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From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 373 out of 6,867

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VAERS ID: 1524491 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Asthenia, Blood pressure increased, Blood pressure measurement, Body temperature, Cold sweat, Dyspnoea, Heart rate, Heart rate increased, Oxygen saturation, Palpitations
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylactic reaction to venom
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood presure; Result Unstructured Data: Test Result:180~200/100 mmHg; Comments: After vaccination 14-JUL-2021 09:35; Test Date: 20210714; Test Name: blood presure; Result Unstructured Data: Test Result:90~160 mmHg; Comments: After vaccination 14-JUL-2021 09:56; Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210714; Test Name: pulse rate; Result Unstructured Data: Test Result:103-120; Comments: After vaccination 14-JUL-2021 09:35; Test Date: 20210714; Test Name: pulse rate; Result Unstructured Data: Test Result:90~120; Comments: After vaccination 14-JUL-2021 09:56; Test Date: 20210714; Test Name: Oxygen saturation; Test Result: 97 %; Comments: After vaccination 14-JUL-2021 09:35
CDC Split Type: JPPFIZER INC202100927372

Write-up: Weakness generalised; Anaphylaxis; Palpitation; cold sweat; dyspnoea; blood pressure was 180~200/100; The pulse was 103~120; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21120671. A 69-year and 6-month-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 09:25 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 69-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Body temperature before vaccination was 36.2 degrees Centigrade. Medical history included anaphylaxis to bee sting. The patient''s concomitant medications were not reported. On 14Jul2021 at 09:35 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 14Jul2021 (the day of vaccination), the patient was admitted to the hospital. On 15Jul2021 (1 days after the vaccination), the outcome of the event was recovered. The course of the event was as follows: At 09:25, The patient received the vaccination. At 09:35, Palpitations, cold sweat and dyspnoea occurred. The blood pressure was 180~200/100. The pulse was 103~120. The SpO2 was 97%. At rest, condition was temporally stable. At 09:56, the symptoms recurred. The patient experienced Weakness generalised. The blood pressure was 90~160. The pulse was 90~120. It was diagnosed as Anaphylaxis poisoning. After injected 0.1% ADRENALIN intramuscularly at the thigh. The patient was emergently transferred to a hospital and admitted. The reporting physician serious (hospitalization from 14Jul2021 to 15Jul2021) and assessed that the causality between the event and bnt162b2 as Associated. There was no other possible cause of the event such as any other diseases. On 15Jul2021, the patient recovered from all events.


VAERS ID: 1524499 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
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, Chest pain, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLEGRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Asthma bronchial; Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result: normal.
CDC Split Type: JPPFIZER INC202100927503

Write-up: Anaphylaxis; Rash generalised; Generalized itching; Chest pain; This is a spontaneous report received from a contactable Physician via a representative. A 68-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jul2021 at 68-years-old (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Medical history included Hypercholesterolaemia, Asthma bronchial, Allergic constitution. Concomitant medications included ALLEGRA taken for Allergic constitution from an unspecified start date and ongoing. The patient has been taking ALLEGRA for a long time because of Allergic constitution. On 14Jul2021 (after the vaccination), the patient Immediately experienced Anaphylaxis, Rash generalised, Generalized itching, and Chest pain. Blood pressure was normal. Treated with intramuscular injection of POLARAMINE. About 15 minutes after injection of POLARAMINE, the condition was stable. About 30 minutes after injection of POLARAMINE, the symptoms were recovered confirming by saw the state. The patient decided to stop the second vaccination. The reporter didn''t provide seriousness assessment. The outcome of the event Anaphylaxis was recovered on an unspecified date, while other events recovered on 14Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Sender''s Comments: Based on the current available information and the strong drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cannot be excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.


VAERS ID: 1524506 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation, Oxygen saturation decreased, Respiratory rate, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (broad), Respiratory failure (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis obliterans (Arteriosclerosis obliterans: Stent insertion into both lower limbs. Choledochal); Diabetes mellitus; Dyslipidaemia; Hypertension; Peripheral artery stent insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:150/64; Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:107/48; Test Date: 20210714; Test Name: BT; Result Unstructured Data: Test Result:36.9; Test Date: 20210714; Test Name: PR; Result Unstructured Data: Test Result:77; Test Date: 20210714; Test Name: SpO2; Test Result: 91 %; Comments: (RA); Test Date: 20210714; Test Name: SpO2; Result Unstructured Data: Test Result:95-97 %; Test Date: 20210714; Test Name: SpO2; Test Result: 96 %; Comments: (RA); Test Date: 20210714; Test Name: RR; Result Unstructured Data: Test Result:16
CDC Split Type: JPPFIZER INC202100927529

Write-up: Left hand shaking; SpO2 decreased; This is a spontaneous report from a contactable physician from the Agency. Regulatory authority report number is v21120666. An 83-year-old female patient received bnt162b2 (COMIRNATY, Solution for intramuscular injection), via an unspecified route of administration on 14Jul2021 (the day of vaccination) at the age of 83 years old (Batch/Lot number and Expiration date were not provided) as dose 1, single for COVID-19 immunization. Relevant medical history included atherosclerosis obliterans, for which a stent insertion into both lower limbs was performed, choledochal (illegible, as reported); diabetes mellitus; hypertension; and dyslipidaemia. The patient''s concomitant medications were not reported. On 14Jul2021, the patient experienced left hand shaking and oxygen saturation (SpO2) decreased. The event term was reported as tremulousness of hands, SPO2 decreased. The date and time of onset was provided on 14Jul2021 (the day of the vaccination). Clinical course of the event was reported as follows: On 14Jul2021, the patient received the 1st dose of vaccine. Twenty (20) minutes later, the patient developed left hand shaking, with SPO2 91% (RA); blood pressure (BP) 150/64. The patient was infused with normal saline on the spot. The symptom of left hand shaking disappeared, with SPO2 restored to 95-97%. The patient came to the reporter''s hospital for referral visit due to suspected side effects. At the time of diagnosis in the reporter''s hospital, the patient''s body temperature (BT) was 36.9; SpO2 96% (RA); respiratory rate (RR) 16; BP 107/48; pulse rate (PR) 77, and the symptom of left hand shaking disappeared. From the results of physical examination, there was no significant problem. After consultation with the patient and his family, the patient withdrew and went home. The reporter classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Additional information included regulatory authority''s comment about vaccine: The following was confirmed with the facility: question mark was added since type of vaccine was uncertain. Therapeutic measures were taken as a result of left hand shaking and SpO2 decreased. As of 14Jul2021, the outcome of the events was recovering. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1524685 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210766487

Write-up: URTICARIA; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-2730] concerned a 29 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: Unknown) 0.5 ml, frequency 1 total administered on 14-JUL-2021 for Covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced urticaria. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from urticaria on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210766487- COVID-19 VACCINE AD26.COV2.S - Urticaria . This event is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1525411 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-07-14
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: ct value; Result Unstructured Data: Test Result:21.46; Comments: Ct value: 21.46 no sequencing of the virus variant available
CDC Split Type: ATPFIZER INC202100926849

Write-up: Vaccination failure symptomatic COVID-19 disease after complete immunization; symptomatic COVID-19 disease; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-37112. A 54-year-old male patient received unspecified dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. There were no medical history and concomitant medications. On 14Jul2021, the patient experienced vaccination failure symptomatic COVID-19 disease after complete immunization, symptomatic COVID-19 disease, and respiratory symptom. The patient underwent lab tests and procedures which included sars-cov-2 test: 21.46 on Ct value: 21.46 no sequencing of the virus variant available. The outcome of the events was reported as unknown. Reporter Comment: Ct value: 21.46 no sequencing of the virus variant available No follow-up activities possible. No further information expected. Batch/LOT number cannot be obtained.; Reporter''s Comments: Ct value: 21.46 no sequencing of the virus variant available


VAERS ID: 1525414 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy (AE); Cyst removal (Cyst operation); Thrombophlebitis (recent Thrombophlebitis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100954871

Write-up: Deep vein thrombosis; Pulmonary embolism bilateral; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number. A 48-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection; Batch/Lot Number: UNKNOWN), intramuscular on 11Jul2021 as single dose for COVID-19 immunisation. Medical history included appendicectomy(ongoing), thrombophlebitis, cyst removal (ongoing Cyst operation) from an unknown date. There were no concomitant medications. Historical vaccine information included first dose of bnt162b2 (COMIRNATY) on 30May2021 for COVID-19 immunisation. The patient experienced deep vein thrombosis and pulmonary embolism bilateral on 14Jul2021. Up to now hospitalization, discharge planned for 19Jul2021 in improved general condition. Treatment received for adverse events as NOAC therapy, NSAIDs, PPI. The outcome for events was not recovered. Follow-up activities not possible. No further information expected. Batch/LOT number cannot be obtained.


VAERS ID: 1525492 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Extensive swelling of vaccinated limb, Eyelids pruritus, Fatigue, Headache, Injection site erythema, Injection site reaction, Injection site swelling, Malaise, Nausea, Pain in extremity, Pyrexia, Skin disorder
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BELLINA; LEVOCETIRIZINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of MALAISE, FATIGUE, SKIN DISORDER, PYREXIA, PAIN IN EXTREMITY, INJECTION SITE ERYTHEMA, HEADACHE, CHILLS, NAUSEA, EYELIDS PRURITUS, EXTENSIVE SWELLING OF VACCINATED LIMB, INJECTION SITE SWELLING and INJECTION SITE REACTION in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included CHLORMADINONE ACETATE, ETHINYLESTRADIOL (BELLINA) and LEVOCETIRIZINE for an unknown indication. On 13-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced MALAISE (seriousness criterion disability), FATIGUE (seriousness criterion disability), SKIN DISORDER (seriousness criterion disability), PYREXIA (seriousness criterion disability), PAIN IN EXTREMITY (seriousness criterion disability), INJECTION SITE ERYTHEMA (seriousness criterion disability), HEADACHE (seriousness criterion disability), CHILLS (seriousness criterion disability), NAUSEA (seriousness criterion disability), EYELIDS PRURITUS (seriousness criterion disability), EXTENSIVE SWELLING OF VACCINATED LIMB (seriousness criterion disability), INJECTION SITE SWELLING (seriousness criterion disability) and INJECTION SITE REACTION (seriousness criterion disability). The patient was treated with PARACETAMOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE, FATIGUE, SKIN DISORDER, PYREXIA, PAIN IN EXTREMITY, INJECTION SITE ERYTHEMA, HEADACHE, CHILLS, NAUSEA, EYELIDS PRURITUS, EXTENSIVE SWELLING OF VACCINATED LIMB, INJECTION SITE SWELLING and INJECTION SITE REACTION was resolving. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Treatment - Ja Paracetamol Evolution of the ADR - ADR description - Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1526477 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Myocarditis; This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 47-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003660) for COVID-19 vaccination. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 12-Jul-2021, received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications reported. Treatment information was not provided by reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1526788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-07-14
   Days after vaccination:49
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934207

Write-up: Delayed period; This is a spontaneous report from a contactable Consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-EYC 00256720, Safety Report Unique Identifier GB-MHRA-ADR 25682538. A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), parenteral on 26May2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced delayed period (assessed as medically significant) on 14Jul2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1526823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling abnormal, Lymph node pain, Lymphadenopathy
SMQs:, Dementia (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: Hypothyroidism (taking levothyroxine daily); Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928574

Write-up: lymph nodes tenderness; brain fog; Swollen lymph nodes; Exhaustion; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107201912544080-9XYGJ, Safety Report Unique Identifier GB-MHRA-ADR 25682808. A 39-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 13Jul2021 (Lot Number: FA1027) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased and underactive thyroid (taking levothyroxine daily). The patient''s concomitant medications were not reported. The patient previously took levothyroxine for underactive thyroid. Patient has not had symptoms associated with COVID-19 and did not had a COVID-19 test. She was not enrolled in clinical trial. She was not currently breastfeeding. The patient has not tested positive for COVID-19 since having the vaccine. The patient experienced lymph nodes tenderness and brain fog on an unspecified date; on 14Jul2021, she had swollen lymph nodes and exhaustion. It was reported that the patient had exhaustion including brain fog from roughly two hours after the jab. Lymph nodes, especially in the under arm, from the following morning. The armpit node was still occasionally painful. The reporter assessed all the events as serious (other medically important condition). The outcome of event lymph nodes tenderness was resolving, swollen lymph nodes was resolved with sequelae, exhaustion was resolved, and brain fog outcome was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526828 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alopecia, Dry skin, Lymphadenopathy, Pain, Swollen tongue, Vulvovaginal swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOPAMAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100928481

Write-up: pain; Dry skin; Swollen tongue; Swollen glands; Hair loss; Vulvovaginal swelling; This is a spontaneous report from a contactable consumer(patient) received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107202230464570-PBSV3. Safety Report Unique Identifier GB-MHRA-ADR 25683683. A 28-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8813, expiry date: not reported) dose 1 via an unspecified route of administration on 14Jul2021 (at the age of 28 Years) as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not currently breastfeeding. Concomitant medication included topiramate (TOPAMAX) taken for an unspecified indication from 01Jan2016 to an unspecified stop date. On an unspecified date, the patient experienced pain. On 17Jul2021, the patient experienced dry skin, swollen glands, swollen tongue. On 16Jul2021, the patient experienced hair loss. On 14Jul2021, the patient experienced vulvovaginal swelling. Additional information as reported: I called Emergency Services and was advised that I could be reacting to one of the ingredients in the vaccine. I was told to take medication to aid with allergies which I have, I took painkillers for the pain and since my condition has improved a lot. The outcome of swollen tongue was reported as recovered on 18Jul2021. The outcome of other events was reported as recovering. Therapeutic measures were taken as a result of pain. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1526852 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped); Comments: Healthy adult with no medical concerns.
Allergies:
Diagnostic Lab Data: Test Date: 20201013; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100934242

Write-up: nerve pain; Spotting menstrual; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107210949196380-JNYYP; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25684972. A 29-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jul2021 (Batch/Lot Number: not known) as dose 1, single for COVID-19 immunization. Medical history included suspected covid-19 from 12Oct2020 to an unknown date (unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient experienced spotting menstrual on 14Jul2021. The patient does not suffer from menstrual spotting normally. She suffered severe nerve pain in my entire right arm. Most sore near the deltoid but pain radiated from shoulder to fingers. Had carried out no rigorous movement the day before to trap a nerve and do not suffer from pain in the arm generally. Pain was excruciating and over the counter pain relief did not diminish it in any way. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event nerve pain was recovering while Spotting menstrual recovered on 14Jul2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1526870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiac monitoring, Chest pain, Dyspnoea, Hypoaesthesia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suppressed lactation
Allergies:
Diagnostic Lab Data: Test Name: Bloods; Result Unstructured Data: Test Result:Normal; Test Name: Heart Monitor; Result Unstructured Data: Test Result:normal; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC202100934431

Write-up: numbness in legs; Pain in chest; Shortness of breath; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202107211136141530-MNRE4, Safety Report Unique Identifier is GB-MHRA-ADR 25685528. An 18-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 12Jul2021 for covid-19 immunisation. Medical history included lactation decreased. It was unsure if patient had had symptoms associated with COVID-19. Patient was not pregnant, 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 were not reported. The patient experienced numbness in legs on an unspecified date with outcome of recovered; shortness of breath on 14Jul2021 with outcome of recovered on 16Jul2021; pain in chest on an unspecified date with outcome of unknown. The shortness of breath, pain in chest and numbness in legs were advised by 111 to go to A&E. The events was considered serious as other medically important condition and caused/prolonged hospitalization. Lab tests included heart monitor and bloods taken, all was normal; COVID-19 virus test was no - negative. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1526953 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Headache, Maternal exposure during breast feeding, Nausea, Off label use, Product use issue, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Neonatal exposures via breast milk (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DESOGESTREL; SERTRALINE
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Contraception
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: high temperature; Result Unstructured Data: Test Result:high
CDC Split Type: GBPFIZER INC202100934015

Write-up: patient was breast feeding; patient was breast feeding; Maternal exposure during breast feeding; Headache; Nausea; Tiredness; High temperature; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107211904549300-EU49P, Safety Report Unique Identifier GB-MHRA-ADR 25689054. This is the maternal case. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot Number: FA1027) as dose 2, single for COVID-19 immunisation. Medical history included ongoing breast feeding, contraception, and anxiety. Patient is not pregnant. Concomitant medications included desogestrel taken for contraception from Nov2020 and sertraline taken for anxiety from 2017. The patient experienced headache, nausea, tiredness, and high temperature on 14Jul2021. Events were described as follows: had my vaccine in the afternoon, the following morning felt so tired that went to bed and slept for 5 hours. The patient was reported to be breast feeding. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient recovered from the events, headache, nausea, tiredness, and high temperature on 15Jul2021. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100941964 baby case


VAERS ID: 1526993 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Presyncope, SARS-CoV-2 test
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Desogestrel
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Date: 07/21/2021; Test Name: COVID-19 virus test; Test Result: Negative.
CDC Split Type: GBPFIZER INC202100934293

Write-up: This is a spontaneous report from a contactable consumer, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107212316592230-MSFVQ; safety report unique identifier: GB-MHRA-ADR 25689768). A 31-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot# FD5613), via an unspecified route of administration, on Jul 13, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation, suspected COVID-19 from Jul 14, 2021 and ongoing and contraception. Patient is not pregnant, nor currently breastfeeding. Concomitant medications included desogestrel for contraception. The patient experienced tiredness (unspecified date), dizziness (Jul 14, 2021) and near fainting (Jul 18, 2021). Events described as follows: Dizziness throughout the day. Stopped her driving and takes her longer to do things. Tiredness in the afternoon; have to nap when she did not before. The dizziness getting stronger day-by-day, making her feel faint. Patient has not tested positive for COVID-19 since the vaccination. The events considered medically significant. The patient underwent lab tests and procedures, which included SARS-COV-2 test: negative on Jul 21, 2021. The patient was recovering from the event; tiredness and not recovered from the remaining events. No follow-up attempts possible. No further information expected.


