous infiltration/bi-carotid atheroma. In 2021, the patient experienced irregular heart sounds and moderate dilatation of the left atrium. The patient underwent lab tests and procedures which included blood pressure measurement: 209/105 on 2021, blood pressure measurement: 174/113 on 26Sep2021, body temperature: 36.4 centigrade on 26Sep2021, computerised tomogram: no intra or peri-cerebral haemorrhage on 26Sep2021 No intracranial expansive process. Leukopathy with little vasculo-degenerative appearance. No systematised cortico-subcortical dedifferentiation zone in favour of territorial ischemia. Ventricles and sulci of appropriate size for age, without morphological abnormalities. Permeability of the supra-aortic trunks without significant stenosis. Calcified atheromatous infiltration of the carotid bulbs. Permeability of the polygon of Willis , diagnostic procedure: clear and symmetrical vesicular murmur on 2021 discrete subcrepitant at the bases, saturation 98% , electrocardiogram: sinus bradycardia, no signs of ischaemia on 26Sep2021 End-Systolic Area and End-Systolic Volume , haemoglobin: 6.2 on 26Sep2021, heart rate: 88 on 2021, heart rate: 79 on 26Sep2021, magnetic resonance imaging head: deep diffusion restriction on 2021 related to recent ischemic damage, visible in FLAIR. There is moderate to marked vasculo-degenerative leukopathy, with several bilateral deep lacunae. The magnetic susceptibility sequence shows no haematoma, microbleeds or thrombus. Permeable ventricular branch. Permeable polygon of Willis artery, with irregular basilar trunk appearance, terminating in superior cerebellar artery bilaterally , neurological examination: oriented, dysarthria on 2021 no lack of words or comprehension problems, no sensory-motor deficits, osteo-tendinous reflexes present and symmetrical, plantar skin reflex in flexion, no epileptoid trepidation, no swallowing problems, normal gag reflex , oxygen saturation: 98 % on 2021, physical examination: presence of dysarthria without aphasia on 26Sep2021 no motor deficit, no sensory disturbance, no lateral homonymous hemianopia, no oculomotor disturbance, no facial paralysis , specialist consultation: irregular heart sounds (known) on 2021 no murmur, pulse +/+, no signs of cardiac insufficiency, ultrasound doppler: moderate bi-carotid atheroma on 2021 without haemodynamic repercussions. In the Emergency Room: pulse 79, blood pressure 174/113, Temperature 36.4?C, haemoglucotest 6.2, presence of dysarthria without aphasia, no motor deficit, no sensory disturbance, no lateral homonymous hemianopia, no oculomotor disturbance, no facial paralysis. Electrocardiogram (ECG): sinus bradycardia, no signs of ischaemia, End-Systolic Area and End-Systolic Volume. Cerebral computed tomography with injection: no intra or peri-cerebral haemorrhage. No intracranial expansive process. Leukopathy with little vasculo-degenerative appearance. No systematised cortico-subcortical dedifferentiation zone in favour of territorial ischemia. Ventricles and sulci of appropriate size for age, without morphological abnormalities. Permeability of the supra-aortic trunks without significant stenosis. Calcified atheromatous infiltration of the carotid bulbs. Permeability of the polygon of Willis. Transfer to Polyvalent Medicine. Cardiologist examination: Blood pressure 209/105, heart rate 88, irregular heart sounds (known), no murmur, pulse +/+, no signs of cardiac insufficiency. Respiratory examination: clear and symmetrical vesicular murmur, discrete subcrepitant at the bases, saturation 98%. Neurological examination: oriented, dysarthria, no lack of words or comprehension problems, no sensory-motor deficits, osteo-tendinous reflexes present and symmetrical, plantar skin reflex in flexion, no epileptoid trepidation, no swallowing problems, normal gag reflex. The remainder of the examination is without any particularity. Additional tests: Doppler of the supra-aortic trunks: moderate bi-carotid atheroma, without haemodynamic repercussions. Trans thoracic ultrasound: moderate dilatation of the left atrium. No other anomalies. Brain magnetic resonance imaging (MRI): deep diffusion restriction related to recent ischemic damage, visible in FLAIR. There is moderate to marked vasculo-degenerative leukopathy, with several bilateral deep lacunae. The magnetic susceptibility sequence shows no haematoma, microbleeds or thrombus. Permeable ventricular branch. Permeable polygon of Willis artery, with irregular basilar trunk appearance, terminating in superior cerebellar artery bilaterally. Conclusion: Recent deep left ischaemic injury. Aetiology: no evidence of recurrent Horton''s disease, non-stenosing atheroma on doppler of the supra-aortic trunks, regular sinus rhythm on electrocardiogram. Scheduled Holter. Evolution marked by regression of facial paralysis and improvement of dysarthria. On the other hand, high blood pressure a long time after the stroke, justifying the introduction of a dual therapy combining ramipril and amlodipine. Treatment was received for events included Bolus ASPEGIC, relay KARDEGIC 75 mg in addition to PLAVIX already present in the patient''s initial treatment, dual platelet aggregation to be continued for 3 weeks, then resumption of monotherapy with KARDEGIC 160 mg in the long term. Introduction of a statin. The outcome of events was ischemic stroke was recovering. The outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1834490 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-09-26
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, C-reactive protein, Cardiac failure, Cardiac murmur functional, Chest pain, Cough, Dyspnoea, Ejection fraction, Electrocardiogram, Full blood count, Heart rate, Heart sounds, Oxygen saturation, Pericarditis, Pyrexia, Specialist consultation, Ultrasound scan
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Grass allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: blood pressure; Result Unstructured Data: Test Result: Normal; Test Date: 20210927; Test Name: cardiac insufficiency; Result Unstructured Data: Test Result: without sign of right or left cardiac insufficiency; Test Date: 20210927; Test Name: Murmur; Result Unstructured Data: Test Result: With out; Test Date: 20210927; Test Name: Cough; Result Unstructured Data: Test Result: No; Test Date: 20210927; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 12; Comments: (normal < 5); Test Date: 20210927; Test Name: Dyspnoea; Result Unstructured Data: Test Result: No; Test Date: 20210927; Test Name: Left ventricular ejection fraction; Result Unstructured Data: Test Result: Normal; Comments: normal visual $g 50%; Test Date: 20210927; Test Name: Right ventricular ejection fraction; Result Unstructured Data: Test Result: Okay; Test Date: 20210927; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: anterolateral ST elevation without mirror; Test Date: 20210927; Test Name: Blood count; Result Unstructured Data: Test Result: Normal; Test Date: 20210927; Test Name: Heart rate; Result Unstructured Data: Test Result: 67; Test Date: 20210927; Test Name: heart sounds; Result Unstructured Data: Test Result: regular; Test Date: 20210927; Test Name: Oxygen Saturation; Test Result: 97%; Test Date: 20210927; Test Name: febrile syndrome; Result Unstructured Data: Test Result: no; Test Date: 20210927; Test Name: Cardiological; Result Unstructured Data: Test Result: pericarditis; Comments: acute viral pericarditis in view of the clinical picture and slight biological inflammatory syndrome; Test Date: 20210927; Test Name: Ultrasound; Result Unstructured Data: Test Result: good echogenicity, hyperechoic pericardium; Comments: No pericardial effusion.
CDC Split Type: FRPFIZER INC202101384273

Write-up: Pericarditis; oppressive chest pain; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority. The regulatory authority number FR-AFSSAPS-LM20213080. A 29-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: J07BX03), intramuscular on 03Jul2021 as single dose for COVID-19 immunisation. The patient''s medical history included allergy pollen and cereal grasses allergy. The patient''s concomitant medications were not reported. The patient reported pericarditis on 26Sep2021 (pending clarification), 3 months after the COVID vaccination requiring hospitalization. Patient was referred to the emergency department on 27Sep2021 by his doctor for suspicion of pericarditis in view of constant oppressive chest pain since the day before, at rest, maximum in a lying position. Corrective treatment was implemented for both events. Put on aspirin and colchicine for 3 months with work leave. Both events resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure: normal, cardiac insufficiency: without sign of right or left cardiac insufficiency, murmur: with out, cough: no, C-reactive protein: 12 (normal < 5), dyspnoea: no, left ventricular ejection fraction: normal (normal visual $g 50%), right ventricular ejection fraction: okay, electrocardiogram: anterolateral ST elevation without mirror, blood count: normal, heart rate: 67, heart sounds: regular, oxygen saturation: 97%, febrile syndrome: no, cardiological: pericarditis (acute viral pericarditis in view of the clinical picture and slight biological inflammatory syndrome), ultrasound: good echogenicity, hyperechoic pericardium (no pericardial effusion), all on 27Sep2021. The outcome of the event pericarditis was recovering, and the outcome of the event oppressive chest pain was unknown.


