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

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



Case Details (Reverse Sorted by Onset Date)

This is page 275 out of 8,010

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VAERS ID: 1717394 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Nausea, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? 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: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased to 80s; Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:improved to 120s
CDC Split Type: JPPFIZER INC202101157375

Write-up: Anaphylaxis; Nausea; Vomiting; Wheals; Blood pressure decreased to 80s; This is a spontaneous report from a contactable pharmacist received from the regulatory authority (Regulatory Authority report number: v21126720). The patient was an 18-year and 6-month-old male (age at vaccination). Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included colitis ulcerative (was taking mesalamine orally). The patient had no history of drug allergy. On 04Sep2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FF4204, Expiration date: 31Oct2021) as dose 1, single, with route of administration unspecified, for COVID-19 immunization. The onset date was reported as 04Sep2021 (the same day of the vaccination). On 04Sep2021 (the same day of the vaccination), the patient was admitted to the hospital. On 04Sep2021 (the same day of the vaccination), the outcome of the events was recovered. The course of the event was as follows: Five minutes after inoculation with Comirnaty, the patient had nausea, vomiting, and wheals; and blood pressure had decreased to 80s. The patient was transported to the emergency room, and intramuscular injection of Bosmin 0.5mg and normal saline solution was performed. Blood pressure had improved to 120s. After administration of Bosmin 0.5mg and Solu-Cortef 200mg, the patient was hospitalized for observation. All symptoms had recovered within the same day. The reporting pharmacist classified the events as serious (hospitalized form 04Sep2021) and assessed that the events was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting pharmacist commented as follows: It was considered that this must be an anaphylaxis caused by vaccination with Comirnaty. According to the regulatory authority classification, it may be level 1. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1717417 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Heart rate decreased, Hypersensitivity, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (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), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/60; Comments: 10 minutes after vaccination; Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:98/60; Comments: rested for a while; Test Date: 20210904; Test Name: Pulse rate; Result Unstructured Data: Test Result:56; Comments: 10 minutes after vaccination; Test Date: 20210904; Test Name: Pulse rate; Result Unstructured Data: Test Result:60; Comments: rested for a while
CDC Split Type: JPPFIZER INC202101162493

Write-up: Loss of consciousness; Acute allergic reaction; Vasovagal reaction; Pulse rate 56; This is a spontaneous report received from a contactable physician via a Pfizer colleague. The patient was a 42-year-old female. The patient has no primary disease and complications. The patient''s concomitant medications were not reported. On 04Sep2021 (the day of vaccination, at 42-year-old), the patient received?the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown, Dosage was 0.3 ML) via intramuscular route of administration for prevention of SARS-CoV-2 infection (as reported). On 04Sep2021 (same day of vaccination), the patient experienced loss of consciousness. The clinical course was reported as follows: 10 minutes after the vaccination, there was loss of consciousness. Blood pressure 90/60, pulse rate 56. It was considered that an acute allergic reaction had occurred. The patient immediately recovered consciousness and became able to talk, rested for a while, then blood pressure 98/60, pulse rate 60 and had no dyspnoea or cyanosis. It was also considered to be vasovagal reaction. After resting (about 30 minutes), returned home on foot. On 04Sep2021 (same day of vaccination), the outcome of loss of consciousness was recovered. The action taken was unknown (as reported). The reporter classified the event as non-serious. The reporter stated that the event probably related to the BNT162B2. The outcome of events loss of consciousness and Pulse rate 56 was recovered on 04Sep2021; outcome of the other events was unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event loss of consciousness and the suspect drug BNT162B2. 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: 1717437 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dysphoria, Nausea, Oxygen saturation, Pallor
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (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? 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: 20210904; Test Name: BP; Result Unstructured Data: Test Result:86/palpation; Comments: at 17:53; Test Date: 20210904; Test Name: BP; Result Unstructured Data: Test Result:96/palpation; Comments: at 18:12; Test Date: 20210904; Test Name: BP; Result Unstructured Data: Test Result:94/palpation; Comments: at 18:30; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210904; Test Name: Spo2; Test Result: 98 %; Comments: at 17:53
CDC Split Type: JPPFIZER INC202101169598