VAERS ID: 1527010 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-07-14
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Mass, Mononeuropathy, Neck mass, SARS-CoV-2 test, Vertigo
SMQs:, Peripheral neuropathy (broad), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef); Lactation decreased; Neurosarcoidosis (in remission); Vertigo (once previously)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934082

Write-up: hard lump formation above left elbow joint which is painful; Hard lump formation on right side of neck in front of glands; vertigo; Mononeuropathy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number: GB-MHRA-WEBCOVID-202107220746161430-NH12Y, Safety Report Unique Identifier: GB-MHRA-ADR 25690869. A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Apr2021 as single dose for COVID-19 immunisation. Medical history included neurosarcoidosis from 2001 in remission, lactation decreased, immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), and vertigo (once previously). Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient had a hard lump formation above left elbow joint which was painful; and sharp needle type pain up and down the arm to the wrist and under the left arm towards the ribs. There was a hard lump formation on right side of neck in front of glands. No raised glands. Both lumps were painful to touch. Patient was concerned as she also experienced vertigo which she only ever had once previously. Patient noted that she was presented with a leaflet after her first vaccination that clearly stated should be given to patient before vaccination. When speaking to others about this, apparently they have all had their leaflets post vaccination and many have also experienced vertigo. GP confirmed of mononeuropathy (onset date: 14Jul2021). The events were considered serious: medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of mononeuropathy was not recovered while other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1527064 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Feeling of body temperature change, Inappropriate schedule of product administration, Malaise, Musculoskeletal stiffness, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100941564

Write-up: feeling unwell; Muscle ache; Neck stiffness; Shoulder pain; Feeling hot and cold; Severe brain fog; Inappropriate schedule of vaccine administered; Fatigue; This is a spontaneous report from a contactable consumer, received from the The regulatory authority report number is GB-MHRA-WEBCOVID-202107222305406140-BQQQQ. Safety Report Unique Identifier GB-MHRA-ADR 25696054. A 27-year-old patient of an unspecified gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FD8813) (at the age of 27-year-old) as single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 (at the age of 27-year-old) (Batch/Lot number EW4109) for COVID-19 immunisation and experienced fatigue and neck stiff. Patient has not had symptoms associated with COVID-19; the patient had not a COVID-19 test. The patient experienced feeling unwell on an unspecified date with outcome of unknown, fatigue on 14Jul2021 with outcome of recovering, muscle ache on 15Jul2021 with outcome of recovered on 16Jul2021, neck stiffness on 15Jul2021 with outcome of not recovered, shoulder pain on 15Jul2021 with outcome of not recovered, feeling hot and cold on 15Jul2021 with outcome of recovering and severe brain fog on 15Jul2021 with outcome of recovered on 18Jul2021; all the events were considered serious as medically significant. The patient received the second dose of the vaccine on 14Jul2021 (inappropriate schedule of vaccine administered). The patient left work due to feeling unwell on 15Jul2021 - took pain killers and had to go to bed for the rest of the day. The patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No Follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100957615 Same patient/Drug/Reporter, different dose number and event.(1st Dose)


VAERS ID: 1527577 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Coma, Heart rate, PO2, Presyncope
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:90/50 mmHg; Test Date: 20210714; Test Name: heart rate; Result Unstructured Data: Test Result:60; Test Date: 20210714; Test Name: PO2; Test Result: 99 %
CDC Split Type: ITPFIZER INC202100939623

Write-up: patient not responding to verbal stimuli; presyncopal event; BP 90/50 mmHg; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number . A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Jul2021 (Lot Number: FE3065, Expiry date not reported) as dose 2, 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced presyncopal event without loss of consciousness with patient not responding to verbal stimuli. At the time of measurement, the patient''s vital signs were: BP 90/50 mmHg, HR 60 bpm, Spo2 99%. The patient was placed in a reclining position and was monitored. Prolonged observation was done. The outcome of the events was recovered on an unknown date. No follow-up attempts possible. No further information expected.


VAERS ID: 1527583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Computerised tomogram, Electrocardiogram, Fibrin D dimer, Gait disturbance, Haematocrit, Haemoglobin, Paraesthesia, Polymerase chain reaction, Troponin
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: encephalon computed tomography; Test Result: Negative; Test Name: ECG; Test Result: Negative; Test Name: d-dimer; Result Unstructured Data: Test Result: 0,93; Comments: minimal movement of d-dimer troponin negative; Test Name: Haematocrit; Result Unstructured Data: Test Result:35.8; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.5; Test Name: polymerase chain reaction; Result Unstructured Data: Test Result: 11.58; Test Name: troponin; Result Unstructured Data: Test Result: minimal movement of d-dimer troponin negative.
CDC Split Type: ITPFIZER INC202100927046

Write-up: This is a non-interventional report from a contactable physician from the Regulatory Authority. The regulatory authority number IT-MINISAL02-757810. A 38-year-old female subject received second dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm right on 13Jul2021 (Lot Number: FF0680; Expiration Date: 31Oct2021) as single dose for COVID-19 immunisation. The subject medical history and concomitant medications were not reported. The subject previously received first dose of BNT162b2 (COMIRNATY) on 06Jun2021 as single dose for COVID-19 immunisation. The subject experienced paresthesias lower limbs and functional impotence with paresthesias upper limbs but allowed mobilization asthenia marked not fever, not anxiety crisis not hyperventilation on 14Jul2021. The events were serious, medically significant. The events required access to emergency department for case investigations. On an unspecified date, the subject underwent lab tests and procedures which included encephalon computed tomography: negative, electrocardiogram (ECG): negative, fibrin D dimer: 0,93 minimal movement of d-dimer troponin negative, hematocrit: 35.8 , haemoglobin: 12.5, polymerase chain reaction: 11.58, troponin: minimal movement of d-dimer troponin negative. The subject outcome of the events was recovering. Reporter Comment: suspected adverse reaction after 2 injections of Pfizer anti-COVID 19 vaccine. The reporter''s assessment of the causal relationship of the event with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected. Reporter''s Comments: suspected adverse reaction after 2 injections of Pfizer COVID19 vaccine. Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: 1527599 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Presyncope
SMQs:, Anticholinergic syndrome (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? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939531

Write-up: Lipothymia; This is as spontaneous report received from a contactable healthcare professional downloaded from the regulatory authority-WEB. The regulatory authority report number i. A 57-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number: FF0688), intramuscularly administered in the left arm on 14Jul2021 10:48 (at the age of 57-years-old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY; lot number was not reported) on 09Jun2021 for COVID-19 immunization. On 14Jul2021, the patient experienced lipothymia. The patient called 112 and went to the emergency room where she had her venous access. The patient was hospitalized for 1 day. The outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527600 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2606 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Neurological examination
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: neurological examination; Result Unstructured Data: Test Result:negative result
CDC Split Type: ITPFIZER INC202100937047

Write-up: Suspected bell''s syndrome; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-758802. A 50-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE2606), intramuscular on 14Jul2021 at 10:30 as 0.3 mL, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced suspected bell syndrome after second dose pfizer administration on 14Jul2021. The patient was placed under observation at the Emergency Room and after about two and a half hours the symptoms spontaneously regressed without the administration of any medication. During the observation was performed neurological examination with negative result in Jul2021. The patient was discharged in Jul2021. The outcome of the event was recovered with Sequel. No follow-up attempts possible. No further information expected.


VAERS ID: 1527654 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Anxiety, Arthralgia, Body temperature, Cardiac disorder, Electrocardiogram, Night sweats, Psychiatric evaluation, Pyrexia, Respiratory disorder, Sinus tachycardia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: fever; Result Unstructured Data: Test Result:fever of 39; Test Name: electrocardiogram; Result Unstructured Data: Test Result:sinus tachycardia, left axial deviation; Test Name: psychiatric examination; Result Unstructured Data: Test Result:no psychopotological acuity
CDC Split Type: ITPFIZER INC202100954994

Write-up: revealed sinus tachycardia; agitation; anxious state; 15Jul, at 10 o''clock, respiratory and cardiac crisis; 15Jul, at 10 o''clock, respiratory and cardiac crisis; on 14 strong pains in the arm and immobilization of the shoulder; on 14 strong pains in the arm and immobilization of the shoulder; in the night sweating; fever of 39; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. A 57-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: FF0688), intramuscular, administered in Arm Left on 13Jul2021 14:45 (at unknown age) as 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is a person who does not habitually take any medicine, healthy. On 14Jul2021, strong pains in the arm and immobilization of the shoulder; in the night sweating and fever of 39; 15Jul2021, at 10 o''clock, respiratory and cardiac crisis. From the emergency room report, the patient was admitted without hospitalization. The electrocardiogram revealed sinus tachycardia, left axial deviation. The patient was in good condition with normal vital parameters. Following the agitation and anxious state, a psychiatric examination was carried out, which did not reveal any psychopotological acuity. Therapy administered at the time Delorazepam 30 drops, discharged after 3 hours with diagnosis of anxiety. All events were life threatening. Actions taken (brought to the balcony, put in oxygen, called doctor and then 118 with the doctor who did the electrocardiogram, calming injection, pill under the tongue, brought to the emergency room for evaluation and emergency therapy). The outcome of the events was recovering.


VAERS ID: 1527665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-14
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s thyroiditis
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Heart rate; Result Unstructured Data: Test Result:45 BPM
CDC Split Type: ITPFIZER INC202100960359

Write-up: myocarditis; bradycardia (45bpm); This is a spontaneous report from a contactable physician downloaded from the regulatory authority -WEB, regulatory authority number . A 42-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 16Jun2021 14:35 (Lot Number: fc5435; Expiration Date: 30Sep2021) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Hashimoto''s thyroiditis. The patient''s concomitant medications were not reported. The patient experienced suspected myocarditis and bradycardia (Heart rate 45bpm), both on 14Jul2021, approximately 28 days after administration of the first dose of COMIRNATY vaccine with outcome of not recovered which were assessed as serious with life threatening. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1527923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-07-14
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Magnetic resonance imaging, Maternal exposure during pregnancy, Ovarian vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:ovarian vein thrombosis; Comments: ovarian vein thrombosis
CDC Split Type: NLPFIZER INC202100939991

Write-up: Ovarian vein thrombosis in pregnancy; Maternal exposure during pregnancy, third trimester; This is a spontaneous report from a contactable other HCP downloaded from the Regulatory Authority. A 30-year-old female pregnant patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC5089) dose 1 via an unspecified route of administration on 26Jun2021 as a DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Past drug therapy BioNTech/Pfizer vaccine (Comirnaty) was none. Previous COVID-19 infection was reported as None. The patient experienced ovarian vein thrombosis in pregnancy on 14Jul2021 and maternal exposure during pregnancy, third trimester on an unspecified date. It was reported that, an other health professional concerns a pregnant woman aged 30 years. She was diagnosed with ovarian vein thrombosis (caused or prolonged hospitalization), 18 days after she was vaccinated with covid-19 vaccine pfizer injection fluid for covid 19 immunisation. Vaccination took place at a pregnancy duration of 30 weeks. This was the first vaccination of the patient. Ovarian vein thrombosis was treated with anticoagulants. The patient had not recovered from ovarian vein thrombosis. Hospitalization required reported as, pain and anticoagulation. The patient was hospitalized for ovarian vein thrombosis in pregnancy from 14Jul2021 to an unknown date. The mother reported she became pregnant while taking bnt162b2. The mother was 30 Weeks pregnant at the onset of the event. The patient underwent lab tests and procedures which included magnetic resonance imaging which was ovarian vein thrombosis on an unspecified date. Outcome of the ovarian vein thrombosis in pregnancy was not recovered and maternal exposure during pregnancy, third trimester was unknown. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no ovarian thrombosis in pregnancy: Hospitalization information: pain and anticoagulation 14Jul admission due to pain, diagnosis of ovarian thrombosis confounding factors: COVID-19 vaccine exposure during pregnancy week: 30wks Previous COVID-19 infection: No


VAERS ID: 1527946 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Investigation
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Investigation NOS; Result Unstructured Data: Test Result:Peripheral facial paresis left side, grade 1-2.; Comments: No cells in spinal fluid, borrelia negative, no other etiology found.
CDC Split Type: NOPFIZER INC202100949158

Write-up: Peripheral facial paresis/Bell''s palsy left side grade 1-2; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Ue2ar4. A 44-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection), Batch/Lot number and Expiry date was not reported) via intramuscularly, administered in Arm Left on 13Jul2021 ( Age at the vaccination: 44-year-old) as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient developed peripheral facial paresis/bell''s palsy, left side, grade 1-2. The patient underwent lab tests and procedures which included investigation: on an unspecified date in Jul2021 no cells in spinal fluid, borrelia negative, no other etiology found. The case was considered to be serious. The outcome of event was not recovered. Reporter''s comments: NIPH: Follow-up received as duplicate report. All information kept in NO-NOMAADVRE-FHI-2021-Ue2ar4 (this report). Report NO-NOMAADVRE-FHI-2021-U1qyjr has been nullified. No follow-up attempts are possible, information on batch numbers could not be obtained.


VAERS ID: 1527990 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: PTJNJFOC20210803014

Write-up: SYNCOPE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-2936] concerned a 27 year old unspecified race and ethnic origin 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) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 14-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210803014-Covid-19 vaccine ad26.cov2.s-Syncope. 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: 1528052 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-14
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5435 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202100949172

Write-up: Peripheral facial paralysis on the left; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from INFARMED Regulatory authority report number [PT-INFARMED-V202107-3613]. A 48-year-old female patient received first dose of BNT162B2 (COMIRNATY; solution for injection; Lot number: FC5435) intramuscularly on 21Jun2021 as dose 1, 0.3 mL single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Previous reactions to the same drug or to other drugs are not known. On 14Jul2021, the patient presented with peripheral facial paralysis on the left 3 weeks after administration. Patient went to the Emergency Department for total facial paralysis on the left. Medicated with prednisolone since then. Patient does not usually take medication and will not have done it in the period before the reaction. Specific treatment included Corticotherapy with MFR (Myofascial release therapy) treatments. Adverse drug reaction improved with treatment. Outcome of the event was recovering. The reporter''s assessment of the causal relationship of the [Facial paralysis] with the suspect product was [Relatedness of drug to reaction(s)/event(s): Source of assessment: Notifier, Method of assessment: Unknown, Result of Assessment: Possible]. Health authority comments: Patient who went to the Emergency Department due to total facial paralysis on the left Treated with prednisolone since then. She does not usually take medication and he will not have done it in the period before the reaction. No follow-up attempts are possible. No further information expected


VAERS ID: 1528070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-14
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4632 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Activated protein C resistance
Preexisting Conditions: Medical History/Concurrent Conditions: DVT
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100939966

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number SE-MPA-2021-062749. A 55-years-old male patient received the first and second dose of bnt162b2 (COMIRNATY), on 11May2021 (Batch/Lot Number: EX6537) as DOSE 1, SINGLE, and on 22Jun2021 (Batch/Lot Number: FA4632) as DOSE 2, SINGLE both via an unspecified route of administration for covid-19 immunisation. Medical history included DVT and ongoing activated protein c resistance. The patients concomitant medications were not reported. The patient experienced pulmonary embolism on 14Jul2021. The patient was hospitalized for the event on an unspecified date. Therapeutic measures were taken as a result of pulmonary embolism included Xarelto. Outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1528356 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214001 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20212

Write-up: ENCEFALIT; This regulatory authority case was reported by a physician and describes the occurrence of ENCEPHALITIS (ENCEFALIT) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214001) for COVID-19 vaccination. No Medical History information was reported. On 06-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ENCEPHALITIS (ENCEFALIT) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, ENCEPHALITIS (ENCEFALIT) was resolving. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Company Comment: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Post vaccination encephalitis has been associated with some vaccines and can occur between 8 and 14 days after vaccination. In this case, occurrence is 8 days post mRNA-1273 administration.; Sender''s Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded. Post vaccination encephalitis has been associated with some vaccines and can occur between 8 and 14 days after vaccination. In this case, occurrence is 8 days post mRNA-1273 administration.


VAERS ID: 1528453 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100964127

Write-up: Deep vein thrombosis; This is a spontaneous report from a contactable other health professional via the Regulatory authority. Regulatory authority report number 591916. A 41-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as a dose 1 single and dose 2 via an unspecified route of administration on an unspecified date in 2021 as a dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced deep vein thrombosis. Onset time in days was reported as 37 days from first dose and 14 days from second dose. The outcome of event deep vein thrombosis was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1529668 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acne, Chest pain, Dyskinesia, Myocardial infarction, Pain in extremity, Polymenorrhoea, Rash, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Dyskinesia (narrow), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941543

Write-up: acne; unexpectedly early period; heart attack; muscle movement; Chest pain; Skin breakout; Vaginal bleeding; Painful L arm; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221301366740-XEO01. Safety Report Unique Identifier GB-MHRA-ADR 25692559 A 26-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient''s medical history included suppressed lactation from an unknown date and unknown if ongoing, acne from an unknown date and unknown if ongoing and concomitant medications were not reported. The patient experienced acne on an unspecified date, unexpectedly early period (polymenorrhoea), on an unspecified date heart attack (myocardial infarction) , muscle movement (dyskinesia) on an unspecified date, painful left arm (pain in extremity) on 14Jul2021, skin breakout (rash) on 16Jul2021, vaginal bleeding (vaginal haemorrhage) on 15Jul2021, chest pain (chest pain) on 19Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. The outcome of the event acne, unexpectedly early period, heart attack, muscle movement, painful left (L)arm was recovered and skin breakout was not recovered and the outcome of the vaginal bleeding was recovering and chest pain was recovered with sequelae. Additional Information: Pain to upper arm approximately 7-8 hours after vaccine. The patient has stated that she was very aware of muscle movement and woke up the following morning with a heavy and unexpectedly early period. This lasted a few days on a heavy flow and then suddenly stopped. 2 days after her vaccination, she woke up with severe acne/a bumpy face rash. This remains. On the Monday following her vaccination she had sudden and severe chest pain and wondered if she was not having a heart attack but did not want to be dramatic. This lasted for a couple of hours where it was sharp and painful. It has come back randomly since then. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. It was unsure if patient has had symptoms associated with COVID-19 Patient is not pregnant, Patient is not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1529697 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test
SMQs:, Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant; Psoriasis; Retinitis pigmentosa
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100943597

Write-up: Shingles; This is a spontaneous report from a contactable consumer or other non-healthcare professional received from The regulatory authority report number is GB-MHRA-WEBCOVID-202107241943362000-HEPVX. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 10Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included retinitis pigmentosa, psoriasis, and clinical trial participant from an unknown date and unknown if ongoing. Psoriasis was severely sight impaired with retinitis pigmentosa. Unsure if patient has had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Study details reported monthly Covid 19 test. Concomitant medication included sertraline taken for depression from Jan2018 to an unspecified stop date. The patient experienced shingles (herpes zoster) (medically significant) on 14Jul2021. Diagnosed by general physician (GP) in video call. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date. The outcome of event was recovering. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1530160 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, 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: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/50 mmHg; Test Date: 20210714; Test Name: Heart rate; Result Unstructured Data: Test Result:52; Test Date: 20210714; Test Name: Spo2; Test Result: 99 %
CDC Split Type: ITPFIZER INC202100939617

Write-up: Sudden orthostatic syncopal event probably of vasovagal origin; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number IT-MINISAL02-757379. A 17-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Jul2021 at the age of 17 years old (Lot Number: FE3065) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden orthostatic syncopal event probably of vasovagal origin (No sweating) on 14Jul2021. The patient does not report agophobia. Vital parameters at the time of the event: blood pressure 100/50 mmHg, Heart rate 52, Spo2 99%. The patient was conscious at the time of the measurement, but did not respond to verbal stimuli. Measurement of vital signs and prolonged observation until the blood pressure parameter improves. The outcome of events was recovered on unspecified date. No follow-up attempts possible. No further information expected.