VAERS ID: 1834565 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Angina pectoris, Aspartate aminotransferase, Blood alkaline phosphatase, Blood creatine, Blood potassium, Blood pressure measurement, Blood triglycerides, Body mass index, C-reactive protein, Cardiac failure, Dyspnoea, Dyspnoea exertional, Echocardiogram, Electrocardiogram, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Haemodynamic test, Haemoglobin, Heart rate, Inflammatory marker increased, Investigation, Lipoprotein (a), Liver function test, Neutrophil count, Oedema peripheral, Orthopnoea, Oxygen saturation, Renal function test, SARS-CoV-2 test, Scan, Serum ferritin, Total cholesterol/HDL ratio, Transferrin, Troponin
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use (Alcohol); Brain tumor (operated on 3 times, in remission since 2011); Cardiomyopathy; Family history of cardiovascular disorder (his paternal grandfather at age 61); Lung disease; Memory impaired; Obesity (BM1 31.1); Pampinocele; Pneumonia aspiration; Tabaquism (60 packs-year vaping since then); Varicocele
Allergies:
Diagnostic Lab Data: Test Date: 20210928; Test Name: alanine aminotransferase; Result Unstructured Data: Test Result:3 times the normal value; Test Date: 20210928; Test Name: aspartate aminotransferase; Result Unstructured Data: Test Result:1.2 times the normal value; Test Date: 20210928; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:1 times the normal value; Test Date: 20210928; Test Name: creatinaemia; Result Unstructured Data: Test Result:74 umol/l; Comments: creatinaemia; Test Date: 20210928; Test Name: potassium ion; Result Unstructured Data: Test Result:4.9 mmol/L; Test Date: 20210928; Test Name: blood pressure; Result Unstructured Data: Test Result:127/93 mmHg; Test Date: 202109; Test Name: triglycerides; Result Unstructured Data: Test Result:0.97 g/l; Test Name: Body mass index; Result Unstructured Data: Test Result:31.1; Test Date: 20210928; Test Name: C-reactive protein; Result Unstructured Data: Test Result:14 mg/l; Test Date: 20210928; Test Name: Cardiac echocardiography; Result Unstructured Data: Test Result:highly dilated non-hypertrophied left ventricle at; Comments: highly dilated non-hypertrophied left ventricle at 72 mm and 220 ml, serious global hypokinesia with left ventricular ejection fraction at 30%. Integral Time Speed 8-9 cm, cardiac output 3 L/min. Undilated initial aorta, tricuspid aortic valve. Grade 1 mitral and aortic regurgitation, type 3 mitral profile with high left ventricular filling pressures. Left atrium dilated to 36 cm2, dilated right chambers with preserved systolic function with Sann Tric at 11 cm/s, grade 2 tricuspid regurgitation, systolic pulmonary artery pressure 60+15=75 mmHg, millimetric pericardial detachment, 28 mm inferior vena cava without inspiratory collapse. Moderate bilateral pleural effusions.Visibly old dilated cardiomyopathy with impaired left ventricular ejection fraction in a context of unusual dyspnoea without evidence of an acute cause such as myocarditis or acute coronary syndrome; Test Date: 202109; Test Name: Post-diuretisation cardiac echocardiography; Result Unstructured Data: Test Result:showed persistent left ventricular ejection fracti; Comments: showed persistent left ventricular ejection fraction impairment around 20-25%, with improvement in overload: Systolic pulmonary artery pressure at 28+8=36mmHg but inferior vena cava still dilated at 22 mm, non-collapsed; Test Date: 20210928; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Regular sinus rhythm, tachycardia at 103 bpm, no r; Comments: Regular sinus rhythm, tachycardia at 103 bpm, no repolarisation disorder, incomplete left bundle branch block, corrected QT interval 491 ms.; Test Date: 20210928; Test Name: D-Dimer; Result Unstructured Data: Test Result:2,100 ng/ml; Test Date: 20210928; Test Name: gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:1.5 times the normal value; Test Date: 20210928; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:99 ml/min; Test Date: 20210928; Test Name: haemodynamics; Result Unstructured Data: Test Result:stable; Test Date: 202109; Test Name: Glycated haemoglobin; Test Result: 6 %; Test Date: 20210928; Test Name: heart rate; Result Unstructured Data: Test Result:105; Comments: bpm, no perceived murmur; Test Date: 202109; Test Name: aetiological assessment; Test Result: Negative ; Test Date: 20210928; Test Name: pro-brain natriuretic peptide; Result Unstructured Data: Test Result:5,752 ng/L; Test Date: 202109; Test Name: high-density lipoprotein; Result Unstructured Data: Test Result:0.40 g/l; Test Date: 202109; Test Name: low-density lipoprotein; Result Unstructured Data: Test Result:1.18 g/l; Test Date: 20210928; Test Name: liver function test; Result Unstructured Data: Test Result:elevated; Test Date: 20210928; Test Name: neutrophils; Result Unstructured Data: Test Result:12 g/l; Comments: hyperleukocytosis; Test Date: 20210928; Test Name: OXYGEN; Test Result: 97 %; Comments: eupnoeic in room air with signs of pleuropulmonary overload (basal crepitus); Test Date: 20210928; Test Name: renal function; Result Unstructured Data: Test Result:preserved; Test Date: 20210928; Test Name: serious acute respiratory syndrome coronavirus 2 polymerase chain reaction; Test Result: Negative ; Test Date: 20210928; Test Name: Thoracic computed tomography scan; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: There are bilateral pleural effusions of low abundance and a linear septal thickening indicative firstly of a cardiogenic congestive overload.; Test Date: 202109; Test Name: ferritin; Result Unstructured Data: Test Result:273 ug/L; Test Date: 202109; Test Name: total cholesterol; Result Unstructured Data: Test Result:1.77 g/l; Test Date: 202109; Test Name: transferrin saturation coefficient; Test Result: 13 %; Test Date: 20210928; Test Name: Troponins; Result Unstructured Data: Test Result:37 ng/L; Test Date: 20210929; Test Name: Troponins; Result Unstructured Data: Test Result:50 ng/L
CDC Split Type: FRPFIZER INC202101384460