Write-up: BP 86/palpation; Dysphoria; Complexion ill; Queasy; This is a spontaneous report from a contactable other HCP received from the regulatory authority. Regulatory authority report number is v21126022. The patient was a 23-years-old female. On 04Sep2021 at 17:47 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8162, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had no medical history. Concomitant medications were not reported. On 04Sep2021 at 17:50 (the day of the vaccination) 3 minutes after the vaccination, the patient complained of Dysphoria, Complexion ill and Queasy. On 04Sep2021 at 17:53(6 minutes after the vaccination) the patient laid on the bed BP 86/palpation Spo2 98%. On 04Sep2021 at 18:12 (25 minutes after the vaccination) BP 96/palpation. On 04Sep2021 at 18:30 (43 minutes after the vaccination) BP 94/palpation. On 04Sep2021 (the day of the vaccination), the outcome of the event was recovered. The reporting other HCP classified the event as non-serious but causality was not provided. The reporting other HCP commented as follows: Blood pressure increased, went back.


VAERS ID: 1717451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Liver disorder, Pyrexia, Rash
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: pyrexia; Result Unstructured Data: Test Result:40 Centigrade; Comments: 1 day after vaccination
CDC Split Type: JPPFIZER INC202101171314

Write-up: liver disorder; skin eruption; pyrexia at 40 degrees Centigrade; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 25-year-old female patient received the first dose of BNT162b2 (COMIRNATY, solution for injection, lot number unknown), intramuscularly on 03Sep2021 (the day of vaccination) at dose 1, 0.3 mL single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 04Sep2021 (1 day after vaccination), the patient experienced pyrexia of 40 degrees Centigrade. On 06Sep2021 (3 days after vaccination), the patient experienced skin eruption and liver disorder. The details of the reaction were reported as follow: on 07Sep2021, a doctor said, a 25-year-old female received the first dose of BNT162b2 0.3 mL on 03Sep2021 and experienced pyrexia at 40 degrees Centigrade on 04Sep2021. The patient started experienced pyrexia at 40 degrees Centigrade on 04Sep2021 and continued on 06Sep2021, skin eruption and liver disorder appeared. Hospitalized in Sep2021 for persistent pyrexia, skin eruption and liver disorder. The outcome of events was unknown. Seriousness and causality of the events were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Pyrexia, Rash, and Liver disorder and BNT162B2. 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: 1717496 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005292 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Depressed level of consciousness, Heart rate, Presyncope
SMQs:, 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), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: 74/40 immediately after vaccination; Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: 110/70 at 16:54; Test Date: 20210904; Test Name: Heart rate; Result Unstructured Data: 45 immediately after vaccination; Test Date: 20210904; Test Name: Heart rate; Result Unstructured Data: 65 at 16:54.
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Decreased consciousness; Vasovagal reflex; This case was received via The Regulatory Authority (Reference number: JP-TAKEDA-2021TJP092094) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case was received via The Regulatory Authority (Reference number: 2021TJP092094) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, initially reported by a physician, was received via the RA (Ref, v21126139). Decreased consciousness was assessed as serious by the RA. On an unknown date, body temperature before the vaccination 36.0 degrees Celsius. On 04-Sep-2021, at 15:57, the patient received the 1st dose of this vaccine. Immediately after the vaccination, vasovagal reflex developed. Several minutes after the vaccination, decreased blood pressure, pallor, cold sweat, and decreased consciousness developed. BP 74/40, and HR 45. Drip infusion was performed in a first-aid room, and the patient was followed up. At 16:54, BP 110/70, and HR 65. It was confirmed that the symptoms resolved. The patient returned home without any problem. The outcome of decreased consciousness and vasovagal reflex was reported as resolved. Follow-up investigation will be made. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns a 23-year-old female patient, with a history of hypertension, who developed the unexpected event of depressed level of consciousness, within several minutes after receiving the first dose of Moderna COVID-19 vaccine. The re-challenge was not applicable. The event was considered as possibly related to the suspect drug per the reporter''s assessment. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1717694 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Conjunctivitis, Erythema, Eye pruritus, Hypersensitivity, Lacrimation increased, Myalgia, Pruritus, Restless legs syndrome, Rhinitis allergic, Rhinorrhoea, Sneezing, Somnolence, Throat irritation
SMQs:, Rhabdomyolysis/myopathy (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: Body temperature; Result Unstructured Data: 39.4 Cel
CDC Split Type: ROJNJFOC20210934431