VAERS ID: 1530254 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Body temperature, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100964935

Write-up: left peripheral facial palsy (Bell''s palsy); left facial palsy / left peripheral facial palsy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121556. A 69-year-old male patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021), via an unspecified route of administration on 06Jul2021 at 15:00 (the day of vaccination) (at the age of 69-year-old) as dose 1, 0.3ml, single for COVID-19 immunization. The patient had a medical history of renal failure chronic. Patient concomitant medications were not reported. Body temperature before vaccination was 36.1 degrees centigrade on 06Jul2021. On the morning of 14Jul2021 (8 days after the vaccination), the patient experienced left peripheral facial palsy. The course of the event was as follows: On 14Jul2021(8 days after vaccination), the patient experienced left facial palsy while getting up. The patient visited the hospital and was diagnosed as left peripheral facial palsy (Bell''s palsy). The patient currently was under treatment by taking prednisolone via oral route. The reporting physician assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The outcome of events was unknown. Prevaccination Screening Questionnaire for COVID-19 vaccine was reported as follows: This is the first time to receive Coronavirus Disease 2019 vaccine. The patient belongs to "65yrs or older " priority vaccination groups. The patient was currently treated (with medications, etc.) for Kidney. The patient was told by the treating physician of the above disease that it is OK to receive this vaccination. The patient had not been sick or had a fever in the past month. The patient was not feeling sick today. The patient had not ever had convulsions (seizures). The patient had not ever had severe allergic reactions (anaphylaxis, etc.) to a medication or food. The patient had not ever been sick after receiving vaccination. The patient had not received any other vaccines in the past two weeks. The patient had no question about this vaccination. The vaccine dose was 0.3ml. Follow-up attempts are completed; no further information is expected.


VAERS ID: 1530312 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-14
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cardiac arrest, Fall, Malaise, Nausea, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Disability NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100967031

Write-up: imbalance; hospital admission after fall; Not feeling well; Nausea; Vomiting; Cardiac arrest; This is a spontaneous report from a contactable consumer from the Regulatory Agency WEB [NL-LRB-00626408]. A 75 years old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: EX0893) at 0.3 ml single on 27May2021 for COVID-19 vaccination. The first dose was on 22Apr2021 at 0.3ml single. Medical history included ongoing disability NOS. COVID19 Previous COVID-19 infection was no. Concomitant medication was not reported. On 14Jul2021, patient experienced cardiac arrest (life threatening), imbalance (caused or prolonged hospitalization), hospital admission after fall (caused or prolonged hospitalization), not feeling well, nausea with vomiting fall following second administration of covid-19 vaccine Pfizer injection fluid. According to the reporter, cardiac arrest was probably treated with a pacemaker. The patient had not recovered from nausea, was recovering from the rest events 1 day after onset. No follow-up attempts possible. No further information expected.


VAERS ID: 1531213 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Malaise, Myalgia, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), 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: DAFALGAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210803210

Write-up: SWEATING; VOMITING; COLD CHILLS; FEELING UNWELL; HEADACHE; MUSCLE PAIN; FATIGUE; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority, BE-FAMHP-DHH-N2021-101685] concerned a 19 year old male. The patient''s weight was 77 kilograms, and height was 188 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE395 expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for covid-19 immunization. Concomitant medications included paracetamol for drug used for unknown indication. On 14-JUL-2021, the patient experienced sweating, nausea, vomiting, cold chills, feeling unwell, headache, muscle pain and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sweating, nausea, vomiting, cold chills, feeling unwell, headache, muscle pain, and fatigue. This report was serious (Other Medically Important Condition, and Disability Or Permanent Damage).; Reporter''s Comments: Sender''s Comments: V0: 20210803210-covid-19 vaccine ad26.cov2.s-sweating. 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). 20210803210-covid-19 vaccine ad26.cov2.s-nausea, vomiting, cold chills, feeling unwell, headache, muscle pain and fatigue. This event(s) is labeled per Information and is therefore considered potentially related.


VAERS ID: 1531220 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (PCR+)
Allergies:
Diagnostic Lab Data: Test Date: 202009; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive
CDC Split Type: ESJNJFOC20210806331

Write-up: BILATERAL PNEUMONIA; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, ES-AEMPS-954290] concerned a 42 year old male. The patient''s weight was 79 kilograms, and height was 169 centimeters. The patient''s past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 dosage forms, 1 total administered on 10-JUL-2021 for covid-19 vaccination. The duration of drug administration was 1 days and start and last period was 5 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date in SEP-2020, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 14-JUL-2021, the patient experienced bilateral pneumonia, and was hospitalized (date unspecified). It was not reported if patient got discharge from hospital or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bilateral pneumonia was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0:20210806331-covid-19 vaccine ad26.cov2.s-BILATERAL PNEUMONIA . 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: 1531370 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210803035

Write-up: MY JOINTS HURT; CHILLS; MUSCLE PAIN; HEADACHE; FATIGUE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, BE-FAMHP-DHH-N2021-101676] concerned a 22year old female. The patient''s weight was 54 kilograms, and height was 169 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C14-02 expiry: UNKNOWN) dose was not reported, 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced joints hurt, chills, muscle pain, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle pain, headache, fatigue, my joints hurt, and chills. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Treatment - No Evolution of the ADR - No improvement situations - Other: Adverse effect that''s all ADR description - I feel like I got run over by a 5T I never have a headache well now there is a jigsaw game in my lobes and I feel like I am 80 years old and have arthritis so my joints hurt; Sender''s Comments: V0: 20210803035-Covid-19 vaccine ad26.cov2.s -Muscle pain, Headache, Fatigue, My joints hurt, and Chills. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1531384 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-14
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Dyspnoea, Heart rate increased, Paraesthesia
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMORA
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202100961063

Write-up: shortness of breath as if I was going to have respiratory arrest; mental confusion; tingling in my hands; accelerated heartbeat; This is a spontaneous report from a contactable consumer (patient. A contactable consumer (patient) reported that a 45-years-old female (Non-pregnant) patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Jul2021 at 13:00 (at the age of 45-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was none. Concomitant medications received, within 2 weeks of vaccination included chlormadinone acetate, ethinylestradiol (AMORA) taken for an unspecified indication, start and stop date were not reported. Patient was not allergic to any medications, food or other products or did not have Other diagnosed illnesses / medical history / chronic health conditions. Patient did not receive any other vaccines within 4 weeks Prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient reported that on 14Jul2021 at 12:00 AM, I has shortness of breath as if I was going to have respiratory arrest, mental confusion, tingling in my hands and accelerated heartbeat. It was reported that, after 14 days of the dose, I felt shortness of breath as if I was going to have respiratory arrest, mental confusion, tingling in my hands and accelerated heartbeat, while exerting myself I still feel acceleration in my heart and shortness of breath. I am afraid of taking the second dose and the symptoms get worse or actually have a respiratory arrest. Event resulted in the Emergency room/department or urgent care. She did not have, Doctor or other healthcare professional office/clinic visit / Hospitalization / Prolongation of existing hospitalization (vaccine received during existing hospitalization) / Life threatening illness (immediate risk of death from the event) / Disability or permanent damage / Patient died / Congenital anomaly or birth defect. No treatment was received for the adverse events. The Outcome of the events were not resolved. The batch number has been requested in follow-up activities.


VAERS ID: 1531758 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, Rhinorrhoea, Sudden hearing loss, Vertigo
SMQs:, Hearing impairment (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC202100948609

Write-up: Hearing loss in left ear; cold; Vertigo; Sniffles; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number CZ-CZSUKL-21008558. A 29-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 13Jul2021 11:30 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The first dose was received on 05Jun2021. There were no medical history and concomitant medications. On 14Jul2021, morning after the vaccine second dose administration, patient found out he''s lost hearing in his left ear on 07:00, he had a cold/ sniffles and head spinning/ vertigo. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532306 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, COVID-19, Headache, Hyperhidrosis, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: high fever; Result Unstructured Data: Test Result:40; Test Date: 20210714; Test Name: Antigen Test; Result Unstructured Data: Test Result:positive; Comments: first: positive at home; Test Date: 20210714; Test Name: Antigen Test; Result Unstructured Data: Test Result:positive; Comments: Citizen test in the vaccination center; Test Date: 20210715; Test Name: PCR test; Result Unstructured Data: Test Result:positive
CDC Split Type: DEPFIZER INC202100927819

Write-up: Antigen test positive + PCR test positive/High fever (40); severe headache; sweating; weakness; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from Biontech (manufacturer control number: 74237), license party for Comirnaty. A male patient of unspecified age received the first dose of BNT162B2 (COMIRNATY; lot number unknown) via an unspecified route of administration on 14Jul2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient reported he was confronted with unexpected side effects on Wednesday, 14Jul2021, also reported as 01Jul2021; 5 to 6 hours after the first vaccination the patient experienced high fever reported as 40, severe headaches, sweating and weakness. That afternoon, he reported "making with great care" an antigen test at home, which was positive. In the evening he had another citizen test at the vaccination center and the next morning a polymerase chain reaction test; all of which were reported as positive. The patient reported he was infected when he was given the first dose of the vaccine. The clinical outcomes of the events were unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1532340 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Intermenstrual bleeding, Vaginal 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100949060

Write-up: Bleeding vaginal/Bleeding between periods; Bleeding between periods; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-945543. A 33-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 10Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced bleeding vaginal/ bleeding between periods. The events were assessed as medically significant. The outcome of the events was unknown. Case details: Who has suffered from ADR (adverse drug reaction): You, I was pregnant at the administration of the vaccine: NO, Has COVID-19 passed: No. Follow-up attempt are not possible. No expected further information.


VAERS ID: 1532345 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3318 / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Discomfort, Disease recurrence, Gynaecological examination, Heavy menstrual bleeding, Platelet count, Pyrexia, Thrombocytopenia, Vaccination site haemorrhage
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombopenia (Thrombopenia in pregnancy on June 2015, admitted in 2016 for severe thrombopenia)
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Fever; Result Unstructured Data: Test Result:up to 39 Centigrade; Test Name: Gynecology; Result Unstructured Data: Test Result:abundant menstruations; Comments: Studied in Gynecology for abundant menstruations; Test Date: 2016; Test Name: platelets; Result Unstructured Data: Test Result:0
CDC Split Type: ESPFIZER INC202100948666

Write-up: Application site purpura; Menorrhagia/ heavy menstruation/ bleeding; Thrombocytopenia; Thrombocytopenia; fever up to 39 ?C; general discomfort; This is a spontaneous report received from a contactable health care professional (HCP) via regulatory authority and downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-948294. A 44-year-old non-pregnant female patient received bnt162b2 (COMIRNATY), administered in left arm on 14Jul2021 (batch/lot number: FF3318) (at the age of 44-year-old) as dose number unknown, single for COVID-19 immunisation. The patient was not pregnant at the administration of the vaccine. The patient''s medical history included thrombopenia from Jun2015 (thrombopenia in pregnancy on June 2015, admitted in 2016 for severe thrombopenia), she was discharged in 2016 due to severe thrombopenia (0 platelets) in the context of flu symptoms of one week of evolution. The patient''s concomitant medications were not reported. On 14Jul2021 the patient experienced application site purpura, menorrhagia, thrombocytopenia, fever up to 39 ?C and general discomfort. The events application site purpura, menorrhagia and thrombocytopenia were reported as serious with medically significant criterion while the other events were reported as non-serious. It was reported that the patient presented a reaction after administration of a vaccination with Pfizer laboratory vaccine on 14Jul2021 presenting a fever of up to 39 ?C and general malaise. She also reported punctate lesions on the left forearm. She referred to heavy menstruation and still continued with bleeding since 14Jul2021. No epistaxis or gingivorrhagia. She was discharged in 2016 due to severe thrombopenia (0 platelets) in the context of flu symptoms of one week of evolution. Studied in gynecology for abundant menstruation. The outcome of the events was unknown for general discomfort and "fever up to 39 ?C", not resolved for "menorrhagia/ heavy menstruation/ bleeding" and resolving for all other events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood creatinine, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, Chest X-ray, Chest pain, Echocardiogram, Electrocardiogram, Glomerular filtration rate, Haematocrit, Haemoglobin, Haemolysis, Heart rate, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Oxygen saturation, Pericarditis, Physical examination, Platelet count, Red blood cell count, Red cell distribution width, Troponin
SMQs:, Haemolytic disorders (narrow), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: SALAZOPYRINA
Current Illness: Uveitis
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:Normal, rhythmic, no murmurs or pericardial fricti; Comments: Normal, rhythmic, no murmurs or pericardial friction.; Test Date: 20210714; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:Vesicular murmur preserved; Test Date: 20210714; Test Name: Creatin Kinase; Result Unstructured Data: Test Result:65 IU/l; Test Date: 20210714; Test Name: Creatine kinase-MB; Result Unstructured Data: Test Result:190 IU/l; Test Date: 20210714; Test Name: Creatinine; Test Result: 0.70 mg/dl; Test Date: 20210714; Test Name: blood glucose; Test Result: 80 mg/dl; Test Date: 20210714; Test Name: potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:121/82; Test Date: 20210714; Test Name: Sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 20210714; Test Name: blood urea nitrogen; Result Unstructured Data: Test Result:17 mg/l; Test Date: 20210714; Test Name: Urea; Test Result: 36 mg/dl; Test Date: 20210714; Test Name: Chest x-ray; Result Unstructured Data: Test Result:Normal, Centered, inspired. Normal CTI, without co; Comments: Normal, Centered, inspired. Normal CTI, without condensation or infiltrates, sinuses free, preserved bone frame.; Test Date: 20210714; Test Name: C-reactive protein; Test Result: 0.70 mg/dl; Test Date: 2021; Test Name: echocardiogram; Result Unstructured Data: Test Result:pending; Test Date: 20210714; Test Name: ECG; Result Unstructured Data: Test Result:55 lpm, narrow QRS normal axis, millimetric elevat; Comments: 55 lpm, narrow QRS normal axis, millimetric elevation of the ST over the entire lower face and doubtfully in V2, V3, V4 without other alterations in repolarization.; Test Date: 20210714; Test Name: Estimated glomerular filtration rate; Result Unstructured Data: Test Result:117.84 ml/min/1.73m^2; Test Date: 20210714; Test Name: Hematocrit; Test Result: 41.9 %; Test Date: 20210714; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.1 g/dl; Test Date: 20210714; Test Name: hemolysis index; Result Unstructured Data: Test Result:77; Test Date: 20210714; Test Name: Heart rate; Result Unstructured Data: Test Result:69; Test Date: 20210714; Test Name: MCHC; Result Unstructured Data: Test Result:33.7 g/dl; Test Date: 20210714; Test Name: Mean corpuscular volume blood; Result Unstructured Data: Test Result:93.3 fl; Test Date: 20210714; Test Name: mean platelet volume; Result Unstructured Data: Test Result:10.2 fl; Test Date: 20210714; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:98; Test Date: 20210714; Test Name: Physical examination; Result Unstructured Data: Test Result:Normal. Symmetric and normoexpansible chest, witho; Comments: Normal. Symmetric and normoexpansible chest, without increased work of breathing. Lower extremities: no edema, no signs of deep vein thrombosis; Test Date: 20210714; Test Name: platelet count; Result Unstructured Data: Test Result:216 10*9/uL; Test Date: 20210714; Test Name: Red blood cells; Result Unstructured Data: Test Result:4.5 10*6/uL; Test Date: 20210714; Test Name: red cell distribution width; Test Result: 12.2 %; Test Date: 20210714; Test Name: Troponin; Result Unstructured Data: Test Result:0.012 ng/ml
CDC Split Type: ESPFIZER INC202100947432

Write-up: Acute pericarditis; Chest pain; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Agency-WEB, regulatory authority report number ES-AEMPS-949952. A 27-year-old female patient received first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: FD7959) intramuscularly administered in left arm on 12Jul2021 as dose 1, single for COVID-19 immunisation. Medical history included ongoing uveitis, smoker and alcohol user. Patient was not pregnant. Concomitant medication included sulfasalazine (SALAZOPYRINA) taken for uveitis from 03Sep2018 and ongoing. The patient experienced acute pericarditis and chest pain on 14Jul2021. Patient was brought to the emergency room. The event pericarditis was reported as serious, medically significant. Patient was treated with Colchicine 0.5 mg in the morning, Ibuprofen 600 mg every 8 hours at least 3 weeks and Omeprazole 20 mg in the morning while taking daily Ibuprofen. The patient underwent lab tests and procedures which included Cardiac Auscultation(14Jul2021): Normal, rhythmic, no murmurs or pericardial friction, Pulmonary Auscultation (14Jul2021): Vesicular murmur preserved, Blood creatine phosphokinase 65 IU/l on 14Jul2021, Blood creatine phosphokinase MB 190 IU/l on 14Jul2021, Blood creatinine 0.70 mg/dl (reference: 0.51 to 0.95mg/dl) on 14Jul2021, Blood glucose 80 mg/dl on 14Jul2021, Blood potassium 4.4 mmol/L 5.1 (reference: 3.5 to 5.1 mmol/L) on 14Jul2021, Blood pressure measurement 121/82 on 14Jul2021, Blood sodium 137 mmol/L (reference: 136 to 145 mmol/L) on 14Jul2021, Blood urea 17 mg/l (reference: 8 to 23mg/l) on 14Jul2021, Blood urea 36 mg/dl (reference: 17 to 49 mg/dl) on 14Jul2021, Chest X-ray (14Jul2021): Normal, Centered, inspired. Normal CTI, without condensation or infiltrates, sinuses free, preserved bone frame, C-reactive protein 0.70 mg/dl on 14Jul2021, Echocardiogram pending on 2021, ECG (14Jul2021): 55 lpm, narrow QRS normal axis, millimetric elevation of the ST over the entire lower face and doubtfully in V2, V3, V4 without other alterations in repolarization, Glomerular filtration rate 117.84 ml/min/1.73m^2 on 14Jul2021, Haematocrit 41.9 % (reference: 36 to 43%) on 14Jul2021, Haemoglobin 14.1 g/dl (reference: 12 to 15 g/dl) on 14Jul2021, Haemolysis 77 on 14Jul2021, Heart rate 69 on 14Jul2021, Mean cell haemoglobin concentration 33.7 g/dl (reference: 31.5 to 34.5 g/dl) on 14Jul2021, Mean cell volume 93.3 fl (reference: 80 to 100 fl) on 14Jul2021, Mean platelet volume 10.2 fl (reference: 9 to 13 fl) on 14Jul2021, Oxygen saturation 98 on 14Jul2021, Physical examination (14Jul2021): Normal. Symmetric and normoexpansible chest, without increased work of breathing. Lower extremities: no edema, no signs of deep vein thrombosis, Platelet count 216 10*9/uL (reference: 150 to 450 10*9/uL) on 14Jul2021, Red blood cell count 4.5 10*6/uL (reference: 3.5 to 5.8 10*6/uL) on 14Jul2021, Red cell distribution width 12.2 % (reference: 11.2 to 15.2%) on 14Jul2021, Troponin 0.012 ng/ml (reference: 0.08 to 0.12 ng/ml ) on 14Jul2021. Outcome of events was recovering. No follow-up attempts are possible, no further information is expected.