Write-up: progressively worsening dyspnoea with the slightest exertion.; Decompensation cardiac; dyspnoea at the slightest effort with orthopnoea; lower limb oedema; mild biological inflammatory syndrome; shortness of breath while at work; chest pain with heart attack-like feeling; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-SE20212565. A 54-years-old male patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No/Lot Number: unknown), via intramuscular on 24Sep2021 as dose 2, single for covid-19 immunization. Medical history included nicotine dependence from an unknown date to May2021, Smoking estimated at about 60 packs-year vaping since then, varicocele from an unknown date and unknown if ongoing , obesity from an unknown date and unknown if ongoing , pneumonia aspiration from an unknown date and unknown if ongoing, Coronary heredity with a myocardial infarction in his paternal grandfather at age 61 from an unknown date and unknown if ongoing, Benign brain tumour operated on 3 times, in remission since 2011, sequelae in the form of memory disorders, cardiomyopathy from an unknown date and unknown if ongoing , lung disorder from an unknown date and unknown if ongoing , varicocele from an unknown date and unknown if ongoing , memory impairment from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously experienced hypersensitivity reaction to AUGMENTIN (cervicofacial skin rash without oedema) on an unknown date. The historical vaccine included, received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE solution for injection Batch No/Lot Number: unknown), on 04Sep2021 as dose 1, single for covid-19 immunization. Patient was not an individual at risk of developing a serious form of COVID-19. The patient did not had Covid-19 and not been tested for Covid-19. Patient Slept well from 26Sep and 27Sep. Then on 27Sep2021, the patient felt shortness of breath while at work. On an unknown date (Last night), patient felt dyspnoea in supine position. The patient consulted the emergency room on 28Sep2021 because of this progressively worsening dyspnoea with the slightest exertion. He was hospitalised in the intensive care unit on 28Sep2021. On admission, his haemodynamics were stable with blood pressure at 127/93 mmHg, heart rate at 105 bpm, there was no perceived murmur. Persisting constrictive chest pain, without radiation, dyspnoea at the slightest effort with orthopnoea, but the patient remains 97% eupnoeic in room air with signs of pleuropulmonary overload (basal crepitus) and lower limb oedema. His Electrocardiography measured Regular sinus rhythm, tachycardia at 103 bpm, no repolarisation disorder, incomplete left bundle branch block, corrected QT interval 491 ms. Laboratory investigations included Troponins 37 ng/l on 28Sep then 50 on 29Sep2021, potassium ion 4.9 mmol/l, pro-brain natriuretic peptide 5,752 ng/l, D-Dimer 2,100 ng/ml, serious acute respiratory syndrome coronavirus 2 polymerase chain reaction negative, renal function preserved with a creatinaemia of 74 umol/L, glomerular filtration rate 99 ml/min. There was a mild biological inflammatory syndrome with a C-reactive protein at 14 mg/L, and a hyperleukocytosis with neutrophils at 12 G/L. liver function test showed aspartate aminotransferase at 1.2 times the normal value, alanine aminotransferase at 3 times the normal value, gamma-glutamyltranspeptidase at 1.5 times the normal value and alkaline phosphatase at 1 times the normal value. The Thoracic computed tomography scan showed no pulmonary embolism. There were bilateral pleural effusions of low abundance and a linear septal thickening indicative firstly of a cardiogenic congestive overload. Cardiac echocardiography showed a highly dilated non-hypertrophied left ventricle at 72 mm and 220 ml, serious global hypokinesia with left ventricular ejection fraction at 30%. Integral Time Speed 8-9 cm, cardiac output 3 L/min. Undilated initial aorta, tricuspid aortic valve. Grade 1 mitral and aortic regurgitation, type 3 mitral profile with high left ventricular filling pressures. Left atrium dilated to 36 cm2, dilated right chambers with preserved systolic function with Sann Tric at 11 cm/s, grade 2 tricuspid regurgitation, systolic pulmonary artery pressure 60+15=75 mmHg, millimetric pericardial detachment, 28 mm inferior vena cava without inspiratory collapse. Moderate bilateral pleural effusions. Visibly old dilated cardiomyopathy with impaired left ventricular ejection fraction in a context of unusual dyspnoea without evidence of an acute cause such as myocarditis or acute coronary syndrome: put on 1 L of oxygen + LASILIX 20 mg + KARDEGIC 75 mg + ARIXTRA 2.5 mg, POTASSIUM syrup, Magnesium. Patient was transferred to the cardiology ward on 29Sep2021. Post-diuretisation cardiac echocardiography showed persistent left ventricular ejection fraction impairment around 20-25%, with improvement in overload: Systolic pulmonary artery pressure at 28+8=36mmHg but inferior vena cava still dilated at 22 mm, non-collapsed; given the situation, oral treatment with LASILIX was continued. Patient was discharged from hospital on 04Oct2021. Patient''s differential diagnosis included risk factor assessment found low-density lipoprotein 1.18 g/L, high-density lipoprotein 0.40 g/L, total cholesterol 1.77 g/L, triglycerides 0.97 g/L. Glycated haemoglobin 6%, Iron balance: ferritin 273 ug/L, transferrin saturation coefficient 13%, no evidence of haemochromatosis. His Coronary angiography was in progress. The treatment received for the events are took 1 g Doliprane for the event "chest pain with heart attack-like feeling" and KARDEGIC 75 mg 1 sachet in the morning, BISOPROLOL 3.75 mg 1 tablet in the morning, ENTRESTO 24/26 mg 1 tablet in the morning and evening and FUROSEMIDE 40 mg 1 tablet in the morning and at noon. The outcome of the events was recovering. Note: Accountability without prejudice to further investigations that could be carried out as part of legal or amicable compensation procedures. No follow-up attempts are possible. No further information expected.


VAERS ID: 1835116 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-26
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Absence of menstruation (2 years since the patient last had a menstrual bleed.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101384372

Write-up: Heavy bleeding for 3 days, after more than 2 years without menstruation; heavy menstrual bleeding 1 month; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB NO-NOMAADVRE-PASRAPP-2021-Urp5mp. A 53-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 11Aug2021 (Lot Number: Unknown) as DOSE 2, SINGLE for CVOID-19 immunisation. Medical history included absence of menstruation from an unknown date, it was 2 years since the patient last had a menstrual bleed. The patient''s concomitant medications were not reported. The patient developed postmenopausal bleeding on 26Sep2021 and heavy menstrual bleeding on 26Sep2021. The patient reports that she experienced a heavy menstrual bleeding 1 month after vaccination with Pfizer. The patient has not had a menstrual bleed in 2 years. The events were considered to be serious due to being an important medical events. The outcome of the events was unknown. The Pharmacovigilance Center did not provide a causality assessment. Reporter Comment: The patient reports that she experienced a heavy menstrual bleeding 1 month after vaccination with Pfizer. The patient has not had a menstrual bleed in 2 years. The patient reported that it is 2 years since her last menstrual bleed. Based on this information the bleeding is considered a POSTMENOPAUSAL BLEEDING. The patient reports that latency for POSTMENOPAUSAL BLEEDING was approximately 1 month. Sender Comment: Upgraded to Serious due to POSTMENOPAUSAL BLEEDING : Important Medical Events. The patient reports Uncertain dosage form/strength: Comirnaty, suspected. The patient reports receiving the Pfizer vaccine in Event desc. No need for follow up. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: The patient reports that she experienced a heavy menstrual bleeding 1 month after vaccination with Pfizer. The patient has not had a menstrual bleed in 2 years. The patient reported that it is 2 years since her last menstrual bleed. Based on this information the bleeding is considered a POSTMENOPAUSAL BLEEDING. The patient reports that latency for POSTMENOPAUSAL BLEEDING was approximately 1 month.