Write-up: SLEEPINESS; ITCHING - GENERALISED; REDNESS GENERALISED; TEARING EYES; RHINOCONJUNCTIVITIS; ITCHING EYES; THROAT IRRITATION; MYALGIA; RESTLESS LEGS; CHILLS; ALLERGIC RHINITIS; SNEEZING; RHINORRHEA; REDNESS; HYPERSENSITIVITY REACTION; This spontaneous report received from a consumer via Regulatory Authority (RO-NMA-2021-SPCOV12536) on 17-SEP-2021 concerned a 34 year old female of unspecified race and ethnic origin. The patient''s weight was 65 kilograms, and height was 168 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: XE393 and expiry: unknown) 1 dosage forms, 1 total administered on 03-SEP-2021 for active immunisation. No concomitant medications were reported. On 14-AUG-2021, the patient had laboratory test of body temperature which was found to be 39.4 Cel. On 04-SEP-2021, the patient experienced rhinoconjunctivitis, had allergic rhinitis, rhinorrhea, sneezing, redness, had hypersensitivity reaction, chills, throat irritation, myalgia, tearing eyes, itching in eyes and had restless legs. On 05-SEP-2021, the patient experienced sleepiness, had generalized redness and generalized itching. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from redness generalised, tearing eyes, rhinoconjunctivitis, sleepiness, allergic rhinitis, sneezing, rhinorrhea, redness, hypersensitivity reaction, itching - generalised, itching eyes, throat irritation, myalgia, restless legs, and chills. This report was serious (Other Medically Important Condition, and Life Threatening).


VAERS ID: 1720719 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Hyperventilation, Investigation, Myocarditis, Palpitations, Pleuritic pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Medical History/Concurrent Conditions: Breathing abnormally deep; Chest pain; Heaviness in limbs; Palpitations; Vaccination site swelling; Comments: HPV vaccine 31/08/2021 - not known which type Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: ECG; Result Unstructured Data: Test Result:Sinus tachycardia, right bundle branch block; Comments: Sinus tachycardia, right bundle branch block and PR depression. Trop 75.6Observed overnight with no worsening of symptoms. Repeat ECG no acute changes Repeat trop 10 h ours alter 10 Awaiting IP ECHO"; Test Date: 20210905; Test Name: Cardiac examination; Result Unstructured Data: Test Result:no cardiomegaly or obvious effusions; Test Date: 20210905; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161035

Write-up: Myopericarditis; pleuritic chest pain; palpitations whilst swimming; worse when taking deep breath; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109051416180050-TMKU5. Safety Report Unique Identifier GB-MHRA-ADR 25897135. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), DOSE 2 via an unspecified route of administration on 12Aug2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included limb discomfort, palpitations, hyperventilation, chest pain, vaccination site swelling. The patient''s concomitant medications included HPV vaccine 31Aug2021 - not known which type. Patient has not had symptoms associated with COVID-19. Historical Vaccine included dose 1 of BNT162B2 via an unspecified route of administration on 22Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Patient experienced myopericarditis on 04Sep2021. Patient experienced episode of sudden onset pleuritic chest pain and palpitations whilst swimming on 04Sep2021. Palpitations settled after 5 minutes rest but ongoing pleuritic chest pain. Worse when taking deep breath, lifting heavy objects or laughing. Patient underwent lab test on 05Sep2021 which included no cardiomegaly or obvious effusions. ECG: Sinus tachycardia, right bundle branch block and PR depression. Trop 75.6Observed overnight with no worsening of symptoms. Repeat ECG no acute changes Repeat trop 10 hours alter 10 Awaiting IP ECHO", COVID-19 virus test: No - Negative COVID-19 test. Outcome of the events was resolved. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720723 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Lethargy, Pollakiuria, Pyrexia, SARS-CoV-2 test, Swelling, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERAZETTE [DESOGESTREL]; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Chills; Dizziness; Fever; Heavy periods
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101161015