VAERS ID: 1532360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-14
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1248 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aphasia, Blood pressure measurement, Computerised tomogram head, Electrocardiogram, Fibrin D dimer, Heart rate, Lymphocyte count, Oxygen saturation, Paraparesis, Perfusion brain scan, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pituitary macroadenoma; Radiotherapy (progression of tumor remains); Transsphenoidal surgery; Urinary tract infection (hospital admission for 3 days and bladder catheterization for 1 month)
Allergies:
Diagnostic Lab Data: Test Name: angiogram; Result Unstructured Data: Test Result:no major vessel filling defects; Test Name: blood pressure; Result Unstructured Data: Test Result:117/67 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:140/50 mmHg; Test Name: head CT; Result Unstructured Data: Test Result:without acute alterations, ASPECTS 10; Test Name: EKG; Result Unstructured Data: Test Result:sinus rhythm at about 60 bpm, normal pr, narrow QR; Comments: sinus rhythm at about 60 bpm, normal pr, narrow QRS without alterations in repolarization.; Test Name: d-dimer; Result Unstructured Data: Test Result:310 ng/ml; Test Name: heart rate; Result Unstructured Data: Test Result:67; Test Name: lymphocyte count; Result Unstructured Data: Test Result:4,5 x10 3/mm3; Test Name: o2 saturation; Test Result: 99 %; Test Name: Perfusion CT; Result Unstructured Data: Test Result:decreased volume and flow throughout the right hem; Comments: decreased volume and flow throughout the right hemisphere, with increased mean transit time throughout the right hemisphere.; Test Name: SARS-COV-2 pcr test; Test Result: Negative ; Test Name: Supra-aortic trunks duplex:; Result Unstructured Data: Test Result:Both carotid axes are insoned both in the axial an; Comments: Both carotid axes are insoned both in the axial and longitudinal planes. Both common carotid artery, left coronary artery and external carotid artery are permeable, with a Doppler spectrogram within the range of normality. Left coronary artery speeds within normal range.; Test Name: Transcranial Doppler; Result Unstructured Data: Test Result:Both carotid axes are insoned both in the axial an; Comments: Both carotid axes are insoned both in the axial and longitudinal planes. Both common carotid artery, left coronary artery and external carotid artery are permeable, with a Doppler spectrogram within the range of normality. Left coronary artery speeds within normal range.
CDC Split Type: ESPFIZER INC202100948762

Write-up: Aphasia; Paraparesis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority report number is ES-AEMPS-950581. A 38-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 03Jul2021 (Batch/Lot Number: FE1248) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Pituitary macroadenoma from Jan2007 to an unknown date: Diagnosed in January 2007 (23 years old) as a result of presenting blurred vision in the left eye and retroorbital headache. Intervened by the transsphenoidal route on 30Apr2007 (Hospital PRIVACY, Anatomical Pathology: pituitary adenoma with high cellularity and mixed-type proliferative activity with predominant secretion for FSH and weak for ACTH and PRL). Subsequent treatment with fractionated stereotaxic radiotherapy in 2009 due to progression of tumor remains, the surgical option having been rejected; transsphenoidal from 30Apr2007 to an unknown date; radiotherapy from 2009 to an unknown date progression of tumor remains; urinary tract infection with acute retention of urine that required hospital admission for 3 days and bladder catheterization for 1 month from Feb2009 to an unknown date. The patient''s concomitant medications were not reported. The patient previously took pantoprazole, paracetamol, ibuprofen and naproxen. On 14Jul2021, the patient experienced aphasia and paraparesis. Course of event: On 14Jul202, patient was admitted due to an acute left cerebral hemispheric syndrome, activating the stroke code and performing IV thrombolysis. He made a full recovery. The Lumbar puncture showed aseptic pleocytosis and hyperproteinorrhea. No headache. Anamnesis completed by colleagues. Around 2:30 p.m., while at work, he began an episode of weakness in both lower limbs and general malaise, progressive towards upper limbs. Later it associates alteration in speaking. They report improvement during the transfer, however upon arrival a new worsening in the speech. Physical exploration: Systolic blood pressure (mmHg): 117.0, Diastolic blood pressure (mmHg): 67.0, Heart rate (beats / min): 67.0, Oxygen saturation - baseline (%): 99. NIHSS SCALE: Level of consciousness: alert (0), Answer to questions: fail both (2), Response to orders: does not obey (2), Language: global aphasia with (3), Dysarthria: Not Valuable (0), Conjugate gaze: normal (0), Visual confrontational campimetry: conserved bilateral threat reflex (0) and Facial paresis: No facial asymmetry (0). Upper limbs motor: Barre maneuver: mild right upper limb paresis that does not reach plane. (1), Lower limbs motor: Mingazzini maneuver: Right lower limb mild paresis (1), CPR: Bilateral flexor, Sensitivity: normal (0), Appendicular dysmetria / ataxia: No alterations. (0), Extinction: no extinction or negligence (0), TOTAL NIHSS was 9. Summary of complementary tests under laboratory for Blood test includes: Hemogram: LYMPHOCYTES 4.5 10E3 / uL (1.3 - 3.5), rest without alterations, Hemostasis: D-dimer 310 ng / mL (0 - 250), rest without alterations, Biochemistry and blood gases: without alterations. Cranial CT: without acute alterations, ASPECTS 10 (final report), Pulmonary capillary pressure AngioTC: no major vessel filling defects (final report), Perfusion CT: decreased volume and flow throughout the right hemisphere, with increased mean transit time throughout the right hemisphere. Other tests included ECG: sinus rhythm at about 60 bpm, normal pr, narrow QRS without alterations in repolarization, PCR SARS CoV2 was Negative. Neurosonological Study: Supra-aortic trunks duplex: Both carotid axes are insoned both in the axial and longitudinal planes. Both common carotid artery, left coronary artery and external carotid artery are permeable, with a Doppler spectrogram within the range of normality. Left coronary artery speeds within normal range. Transcranial Doppler: Insonated by transstemporal window in axial plane at mesencephalus level both anterior cerebral artery, arteria cerebral anterior (M1 and M2) and both arteria cerebral posterior (P1 and P2). Symmetric, patent vessel findings with Doppler spectrogram and velocities within the normal range. Conclusion: No pathological findings. Clinical course details: Patient was brought in by Emergency Services without activating the stroke code due to the symptoms of onset at 2:00 p.m. (as reported, approximately), characterized by progressive weakness in the lower limbs, later generalized weakness followed by alteration in the speech. He received 2nd dose of SARS-CoV2 vaccine 1 week ago, Pfizer. Upon his arrival, he scored 9 on the NIHSS scale at the expense of incomplete left hemispheric syndrome. BP: 140/50 mmHg. ECG in sinus rhythm. Given the diagnostic doubts and antecedent of intracranial surgery, in the Shock Room 1/2 ampoule of rivotril was administered without improvement of the symptoms. In blood test, Lymphocytosis (4,5) and D Dimer of 300 stand out. Cranial CT and Angio CT were requested without alterations. A perfusion study was completed showing a decrease in volume and flow throughout the right hemisphere, with an increase in mean transit time throughout the right hemisphere. TSA and transcranial Doppler was performed showing permeable vessels, without flow asymmetry and velocities in range. They discussed the case with localized diagnostic neuroradiologists, who confirmed alteration of global perfusion in the left hemisphere without vessel occlusion (to rule out HaNDL, SMART type, less likely vascular). Since there is no contraindication (commented with vascular equipment), it is started after consultation informed the parents Interventricular septum for 83kg at 6:00 p.m. for 83 kg, referred by relatives. The patient has a history of secondary ADRENAL INSUFFICIENCY, for which he prescribed ACTOCORTINA 100mg as indicated by his endocrine system in case of severe acute processes. He was kept under close surveillance in stroke unit. Principal diagnostic: Left hemispheric syndrome under study, probable mimic stroke, to assess SMART or HaNDL. Other diagnoses: Intravenous thrombolysis. The outcome of events was reported as recovered. The events were considered as serious, involved inpatient hospitalization and life threatening. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1532716 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dysmenorrhoea, Hypoaesthesia, SARS-CoV-2 test, Sweating fever, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fainting; Sweating fever; Period pains; Numbness in fingers; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), SWEATING FEVER (Sweating fever), DYSMENORRHOEA (Period pains) and HYPOAESTHESIA (Numbness in fingers) in a 27-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria hospitalization and medically significant), SWEATING FEVER (Sweating fever) (seriousness criteria hospitalization and medically significant), DYSMENORRHOEA (Period pains) (seriousness criteria hospitalization and medically significant) and HYPOAESTHESIA (Numbness in fingers) (seriousness criteria hospitalization and medically significant). On 14-Jul-2021, SWEATING FEVER (Sweating fever) had resolved. On 16-Jul-2021, HYPOAESTHESIA (Numbness in fingers) had resolved. At the time of the report, SYNCOPE (Fainting) and DYSMENORRHOEA (Period pains) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not provided. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1532764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Catarrh, Dizziness, Fatigue, Oropharyngeal pain, Pain, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941728

Write-up: Vaginal bleeding; Sore throat; Nasal catarrh; Fatigue; Ache; Dizziness; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221556330920-LAZEU, Safety Report Unique Identifier GB-MHRA-ADR 25693666. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Jul2021 (Lot number was not reported) as second dose, 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. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 14Jul2021, the patient experienced fatigue, ache, dizziness. On 15Jul2021, the patient experienced sore throat and nasal catarrh. On 20Jul2021, the patient experienced vaginal bleeding. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on 19Jul2021. Therapeutic measures were taken as a result of all the events which included paracetamol. Outcome of the event sore throat was recovered on 20Jul2021; event fatigue was recovered on 14Jul2021; event ache was recovered on 16Jul2021. Outcome of the events vaginal bleeding, dizziness and nasal catarrh was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-14
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100941838

Write-up: Heavy periods; This is a spontaneous report from a contactable consumer (Patient). This report received from the . The regulatory authority report number is GB-MHRA-WEBCOVID-202107222030503620-HQLMJ. Safety Report Unique Identifier GB-MHRA-ADR 25695429. This consumer reported that the 34-yeas-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history included lactation decreased. The patient concomitant medications were not reported. On 14Jul2021 the patient had heavy periods. Extremely heavy period with large clots. Used night- time maxi sanitary pads which had to be changed every half hour. Blood was literally flowing down my legs over a number of hours. The patient underwent lab tests and procedures which included SARS-CoV-2 test was negative. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The event was medically significant. The outcome of the event was recovered on 20Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1532846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-14
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943430

Write-up: Late period; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory. The regulatory authority report number is GB-MHRA-WEBCOVID-202107231001098600-YFVF7, Safety Report Unique Identification Number: GB-MHRA-ADR 25697640. A 21-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jun2021 at single dose for COVID-19 immunization. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced late period on 14Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1533132 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100943315

Write-up: Shivering; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107241829550770-TM1NY, Safety Report Unique Identifier GB-MHRA-ADR 25703307. A 38-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 14Jul2021 (Batch/Lot number was not reported) at the age of 38-year-old, as dose 2, single for covid-19 immunisation. Medical history included pregnancy. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced headache on 14Jul2021, shivering on 15Jul2021. Events seriousness criteria was medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of events was recovered on 16Jul2021. No follow-up attempts are possible. Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1533343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-07-14
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100997394

Write-up: Contracted covid a few months after being vaccinated; Contracted covid a few months after being vaccinated; Feeling unwell; This is a spontaneous report from a contactable consumer via medical information team. A 46-year-old female patient received the second dose and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 19Feb2021, first dose on 29Jan2021, both via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medical were not reported. On 16Jul2021, the patient experienced contracted COVID a few months after being vaccinated. The patient was diagnosed with COVID on the 16th. On 14Jul201, the patient felt unwell. The patient stated felt fine after the vaccine. Raised AE due to contracting COVID following vaccination. Patient was a Employee and was happened to be contacted for follow up. The outcome of feeling unwell was recovering, the outcome of other events was unknown. Information on the lot/batch number has been requested.


VAERS ID: 1533488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3065 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dizziness, Eyelid function disorder, Heart rate, Nausea, Oxygen saturation, Vertigo, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:140/90 mmHg; Test Name: heart rate; Result Unstructured Data: Test Result:105; Test Name: spo2; Test Result: 99 %
CDC Split Type: ITPFIZER INC202100949133

Write-up: Patient both at I and II doses experienced sudden dizziness, reported as subjective with inability to open eyelids and lasted for 3 days after I dose. Nausea with vomiting started./ vertigo; Patient both at I and II doses experienced sudden dizziness, reported as subjective with inability to open eyelids and lasted for 3 days after I dose. Nausea with vomiting started.; Patient both at I and II doses experienced sudden dizziness, reported as subjective with inability to open eyelids and lasted for 3 days after I dose. Nausea with vomiting started.; sudden dizziness; inability to open eyelids; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Ageny-WEB. The regulatory authority report number IT-MINISAL02-757494. A 29-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Jul2021 (Batch/Lot Number: FE3065) as DOSE NUMBER UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden dizziness, and reported as subjective with inability to open eyelids and lasted for 3 days with nausea, vomiting and vertigo on 14Jul2021. The patient underwent lab tests and procedures which included blood pressure measurement: 140/90 mmhg, heart rate: 105 and oxygen saturation: 99 %. The outcome of events was recovered with sequelae.


VAERS ID: 1533489 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Immune thrombocytopenia, Investigation, Petechiae, Platelet count, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thrombocytopenic purpura
Allergies:
Diagnostic Lab Data: Test Name: 20 x 10 ^ 3 IU / L; Result Unstructured Data: Test Result:20 x 10 ^ 3 IU / L; Test Date: 20210714; Test Name: Platelet count; Test Result: 20 k[iU]; Test Date: 20210710; Test Name: PLT count; Result Unstructured Data: Test Result:around 100,000
CDC Split Type: ITPFIZER INC202100949144

Write-up: The patient comes to the emergency room for evidence to the laboratory tests of thrombocytopenia. the patient reports that she has m. of werloff with a PLT count of around 100,000; The patient comes to the emergency room for evidence to the laboratory tests of thrombocytopenia. the patient reports that she has m. of werloff with a PLT count of around 100,000; The patient comes to the emergency room for evidence to the laboratory tests of thrombocytopenia. the patient reports that she has m. of werloff with a PLT count of around 100,000; The patient comes to the emergency room for evidence to the laboratory tests of thrombocytopenia. the patient reports that she has m. of werloff with a PLT count of around 100,000; This is a spontaneous report from a contactable physician IT-MINISAL02-757502. A 42-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 10Jul2021 (Batch/Lot Number: Unknown) as 0.3ml single for COVID-19 immunization. Medical history included thrombocytopenic purpura from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced Thrombopenia, Petechia, Werlhof''s syndrome, and Asthenia on 14Jul2021. The patient comes to the emergency room for evidence to the laboratory tests of thrombocytopenia. The patient reports that she has "M. of Werloff" with a PLT count of around 100,000 on 14Jul2021. Last Saturday (10Jul2021) he practiced II dose of Pfizer vaccine. Events required Emergency Room Visit. The patient was hospitalized for the events. The patient underwent lab tests and procedures which included investigation: 20 x 10 ^ 3 IU / L on an unspecified date, platelet count: 20 kiU on 14Jul2021, platelet count: around 100,000 on 10Jul2021. The outcome of the events was unknown. No follow-up attempts are possible, information on lot/batch number cannot be obtained.


VAERS ID: 1533523 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Haemorrhoidal haemorrhage, Haemorrhoids, Investigation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: examination for bleeding; Result Unstructured Data: Test Result:results unknwn
CDC Split Type: ITPFIZER INC202100948667

Write-up: bleeding from haemorrhoids; Haemorrhoids; second dose of vaccine carried out on 14Jul2021 with pfizer, in the evening diarrhoea appeared, on 15Jul2021 diarrhoea; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority, regulatory authority number IT-MINISAL02-759704. A 42-years-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: FE2707), via an unspecified route of administration on 14Jul2021 (at the age of 42-years-old) as dose 2, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced second dose of vaccine carried out on with pfizer, in the evening diarrhoea appeared. On15Jul2021, the patient experienced haemorrhoids with slight bleeding. On 16Jul2021, the patient had bleeding from haemorrhoids. Events were considered to be medically significant. The patient underwent lab tests and procedures which included investigation results unknown. The patient underwent lab tests and procedures which included investigation results unknown. Therapeutic measures were taken as a result second dose of vaccine carried out on 14Jul2021 with pfizer, in the evening diarrhoea appeared, on 15Jul2021 diarrhoea, haemorrhoids with slight bleeding on 16Jul2021 bleeding from haemorrhoids, diarrhoea. The outcome of the events was not recovered. Health authority comment: The patient has never suffered from haemorrhoids. Sender''s comments: 19/Jul2021 Center of Pharmacovigilance: requested from reporter no. lot. Awaiting reply. 21Jul2021 Acknowledgement received, card field updated. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1533541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Diarrhoea, Dysentery, Fatigue, Immunoglobulins, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:37.5; Test Name: immunoglobulin; Result Unstructured Data: Test Result:IgGK - Presence of a monoclonal fraction referable; Comments: IgGK - Presence of a monoclonal fraction referable to an IgG immunoglobulin mounting Kappa light chains.
CDC Split Type: ITPFIZER INC202100945008

Write-up: Muscle and joint pains. Fever 37.5. Dysentery. Tiredness; Muscle and joint pains. Fever 37.5. Dysentery. Tiredness; Muscle and joint pains. Fever 37.5. Dysentery. Tiredness; Muscle and joint pains. Fever 37.5. Dysentery. Tiredness; diarrhea without blood loss; Muscle and joint pains. Fever 37.5. Dysentery. Tiredness; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB:IT-MINISAL02-759883. A 47-year-old female patient received second dose bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FF0688, expiry date not reported), intramuscularly administered in Arm Left (shoulder) on 13Jul2021 at 14:04 as dose 2, 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced muscle and joint pains, fever 37.5, dysentery, tiredness, diarrhea without blood loss. The patient took 1 tachipirina 500 and rest as a corrective measure for all the events. The impact on quality of life was reted as 8/10. After consulting the doctor on 23Jul2021 as requested by the regional pharmacovigilance service, it was specified profuse diarrhea without blood loss and no dysentery. The patient underwent lab tests and procedures which included body temperature: 37.5 on 14Jul2021, immunoglobulins: IgGK - Presence of a monoclonal fraction referable to an IgG immunoglobulin mounting Kappa light chains on an unknown date. The outcome of all the events was recovering. Senders comments: vaccine administered at 14.04 After consulting the doctor on 23Jul2021 as requested by the regional pharmacovigilance service, it is specified profuse diarrhea without blood loss and no dysentery No follow-up attempts possible. No further information expected.; Reporter''s Comments: IgGK - Presence of a monoclonal fraction referable to an IgG immunoglobulin mounting Kappa light chains.