VAERS ID: 1838155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-24
Onset:2021-09-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Dizziness, Fatigue, Heavy menstrual bleeding, Malaise, Menstruation irregular, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101400879

Write-up: fainting; Vaginal bleeding/Irregular periods; period lasted 15 days/bleeding was heavier than usual with blood clots present; dizzy/felt like fainting when performing any activities; tired; felt sick; This is a spontaneous report from a contactable other health professional (patient). This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202110172217058210-XQUX8, Safety Report Unique Identifier GB-MHRA-ADR 26085750. A 35-year-old female patient received BNT162B2 (COMIRNATY, lot numer unknown), via an unspecified route of administration on 24Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included none. She was a healthy person. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Last menstrual period date was 26Sep2021 (as reported, pending clarification). The patient''s concomitant medications were not reported. The patient experienced fainting on an unspecified date. The patient experienced vaginal bleeding/irregular periods on 26Sep2021. She finished her period on 10Sep2021, correctly. Post vaccine period, she was 2 weeks too early and lasted 15 days. The bleeding was heavier than usual with blood clots present. She felt dizzy, tired, and sick everyday. She felt like fainting when performing any activities. The events were medically significant. The patient underwent lab tests and procedures which included blood test with unknown results and COVID-19 virus test was no - negative COVID-19 test on an unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the syncope was recovered, of the irregular periods was recovering, while of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1838424 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FJ7489 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Dyskinesia, Ear discomfort, Eye movement disorder, Facial paralysis, Hypoacusis, Inappropriate schedule of product administration, Limb discomfort, Malaise, Physical deconditioning, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Ocular motility disorders (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Roentgen for the leg symptoms; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101393419

Write-up: the patient''s left side eye could not be close; his mouth could not be close; malaise of his whole left side body; Sensation of heaviness; heaviness in leg; Facial paralysis; Physical deconditioning; slightly could not hear clearly; his left ear had a blocked feeling; first dose on 09Sep2021/second dose on 26Sep2021; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 19-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Sep2021 (Lot Number: FJ7489; Expiration Date: 31Jan2022, at the age of 19-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 09Sep2021 (Lot number FF9944, Expiration Date: 30Nov2021, at the age of 19-year-old) as single dose for covid-19 immunization. On 26Sep2021, the patient received vaccination and about 3 days after that (29Sep2021), the patient experienced physical deconditioning, facial paralysis, on 29Sep2021, the patient slightly could not hear clearly, his left ear had a blocked feeling. By Oct2021, the patient''s left side eye could not be close and his mouth could not be close either, it seemed like a pear could come out from his mouth (as reported). The vaccination was on the left side body, so the patient developed malaise of his whole left side body. There were also sensation of heaviness, especially heaviness in leg. It was 2 weeks after the vaccination, but the symptoms were not recovered. The patient received Roentgen for the leg symptoms, but there was no abnormality. The heaviness in leg was also persisted from the vaccination. The patient visited the hospital but the answer he got was "it was just the adverse reaction of COVID vaccine." The right side of body was totally fine, but the malaise of left side was still persisted. The symptoms began to affect his daily life. The outcome of the event "first dose on 09Sep2021/second dose on 26Sep2021" was unknown, for other events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1840843 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Chest pain, Hypertension, Lethargy
SMQs:, Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101403063

Write-up: Arrhythmia; Chest pain; Hypertension; Lethargy; This is a spontaneous report from a contactable healthcare professional via the regulatory authority. Regulatory authority report number is 644002. A 14-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 26Sep2021 (Batch/Lot number was not reported) (at the age of 14 years old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced arrhythmia, chest pain, hypertension and lethargy on 26Sep2021. The onset time of event in days from the suspect drug was 0 days. 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: 1840886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SPIRIVA; TAMSULOSINE [TAMSULOSIN]; HALDOL; LORMETAZEPAM; PANTOMED [DEXPANTHENOL]; DIAZEPAM; HALDOL; BICARBONATE SODIUM; QUETIAPINE; PERMIXON; UVEDOSE; TARDYFERON; DESLORATADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypoxemia (Paroxysmal episodes hypoxemia clinically confirmed unclear etiology limited pulmonary investigations); Psychotic disorder (Psychotic disorders evolving in a shizophrenia mode); Smoker
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:70 IU/ml
CDC Split Type: BEPFIZER INC202101414182

Write-up: drug ineffective; COVID-19 infection after vaccination; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-107691. A 57-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included psychotic disorders (Psychotic disorders evolving in a shizophrenia mode), hypoxemia from 2018 to an unknown date (Paroxysmal episodes of hypoxemia, clinically confirmed, of unclear etiology (limited pulmonary investigations)), active smoking. Concomitant medications included tiotropium bromide monohydrate (SPIRIVA) 2 puffs 1x/day; tamsulosine [tamsulosin] 0,4 mg 1x/day; haloperidol (HALDOL) 20 drops at bedtime; lormetazepam 2 mg 1x/day; dexpanthenol (PANTOMED [DEXPANTHENOL]) 40 mg 1x/day; diazepam 10 mg 3x/day; haloperidol (HALDOL) 5 mg 1x/day; sodium bicarbonate 3x/day; quetiapine 300 mg 1x/day; serenoa repens extract (PERMIXON) 160mg 2x/day; colecalciferol (UVEDOSE) 1x/2 months; ferrous sulfate (TARDYFERON) 80 mg 1x/day; desloratadine 1x/day, all taken for an unspecified indication, start and stop date were not reported. The patient experienced COVID-19 on 26Sep2021 with outcome of recovering. The event required hospitalization. The patient underwent lab tests and procedures which included SARS-CoV-2 antibody test: 70 iu/ml on an unspecified date in 2021. Therapeutic measures were taken as a result of the event. Reporter Comment: Treatment: - Yes (not specified) Evolution of the ADR: Recovering: 16 days Examinations: SARS-CoV-2 IgG serology: 70 BAU / ml No follow-up attempts are possible. No further information is expected. Information about lot/batch# cannot be obtain.; Reporter''s Comments: Treatment: - Yes (not specified) Evolution of the ADR: Recovering: 16 days Examinations: SARS-CoV-2 IgG serology: 70 BAU / ml


VAERS ID: 1840940 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-09-26
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Body temperature, C-reactive protein, COVID-19, Chest X-ray, Gait disturbance, General physical health deterioration, Inflammation, Lymphocyte count, Lymphopenia, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ROSUVASTATIN; DULOXETINE; RIVAROXABAN; RIVASTIGMINE; MEMANTINE; FOLIC ACID; LEVOTHYROXINE; BUDESONIDE; AMYLASE; LIPASE; PROTEASE [PROTEASE NOS]; POTASSIUM CHLORIDE; DAFALGAN; XARELTO
Current Illness: Age-related macular degeneration; Atrial fibrillation (anticoagulated with Xarelto); Internal carotid artery atherosclerosis (on rosuvastatin); Memory impairment (on memantine and rivastigmine)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic diarrhea; Colitis microscopic
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210926; Test Name: thorax x-ray; Result Unstructured Data: Test Result:no interstitial infiltrates; Comments: no interstitial infiltrates or frank pneumonia. There were no signs of cardiac overload or pleural effusion.; Test Date: 20210926; Test Name: CRP; Result Unstructured Data: Test Result:16 mg/l; Test Date: 20210926; Test Name: lymphocyte count; Result Unstructured Data: Test Result:0.64 x10 9/l; Comments: lymphopenia; Test Date: 20210927; Test Name: Sars-cov-2 test; Test Result: Positive
CDC Split Type: CHPFIZER INC202101413749