Write-up: Dizziness; Local swelling; injection site was red, hot and swollen; injection site was red, hot and swollen; injection site was red, hot and swollen; Fever chills; Frequency urinary; chills; fever; lethargia; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109060729039200-ODJIJ, Safety Report Unique Identifier GB-MHRA-ADR 25898328. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Sep2021 (Lot number was not reported) (at the age of 29-years-old) as single dose for COVID-19 immunization. Medical history included dizziness, chills, fever, heavy periods, asthma. Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. Concomitant medications included desogestrel (CERAZETTE [DESOGESTREL]) taken for heavy menstrual bleeding from 05Jul2021 to an unspecified stop date; salbutamol taken for asthma, start and stop date were not reported. Patient noticed a big increase in the frequency of needing to urinate from 04Sep2021, seemed to be every hour or so which was far more than normal. Also had the chills with fever and lethargia from the evening on the day patient had the vaccine (04Sep2021) and dizziness started 2 days later (06Sep2021). The injection site was red, hot and swollen and had been since the day after being vaccinated (04Sep2021). Patient also experienced fever chills on 04Sep2021 and local swelling on 05Sep2021. Patient had not tested positive for COVID-19 since having the vaccine. Outcome of frequency urinary and dizziness was not resolved. Outcome of chills with fever and lethargia, injection site was red, hot and swollen was resolved. Outcome of local swelling and fever chills was resolving. This case was reported as serious with seriousness criteria-other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720724 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MICROGYNON [ETHINYLESTRADIOL;LEVONORGESTREL]; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Vomiting
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168228

Write-up: Vomited; Nausea; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109060843039850-1MMPA with Safety Report Unique Identifier of GB-MHRA-ADR 25898850. A 26-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Sep2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included vomiting and acid reflux (esophageal). The patient had no symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not pregnant and was not currently breastfeeding. Concomitant medications included ethinylestradiol/levonorgestrel (MICROGYNON) taken for birth control and omeprazole (OMEPRAZOL) taken for acid reflux (esophageal); both from unknown dates and unknown if ongoing. On 04Sep2021, the patient experienced nausea; on 05Sep2021, one day after vaccination, the patient experienced vomiting; both the events were reported as serious for being medically significant. The clinical course was reported as follows: The patient was sick about 10 times in a row. Before the jab the patient had been feeling well. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events vomiting and nausea were resolved on 05Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720742 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FR8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac flutter, Dyspnoea, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168210

Write-up: Heart fluttering; Shortness of breath; Fatigue; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109062009508690-8T6GW, Safety Report Unique Identifier GB-MHRA-ADR 25902847. A 23-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8087) via an unspecified route of administration on 04Sep2021(at the age of 23-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 04Sep2021, the patient experienced fatigue; on 05Sep2021, 1 day after vaccination, the patient experienced heart fluttering and shortness of breath; all reported as serious for being medically significant. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events fatigue, heart fluttering and shortness of breath was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Drug hypersensitivity, Dyspnoea, Erythema, Hyperaesthesia, Lymphadenopathy, Neck pain, Rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency; Rash
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168327

Write-up: Red, hot and sore rash on either side of neck; cough; Cough affecting breathing; sore rash on either side of neck/pressure at front of neck; hypersensitivity; Swollen lymph nodes; Neck rash; Hypersensation skin; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109062125091930-QD7KI. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Sep2021 (Lot/batch number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included immunodeficiency and rash, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced Red, hot and sore rash on either side of neck, cough, cough affecting breathing, sore rash on either side of neck/pressure at front of neck and hypersensitivity on an unspecified date; neck rash and swollen lymph nodes on 05Sep2021; and hypersensation skin on 04Sep2021. The events were assessed as serious (medically significant). The outcome of the events ''neck rash'', ''hypersensation skin'' and ''swollen lymph nodes'' was not recovered and outcome of the other events was unknown. The clinical course was reported as follows: Red, hot and sore rash on either side of neck. Spread overnight towards front of neck plus pressure at front of neck. Swollen lymph nodes. Cough affecting breathing. Confirmed hypersensitivity caused by Pfizer. Medical staff said immune system went into overdrive. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720755 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vertigo
SMQs:, Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101176022