VAERS ID: 1533597 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; OMEPRAZOLE; CANDESARTAN; MAGNESIUM; PANTETHINE; DOPACOL; DONEPEZIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Convulsion (It happened two years ago, but it didn''t happen within a year.); Dementia; Hypertension; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100944201

Write-up: Urticaria; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120909. The patient was a 83-year and 4-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. it was unknown wether the patient had family history or not. The Birth weight was unknown. The patient had history include: Hypertension, Parkinson''s disease, Dementia. No drug allergy, no drug adverse event. Oral medications included: Amlodipine OD(5) 1 tablet 1 day, Omeprazole(10) 1 tablet 1 day, Candesartan(4) 2 tablets 2 day, Magnesium 1.5g 3days, Pantethine Powder 20% 2.0g, 3 days, DOPACOL(100) 3 tablet 3 days, Donepezil OD(5), 1 tablets 1 day. On 13Jul2021 at 18:30 (the day of vaccination), the patient received the first dose (0.3ml) of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC5295, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 14Jul2021 at 13:00 (1 day after the vaccination), the patient experienced Urticaria. On unspecified date, the outcome of the event was unknown. The course of the event was as follows: On 13Jul2021, at 18:00, the patient received COVID-19 vaccine (Pifer). On 14Jul2021, in the morning, no abnormal, and the patient went to elderly day care. After the noon passed and the patient returned home, the patient''s family found the patient had urticaria on the precordial. At 16:45 in the evening, the patient went to the hospital for check-up. It was confirmed that excepet the precordial, both arms also had Urticaria. The patient went to a emergency outpatient department for a check-up due to spread of symptoms. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: During the elderly day care period, the patient had lunch. Thought it might be due to the allergy caused by this incident, but so far, the patient had no food allergy history, so it cannot be denied that it was due to the adverse event caused by COVID-19 vaccine. The 2nd dose of vaccination cancelled. Prevaccination Screening Questionnaire for COVID-19 vaccine provided as follows: The patient was currently treated (with medications, etc.) for Hypertension, Parkinson''s disease, Dementia. The patient had not been sick or had a fever in the past month. The patient was not feeling sick on the day of vaccination. The patient had convulsion (seizure), It happened two years ago, but it didn''t happen within a year. The patient did not have severe allergic reactions (anaphylaxis, etc.) to a medication or food. The patient had never been sick after receiving vaccination. The patient was not possibly pregnant (e.g late period) or currently breast-feeding. The patient had not received any other vaccines in the past two weeks.


VAERS ID: 1533641 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adrenal insufficiency, Blood aldosterone, Blood cortisol, Computerised tomogram abnormal, Dehydration, Dizziness, Haemodynamic instability, Heat illness, Hyperhidrosis, Malaise, Orthostatic hypotension, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Aldosterone; Result Unstructured Data: Test Result:4.0 or less unmeasurable; Test Date: 20210715; Test Name: Cortisol; Result Unstructured Data: Test Result:16.1; Test Date: 20210715; Test Name: CT; Result Unstructured Data: Test Result:was suspected Adrenal failure
CDC Split Type: JPPFIZER INC202100952448

Write-up: Acute Adrenal failure/ Adrenal failure/ drug-induced Adrenal failure/ Aldosterone was 4.0 or less unmeasurable/ Cortisol was 16.1; Orthostatic hypotension; Haemodynamic instability; Sweaty; Giddiness; Vomiting; general malaise; Heat illness; Dehydration symptom; This is a spontaneous report received from a contactable physician via a company representative. The patient was a male in his 70s (reported as 8-decade). On 06Jul2021 (the day of vaccination), the patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown) intramuscular as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 15Jul2021 (also reported as 6 days after vaccination), the patient experienced acute adrenal failure. Clinical course of events was reported as follow: on 06Jul2021, the patient vaccinated the second intramuscular vaccination and lot number unknown due to vaccination at another facility. On 14Jul2021, the patient experienced sweaty, giddiness, vomiting, and general malaise during the morning walk, and the patient visited the clinic. Considered to be due to heat illness and took measures for dehydration symptom. On 15Jul2021, condition was more aggravated than the previous day, the patient experienced orthostatic hypotension, haemodynamic instability. By computerised tomogram (CT) showed that the patient was not head bleeding, was suspected adrenal failure, aldosterone was 4.0 or less unmeasurable, cortisol was 16.1. On 16Jul2021, there was no adrenal haemorrhage, and the patient was diagnosed with drug-induced adrenal failure based on the aldosterone concentration. The patient took hydrocortisone (CORTRIL) 15 mg per day to obverse. The patient took a week off from work. The patient was able to eat at that time. The patient scheduled to visit another hospital for examination on 03Aug2021. No Hepatic function abnormal. Considering the timing of antibody production, it seems to be due to vaccination. The outcome of the events as well as seriousness were not provided. The causality between the suspect drug and event was related. The outcome of the events was unknown. Information about lot/batch number has been requested.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1533693 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003658 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Decrease; Test Name: Body temperature; Result Unstructured Data: 36.4 degree Celsius
CDC Split Type: JPTAKEDA2021TJP068321

Write-up: Loss of consciousness; Bradycardia; Vasovagal reflex (decreased blood pressure); This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP068321) on 23-Jul-2021 and was forwarded to Moderna on 03-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) and BRADYCARDIA (Bradycardia) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003658) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), BRADYCARDIA (Bradycardia) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reflex (decreased blood pressure)). At the time of the report, LOSS OF CONSCIOUSNESS (Loss of consciousness), BRADYCARDIA (Bradycardia) and PRESYNCOPE (Vasovagal reflex (decreased blood pressure)) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Blood pressure measurement: decrease (Low) Decrease. On an unknown date, Body temperature: 36.4 degree Celsius (normal) normal. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness), BRADYCARDIA (Bradycardia) and PRESYNCOPE (Vasovagal reflex (decreased blood pressure)) to be not related. No concomitant medications were reported. No medical treatment information was reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: This case was reported in accordance with the patient''s complaint.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1533709 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-14
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002913 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure diastolic, Blood pressure increased, Blood pressure systolic, Chest pain, Dyspnoea, Palpitations
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; ROSUVASTATIN; CLOPIDOGREL; METFORMIN; LOSARTAN
Current Illness: Primary hypertension; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Stent placement (Procedure for stent placement was performed in 2019.); Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Blood pressure diastolic; Result Unstructured Data: Blood pressure increased; Test Date: 20210715; Test Name: Blood pressure systolic; Result Unstructured Data: Blood pressure increased
CDC Split Type: LVMODERNATX, INC.MOD20212

Write-up: Palpitations; Chest pain; Shortness of breath; Arrhythmia NOS; Blood pressure increased; This regulatory authority case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmia NOS), PALPITATIONS (Palpitations), CHEST PAIN (Chest pain) and BLOOD PRESSURE INCREASED (Blood pressure increased) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002913) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. The patient''s past medical history included Stent placement (Procedure for stent placement was performed in 2019.) in 2019. Concurrent medical conditions included Primary hypertension and Type 2 diabetes mellitus. Concomitant products included ACETYLSALICYLIC ACID, ROSUVASTATIN, CLOPIDOGREL, METFORMIN and LOSARTAN for an unknown indication. On 28-Jun-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced ARRHYTHMIA (Arrhythmia NOS) (seriousness criterion medically significant) and BLOOD PRESSURE INCREASED (Blood pressure increased) (seriousness criterion medically significant). On 14-Jul-2021 at 7:00 AM, the patient experienced PALPITATIONS (Palpitations) (seriousness criterion medically significant), CHEST PAIN (Chest pain) (seriousness criterion medically significant) and DYSPNOEA (Shortness of breath). At the time of the report, ARRHYTHMIA (Arrhythmia NOS), PALPITATIONS (Palpitations), CHEST PAIN (Chest pain), BLOOD PRESSURE INCREASED (Blood pressure increased) and DYSPNOEA (Shortness of breath) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Blood pressure diastolic: 109 millimetre of mercury Blood pressure increased. On 15-Jul-2021, Blood pressure systolic: 178 millimetre of mercury Blood pressure increased. Treatment information were not provided by the reporter. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1533798 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0900 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Heart rate, Hyperhidrosis, Malaise, Muscle contractions involuntary, Oxygen saturation, Palpitations, Physical examination, Tachycardia, Tension, Tryptase
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dystonia (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:176/96 mmHg; Comments: 176/96 mmHg. After second dose of epinephrine, and polaramine+hydrocortisone.; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/100 mmHg; Comments: 180/100 mmHg. Measured by emergency team upon arrival.; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Test Result:160; Comments: Units:{beats}/min; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Test Result:140; Comments: Units:{beats}/min; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Test Result:124-130; Comments: 124-130 bpm. After second dose of epinephrine, and polaramine+hydrocortisone.; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Test Result:150; Comments: Units:{beats}/min; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Test Result:124-132; Comments: 124-132 bpm after 0.5 mg of epinephrine i.m. left thigh.; Test Date: 20210714; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:97-98 %; Comments: 97-98%. Measured by emergency team upon arrival.; Test Date: 20210714; Test Name: Oxygen saturation; Test Result: 97 %; Test Date: 20210714; Test Name: Physical examination; Result Unstructured Data: Test Result:Lying down, very tense, almost stiff; Comments: Observation from the emergency team upon arrival: Lying down, very tense, almost stiff and with slight twitches of feet and arms. Mentally clear, warm, no pallor of face or hands, slightly sweaty. No difficulty breathing, no rash or pruritus or symptoms from mouth or throat. No chest pain or feeling or pressure or closure of chest.; Test Date: 20210714; Test Name: Physical examination; Result Unstructured Data: Test Result:more unwell, more tense and became more sweaty; Comments: After 20 minutes of observation the patient felt more unwell, more tense and became more sweaty.; Test Date: 20210714; Test Name: Physical examination; Result Unstructured Data: Test Result:Feeling more unwell, tense, warm and mentally clea; Comments: 30 minutes after first dose of epinephrine was given. Feeling more unwell, tense, warm and mentally clear, no breathing difficulties. Administered new dose of epinephrine 0.5 mg i.m. right thigh and also polaramine 5 mg in left thigh, in addition Solu-Cortef (hydrocortisone) 100 mg i.v. over time, 1000 Ringer.; Test Date: 20210714; Test Name: Tryptase; Result Unstructured Data: Test Result:results not ready; Comments: Taken, but results not ready at the time of the report.
CDC Split Type: NOPFIZER INC202100949291

Write-up: shivers; Powerful long lasting 2 hours + Tachycardia 140-160; muscular twitching/muscle fasciculation, feet and arms without any hyperventilation, no difficulty breathing no rash; Tension; Feeling unwell; palpitations; slightly sweaty/ more sweaty; blood pressure measurement: 180/100 mmhg on 14Jul2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Ugrjqp. A 47-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FF0900, Expiration date: Unknown), intramuscular, administered in left arm on 14Jul2021 12:10 (at the age of 47-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced feeling unwell, powerful long lasting 2 hours + tachycardia 140-160, muscular twitching/muscle fasciculation, feet and arms without any hyperventilation, no difficulty breathing no rash and tension. On 14Jul2021, few minutes after the vaccination, the patient was feeling unwell, with shivers and palpitations. The patient was placed lying down on a bench and the emergency team was called upon. When they arrived the patient had tension, tachycardia and muscle fasciculation, feet and arms. The patient was otherwise Mentally clear, warm, no pallor of face or hands, slightly sweaty. No difficulty breathing, no rash or pruritus or symptoms from mouth or throat. No chest pain or feeling or pressure or closure of chest. His pulse rate was 140 bpm regular, blood pressure 180/100 mmHg, oxygen saturation 97-98%. After 20 minutes of observation, the patient felt more unwell, more tense and became more sweaty. Pulse rate 150 bpm regular. The emergency team then decided to administer 0.5 mg epinephrine, and the pulse rate decreased to 124-132 bpm. After another 30 minutes of observation the pulse rate increased to 160 bpm, oxygen saturation was 97%. The patient was feeling more unwell, tense, but was warm and mentally clear, no breathing difficulties. Administered new dose of epinephrine 0.5 mg i.m. right thigh and also polaramine 5 mg in left thigh, in addition Solu-Cortef (hydrocortisone) 100 mg i.v. over time, 1000 Ringer. The pulse rate then decreased to 124-130 bpm and the blood pressure was 176/96 mmHg. After this the patient was admitted to hospital. The emergency team interpreted the symptoms as an allergic reaction due to persistent tachycardia and worsening of the symptoms after more than 45 minutes. The patient was discharged from hospital the following day and had recovered. The hospital had concluded that the symptoms was an atypical allergic reaction. The patient was hospitalized for the events from 14Jul2021 to 15Jul2021. The patient underwent lab tests and procedures which included blood pressure measurement: 176/96 mmhg, 176/96 mmHg on 14Jul2021. After second dose of epinephrine, and polaramine+hydrocortisone , blood pressure measurement: 180/100 mmhg on 14Jul2021 180/100 mmHg. Measured by emergency team upon arrival, heart rate: 160 on 14Jul2021 Units: {beats}/min, heart rate: 140 on 14Jul2021 Units: {beats}/min, heart rate: 124-130 on 14Jul2021 124-130 bpm. After second dose of epinephrine, and polaramine+hydrocortisone, heart rate: 150 on 14Jul2021 Units: {beats}/min, heart rate: 124-132 on 14Jul2021 124-132 bpm after 0.5 mg of epinephrine i.m. left thigh, oxygen saturation: 97-98 % on 14Jul2021 97-98%. Measured by emergency team upon arrival, oxygen saturation: 97 % on 14Jul2021, physical examination: lying down, very tense, almost stiff on 14Jul2021 Observation from the emergency team upon arrival: Lying down, very tense, almost stiff and with slight twitches of feet and arms. Mentally clear, warm, no pallor of face or hands, slightly sweaty. No difficulty breathing, no rash or pruritus or symptoms from mouth or throat. No chest pain or feeling or pressure or closure of chest, physical examination: more unwell, more tense and became more sweaty on 14Jul2021 After 20 minutes of observation the patient felt more unwell, more tense and became more sweaty, physical examination: feeling more unwell, tense, warm and mentally clear on 14Jul2021 30 minutes after first dose of epinephrine was given. Feeling more unwell, tense, warm and mentally clear, no breathing difficulties. Administered new dose of epinephrine 0.5 mg i.m. right thigh and also polaramine 5 mg in left thigh, in addition Solu-Cortef (hydrocortisone) 100 mg i.v. over time, 1000 Ringer, tryptase: results not ready on 14Jul2021 Taken, but results not ready at the time of the report. Therapeutic measures were taken as a result of the events with 0.5 mg epinephrine, polaramine 5 mg and Solu-Cortef. The outcome of the events was recovered on 15Jul2021. Sender Comment: It is stated that the patient developed tachycardia, which can be perceived as a major or minor symptom, but then in combination with, for example, tachycardia. The symptoms reported in the report have only affected the circulation, and no symptoms relevant to anaphylaxis from other organ systems have been described. Muscle twitching is not a symptom that is included among typical anaphylaxis symptoms. Tryptase samples have been taken, but results are not available at the time of notification. The Regional Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1533818 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210807799

Write-up: FEVER; TIREDNESS; HEADACHE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-2933] concerned a 37 year old male with unknown race and ethnicity. 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) 0.5 ml, 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced headache. On 15-JUL-2021, the patient experienced fever and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, fever and tiredness was not reported. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Concomitant Medication-None Medication Error Occurred?-None; Sender''s Comments: V0: 20210807799-COVID-19 VACCINE AD26.COV2.S- headache, fever, tiredness. This event(s) is labeled and is therefore considered potentially related.