Write-up: developed SARS-CoV-2 infection despite 2 doses of vaccine approximately 6 months after the second COVID-19 vaccine injection /nasopharyngeal smear came back positive for SARS-CoV2; developed SARS-CoV-2 infection despite 2 doses of vaccine approximately 6 months after the second COVID-19 vaccine injection /nasopharyngeal smear came back positive for SARS-CoV2; decreased general condition; walking and balance disorders; walking and balance disorders; fever up to 39?C; mild inflammatory syndrome with CRP at 16 mg/L; lymphopenia at 0.64 G/L; This is a spontaneous report received from a contactable physician via regulatory authority. Regulatory authority report numberCH-SM-2021-26759. An 84-year-old female patient of an unspecified age received bnt162b2 (COMIRNATY) on 25Mar2021 (lot number was not reported) as dose 2 single and on 04Mar2021 (lot number was not reported) as dose 1 single, both intramuscular for COVID-19 immunization (age at vaccination was 83 years). Medical history included ongoing atrial fibrillation anticoagulated with Xarelto from an unknown date, ongoing carotid arteriosclerosis on rosuvastatin from an unknown date, microscopic colitis with chronic diarrhea from an unknown date and unknown if ongoing, significant memory impairment on memantine and rivastigmine from 2014 and ongoing and ongoing age-related macular degeneration from an unknown date. Concomitant medication included rosuvastatin (manufacturer unknown) taken for carotid arteriosclerosis from an unspecified start date and ongoing; rivastigmine (manufacturer unknown) taken for memory impairment from an unspecified start date and ongoing; memantine (manufacturer unknown) taken for memory impairment from an unspecified start date and ongoing; rivaroxaban (XARELTO) taken for atrial fibrillation from an unspecified start date and ongoing. The patient was also taking duloxetine (manufacturer unknown); rivaroxaban (manufacturer unknown); folic acid (manufacturer unknown); levothyroxine (manufacturer unknown); budesonide (manufacturer unknown); amylase (manufacturer unknown); lipase (manufacturer unknown); protease (manufacturer unknown); potassium chloride (manufacturer unknown) and paracetamol (DAFALGAN), all taken for an unspecified indication, start and stop date were not reported. The patient developed SARS-CoV-2 infection despite 2 doses of vaccine approximately 6 months after the second COVID-19 vaccine injection requiring hospitalization. It was reported that the patient has been hospitalized since 26Sep2021 due to decreased general condition with walking and balance disorders. In the emergency room on 26Sep2021, the patient presented with a fever up to 39?C. She was eupnoeic on room air. The blood test showed a mild inflammatory syndrome with CRP at 16 mg/L without leukocytosis but with lymphopenia at 0.64 G/L. Thorax x-ray showed no interstitial infiltrates or frank pneumonia. There were no signs of cardiac overload or pleural effusion. The nasopharyngeal smear came back positive for SARS-CoV2 on 27Sep2021. In view of the absence of oxygen requirements, no corticosteroid or antibiotic therapy was administered during the hospitalization. The clinico-biological evolution is favorable, nevertheless the patient still remains hospitalized for rehabilitation as of 08Oct2021. The patient was hospitalized due to the events on 26Sep2021. The outcome of the events was recovering. The events were reported as serious. It was reported that accountability of the vaccine is possible. A causal relationship between COMIRNATY and all of the events was assessed as being possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1841108 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-10
Onset:2021-09-26
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Nephrolithiasis, Urine analysis, Urological examination
SMQs:

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: Medical History/Concurrent Conditions: Alcohol use (very rarely drinks a beer (2-3 times a year) and occasionally a glass of red wine)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Computerised tomography; Result Unstructured Data: Test Result:left kidney stone diagnosed; Test Date: 2021; Test Name: Urine analysis; Result Unstructured Data: Test Result:left kidney stone diagnosed; Test Date: 20211005; Test Name: Urological examination; Result Unstructured Data: Test Result:only the suspicion of several tiny microcalcificat; Comments: only the suspicion of several tiny microcalcifications in the renal parenchyma was raised.
CDC Split Type: CHPFIZER INC202101412943

Write-up: Nephrolithiasis; This is a spontaneous report received from a contactable physician via the regulatory authority. Regulatory authority report number CH-SM-2021-26993. A 62-year-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FD0350, Expiry date: unknown) via unspecified route on 10Sep2021 (age at the time of vaccination was 62 years) as dose 1, single for COVID-19 immunization. Relevant medical history as reported: There were no pre-existing conditions. In particular, the patient has never suffered from cystitis, renal colic/stone, other kidney diseases or any other metabolic problems. Furthermore, the patient is above average when it comes to being active in sports, does not consume any addictive substances and very rarely drinks a beer (2-3 times a year) and occasionally a glass of red wine. Concomitant medication was not reported. On 26Sep2021 at around 02:00, the patient suddenly developed serious abdominal pain and repeated vomiting attacks. The patient went to the emergency ward due to persistent symptoms. A left kidney stone was diagnosed. The patient suffered from serious pain which did not improve even with drug therapy until 01Oct2021. Constant serious colic in the kidney and ureter area. On 01Oct2021, there was a spontaneous stone discharge. The patient noticed a large blood clot in the urine strainer, which was brought for laboratory chemistry examination. However no evaluation could be doe, due to the small amount of material. The patient had been pain free since stone discharge and was no longer taking any medication. The patient had fully recovered at the time of the report. Therapeutic measures were taken with paracetamol, Optifen (ibuprofen), Novalgin (metamizole) and tamsulosin. The patient underwent lab tests and procedures, which included physical examination, laboratory/urine status and computer tomography diagnosed left kidney stone in 2021 and urological examination: only the suspicion of several tiny microcalcifications in the renal parenchyma was raised on 05Oct2021. The outcome of the event was recovered on 01Oct2021. Sender''s comments: Comirnaty (tozinameran) is indicated for active immunization to prevent COVID-19 caused by the Severe Acute Respiratory Syndrome-CoV-2 virus in people aged 12 and over. The Swiss summary of product characteristics on Comirnaty (Tozinameran) does not explicitly mention the occurrence of kidney stones as an adverse drug reaction. Since 2020, the World Health Organization pharmacovigilance database lists out of a total of 1,028,168 individual safety reports on Tozinameran, 194 cases of particle therapy: Nephrolithiasis. The literature available to us does not have any reports on kidney stones in combination with the use of Comirnaty (tozinameran) or COVID-19 vaccines. The American Micromedex and UpToDate databases do not report the occurrence of kidney stones with the administration of Comirnaty (tozinameran) or Covid-19 messenger RNA vaccines. There is a temporal relationship between the use of Comirnaty (tozinameran) and the occurrence of kidney stones. The regression of the symptoms over the course (notwithstanding medicinal intervention) represents a positive dechallenge. In summary, based on the temporal relationship, the documentation in the World Health Organization database, the positive dechallenge, and possible other non-drug causes that cannot be excluded (risk factors, endogenous causes), we formally assess the causality between the use of Comirnaty (tozinameran) and the occurrence of the kidney stones as possible according to World Health Organization/Council for International Organizations of Medical Sciences criteria. A causal relationship between Comirnaty and Nephrolithiasis was assessed as being Possible. This case was reported as serious: hospitalisation, medically significant. No follow-up attempts possible. No further information expected.