Write-up: Vertigo; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory Authority report number GB-MHRA-WEBCOVID-202109071000458390-D1YPB, Safety Report Unique Identifier GB-MHRA-ADR 25905630. A female patient of unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; batch/Lot Number: not known), via an unspecified route of administration on 03Sep2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unsure if the patient had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On 04Sep2021, the patient experienced vertigo; the event was reported as serious for being medically significant. The patient underwent lab test 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. The clinical outcome of the event vertigo was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1720830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram thorax, Echocardiogram, Magnetic resonance imaging heart, Myocarditis, Rash papular, SARS-CoV-2 test, Troponin, Troponin increased
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (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: TRIMETOPRIM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acne
Allergies:
Diagnostic Lab Data: Test Name: CTPA; Result Unstructured Data: Test Result:Unknown results; Test Name: ECHO; Result Unstructured Data: Test Result:Normal; Test Name: cardiac MRI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210906; Test Name: troponins; Result Unstructured Data: Test Result:482; Test Date: 20210906; Test Name: troponins; Result Unstructured Data: Test Result:570
CDC Split Type: GBPFIZER INC202101190783

Write-up: chest pain; raised troponins 482; Rash papular; Myocarditis; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109091146361370-ZP1V7. Safety Report Unique Identifier GB-MHRA-ADR 25917470. A 21-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Lot number: FE8087 and Expiration date: unknown), via an unspecified route of administration on 03Sep2021 as dose 2, single for covid-19 immunisation. Medical history included acne from an unknown date. Concomitant medication(s) included trimetoprim taken for acne. The patient previously took first dose of bnt162b2 on an unspecified date as dose 1, single for covid-19 immunisation. On 04Sep2021, patient experienced myocarditis. On an unspecified date, the patient experienced chest pain and admitted to hospital on 06Sep2021 after experiencing it for 2 days. The patient also experienced raised troponins 482 then 570 on 06Sep2021. The patients ECHO report was normal. Awaiting cardiac MRI. Patient was to be started on colchicine 500 mch OD for 3 months and started on bisoprolol 3.75 mg OD. On an 06Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test: negative (No - Negative COVID-19 test). Patient had not tested positive for covid-19 since having the vaccine. Patient was not enrolled in clinical trial. Therapeutic measures were taken as a result of events. Outcome of event raised troponins 482 and rash papular was recovering while not recovered for myocarditis and unknown for chest pain. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1720961 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-09-04
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101223235

Write-up: CONFIRMED CASE OF COVID-19; CONFIRMED CASE OF COVID-19; This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (Regulatory authority report number: not provided), based on information received by Pfizer from BioNTech (manufacturer control number: HK-Fosun-2021FOS003416), license party for bnt162b2. This is a spontaneous report received from a non-contactable HCP received via Regulatory Authority. The regulatory authority report number is not applicable. As of 0:00 am, 07-Sep-2021, Regulatory Authority announced that two additional confirmed cases of COVID-19 after CBNT162B2 vaccination. This case was split for 1 of 2 cases that confirmed COVID-19 after BNT162B2 vaccination. A 46-year-old male patient received bnt162b2, Solution for injection, (lot number: unknown), via unspecified route on 11Jun2021 as dose 1, single for COVID-19 immunization. Also received bnt162b2, Solution for injection, (lot number: unknown), via unspecified route on 02Jul2021 as dose 2, single COVID-19 immunization. Medical history, concomitant medication(s) and past product were not reported. On an unknown date, the patient arrived from abroad. On 04Sep2021, the patient had symptoms and was confirmed as COVID-19. The adverse event Confirmed case of COVID-19 was considered as Important Medical Event. The events seriousness was assessed as medically significant. At the time of the report, the outcome of the event was unknown. Initial report was received on 08-Sep-2021. This is one of two reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS003364 (master case) and 2021FOS003416. Follow-up closed; no further information is possible.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-202101217953 same reporter/product, different patient/event