VAERS ID: 1533879 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: no medical history was provided
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Syncope; Dizziness; Nausea; Vomiting; Chills; This regulatory authority case was reported by an other health care professional and describes the occurrence of SYNCOPE (Syncope) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was provided. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills). At the time of the report, SYNCOPE (Syncope) outcome was unknown and DIZZINESS (Dizziness), NAUSEA (Nausea), VOMITING (Vomiting) and CHILLS (Chills) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. The patient was told to drink more water Based on the currently available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Translation received 04Aug2021: Case Upgraded to serious due to addition of event syncope which is medically significant. Event dizziness was also added upon Follow-up. outcome of the events chills, nausea, vomiting, and dizziness. were captured as recovering/resolving; Sender''s Comments: Based on the currently available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1534594 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-14
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100964236

Write-up: Local reaction; This is a spontaneous report from a non-contactable consumer received via the Regulatory Authority. The regulatory authority number is ZA-SAHPRA-202107141605007520-XWZ6L. A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: FD0927), via an unspecified route of administration on 14Jun2021 (at the age of 61-years old) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Jul2021 (1 month after the vaccination), the patient experienced local reaction. The event was considered serious (hospitalization). The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1534595 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: ZAPFIZER INC202100964238

Write-up: Afebrile seizure; This is a spontaneous report from a non-contactable consumer received via the Regulatory Authority. The regulatory authority number is ZA-SAHPRA-202107150836261520-LGSEE. A 79-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 12Jul2021 (Batch/Lot Number: Fe2090) as single dose (at the age of 79-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced afebrile seizure. The patient was hospitalized due to the event. The patient was recovering from the event. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1534607 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Gait inability, Hallucination
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (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: ZAPFIZER INC202100970793

Write-up: Hallucination; Decreased appetite; Unable to walk; This is a spontaneous report from a non-contactable consumer received via the Regulatory Authority, with regulatory authority number ZA-SAHPRA-202107211410387580-3WTHG. A 71-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jul2021 (Lot Number: FC1436, Expiry date 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 hallucination, decreased appetite and unable to walk on 14Jul2021. The events were reported with a seriousness of disabling/ incapacitating. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1535812 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: PTJNJFOC20210808765

Write-up: FAINT; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-B202107-2950] concerned a 29 year old male with unspecified race and ethnicity. The patient''s weight was 85 kilograms, and height was 186 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: unknown) 0.5 ml, 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced faint. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from faint on 14-JUL-2021. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Concomitant Medication-No Medication Error Occurred?-No; Sender''s Comments: V0: 20210808765-COVID-19 VACCINE AD26.COV2.S - Faint. This event is considered unassessable. The event 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.


VAERS ID: 1535814 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210810331

Write-up: LOSS OF KNOWLEDGE; TONIC-CLONICS MOVEMENTS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-2966] concerned a 33 year old of unspecified sex, race and ethnicity The patient''s weight was 58 kilograms, and height was 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) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced loss of knowledge, and tonic-clonics movements. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss of knowledge, and tonic-clonics movements on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Concomitant Medication-No Medication Error Occurred-No; Sender''s Comments: V0: 20210810331-COVID-19 VACCINE AD26.COV2.S- loss of knowledge, and tonic-clonics movements. 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: 1537873 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100982204

Write-up: Facial palsy; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the regulatory authority, number DE-PEI-202100141387. A 56-year-old male patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: FE7011), via an unspecified route of administration on 09Jul2021 (at the age of 56-years-old) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received Comirnaty on 27May2021 for covid-19 immunization. Similar symptoms in 2018 after flu vaccination. On 14Jul2021, the patient experienced facial palsy. Reporter considered the case as non-serious. At the time of report, the outcome of event was not recovered. Sender''s comment: First vaccination Comirnaty on 27May2021. Diagnosis only clinical. Similar symptoms in 2018 after flu vaccination. Relatedness of drug to reactions/events. Comirnaty/ Facial palsy/ PEI/ D. Unclassifiable No follow-up attempts possible. No further information expected.


VAERS ID: 1538008 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Depressed level of consciousness, Dizziness, Hypertension, Tremor
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100954684

Write-up: LITTLE HIGH BLOOD PRESSURE; Dizziness; Obtundation; Shakiness; Loss of memory; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority, regulatory authority number ES-AEMPS-951528. A non pregnant 40-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm on 14Jul2021 (Batch/Lot Number: FC1435) as dose 1, single for covid-19 immunization(vaccination at 40-years-old). The patient medical history was not reported. Concomitant medication(s) included escitalopram (ESCITALOPRAM) taken for an unspecified indication from 14Jul2021 to an unspecified stop date. The patient experienced dizziness (dizziness) (medically significant) on 14Jul2021 with outcome of not recovered , obtundation (depressed level of consciousness) (medically significant) on 14Jul2021 with outcome of not recovered , shakiness (tremor) (medically significant) on 14Jul2021 with outcome of recovered , loss of memory (amnesia) (medically significant) on 14Jul2021 with outcome of not recovered , little high blood pressure (hypertension) (non-serious) on an unspecified date with outcome of unknown. Reffered to primary care for a little high blood pressuere. No follow-up attempts are possible. No further information expected.


VAERS ID: 1538029 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202100958964

Write-up: Fainting; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority number ES-AEMPS-955478. A 36-year-old male patient received the second dose of bnt162b2 (COMIRNATY), on 14Jul2021 at the age of 36 years (Batch/Lot Number: FD9309) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY, Lot number: FD8274) on 23Jun2021 for covid-19 immunisation. The patient experienced fainting on 14Jul2021. Outcome of the event was unknown. No follow-up attempts are possible. No expected further is information.


VAERS ID: 1538145 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypertension
SMQs:, Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Test Result:190/20 mmHg
CDC Split Type: FRPFIZER INC202100954901

Write-up: arterial hypertension (blood pressure 190/20 mmHg); This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20212816. A 76-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on 13Jul2021 (Batch/Lot number was not reported; at the age of 76 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021 (day 2), the patient experienced arterial hypertension (blood pressure 190/20 mmHg) having motivated a medical consultation and the setting on antihypertensive treatment (molecule not specified). Favourable evolution. The patient recovered from the event in Jul2021. The event was assessed as serious (medically significant). Information on the lot/batch number has been requested.


VAERS ID: 1538178 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2296 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood count, Blood creatine phosphokinase, Blood pressure measurement, Condition aggravated, Echocardiogram, Heart rate, Pericarditis, SARS-CoV-2 test, Specialist consultation, Troponin
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute pericarditis (11 episodes); Gastric ulcer; Renal colic; Smoker; Valvular heart disease NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood count; Result Unstructured Data: Test Result:Normal; Test Date: 20210714; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:Normal; Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: Test Result:110/70 mmHg; Test Date: 20210714; Test Name: echocardiography; Result Unstructured Data: Test Result:showing no sign of pericardial effusion.; Comments: showing no sign of pericardial effusion.; Test Date: 20210715; Test Name: echocardiography; Result Unstructured Data: Test Result:left atrium slightly dilated, mitral valve remodel; Comments: left atrium slightly dilated, mitral valve remodeled, left ventricle not dilated, normal segmental motion, aortic root not dilated and presence of a 4mm pericardial effusion.; Test Date: 20210715; Test Name: Electrocardiography; Result Unstructured Data: Test Result:sinus rhythm and regular, Heart Rate at 72bpm, nor; Comments: sinus rhythm and regular, Heart Rate at 72bpm, normal PR space, no sequelae of myocardial necrosis, no repolarisation disorder, no extrasystole.; Test Date: 20210715; Test Name: heart rate; Result Unstructured Data: Test Result:regular; Test Date: 20210715; Test Name: heart rate; Result Unstructured Data: Test Result:72; Comments: bpm; Test Date: 20210628; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210715; Test Name: specialist medical consultation; Result Unstructured Data: Test Result:patient in good general condition, presenting with; Comments: patient in good general condition, presenting with retrosternal chest pain, regular heart sounds, no murmur, Blood pressure 110/70mmHg, no signs of cardiac insufficiency.; Test Date: 20210714; Test Name: Troponin; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC202100954843

Write-up: Pericarditis; Pericarditis; This is a spontaneous report from a contactable physician downloaded from a regualtory authority. A 42-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 24Jun2021 (Lot Number: FE2296) as DOSE 2, 0.3 ML SINGLE for covid-19 immunization. Medical history included acute pericarditis from an unknown date 11 episodes, renal colic from Mar2018 to Mar2018, gastric ulcer from Jun2017, valvular heart disease from an unknown date, and smoking from an unknown date. The patient previously had COMIRNATY dose 1 on unspecified date for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient had no history of COVID-19. The patient experienced pericarditis on 14Jul2021. On 28Jun2021: Polymerase Chain Reaction (PCR) test done: negative. Between 09Jul2021 and 14Jul2021, the patient reports a heavy workload with organising and managing the health protocol for a public event. On the morning of 14Jul2021, onset of retrosternal chest pain, unrelated to exercise and increased by deep breathing. Medical consultation at the event site on 14Jul2021: electrocardiogram unremarkable, oral administration of trinitrine in decubitus, malaise and then discrete clinical improvement. Emergency medical consultation on 14Jul2021: biological check-up without any particularities with normal Complete blood count, normal troponin and Creatine phosphokinase, echocardiography showing no sign of pericardial effusion. Specialist medical consultation on 15Jul2021: on clinical examination, patient in good general condition, presenting with retrosternal chest pain, regular heart sounds, no murmur, Blood pressure 110/70mmHg, no signs of cardiac insufficiency. Electrocardiography of 15Jul2021: sinus rhythm and regular, Heart Rate at 72bpm, normal PR space, no sequelae of myocardial necrosis, no repolarisation disorder, no extrasystole. Echocardiography on 15Jul2021: left atrium slightly dilated, mitral valve remodeled, left ventricle not dilated, normal segmental motion, aortic root not dilated and presence of a 4mm pericardial effusion. Introduction of acetylsalicylic acid 3000mg/day for 3 weeks combined with pantoprazole. On 20Jul2021, patient not recovered and complaining of marked asthenia. Specialty name unknown for acetylsalicylic acid and pantoprazole. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected.


VAERS ID: 1538294 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEMODETTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100956521

Write-up: Joint pain; Headache; Muscle ache; Feeling sick; Fatigue; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 28-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 14Jul2021 as dose 2 single (at the age of 28-years-old) for COVID-19 immunization. Medical history included contraception. Concomitant medication included ethinylestradiol, gestodene (FEMODETTE) as contraception. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. On 14Jul2021, patient experienced fatigue. On 15Jul2021, patient experienced headache, muscle ache, feeling sick. On 17Jul2021, patient experienced joint pain. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date No - Negative COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event headache, muscle ache was not recovered, outcome of the event feeling sick was recovered on 17Jul2021 and outcome of the events fatigue, joint pain was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected


VAERS ID: 1538806 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Type I hypersensitivity, Vital signs measurement
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Vital functions monitored; Result Unstructured Data: Test Result: not reported.
CDC Split Type: ITPFIZER INC202100944925

Write-up: Immediate hypersensitivity; This is a spontaneous report from a contactable other hcp from the regulatory authority number IT-MINISAL02-757475. A 27-year-old female patient received first dose of bnt162b2 (COMIRNATY; Solution for injection; lot number: FF0688; expiration date: 31Oct2021) intramuscularly in left arm on 14Jul2021 at 15:35 (at the age of 27-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On 14Jul2021, after receiving first dose of vaccination, patient experienced Immediate hypersensitivity. Vital functions were monitored, results not reported. Treatment included administration of Cetirizine 10mg orally. Outcome of the event was resolved on 14Jul2021.


VAERS ID: 1538871 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cystitis haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAGNESIUM SUPREME; BROMELAIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100953662

Write-up: An hour after the second dose of vaccine, patient developed hemorrhagic cystitis; This is a spontaneous report from contactable consumer IT-MINISAL02-760957. A 27-year-old female patient received the second dose of bnt162b2 (COMIRNATY; Batch/Lot number was not reported) intramuscularly administered into left arm on 14Jul2021 (at the age of 27-year-old) as dose 2, 0.3 mL, single for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included magnesium glycinate, magnesium oxide (MAGNESIUM SUPREME) and bromelains (BROMELAIN). The patient previously received the first dose of bnt162b2 (COMIRNATY; lot number: FC5453, expiration: 30Sep2021) administered into left shoulder on 16Jun2021 17:25 for COVID-19 immunisation. On 14Jul2021, an hour after the second dose of vaccine, patient developed hemorrhagic cystitis. Patient was initially given unspecified natural supplements, but after a few days the event had not improved. At that point, patient was prescribed with an antibiotic AUGMENTIN twice a day for 6 days. Outcome of event recovered on an unspecified date. Reporter''s comments: Currently the supplements patient used are: Magnesium Supreme and Bromelain. Sender''s comments: 1st dose Comirnaty on 16Jun2021 at 17:25. left shoulder. lot number: FC5453; expiration: 30Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Currently the supplements patient used are: Magnesium Supreme and Bromelain.


VAERS ID: 1538879 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100960326

Write-up: Myocarditis; This is a spontaneous report from a contactable physician from the regulatory authority number IT-MINISAL02-761598. A 19-year-old male patient received the first dose of BNT162b2 (COMIRNATY), intramuscular, administered in right deltoid on 07Jul2021 (Batch/Lot Number: Fe2625; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced myocarditis on 14Jul2021. The patient was admitted to hospital. Outcome of the events was not recovered. 23Jul2021 updated reporter comment field for sensitive data, further information required for clinical evolution, concomitant pathologies/therapies, outcome of instrumental investigations and lab clinical report/anamnestic report, therapy performed. No follow-up attempts are possible. No further information expected.


VAERS ID: 1538961 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Interstitial lung disease, Investigation, Pyrexia, Viral test, X-ray
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: Medical History/Concurrent Conditions: Discoid lupus erythematosus; Gallbladder disorder; Internal carotid artery stenosis
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:39s Centigrade; Comments: pyrexia for several consecutive days; Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:38-39 Centigrade; Comments: from the second day to about the eighth day; Test Name: CT; Result Unstructured Data: Test Result:frozen glass shadow seems to be recovering; Test Name: filmarray; Test Result: Negative ; Test Name: virus tests; Test Result: Negative ; Test Name: X-ray; Result Unstructured Data: Test Result:Frosted glass shadow; Comments: it was suspected that it might be interstitial pneumonia
CDC Split Type: JPPFIZER INC202100955441

Write-up: Interstitial pneumonia; pyrexia 38-39 centigrade; This is a spontaneous report received from a contactable physician via medical information team. The patient was a 65-year-old male. The basic diseases of the patient include gallbladder adenomyosis, left internal carotid artery stenosis, and discoid lupus erythrosus. On 13Jul2021, the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. Detail of the reaction was as follows: It was not so much a patient who came to see a doctor as the husband of a colleague who worked in the same hospital. After the second vaccination of CMT, her husband continued to have pyrexia from the second day (14Jul2021) to about the eighth day (20Jul2021), and his temperature was about 38-39 centigrade. Therefore, it also consumed a lot of physical strength. Frozen glass shadow appeared by X-ray, so it was suspected that it might be interstitial pneumonia. A small amount of 5 mg, 2.5 mg and other steroids were used. At the same time, he also had filmarray and a variety of virus tests, but the results of these tests were negative. It was said that he was also injected with a painkiller called Acelio, but when the effect was over, his temperature rose. It had lasted for a long time. If there was any reason, it might be the slight reaction caused by CMT vaccination. Because it was a symptom after vaccination, the reporter called. Although it was after that, CT again after that. The reporter thought frozen glass shadow seems to be recovering. There was no need for oxygen. The patient had not yet reached the point where oxygen was needed. It was just that pyrexia for several consecutive days, and temperature was about 39 degrees. Once acetaminophen or Loxonin were given, the body temperature would drop, but the pyrexia symptoms continue until now. As the second vaccination was 13Jul2021, (the duration of pyrexia symptoms) was very long. The outcome of interstitial pneumonia was recovering; pyrexia was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of interstitial pneumonia due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: 1538982 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Cough, Dyspnoea, Oropharyngeal discomfort, Pruritus, Pyrexia, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TELMISARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade
CDC Split Type: JPPFIZER INC202100958289

Write-up: Pyrexia; Persistent dry cough; Pharynx closed sensation of; Dyspnoea; Pharynx strange sensation of, oral strange sensation of; Itching; Anaphylaxis; This is a spontaneous report from a contactable healthcare professional and contactable nurse. This is a report received from the Regulatory authority report number is v21121289. A 49-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: FC9880; Expiration Date: 30Sep2021), intramuscular on 14Jul2021 at 13:32 at a 30ug, single for covid-19 immunisation. Medical history included hypertension. The patient did not have a history of anaphylaxis. Concomitant medication included telmisartan (MANUFACTURER UNKNOWN) taken for hypertension. On 14Jul2021 13:42, the patient experienced anaphylaxis, which was serious for hospitalization from 14Jul2021 to 15Jul2021 and life-threatening. On 14Jul2021 13:42, the patient experienced persistent dry cough, pharynx closed sensation of, dyspnoea, Pharynx strange sensation of, oral strange sensation of, and itching, which was serious for hospitalization from 14Jul2021 to 15Jul2021. On 15Jul2021, the patient experienced pyrexia, which was serious for hospitalization from 14Jul2021 to 15Jul2021. The clinical course was as follows: on 14Jul2021 at 13:32 (the day of vaccination), the patient received the first dose of bnt162b2. The onset date of events was reported as 14Jul2021 at 13:42. The event term was reported as anaphylaxis. On 14Jul2021 (the day of vaccination), the patient was admitted to the hospital. On 15Jul2021 (1 day after the vaccination), the patient was discharged. The events were further described as follows: symptoms: persistent dry cough, Pharynx closed sensation of, Pharynx strange sensation of, oral strange sensation of, Dyspnoea, itching. Diagnosis: Given that the patient''s anaphylaxis was atypical but could not deny the anaphylaxis, treatment was based on anaphylaxis. Treatment: Drip (normal saline 250ml, solu-cortef1V, polaramine1A), Bosmin 0.3ml, IM. After the above treatment, the patient was transported to the hospital by ambulance. The patient underwent lab tests and procedures which included body temperature: 36.6 degrees Centigrade on 14Jul2021 before vaccination and body temperature: 37.8 degrees Centigrade on 15Jul2021. Therapeutic measures were taken as a result of anaphylaxis, persistent dry cough, pharynx closed sensation of, dyspnoea, pharynx strange sensation of, oral strange sensation of, and itching. The clinical outcome of the event, anaphylaxis, was recovered on 14Jul2021. The clinical outcome of the event, pyrexia, was unknown. The clinical outcome of the event, persistent dry cough, pharynx closed sensation of, dyspnoea, pharynx strange sensation of, oral strange sensation of, and itching, was recovering. The reporting healthcare professional classified the event as serious (hospitalized from 14Jul2021 to 15Jul2021) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was not provided. The reporting nurse classified the event, anaphylaxis as serious (life-threatening, hospitalization) and assessed it as probably related to BNT162b2. REPORTER COMMENT: the patient''s symptoms were confirmed in a phone call on 16Jul2021. Although the patient''s respiratory symptoms recovered, the patient had the pyrexia of 37.8 degrees centigrade since the evening of 15Jul2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1539007 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Quadriplegia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: JPPFIZER INC202100963356

Write-up: Cerebral haemorrhage; Paralysis in hands and feet/Quadriplegia/mild paralysis; This is a spontaneous report from a contactable physician received via Team. A 58-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced cerebral haemorrhage and paralysis in hands and feet/quadriplegia/mild paralysis (hospitalization, medically significant). Details: On 12Jul2021, the patient received first dose of vaccination in another hospital. (Lot number unknown). On 14Jul2021 (2 days after the vaccination), the patient visited because of Quadriplegia, and Cerebral hemorrhage occurred, the cause was cerebral hemorrhage. The patient was hospitalized, could walk and live daily life, in a state of mild paralysis remained but not completely restored. There was unrelated because there were few reports. The outcome of event (Paralysis in hands and feet/Quadriplegia/mild paralysis) was not recovered and outcome of event (Cerebral haemorrhage) was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event of Quadriplegia, and Cerebral hemorrhage. 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: 1539144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-14
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, COVID-19, Drug ineffective, Dyspnoea, Electrocardiogram, Headache, Pericarditis, SARS-CoV-2 test positive, Troponin
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result: Infection parameters low; Test Name: ECG; Result Unstructured Data: Test Result: negative t-waves; Comments: in lateral, indicated in pericarditis; Test Date: 20210714; Test Name: SARS-CoV-2 test positive; Test Result: Positive; Test Name: Troponin; Result Unstructured Data: Test Result: low.
CDC Split Type: NLPFIZER INC202100982499

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; Pericarditis; Dyspnoea; Headache; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number NL-LRB-00626928. A 43-years-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection; Batch/Lot number: FE2625) via an unspecified route of administration on 05Jul2021 as a dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, the patient was affected with sars-cov-2 infection. On 14Jul2021 the patient experienced dyspnoea, pericarditis and headache. On an unspecified date, the patient underwent lab tests and procedures which included blood test: infection parameters low, ECG which results negative t-waves on in lateral, indicated in pericarditis, Troponin which results low. On 14Jul2021 sars-cov-2 test positive which results positive. The patient was not recovered from all the events. No follow-up attempts possible. No further information expected.