VAERS ID: 1841275 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-09-26
   Days after vaccination:174
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211002; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: EEPFIZER INC202101405861

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician from the Regulatory Authority. The Regulatory Authority number EE-SAM-53542110031. An 86-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 12Mar2021 (Batch/Lot Number: EL1491 and expiration date: 30Apr2021) as dose 1, 0.3 ml single, intramuscular on 05Apr2021 (Batch/Lot Number: J07BX03) as dose 2, 0.3 ml single for covid-19 immunizations. The patient has no concomitant diseases or allergies. Concomitant medications were not reported. On 26Sep2021, the patient experienced vaccination failure and COVID-19. The events received treatment and caused hospitalization. The clinical course was reported as the patient was vaccinated with the first and second dose of Comirnaty vaccine on 12th March and 5th April 2021 respectively. On 26th September 2021, the patient developed COVID symptomatic infection. On 2nd October 2021, the patient was taken to the hospital by ambulance. SARS-CoV-2 PCR test was positive on October 2nd. The course of the disease is moderate, the patient needs oxygen therapy. She has not yet recovered, currently in hospital. The patient has no concomitant diseases or allergies. The outcome for vaccination failure and COVID-19 was not recovered. Information received from product quality complaint team received on 21Oct2021 regarding consumer''s complaint about Product (PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE), lot: EL1491, expiration date: 30Apr2021). Investigational report conclusion 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 ID resulted in the following conclusion Reference ID 5616433. The complaint for LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EL1491. 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. 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 causes were identified as the complaint was not confirmed. Serious vaccine ineffectiveness report. The causal relationship is considered possible. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841288 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-09-26
   Days after vaccination:151
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Aortic stenosis, Blood calcium, Blood fibrinogen, Carcinoembryonic antigen, Chest X-ray, Computerised tomogram, Deep vein thrombosis, Diabetes mellitus inadequate control, Echocardiogram, Electrocardiogram, Heart rate, International normalised ratio, Mitral valve incompetence, Oxygen saturation, Physical examination, Prothrombin level, Prothrombin time, Pulmonary embolism, Respiratory rate, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOVOMIX; PREDNISONE; MYCOPHENOLATE; MESTINON; ESCITALOPRAM; EZETIMIBE;ROSUVASTATIN; INDAPAMIDE; OMEPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Blood glucose abnormal; Dyslipidemia; Generalized osteoarthritis; Hypertension arterial; Myasthenia gravis (type IIa classification); Osteopenia
Allergies:
Diagnostic Lab Data: Test Name: APTT; Test Result: 30 s; Comments: control; Test Date: 20211008; Test Name: APTT; Test Result: 23.2 s; Test Date: 20211008; Test Name: APTT RATIO; Result Unstructured Data: Test Result:0.77; Test Name: Ca antigen; Result Unstructured Data: Test Result:19.9; Test Date: 20211008; Test Name: fibrinogen; Result Unstructured Data: Test Result:448 mg/ml; Test Name: CEA; Result Unstructured Data: Test Result:slight elevation; Test Name: chest X-ray; Result Unstructured Data: Test Result:Little valuable; Comments: Little valuable due to poor technique (very rotated). No clear infiltrates or condensations.; Test Date: 20211001; Test Name: Computerised axial tomogram; Result Unstructured Data: Test Result:acute thrombus in the right main pulmonary branch; Comments: The study shows an important filling defect compatible with acute thrombus, which is located in the right main pulmonary branch, ending its bifurcation and almost completely occluding the lumen of the lobar branches of the superior lobe and the inferior lobe of this hemithorax, as well as much of the segmental branches the same. No radiological signs of pulmonary hypertension, right overload, pulmonary infarctions or pleural effusions, associated with pulmonary thromboembolism, were observed.; Test Date: 20211008; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Obstructive septal asymmetric hypertrophy; Comments: Obstructive septal asymmetric hypertrophy with moderate mitral regurgitation due to systolic anterior movement. Mild aortic stenosis.; Test Date: 20211001; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm at 89 bpm.; Comments: Normal axis. Constant and normal PR. Complete right bundle branch block; Test Name: heart rate; Result Unstructured Data: Test Result:75-80 bpm; Test Name: heart rate; Result Unstructured Data: Test Result:75 bpm; Comments: upon discharge; Test Date: 20211008; Test Name: INR; Result Unstructured Data: Test Result:1; Test Name: oxygen saturation; Test Result: 95 %; Test Name: oxygen saturation; Test Result: 96 %; Comments: upon discharge; Test Name: Physical exploration; Result Unstructured Data: Test Result:Good general condition.; Comments: Normohydrated, normocoloured and normoperfused. Tachypneic at rest. Cardiac auscultation: Rhythmic and without murmurs. Pulmonary auscultation: preserved vesicular murmur. No extra pathological heart sounds. Lower limbs: -Left lower limb: Hematomas in the proximal third (due to insulin administration) Increase in volume compared to right lower limb. Pitting edema up to the knee. Stuffing of the distal third of the limb with redness, heat and tenderness on palpation. Positive Homans sign. -Right lower limb: Hematomas in the proximal third (due to insulin administration). Pitting edema in the distal third. No signs of DVT (deep vein thrombosis).; Test Date: 20211008; Test Name: prothrombin activity; Test Result: 107.0 %; Test Name: prothrombin time; Test Result: 11.3 s; Comments: control; Test Date: 20211008; Test Name: prothrombin time; Test Result: 10.8 s; Test Date: 20211001; Test Name: respiratory rate; Result Unstructured Data: Test Result:Tachypneic at rest; Test Date: 20211001; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Comments: SARS-CoV-2 RNA is not detected; Test Date: 20211001; Test Name: Ultrasound Doppler; Result Unstructured Data: Test Result:DTV; Comments: Echo Doppler venous of the left lower limb: The deep venous system of the left lower limb is explored from the common femoral vein to the popliteal vein, including the arch of the greater saphenous vein and the proximal portion of the deep femoral vein , showing ultrasound signs compatible with DVT in the common femoral vein, superficial femoral vein and popliteal vein
CDC Split Type: ESPFIZER INC202101461827