VAERS ID: 1721131 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Heart rate, Heart rate decreased, Menstruation delayed, Pallor, Peripheral coldness, Presyncope, Weight decreased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Fertility disorders (broad), Hypotonic-hyporesponsive episode (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eating disorder (Other possible cause of the event such as any other diseases was the patient may had eating disorder); Menstrual disorder; Weight decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:87/55; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination.; Test Date: 20210904; Test Name: heart rate; Result Unstructured Data: Test Result:36; Comments: /min
CDC Split Type: JPPFIZER INC202101155887

Write-up: weight decreased; menstruation had not came; blood pressure 87/55; Heart rate 36/min; Vasovagal reflex; pallor; Cold extremities; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and regulatory authority. Regulatory authority report number is v21125907. The patient was a 14-year and 3-month-old female. Body temperature before vaccination was 36.2 degrees Centigrade. The patient''s family history was reported as unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Sep2021 at 09:40 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3622, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 04Sep2021 at 09:50 (10 minutes after the vaccination), the patient experienced Vasovagal reflex. On 04Sep2021 (the day of vaccination), the outcome of the event was recovered.It was described as follows: About 10 minutes after the vaccination, the patient experienced pallor and was in a lying position. Blood pressure 87/55, heart rate 36/min and experienced cold extremities. Blood pressure recovered in about 15 minutes, and the patient walked home. While the patient was resting in the lying position, the patient said that she did diet excessively, exercises excessively, then weight decreased and menstruation had not came. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was: the patient may had eating disorder. The outcome of the events weight decreased and menstruation had not came was unknown for all other events was recovered.


VAERS ID: 1721139 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Heart rate, Hypoaesthesia, Oropharyngeal discomfort, Oxygen saturation, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: BP; Result Unstructured Data: Test Result:128/83; Test Date: 20210904; Test Name: BP; Result Unstructured Data: Test Result:123/63; Test Date: 20210904; Test Name: PR; Result Unstructured Data: Test Result:77; Test Date: 20210904; Test Name: PR; Result Unstructured Data: Test Result:72; Test Date: 20210904; Test Name: SPO2; Test Result: 98 %; Test Date: 20210904; Test Name: SPO2; Test Result: 98 %; Test Date: 20210904; Test Name: vital; Result Unstructured Data: Test Result:no problem
CDC Split Type: JPPFIZER INC202101163157

Write-up: numbness of fingers of both hands/ numbness of fingers; Chest pressure sensation; throat clogged; This is a spontaneous report from a contactable physician (vaccinator) received from the regulatory authority . Regulatory authority report number is v21125957. A 42-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Sep2021 10:00 (Lot Number: FF5357; Expiration Date: 30Nov2021) as single for COVID-19 immunization. Medical history included food allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient was a 42-year-old (age at vaccination) female. The patient had medical history of food allergy. On 04Sep2021 at 10:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF5357, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date/time was reported as 04Sep2021 at 10:00 (0 minute after the vaccination, as reported). On 04Sep2021 (the same day of the vaccination), the outcome of the events was recovered. The course of the events was as follows: 15 minutes after the vaccination (as reported), numbness of fingers of both hands, and chest pressure sensation occurred. Skin eruption was not recognized. BP 128/83, PR 77, SPO2 98%, so vital showed no problem. Then, POLARAMINE was administrated. After that, the symptoms improved. At 11:35, the second time of vital signs measurement resulted in BP 123/63, PR 72, SPO2 98%. Throat clogged and numbness of fingers occurred. Lactec infusion was administrated. At 13:30, the patient was told the condition was stable. Then, the patient went home. The reporting physician (vaccinator) classified the events as non-serious and assessed that the events were related to bnt162b2. There was no other possible cause of the events such as any other diseases.