VAERS ID: 1539262 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Dizziness, Fall, Fatigue, Lumbar vertebral fracture, Malaise, Muscle atrophy, Myalgia, Nausea, Pain, Pyrexia, Rib fracture, Upper limb fracture, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Osteoporosis/osteopenia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Autoimmune disorder (three diseases); Blood disorder (one blood disease)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: body temperature; Result Unstructured Data: Test Result:35.0; Test Date: 20210506; Test Name: body temperature; Result Unstructured Data: Test Result:38.5
CDC Split Type: SEPFIZER INC202100948987

Write-up: fall handless/fell headlong/fell over uncontrollably; three fractures in the ribs, lumbar spine and one shoulder; three fractures in the ribs, lumbar spine and one shoulder; three fractures in the ribs, lumbar spine and one shoulder; fall handless in the bathroom without possibility to receive, all muscles laid down; general feeling of illness; fever/GALLOPING FEVER, FROM 38.5 TO 35.0 WITHIN 5 MINUTES FOR SEVERAL HOURS,; muscle pain; body pain; fatigue; pain at the vaccination site; dizziness; nausea; joint pain; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number SE-MPA-2021-061974. A 57-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 2021 (Batch/Lot Number: unknown) as dose 2, single for COVID-19 immunisation. Medical history included ongoing autoimmune disease with three diseases and one blood disease. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Solution for injection), on unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation and experienced general malaise and nausea. Reported suspected adverse reactions on unspecified date in 2021 were fever, general feeling of illness (also reported as general malaise), nausea, joint pain, muscle pain (also reported as muscle aches), body pain (also reported as body aches), pain at the vaccination site, fatigue, dizziness, then on 14Jul2021 fall handless in the bathroom without possibility to receive, all muscles laid down (also reported as fell headlong into the bathroom without the opportunity to receive, all muscles put off), then on 06May2021 galloping fever, from 38.5 to 35.0 within 5 minutes for several hours. The reporter stated that the man fell over uncontrollably. The first time straight into the wall next to the sink and received three fractures in the ribs, lumbar spine and one shoulder. The man sat down for five minutes and then tried to get up but fell again three times. The last time patient held a firm grip on the sink with both hands but still fell and crushed one porcelain vase with sharp shards. The reporter stated that it was as if all the muscles were completely shut down and the man could not turn. The patient underwent lab test and procedures which included body temperature: 38.5 to 35.0 on 06May2021. The outcome of the event fatigue, nausea, fall handless in the bathroom without possibility to receive, all muscles laid down was recovering; fever, pain at the vaccination site was recovered on unspecified date in 2021; while the outcome of the other events was not recovered. The case assessed as serious, hospital care. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-MPA-2021-046535 MPA


VAERS ID: 1539279 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram, Dyspnoea exertional, Fatigue, Haemoptysis, Investigation, Pulmonary embolism, Pyrexia, Serum ferritin, Serum ferritin increased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METADON NORDIC DRUGS; STESOLID; BUVENTOL EASYHALER; BUFOMIX EASYHALER; ZOPICLONE
Current Illness: Asthmatic
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse reaction to antibiotics (Previous drug interaction: patient experienced side effects on azitromax in the form of muscle aches, difficulty sleeping, and personality changes.); Cigarette smoker (Male quit smoking 10 years ago)
Allergies:
Diagnostic Lab Data: Test Name: CT thorax; Result Unstructured Data: Test Result:scattered peripheral pulmonary emboli; Comments: subsegmentally peripheral right but also left lower lobe; Test Name: UCG; Result Unstructured Data: Test Result:normal sized left ventricle; Comments: with normal EF, right side of heart was not enlarged.; Test Name: ferritin; Result Unstructured Data: Test Result:slightly elevated
CDC Split Type: SEPFIZER INC202100955028

Write-up: Later in the day he has noticed dyspnea on exertion; hemoptysis; bilateral pulmonary embolisms; The man has been severely fatigued after vaccination; slightly elevated ferritin.; on the night of 15/7 he woke up with stabbing pain lateral right thorax, which is described to be aggravated by deep breathing; He is also reported to have had a fever since 14/7; This is a spontaneous report from a contactable physician downloaded from the WEB SE-MPA-2021-064052. A 42-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included mild asthma symptoms, substitution therapy, and previous side effects of Azitromax experienced by the man in the form of muscle aches, difficulty sleeping, and personality changes. Concomitant medication(s) included methadone hydrochloride (METADON NORDIC DRUGS) taken for an unspecified indication, start and stop date were not reported; diazepam (STESOLID) taken for an unspecified indication, start and stop date were not reported; salbutamol sulfate (BUVENTOL EASYHALER) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (BUFOMIX EASYHALER) taken for an unspecified indication, start and stop date were not reported; zopiclone taken for an unspecified indication, start and stop date were not reported. Reported suspected adverse event was bilateral pulmonary embolism. The man has been severely fatigued after vaccination. He is also reported to have had a fever since 14Jul, on the night of 15Jul he woke up with stabbing pain lateral right thorax, which is described to be aggravated by deep breathing. Later in the day he has noticed dyspnea on exertion and onset of hemoptysis. The man presents to the emergency department on 16Jul with hemoptysis and dyspnea. It is described in the report that it is assessed as probable pulmonary embolism and is admitted and given Fragmin.CT thorax showed scattered peripheral pulmonary emboli subsegmentally peripheral right but also left lower lobe. UCG showed normal sized left ventricle with normal EF, right side of heart was not enlarged. PA pressure was not assessable with vena cava interior reacting without remark. Normal labs, however slightly elevated ferritin. Male quit smoking 10 years ago, no immobilization, trauma, no clinical signs suggestive of malignancy. There is also information in the report that the man was discharged on 19Jul with continued treatment with Xarelto and further follow-up at the thrombosis clinic. Case considered serious and reported as hospitalization and major medical event. Outcome of events was unknown. Treatment received for bilateral pulmonary embolisms. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1539304 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphadenopathy, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: SEPFIZER INC202100991135

Write-up: new bump appeared a little deeper on the neck, both about 2-2.5 cm in diameter; lymph node enlargement occurred again two days after dose 2; This is a spontaneous report from a contactable physician and a consumer reported different events for same patient. This is second of two reports. The first report was from the Regulatory Authority SE-MPA-2021-058916. A 28-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jul2021 (Lot Number: FD6840) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose bnt162b2 (COMIRNATY), (Lot # Unknown) on 07Jun2021 for COVID-19 immunisation and experienced taste altered, lymph node in the supraclavicular fossa, mouth felt numb. The patient experienced lymph node enlargement occurred again two days after dose 2 (medically significant) on 14Jul2021 with outcome of not recovered, new bump appeared a little deeper on the neck, both about 2-2.5 cm in diameter on an unspecified date with outcome of not recovered. No follow-up attempts possible. No further information expected. Linked Report(s): SE-PFIZER INC-2021896094 Same vaccine, different dose, different event combination.


VAERS ID: 1539996 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Liquid product physical issue, Syncope, Vaccination site pain
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: PTJNJFOC20210810250

Write-up: SYNCOPE; LIQUID IS MUCH FATTER; SEVERE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-2768] concerned an 18 year old male of unknown race and ethnicity. The patient''s weight was 60 kilograms, and height was 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) .5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope, severe pain and liquid is much fatter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 14-JUL-2021, and the outcome of liquid is much fatter and severe pain was not reported. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information-We received the XE393 batch of janssen yesterday directly from sensitive information redacted we started using it today at the sensitive information redacted. Until This hour we have had more than 20 male users, young with syncope and one of them had a seizure. Colleagues report that the liquid is much fatter and the patients report a lot of pain; Sender''s Comments: V0: 20210810250-Covid-19 vaccine ad26.cov2.s-Syncope, Liquid is much fatter. 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). V0: 20210810250-Covid-19 vaccine ad26.cov2.s-Severe pain. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1540177 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Bradycardia, Pharyngeal swelling, Rash erythematous, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963434

Write-up: Bradycardia; Blood pressure increased; Pharyngeal swelling; Rash erythematous; Urticaria; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 588174. A 38-year-old male patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 14Jul2021 (at the age of 38-years-old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced bradycardia, blood pressure increased, pharyngeal swelling, rash erythematous and urticaria. The outcome of the events was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1540179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dizziness, Dyspnoea, Fatigue, Hot flush, Laryngitis, Lymphadenopathy, Oropharyngeal pain, Pneumonia, Rhinorrhoea, Sputum discoloured
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963582

Write-up: Pneumonia; Chest discomfort; cough; dizziness; Dyspnoea; fatigue; hot flush; Laryngitis; Lymphadenopathy; Oropharyngeal pain; Rhinorrhoea; Sputum discoloured; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 588855. A 40-year-old female patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 13Jul2021 as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced pneumonia, chest discomfort, cough, dizziness, dyspnoea, fatigue, hot flush, laryngitis, lymphadenopathy , oropharyngeal pain, rhinorrhoea and sputum discoloured. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1540301 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis, Body temperature, Computerised tomogram abdomen, Oxygen saturation, Peritonitis, Respiratory rate
SMQs:, Gastrointestinal perforation (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Temp; Result Unstructured Data: Test Result:37.5 - 37.6; Test Date: 20210715; Test Name: Abdominal CAT; Result Unstructured Data: Test Result:Thickened cecal appendix with a caliber of up to 1; Comments: Thickened cecal appendix with a caliber of up to 13 mm at its distal end WITH AN 18X4 MM APPENDICOLITE IN ITS MIDDLE THIRD.; Test Date: 20210714; Test Name: Sat; Result Unstructured Data: Test Result:99; Comments: on room air; Test Date: 20210714; Test Name: Eupneic; Result Unstructured Data: Test Result:Eupneic at rest
CDC Split Type: ESPFIZER INC202100960236

Write-up: Acute peritonitis; Acute appendicitis; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Agency WEB, regulatory authority number ES-AEMPS-955041. A 38-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Jul2021 (Batch/Lot Number: FE6208) as dose 1, 0.3 mL single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient went to the hospital emergency room and reported abdominal pain in the area of FII and hypogastrium since yesterday afternoon, associated with vomiting and low-grade fever. No depositional alterations or voiding symptoms. No other symptoms in anamnesis due to devices. General examination: Temp 37.5 - 37.6 Sat 99 AA. Conscious, oriented, good general condition (GWB), Well hydrated and colored. Eupneic at rest. No work of breathing. Abdomen: soft, tender on left iliac fosa (FII). Positive Blumberg. NO masses are palpable. bilateral renal fist percussion: discomfort on both sides. lower extremities (LES): no edema or signs of deep vein thrombosis (DVT). Supplementary test. Abdominal computerized tomogram (CT): Thickened cecal appendix with a caliber of up to 13 mm in its distal end with an 18x4 mm appendicolith in its middle third. Findings suggestive of uncomplicated acute appendicitis. The case with surgery is discussed. Given suspicion of acute appendicitis, urgent surgical intervention was decided. Operational findings: Acute gangrenous appendicitis with an appendicolith in the middle third and perforated at that level. Peritonitis in the right hemiabdomen, abundant free fluid with a purulent appearance. After 7 days, discharge is decided with recommendations and a follow-up appointment by a primary care physician. The patient recovered from the events on 22Jul2021. The temporal sequence is coherent but we lack sufficient information to be able to establish a causal relationship between the vaccine and the episode of appendicitis with peritonitis. No follow-up attempts are possible. No further information expected.


VAERS ID: 1541217 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (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: Diabetes.
Preexisting Conditions: Comments: Unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210814348

Write-up: ACUTE RESPIRATORY FAILURE; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, FR-AFSSAPS-TS20213257] concerned a 76 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total administered on 03-MAY-2021 for covid-19 vaccination (drug start period: 73 days; drug last period: 73 days and duration of drug administration: 1 day). The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 14-JUL-2021, the patient experienced vaccination failure. On 28-JUL-2021, the patient experienced acute respiratory failure. The patient was hospitalized (date and duration unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from acute respiratory failure, and vaccination failure. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210814348- covid-19 vaccine ad26.cov2.s -Acute respiratory failure, vaccination failure. 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: 1541757 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Auditory disorder, Blood pressure measurement, Body temperature, Cold sweat, Coma scale, Deafness unilateral, Dyspnoea, Headache, Heart rate, Hyperhidrosis, Hypersensitivity, Nausea, Oxygen saturation, Pain in extremity, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:106/65; Comments: At 19:50; Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:111/66; Comments: 15 minutes later; Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:114/68; Comments: 30 minutes later; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: At 19:50; Test Date: 20210714; Test Name: (coma scale); Result Unstructured Data: Test Result:0; Test Date: 20210714; Test Name: (coma scale); Result Unstructured Data: Test Result:clear; Comments: at 19:50; Test Date: 20210714; Test Name: (coma scale); Result Unstructured Data: Test Result:clear; Test Date: 20210714; Test Name: pulse rate; Result Unstructured Data: Test Result:59; Comments: beats,at 19:50; Test Date: 20210714; Test Name: SpO2; Test Result: 98 %; Comments: at 19:50
CDC Split Type: JPPFIZER INC202100965166

Write-up: left thigh pain; Pallor facial; sweaty; mild sense of dyspnoea; abnormal auditory perception; deafness left ear; feeling queasy/queasy; headache; cold sweat; allergic reaction; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21121522. A 24-year and 6-month male patient received bnt162b2 (COMIRNATY Solution for injection, 0.3ML), dose 1 via an unspecified route of administration on 14Jul2021 19:35 (the day of vaccination) (Batch/Lot Number: FD0348; Expiration Date: 31Oct2021) as 0.3 ml single for covid-19 immunisation at the age of 24-year and 6-month. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. The patient experienced deafness left ear, feeling queasy/queasy, headache, all on 14Jul2021 19:45 with outcome of recovering, cold sweat on 14Jul2021 with outcome of recovering, sweaty, mild sense of dyspnoea, abnormal auditory perception, all on 14Jul2021 19:45 with outcome of recovered on 14Jul2021 19:50, left thigh pain on 14Jul2021 20:05 with outcome of recovering, allergic reaction on 14Jul2021 with outcome of recovering, pallor facial on 14Jul2021 19:50 with outcome of recovering. Body temperature before vaccination was 36.5 degrees Centigrade. On 14Jul2021 at 19:45 (the day of vaccination), the patient experienced feeling queasy, headache, deafness left ear. On 15Jul2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: About 5 to 10 minutes after the vaccination, feeling queasy, headache, deafness left ear, and cold sweat developed. After the patient lay down, feeling queasy, deafness, and cold sweat were recovering. The consciousness level was coma scale 0. Vital signs: blood pressure 106/65; SpO2 98%; pulse rate 59 beats; body temperature 36.9 degrees Centigrade. 15 minutes after that, the blood pressure was 111/66. 30 minutes later, the blood pressure was 114/68. The patient lay down and was observed; however, headache was not recovering. An ambulance call was made for observation. The patient did not have cutaneous symptoms, mucosal symptoms, or respiratory symptoms. The reporting physician classified the event as non-serious (note: The event might not be anaphylaxis, but was unassessable) and the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was VVR or allergic reaction to the vaccine. The reporting physician commented as follows: The event was VVR or allergic reaction to the vaccine. First-aid station response course record: On 14Jul2021 at 19:35, Status at onset: Ten minutes after the vaccination, sweaty, mild sense of dyspnoea, and queasy developed. The patient reported to a staff member standing by him and was guided to the first-aid station. Consciousness: (coma scale) clear. Vital signs: at 19:50(as reported), blood pressure 106/65, SpO2 98%, pulse rate 59, body temperature 36.9; 15 min later, blood pressure 111/66; 30 min later (20:05), blood pressure 114/68. Course: The patient experienced queasy and abnormal auditory perception but was able to hear. He lay down and was observed with his legs elevated with a pillow. Dyspnoea, Sweaty and the symptom of abnormal auditory perception recovered in about 5 minutes. On 14Jul2021 at 19:50, queasy was ongoing. BP 111/66 mmHg. 30 minutes later, the blood pressure did not decrease. The patient experienced left thigh pain and headache, which were within his control. The patient was able to call his mother by himself. The nurse made an ambulance call. The patient told his mother that he would visit a hospital. On 14Jul2021 at 20:15, the emergency response team arrived, the patient was transferred in a wheelchair. On 14Jul2021 at 20:05, The patient had two sips of water and did not have vomiting. Queasy was ongoing. Physician''s report as follow: on 14Jul2021 at 19:50, (coma scale): clear. Pallor facial developed. The vital signs were as stated above. The patient was able to talk. The patient did not have cutaneous symptom, respiratory symptom, or mucosal symptoms. On auscultation, the breath sounds were clear, and the heart sounds were regular. Airway stenosis sound was not heard. At this point, judged as anaphylaxis. The patient lay down and was observed with blood pressure measurement at an interval of 15 minutes. There was only slight recovering. The events were not symptoms of anaphylaxis. The physician considered that the patient experienced some sort of allergic reaction caused by the vaccine or VVR. The physician talked to two other physicians and decided to transfer the patient to a nearby hospital by an ambulance for observation. On 14Jul2021 at 20:15, the emergency response team arrived. On 14Jul2021 at 20:35, The patient was transferred to a nearby hospital by an ambulance. In this period, the symptoms were recovering slightly and did not worsen. On 15Jul2021(one day after the vaccination), Healthcare Center confirmed that the reporter contacted the patient. The patient was transported late, hence he was observed in the hospital for one night just to be safe. In the morning, his condition was good and left the hospital around 10:00. Pre-vaccination Screening Questionnaire for COVID-19 vaccine: The patient did not have a fever or get sick in the last month. There were not any parts of the patient''s body that were not feeling well that day. The patient never had a convulsion. The patient did not ever experienced severe allergic symptoms (such as anaphylaxis) from medications or foods. The patient did not experience sick after receiving a vaccine. The patient did not receive any vaccines within the last two weeks. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1541971 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (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: Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210813151

Write-up: FAINTING; CHANGE IN BLOOD PRESSURE; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-2997] concerned a 34 year old male. The patient''s weight was 105 kilograms, and height was 189 centimeters. The patient''s concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) 0.5 ml, frequency 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced change in blood pressure and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from change in blood pressure and fainting on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information-Asthmatic patient; Sender''s Comments: V0: 20210813151-Covid-19 vaccine ad26.cov2.s-Change in blood pressure, Fainting. 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: 1541972 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210813092

Write-up: BODY PAIN; CHILLS; VOMITING; TEMPERATURE AROUND 39.5?C; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3063] concerned a 25 year old male. The patient''s weight was 58 kilograms, and height was 181 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced body pain, chills, vomiting and temperature around 39.5?c. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, vomiting, temperature around 39.5?c and body pain was not reported. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210813092-Covid-19 vaccine ad26.cov2.-General body pain. 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). 20210813092-Covid-19 vaccine ad26.cov2.-Chills, Pyrexia, Vomiting. This event(s) is labeled per Agency and is therefore considered potentially related.