Write-up: Deep vein thrombosis; Pulmonary thromboembolism; Uncontrolled diabetes mellitus; Obstructive asymmetric septal hypertrophy with moderate mitral regurgitation due to systolic anterior movement.; Mild aortic stenosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB ES-AEMPS-1029703. A 77-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28Apr2021 (Lot Number: EY2172) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included Myasthenia gravis from 2015 (type IIa classification, under follow-up by Neurology). IGs IV + Plasmapheresis Jul2021. - In Endocrinology follow-up due to uncontrolled blood glucose levels due to corticosteroid treatment. Hypertension arterial, dyslipidaemia, Anxious-depressive disorder, Advanced osteopenia, Generalized osteoarthritis. Concomitant medications included insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX); prednisone (PREDNISONE); mycophenolate mofetil (MYCOPHENOLATE); pyridostigmine bromide (MESTINON); escitalopram (ESCITALOPRAM); ezetimibe;rosuvastatin (EZETIMIBE;ROSUVASTATIN); indapamide (INDAPAMIDE); omeprazole (OMEPRAZOLE); paracetamol (PARACETAMOL). The patient previously received first dose of bnt162b2 on 08Apr2021 (lot: EW2243) for COVID-19 immunisation. The patient experienced deep vein thrombosis (hospitalization, life threatening) on 26Sep2021 with outcome of recovered, pulmonary thromboembolism (hospitalization, life threatening) on 26Sep2021 with outcome of recovered. Obstructive asymmetric septal hypertrophy with moderate mitral regurgitation due to systolic anterior movement. Mild aortic stenosis on 08Oct2021 with outcome of unknown. Uncontrolled diabetes mellitus on unspecified date with outcome of unknown. The clinical course was reported as follows: Reaction/event as reported by primary source: Deep vein thrombosis with pulmonary thromboembolism. Additional information on ADRs: It is the first thrombotic episode that the patient has. The patient referred to the ER by her Primary Care Physician due to increased volume of the left leg. She refers that the increase in volume began 4 days ago, at which time an increase in diuretics was prescribed without improvement in the condition. She progressively noticed pain and redness in the same leg. She commented on an increase in habitual dyspnea that was related to the onset of symptoms in the lower limb, reminiscent of previous episodes of dyspnea due to her underlying disease (myasthenia gravis). No cough or expectoration. No chest pain. No fever. No other symptoms of interest. Physical exploration: Good general condition. Normohydrated, normocoloured and normoperfused. Tachypneic at rest. Cardiac auscultation: Rhythmic and without murmurs. Pulmonary auscultation: preserved vesicular murmur. No extra pathological heart sounds. Lower limbs: Left lower limb: Hematomas in the proximal third (due to insulin administration) Increase in volume compared to right lower limb. Pitting edema up to the knee. Stuffing of the distal third of the limb with redness, heat and tenderness on palpation. Positive Homans sign. Right lower limb: Hematomas in the proximal third (due to insulin administration). Pitting edema in the distal third. No signs of DVT (deep vein thrombosis). ECG: Sinus rhythm at 89 bpm. Normal axis. Constant and normal PR. Complete right bundle branch block (already described in 2015). Echocardiogram (08Oct2021): Obstructive septal asymmetric hypertrophy with moderate mitral regurgitation due to systolic anterior movement. Mild aortic stenosis. Coagulation: prothrombin time 10.8 sec. (11.0-14.6), prothrombin control 11.3 sec. prothrombin activity 107.0% (70.0 -120.0) inr 1, APTT 23.2 sec. (25.0 - 38.0) APTT control 30 sec. APTT ratio (patient / control) 0.77 (0.8 - 1.3) fibrinogen 448 mg / dl (200 - 450). SARSCoV-2 PCR Result (Nasopharyngeal Ex.): SARS-CoV-2 RNA is not detected. Chest X-ray: Little valuable due to poor technique (very rotated). No clear infiltrates or condensations. ECHO DOPPLER LOWER LIMBS: Echo Doppler venous of the left lower limb: The deep venous system of the left lower limb is explored from the common femoral vein to the popliteal vein, including the arch of the greater saphenous vein and the proximal portion of the deep femoral vein , showing ultrasound signs compatible with DVT in the common femoral vein, superficial femoral vein and popliteal vein. CT angio: The study shows an important filling defect compatible with acute thrombus, which is located in the right main pulmonary branch, ending its bifurcation and almost completely occluding the lumen of the lobar branches of the superior lobe and the inferior lobe of this hemithorax, as well as much of the segmental branches the same. No radiological signs of pulmonary hypertension, right overload, pulmonary infarctions or pleural effusions, associated with pulmonary thromboembolism, were observed. Evolution: In the ER: During her stay in the ER, the patient remains clinically and hemodynamically stable. Maintains 95% satO2 without nasal glasses. Treatment with enoxaparin at an anticoagulant dose was started and admission to Internal Medicine was decided. On the ward: After diagnosis of DVT at the femoral level and coinciding with the onset of dyspnea with the onset of pain and edema in left lower limb, therefore, CT angiography was requested, objectifying pulmonary thromboembolism. We performed a study of thrombophilia and tumor markers showing elevation of Ca 19.9 and slight elevation of CEA. The patient does not report symptoms compatible with digestive neoplasm, but CT scan is requested. On 04Oct, treatment with Sintrom was started. On 09Oct, treatment with beta-blocker (bisoprolol 2.5mg / d) began, with adequate tolerance and adequate heart rate control (approx. 75-80bpm). She required analgesia with minor opiates and NSAIDs due to gonalgia, resolved at discharge. Sat.O2 (at discharge): 96% (without O2). Heart rate: 75bpm. Clinical Judgment: Acute pulmonary embolism in the right main pulmonary branch. DVT in the common femoral vein, superficial femoral vein and popliteal vein, probably related to a decrease in physical activity. Obstructive asymmetric septal hypertrophy with moderate mitral regurgitation due to systolic anterior movement. Mild aortic stenosis. Elevation of Ca 19.9 and slight elevation of CEA, without relevant pathology in abdominal CT. Uncontrolled diabetes mellitus. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-26
Onset:2021-09-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Erythema, Fatigue, Feeling hot, Headache, Limb discomfort, Pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLUCOSAMINE; LETROZOLE; LOSARTAN; OMEPRAZOLE; SERTRALINE; VIT D [VITAMIN D NOS]; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Breast cancer (Breast cancer treatment in 2019); Neoplasm (Recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)); Radiotherapy (finished radiotherapy Oct2019.); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210927; Test Name: temp; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210927; Test Name: Lat flow test; Test Result: Negative ; Test Date: 20210929; Test Name: Lat flow test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101400947

Write-up: redness; headache; Arm discomfort; Large arm swelling; Joint pain; Shivers; painful swelling; hot to touch; Fatigue; This is a spontaneous report from a contactable consumer (patient). This is the first of 2 reports. The first report is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110170155163420-Q9RIE, Safety Report Unique Identifier GB-MHRA-ADR 26085216. A 57-year-old female patient received third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date in 26Sep2021 as dose 3 (booster), single for COVID-19 immunisation. Medical history included breast cancer (breast cancer treatment in 2019) from an unknown date, radiotherapy from an unknown date to Oct2019, neoplasm (recently had treatment for cancer, leukaemia or lymphoma (radiotherapy or chemotherapy)) from an unknown date, diet controlled type 2 diabetes mellitus and high blood pressure from an unknown date. Concomitant medications included glucosamine taken for an unspecified indication, start and stop date were not reported; letrozole taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported; sertraline taken for an unspecified indication, start and stop date were not reported; vitamin D taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported. The patient previously took omeprazol and atorvastatin. The patient previously received first dose of BNT162B2 on an unspecified date in Jan2021 and reported to have no problems at all and second dose of BNT162B2 on an unspecified date in Mar2021 and experienced mild joint pain, fatigue, sore arm and red/swelling at vax site, headache; all resolved in 3 days. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced fatigue on 26Sep2021, redness, headache, arm discomfort, large arm swelling, joint pain, shivers, painful swelling and hot to touch from shoulder to elbow all on 27Sep2021. The events were reported as serious (medically significant). Clinical course was reported as follows: First Pfizer vaccine in Jan2021 had no problems at all. Second Pfizer vaccine in Mar2021 had mild joint pain, fatigue, sore arm and red/swelling at vax site, headache, all 100% resolved in 3 days. 26Sep2021, Pfizer COVID booster vaccine. 6 hours post vaccine fatigue set in. Following day, 27Sep2021 horrid shivers set in, I took my temperature and it was 36.4?C also did a Lat flow test which was negative. 27Sep2021, I developed painful swelling and redness that was hot to touch from shoulder to elbow in my vaccinated upper arm. I also suffered all over joint pain and headache. I repeated a Lat flow test on 29Sep2021 it was again negative. Daily I take the following prescribed medication: Omeprazole, Atorvastatin, Losartan, 150mg Sertraline, Letrozole, Vitamin D and Glucosamine supplement pill. I don''t take ant-inflammatory meds as they upset my stomach. To help relieve the symptoms, I took over the counter paracetamol & codeine plus antihistamine. I felt so much worse after the 3rd booster than the previous 2 vaccinations. On about day 6, I woke up and felt fine and all side effects had resolved. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient recovered from shivers on 28Sep2021; arm discomfort and large arm swelling on 30Sep2021; fatigue on 03Oct2021 while patient recovered from the other events on 01Oct2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : PFIZER INC-202101408236 same patient and product; similar events; different dose


VAERS ID: 1841498 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-22
Onset:2021-09-26
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Tendon injury
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Tendinopathies and ligament disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Polycystic ovarian syndrome; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417731

Write-up: Achilles tendon injury; bruising; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from the regulatory AUTHORITY. The regulatory authority report number is GB-MHRA-WEBCOVID-202110190105274340-BX0ZM, Safety Report Unique Identifier GB-MHRA-ADR 26090352. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), DOSE 1 via an unspecified route of administration on 22Sep2021 (Lot Number: FF2153) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS), and suspected covid-19 from 21Jan2020 to 28Jan2020. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced bruising on an unspecified date in 2021 and Achille''s tendon injury on 26Sep2021. events reported as medically significant. It was reported that four days after vaccine administration, patient had tearing sensation in right Achille''s tendon, whilst taking a step-in house (no strenuous activity at all) severe focal pain only at location of where the tendon joins the bone at the heel, when pushing off on foot & calf muscle was engaged. No swelling or bruising initially at the site of pain, she was not prone to it & often didn''t show signs of injury) Later that evening she was surprised to see a series of bruising between the bones on the top of her foot near the toes. It was quite odd, clearly an injury of some kind had occurred, and blood has settled down into her foot. Outcome was not resolved for event bruising and was resolved with sequelae for event chille''s tendon injury on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-23
Onset:2021-09-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8222 / 1 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (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: Pulsatile tinnitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101417469