VAERS ID: 1721147 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, Heart rate decreased, Hypersensitivity, Loss of consciousness, Oxygen saturation, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Angioedema (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), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:90/60; Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:98/60; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210904; Test Name: pulse rate; Result Unstructured Data: Test Result:56; Test Date: 20210904; Test Name: pulse rate; Result Unstructured Data: Test Result:60; Test Date: 20210904; Test Name: oxygen saturation; Result Unstructured Data: Test Result:99
CDC Split Type: JPPFIZER INC202101163963

Write-up: Loss of consciousness; Pulse rate was 56; it could be considered as Acute allergic reaction occurring; It could be considered to be Vasovagal reflex; This is a spontaneous report from a contactable physician received from the Regulatory Authority. (Regulatory Authority report number: v21125953). The patient was a 42-year-old female. The patient''s body temperature on 04Sep2021 (before vaccination) was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Sep2021 at 11:30 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: FE8162, Expiration date: 30Nov2021) as dose 1, single, with route of administration unspecified, for COVID-19 immunization. The onset date of the events was reported as 04Sep2021 at 11:40 (10 minutes after the first dose of vaccination). On 04Sep2021 (the day of vaccination), the outcome of the events was recovered. The course of the event was as follows: On 04Sep2021 at 11:40 (10 minutes after the vaccination), the patient experienced loss of consciousness; blood pressure was 90/60; pulse rate was 56; oxygen saturation was 99, and it could be considered as acute allergic reaction occurring. The patient''s consciousness recovered immediately, and conversation also became possible. The patient rested for a while, and blood pressure was 98/60, pulse rate was 60, and it was not considered to be dyspnoea or cyanosis. It could be considered as vasovagal reflex. The patient went home on foot after resting (about 30 minutes). The reporting physician classified the events as non-serious and assessed that the events were related to BNT162B2. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1721148 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dizziness, Investigation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:70/40; Comments: decreased; Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:70s; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210904; Test Name: medical examination; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: JPPFIZER INC202101163988

Write-up: Vasovagal reflex; subjective symptoms of Light-headed feeling and Giddiness appeared; Blood pressure decreased (70/40); This is a spontaneous report from a contactable physician received from the Pharmaceuticals and regulatory authorithy. The regulatory authority report number is v21125932. A 17-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FH0151, expiration date: 31Dec2021), via an unspecified route of administration on 04Sep2021 at 14:30 (at the age of 17-years-old) at dose 1, single for COVID-19 immunisation. Body temperature before vaccination on 04Sep2021 was 36.3 degrees Centigrade. The patient''s medical history and concomitant medications were reported as none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Sep2021 at 14:40 (10 minutes after the vaccination), subjective symptoms of light-headed feeling and giddiness appeared. His blood pressure decreased to 70/40. After that, because the blood pressure continued at 70s, infusion with SOLU-CORTEF 200 mg was carried out. There was no respiratory disorder. Just in case, the patient was transported to a hospital. It was not anaphylaxis. It was diagnosed as vasovagal reflex. The second dose of vaccination was possible. The patient went home after medical examination (with unknown result). It was reported that he had an appetite. The events required physician office visit. On 04Sep2021 (the day of vaccination), the outcome of the events was recovering. The reporting physician classified the events as non-serious (as the source reported) and assessed that the events were related to BNT162B2. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: The patient was transported to privacy hospital. It was not anaphylaxis. It was diagnosed as vasovagal reflex. The second dose of vaccination was possible. The patient went home after medical examination. The patient had appetite. On 05Sep2021 (1 day after the vaccination), patient''s mother answered the telephone confirmation. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: The patient was transported to privacy hospital. It was not anaphylaxis. It was diagnosed as vasovagal reflex. The second dose of vaccination was possible. The patient went home after medical examination. The patient had appetite. On 05Sep2021 (1 day after the vaccination), patient''s mother answered the telephone confirmation.