VAERS ID: 1541980 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: PTJNJFOC20210815772

Write-up: FAINTING; This spontaneous report received from a consumer via a Regulatory Authority (EMEA EVHUMAN NLP, PT-INFARMED-T202107-3469) concerned a 29 year old male. The patient''s weight was 85 kilograms, and height was 172 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: UNKNOWN) .5 ml, one total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced fainting for 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting on 14-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210815772-covid-19 vaccine ad26.cov2.-Fainting. 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: 1544701 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hypoaesthesia, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100966977

Write-up: Numbness facial; Headache; Chills; Application site pain; This is a spontaneous report from contactable consumer (patient) downloaded from the regulatory authority. The regulatory authority number is AT-BASGAGES-2021-37456. A 36-year-old female patient received BNT162B2 (COMIRNATY Solution for injection), via an unspecified route of administration, on 14Jul2021 (Batch/lot number: FE6208), at age 36 years old, as dose 2, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient has no known risk factors. On 14Jul2021, the patient experienced application site pain and numbness facial. On 15Jul2021, the patient experienced headache and chills. The patient was hospitalized on an unspecified date due to numbness facial. The patient recovered from application site pain on 15Jul2021 and from headache and chills on an unspecified date. The outcome of numbness facial was not recovered. The health authority assessed the event numbness facial as serious (hospitalization). Sender Comment: The report is for myself. No follow-up attempts possible. No further information expected.


VAERS ID: 1544721 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Fatigue, Pyrexia, Rash, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100964065

Write-up: Cardiac flutter; Fatigue; Injection site pain; Pyrexia; Rash; This is a spontaneous report from a contactable other healthcare professional received via the Agency Regulatory Authority. Regulatory authority report number: 591232. A 49-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. The patient''s medical history and concomitant medications were not reported. On 14Jul2021, the patient experienced cardiac flutter, fatigue, injection site pain, pyrexia and rash. The outcome of the events was not resolved. No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1544768 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Fatigue, Headache, Illness, Influenza like illness, Malaise, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Smoker (4 cigarettes a day, sometimes 0)
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: fever; Result Unstructured Data: Test Result:fever
CDC Split Type: BEPFIZER INC202100973268

Write-up: Shivering; Headache; Malaise; Fever; Flu-like symptoms; Nausea; Fatigue; Myalgia; I''m sick; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, Regulatory Authority number BE-FAMHP-DHH-N2021-101580. A 50-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number FE2625), via an unspecified route, on 13Jul2021 at single dose for COVID-19 immunisation. The patient is a smoker (4 cigarettes a day, sometimes 0). No additional medical history was provided. No relevant concomitant medications were provided. On 14Jul2021, the patient had fever, malaise, shivering, fatigue, nausea, myalgia, headache and flu-like symptoms. The events were reported serious for disability. The patient went to the emergency room (ER) due to fever. The patient verbally stated: is the first time in 15 years that I am sick and have 1 day off work. The outcome of ''sick'' was unknown while the outcome of the remaining events was recovered on 14Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1544776 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: BEJNJFOC20210811479

Write-up: JOINT PAIN; CHILLS; HEADACHE; MUSCLE PAIN; FATIGUE; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [BE-FAMHP-DHH-N2021-102252] concerned a 45-year-old female of unspecified race and ethnicity. The patient''s weight was 70 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21c14-02 expiry: unknown) dose was not reported, 1 total, administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 14-JUL-2021, the patient experienced joint pain, chills, headache, muscle pain, fatigue, fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from joint pain, chills, headache, muscle pain, fatigue, and fever on 17-JUL-2021. This report was serious (Disability or Permanent Damage).; Reporter''s Comments: Treatment - Yes Dafalgan Evolution of the ADR - Recovery with sequelae Situations - Other:; Sender''s Comments: V0: 20210811479-covid-19 vaccine ad26.cov2.s -Joint pain, chills, headache, muscle pain, fatigue, fever . This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1544801 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA9099 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis, C-reactive protein normal, Computerised tomogram, Inappropriate schedule of product administration, Physical examination, White blood cell count
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CIPROFLOXACIN
Current Illness: GERD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: contrast CT; Result Unstructured Data: Test Result:appendicities was confirmed; Test Date: 202107; Test Name: C reactive protein; Result Unstructured Data: Test Result:normal; Test Date: 202107; Test Name: physical examination; Result Unstructured Data: Test Result:appendicities was confirmed; Test Date: 202107; Test Name: White Blood Count; Result Unstructured Data: Test Result:15,000; Test Date: 202107; Test Name: White Blood Count; Result Unstructured Data: Test Result:8,000
CDC Split Type: CAPFIZER INC202100956354

Write-up: uncomplicated acute appendicitis; dose 1 on 24Mar2021, dose 2 on 14Jul2021; This is a spontaneous report from a contactable nurse (patient) via regulatory authority. A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) intramuscular, administered in arm left on 14Jul2021 11:45 (Batch/Lot Number: FA9099) (at age 31-year-old) as dose 2, single for covid-19 immunisation. The first dose was received on 24Mar2021 12:15 (lot number: ER1742), intramuscular on the left arm. Medical history included ongoing gastrooesophageal reflux disease. Concomitant medication(s) included ciprofloxacin (CIPROFLOXACIN) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jul2021, patient developed pain in right lower quadrant and ignored it as flatulence. However, the pain got worse after he walked for 30 minutes and therefore visited the emergency. Patient was diagnosed with uncomplicated acute appendicitis on 23Jul2021 21:45 and was admitted and stayed in the hospital for about 18 hours. He received intravenous Metronidazole 500 mg three time a day(TID) during this time. The appendicitis was confirmed on physical examination and contrast computed tomography (CT) on Jul2021. Patient''s C-reactive protein was normal, but white blood count was about 15,000 on Jul2021. After the initial intravenous (IV) therapy, blood count was reduced to 8,000. Since patient responded well to the antibiotics, appendectomy was not advised. Therefore, he was currently receiving Amoxicillin 500 mg by mouth (PO) TID for seven days. Patient still have mild abdominal pain and cramps on Jul2021. The event appendicitis resulted in emergency room/department or urgent care. Outcome of the event uncomplicated acute appendicitis was recovering. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested post vaccination


VAERS ID: 1546040 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bone pain, C-reactive protein, Dizziness, Leukocytosis, Malaise, Paraesthesia, Platelet count, Syncope, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Osteonecrosis (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:normal; Test Name: Thrombocytes; Result Unstructured Data: Test Result:normal; Test Name: WBC; Result Unstructured Data: Test Result:mild leukocytosis; Comments: In analysis - mild leukocytosis (likely a reaction to the vaccine)
CDC Split Type: EEPFIZER INC202100972572

Write-up: Syncope; Bone pain; Paresthesia foot; Asthenia; Malaise; Dizziness; mild leukocytosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number EE-SAM-44752107164. A 37-year-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot Number: FE3064), intramuscularly on 14Jul2021 at 09:30 (At the age of 37-year), as a dose 2, 0.3 ml, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Jul2021 at 13:00, the patient experienced syncope, bone pain, paresthesia foot, asthenia, malaise, dizziness and mild leukocytosis. The patient underwent lab tests and procedures which included c-reactive protein: normal, platelet count: normal, white blood cell count: mild leukocytosis (In analysis - mild leukocytosis (likely a reaction to the vaccine)) on an un-specified date. Therapeutic measures were taken as a result of bone pain, paresthesia, asthenia, malaise, dizziness, leukocytosis: patient visited the Department of Emergency Medicine, and is advised to take paracetamol 1g when necessary. Event syncope was assessed as serious (medically significant) and all the other events were non-serious. The outcome of the event asthenia and dizziness was recovering, and the event mild leukocytosis was unknown. The outcome of the event syncope was recovered on an unspecified date and the events bone pain, paresthesia foot and malaise were recovered on 16Jul2021. Sender''s comments: Non-serious known side effects of the vaccine, except for bone pain. The causal relationship is possible. No follow-up attempts possible. No further information expected.


VAERS ID: 1546049 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood fibrinogen, Body temperature, Chest X-ray, Chest discomfort, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Headache, Investigation, Myalgia, Myocarditis, Physical examination, Pleuritic pain, Polymerase chain reaction, Pyrexia, SARS-CoV-2 test, Sinus tachycardia, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: GPT; Result Unstructured Data: Test Result:65.6; Test Date: 20210717; Test Name: Thoracic angioTC; Result Unstructured Data: Test Result:signs of TEP are ruled out; Test Date: 20210721; Test Name: GOT; Result Unstructured Data: Test Result:43.9; Test Date: 20210721; Test Name: CK; Result Unstructured Data: Test Result:33.2; Comments: 06:53; Test Date: 20210721; Test Name: CK-MB; Result Unstructured Data: Test Result:12.5; Comments: 06:53; Test Date: 20210721; Test Name: fibrinogen; Result Unstructured Data: Test Result:902; Test Date: 20210714; Test Name: fever; Result Unstructured Data: Test Result:41 Centigrade; Test Date: 20210723; Test Name: Chest Rx; Result Unstructured Data: Test Result:infiltrated; Test Date: 20210722; Test Name: Echocardiogram; Result Unstructured Data: Test Result:no significant findings; Test Date: 20210722; Test Name: ECG; Result Unstructured Data: Test Result:Normal RS. Normal PR. Narrow QRS. No alterations; Comments: in repolarization; Test Date: 20210721; Test Name: GGT; Result Unstructured Data: Test Result:140.7; Test Date: 20210721; Test Name: D-Dimer; Result Unstructured Data: Test Result:1525; Test Date: 20210722; Test Name: D-Dimer; Result Unstructured Data: Test Result:1625; Test Date: 20210722; Test Name: Telemetry; Result Unstructured Data: Test Result:100; Comments: 100 bpm; Test Date: 20210723; Test Name: PCR; Result Unstructured Data: Test Result:In descent; Test Date: 20210719; Test Name: SARS-CoV-2 AG; Test Result: Negative ; Test Date: 20210720; Test Name: SARS-CoV-2 PCR; Test Result: Negative ; Test Date: 20210721; Test Name: TnT; Result Unstructured Data: Test Result:17.2; Comments: 06:53 17,2 (14); Test Date: 20210722; Test Name: TnT; Result Unstructured Data: Test Result:35.67; Comments: 21:06; Test Date: 20210723; Test Name: TnT; Result Unstructured Data: Test Result:23.03; Comments: troponin T normal
CDC Split Type: ESPFIZER INC202100960284

Write-up: Myopericarditis; Sinus tachycardia at 100 bpm; chest tightness; headache; myalgia; pleuritic chest pain; fever up to 41?C; This is a spontaneous report from a contactable physician downloaded from the WEB. The regulatory authority report number is ES-AEMPS-950075. A 38-year-old male patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FC1435), via intramuscular (IM), on 13Jul2021 (also reported on 14Jul2021), as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY; lot number: FC5436), via IM, on 23Jun2021 as dose 1 for COVID-19 immunisation. On 14Jul2021, it was reported that the patient experienced fever up to 41 C (Celsius), pleuritic chest pain, chest tightness that improved in supine decubitus, myalgias and headache. It was also reported that the patient experienced myopericarditis (hospitalization) wherein the patient was still admitted and under study at the time of the report. The patient underwent laboratory test and procedures daily electrocardiogram (ECG) cardiac enzymes on 21Jul2021 at 06:53 which showed Blood creatine phosphokinase (CK) of 33.2, Blood creatine phosphokinase MB (CK-MB of 12.5) and Troponin T (TnT) of 17.2 (14); on 22Jul2021 at 21:06 which showed TnT of 35.67, and 23.03 (troponin T normal) on 23Jul2021. Other analytical alterations on 21Jul2021 showed GPT(Alanine aminotransferase) of 65.6, liver enzymes (GOT (Aspartate aminotransferase) of 43.9, and GGT (Gamma-glutamyltransferase) of 140.7), fibrinogen of 902, D-Dimer of 1525 and 1625 on 22Jul2021; SARS-CoV-2 AG (Antigen) on 19Jul2021 was negative, SARS-CoV-2 PCR (polymerase chain reaction) from 20Jul2021 was negative; Thoracic angioTC on 17Jul2021 showed signs of TEP are ruled out; ECG from 22Jul2021: Normal RS. Normal PR. Narrow QRS. No alterations in repolarization Echocardiogram on 22Jul2021 showed no significant findings; Telemetry on 22Jul2021 showed sinus tachycardia at 100 bpm without events. Evolutionary on 23Jul2021 showed fever persists but GGC (Good general condition) without headache, negative meningeal signs. Similar pleuritic chest pain in right hemithorax, chest Rx (chest radiograph) were infiltrated. Analysis: PCR (Polymerase chain reaction) in descent, troponin T normal. The outcome of the event myopericarditis was recovering, while for the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1546188 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase increased, Asthenia, Blood alkaline phosphatase, Blood lactate dehydrogenase, Body temperature, C-reactive protein, Full blood count, Gamma-glutamyltransferase, Headache, Hepatic cytolysis, Hyperkalaemia, Hyperthermia, Magnetic resonance imaging head, Pyrexia, Serology test, Ultrasound scan
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Glutamate-pyruvate transaminase; Result Unstructured Data: Test Result:347 IU/l; Test Name: Glutamate-oxaloacetate-transaminase; Result Unstructured Data: Test Result:279 IU/l; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:170 IU/l; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:349 IU/l; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Name: C-reactive protein; Result Unstructured Data: Test Result:11 mg/l; Test Name: Complete blood count; Result Unstructured Data: Test Result:Normal; Test Name: Gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:96 IU/l; Test Name: Hepatic cytolysis; Result Unstructured Data: Test Result:10N; Test Name: Hyperkalaemia; Result Unstructured Data: Test Result:5.1 mmol/L; Test Name: Brain magnetic resonance imaging; Result Unstructured Data: Test Result:Normal; Comments: Normal encephalic magnetic resonance imaging, no cerebral venous thrombosis; Test Name: Serologies; Test Result: Negative ; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:Normal; Comments: Borderline non-dysmorphic liver with no suspect focal lesion. Permeability of efferent afferent hepatic vessels, no dilation of the intra- or extra-hepatic bile ducts. Integrity of the gallbladder. Integrity of the pancreatic gland. Homogeneous splenomegaly. Nothing to report with regard to the kidneys
CDC Split Type: FRPFIZER INC202100967020

Write-up: hyperkalaemia; asthenia; fever of 39 C; hyperthermia; headaches; hepatic cytolysis (also reported as cardiac cytolysis); This is a spontaneous report received from a contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20215058. A 39-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 13Jul2021 (Batch/Lot Number: FE7010) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hepatic cytolysis (also reported as cardiac cytolysis) (reported as medically significant) on 14Jul2021, asthenia and fever of 39 C, hyperthermia and headaches on unknown dates. Patient experienced asthenia, fever, severe headaches+++. Emergency room report: hepatic cytolysis at 10N worsening in progress, negative serologies, normal abdominal ultrasound, normal brain magnetic resonance imaging. Comments: additional information obtained by the regulatory auth in the Emergency Room on Day 7 of the vaccination for hyperthermia and headaches, indication of hepatic cytolysis. No particular medical history and no long-term treatment. Since vaccination, asthenia and fever of 39 C not receding with paracetamol. Clinical examination: bilateral neuro-headaches at the frontal and occipital level aggravated by mobilization, no vomiting no nausea no phot-phonophobia no meningeal syndrome, normal cranial pairs. At the gastrointestinal level, no bowel problems and abdomen soft, no guarding or tenderness. Additional Examinations: Complete blood count normal, hyperkalaemia 5.1mmol/l, C-reactive protein 11mg/l, cytolysis 10N (glutamate-oxaloacetate-transaminase 279 IU/l, glutamate-pyruvate transaminase 347 IU/l, alkaline phosphatase 170 IU/l, gamma-glutamyltranspeptidase 96 IU/l, lactate dehydrogenase 349 IU/l). Ultrasound of the abdomen: borderline non-dysmorphic liver with no suspect focal lesion. Permeability of efferent afferent hepatic vessels, no dilation of the intra- or extra-hepatic bile ducts. Integrity of the gallbladder. Integrity of the pancreatic gland. Homogeneous splenomegaly. Nothing to report with regard to the kidneys. Cerebral magnetic resonance imaging: Normal encephalic magnetic resonance imaging, no cerebral venous thrombosis. Conclusion: resolving headaches without criteria of severity in a context of recent vaccination, discovery of hepatic cytolysis without criteria of severity. Events hepatic cytolysis, hyperthermia, headache resulted in ER visit. The outcome of event headache was recovering, while for other events was not recovered. No follow-up attempts are possible. No further information is expected.


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