Write-up: Pulsatile tinnitus; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202110192131504730-SUBWK, Safety Report Unique Identifier is GB-MHRA-ADR 26094922. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF8222), via an unspecified route of administration, in right arm on 23Sep2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing pulsatile tinnitus and was otherwise healthy with no medical conditions. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. On 26Sep2021, patient had pulsatile tinnitus in her right ear for almost a month now and it had not disappeared. She also had her vaccine in the right arm. She went to saw an audiologist who said a lot of similar complaints had been made regarding COVID vaccines causing or exacerbating tinnitus in patients. She had been told that tinnitus had no cure and she just have to wait for it to go away. It had put her off having the second dose because she was worried it would make the problem worse. Patient stated did not relate to possible inflammation of the heart (myocarditis or pericarditis). The event was assessed as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Not had a COVID-19 test. Outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1841912 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-09-26
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis
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:
CDC Split Type: PHPFIZER INC202101418879

Write-up: COVID-19 Confirmed, Mild; drug ineffective; Cold; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. The Regulatory authority report number PH-PHFDA-300112070 and subsequently from the product quality group . A 27-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 16Jul2021 (Batch/Lot Number: FD5996) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced on 26Sep2021 06:00 covid-19 confirmed, mild, and cold. The outcome of the events was recovered. Subsequently the product quality group provided the following investigation results 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 ID resulted in the following conclusion Reference ID 6168537. The complaint for "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 FD5996 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. 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 causes were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1841947 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-13
Onset:2021-09-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC0681 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute polyneuropathy, Albumin CSF abnormal, Aphasia, Back pain, Diplegia, Dizziness, Dysphagia, Facial asymmetry, Facial paresis, Fall, Hyporeflexia, Lumbar puncture, Muscular weakness, Paraesthesia, Paraesthesia oral, Quadriparesis, SARS-CoV-2 test, Urinary retention
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TRIPLIXAM
Current Illness: Arterial hypertension (grade III essential hypertension)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20211001; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:albumin-cytological dissociation; Test Date: 20211001; Test Name: COVID-19; Test Result: Negative
CDC Split Type: ROPFIZER INC202101455221

Write-up: Acute polyradiculoneuritis; Facial asymmetry; word pronunciation disorders; Back pain; an episode of falling down without losing the conscious state; osteotendinous reflexes abolished progressively distal to proximal; acute urinary retention; Deglutition disorder; flaccid tetra paresis with the predominance of the right$g left paraparesis; Dizziness; Paresthesia foot; facial diplegia; generalized muscle weakness; lumbar puncture showed albino-cytological dissociation; left peripheral facial paresis; Paresthesia hand; distal paresthesia in all limbs that have progressively worsened; Paresthesia tongue; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number RO-NMA-2021-SPCOV13339. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 13Sep2021 (Batch/Lot Number: FC0681) as single dose for COVID-19 immunisation. Medical history included ongoing Arterial hypertension (grade III essential hypertension). Concomitant medication included amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM). On 26Sep2021, the patient experienced acute polyradiculoneuritis, facial asymmetry, word pronunciation disorders, back pain, an episode of falling down without losing the conscious state, osteotendinous reflexes abolished progressively distal to proximal, acute urinary retention, deglutition disorder, flaccid tetra paresis with the predominance of the right$g left paraparesis, dizziness, paresthesia foot, facial diplegia, generalized muscle weakness, lumbar puncture showed albino-cytological dissociation, left peripheral facial paresis, paresthesia hand, distal paresthesia in all limbs that have progressively worsened , paresthesia tongue. The clinical course was reported as: At that time of vaccination, the patient was clinically healthy, with no infectious symptoms, without any symptoms. Symptoms began approximately 2 weeks after the time of the vaccine, with distal paresthesia in all limbs progressively aggravated. Over the next few days, the patient experienced dysphasia with facial asymmetry and paresthesia of the tongue. Associate the patient described an episode of falling from her own height, without losing her condition of consciousness, with generalized muscle weakness. The patient presented to the hospital and was hospitalized. Neurological objective at hospitalization: left peripheral facial paresis, hand and foot paresthesia, ROT Achilles diminished bilaterally dr$g stg, walking possible, without support, accuses dizziness non-specific. In the next 2 days the patient''s condition worsened neurologically with facial diplegia, deglutition disorders for which installation was necessary nasogastric tube, flaccid tetra paresis with predominance of right$g left paraparesis, osteotendinous reflexes abolished progressively distal to proximal, significant back pain and finally acute urinary retention, for which a urinary catheter was fitted. Lumbar puncture was performed which showed albumin-cytological dissociation. Considering the clinical neurological picture with aggravated sensory-motor deficit progressive, multiple damage to cranial nerves, acute urinary retention, but also CSF examination with albumin-cytological dissociation, the diagnosis was made acute polyradiculoneuritis and treatment with Immunoglobulin was initiated (infusion 0.4g / kg / day ) for a period of 5 days, with the clinical improvement of the patient. The patient was tested for COVID-19 infection on 01Oct2021 and the result was negative. The events were reported as serious due to life threatening, hospitalization and disabling/incapacitating. The patient was recovering. No follow up attempts possible. No further information is expected.


VAERS ID: 1843925 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211108784

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-052601] concerned a 27 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) dose was not reported, 1 total, administered on 17-JUL-2021 for product use for unknown indication. No concomitant medications were reported. On 26-SEP-2021, the patient''s laboratory data included: COVID-19 PCR test (NR: not provided) was positive which indicates sars-cov-2 infection (severe acute respiratory syndrome coronavirus 2 infection) and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product complaint number.


VAERS ID: 1843927 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211108104

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-052618] concerned a 23 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, frequency one total, administered on 07-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 26-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1843929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211107999

Write-up: VACCINATION FAILURE; SARS-CoV-2 infection; This spontaneous report received from a physician via a Regulatory Authority [regulatory authority, AT-BASGAGES-2021-052646] concerned a 45 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: unknown) dose was not reported, 1 total (first dose) administered on 09-JUN-2021 for an unknown indication. No concomitant medications were reported. On 26-SEP-2021, the patient experienced severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection and vaccination failure. Laboratory data included: coronavirus disease (COVID-19) polymerase chain reaction (PCR) test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1843932 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109351

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [AT-BASGAGES-2021-052682] concerned a 31 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total first dose administered on 24-JUN-2021 for an unspecified indication. No concomitant medications were reported. On 26-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested.


VAERS ID: 1843938 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109466

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-052930] on 03-NOV-2021 concerned a 42 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: UNKNOWN) dose was not reported, frequency time 1 total administered on 18-AUG-2021 for an unspecified indication. No concomitant medications were reported. On 26-SEP-2021, the patient experienced SARS-COV-2 (severe acute respiratory syndrome coronavirus) infection and vaccination failure. Laboratory data included: COVID-19 PCR( polymerase chain reaction test) (NR: not provided) with positive result. 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: 1843940 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-26
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210926; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: ATJNJFOC20211109242

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, AT-BASGAGES-2021-052988] concerned a 30 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: UNKNOWN) dose was not reported, 1 total first dose administered on 12-JUL-2021 for an unspecified indication. No concomitant medications were reported. On 26-SEP-2021, the patient experienced sars-cov-2 infection and vaccination failure. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested.


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