VAERS ID: 1721155 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Feeling abnormal, Oropharyngeal discomfort, Oxygen saturation, Pain, Pruritus
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result: 112/74; Comments: 10 minutes after the vaccination; Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.7 Centigrade; Comments: before vaccination; Test Date: 20210904; Test Name: SpO2; Test Result: 99%; Comments: 10 minutes after the vaccination.
CDC Split Type: JPPFIZER INC202101164721

Write-up: Anaphylaxis; Fuzzy head; pharynx strange sensation of; Pantalgia; itching; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21126013. A 39-year-old female patient received bnt162b2 (COMIRNATY; Batch/Lot Number: FF3620; Expiration Date: 30Nov2021), via an unspecified route of administration, on 04Sep2021 at 14:30 (at the age of 39 years old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 04Sep2021 at 14:30 (the day of vaccination), it was reported that the patient experienced anaphylaxis. On 04Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was 10 minutes after the vaccination, the patient complained of pharynx strange sensation of, Pantalgia, itching, and Fuzzy head. Blood pressure 112/74, and SpO2 99%. Although no allergic symptoms were confirmed, the symptoms were considered as anaphylaxis (medically significant), Immediately, subcutaneous injection of BOSMINE 0.3 g and drip infusion of SOLU-CORTEF 100 mg were performed. ALLEGRA 50 mg was orally administered, and the patient was observed, one hour and a half later, the patient recovered and went home. The outcome of the events was recovered on 04Sep2021. The reporting physician did not provided seriousness of event and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1721165 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101167414

Write-up: Redness expended from trunk to whole body; Wheals expended from trunk to whole body; Itching expended from trunk to whole body; This is a spontaneous report from a contactable physician. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (Solution for injection), intramuscular, administered in arm left on 03Sep2021 (Lot Number: FF9942; Expiration Date: 30Nov2021) (at the age of 33-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received medication of supplement (the specific product name was not provided) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Medical history was none. On 03Sep2021 (the day of vaccination), the patient received first single dose of BNT162b2. The clinical course was reported as follows: on 04Sep2021 in the evening (the second day of vaccination), the patient experienced redness, wheals with itching. The redness, wheals with itching was gradually expended from trunk to whole body. The outcome of the events was not recovered with treatment including STRONGER NEO-MINOPHAGEN C intravenously injection, medicine of antihistamine orally and external application medicine of steroid. The reporter stated the events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events of erythema, urticaria and pruritus. 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: 1721175 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Computerised tomogram head, Magnetic resonance imaging head, Muscular weakness, Quadriplegia, Seizure
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Date: 20210905; Test Name: head CT; Result Unstructured Data: Test Result:no abnormal signs; Test Date: 20210904; Test Name: head MRI; Result Unstructured Data: Test Result:no abnormal signs
CDC Split Type: JPPFIZER INC202101169537

Write-up: Quadriplegia; Consciousness disturbed; Convulsion attack; Weakness of limbs; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126936. The patient was a 50-year and 0-month-old female. On 04Sep2021 at 13:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.1 degrees Centigrade. The patient had no medical history. Concomitant medications were not reported. On 04Sep2021 at 13:40 (10 minutes after the vaccination), the patient experienced the patient experienced altered state of consciousness, convulsion attack and weakness of limbs to quadriplegia. No abnormal signs showed in head MRI. On 04Sep2021 (the day of vaccination), the patient was admitted to the hospital in ICU. On 05Sep2021 (1 day after the vaccination), the patient could have conversation. No abnormal signs showed in head CT. The patient was transported to another private hospital. The patient was discharged on 05Sep2021. On 05Sep2021 (1 day after the vaccination), the outcome of the events was not recovered. The reporting physician classified the event as serious (Hospitalized from 04Sep2021 to 05Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: These events onset during observation after vaccination. No relevant medical history specified in vaccine screening questionnaire. Considered related to vaccination. No follow-up attempts needed. No further information expected.


VAERS ID: 1721210 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: 40 degrees Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: COVID-19 infection; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP087304) on 07-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This case was reported by a family member of a vaccine recipient via the Drug Information Center. COVID-19 infection was assessed as serious by the MAH. On 30-Aug-2021, the patient received the 1st dose of this vaccine. On 04-Sep-2021, the patient was found infected with COVID-19, and pyrexia of nearly 40 degrees Celsius and cough developed. On an unknown date, the symptoms were resolving. The outcome of COVID-19 infection was reported as resolving. Follow-up investigation will be impossible due to the reporter''s non-cooperation.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a female patient of unreported age with no relevant medical history, who experienced serious unexpected event of COVID-19. The event occurred approximately 4 days after the first dose of Spikevax. Rechallenge was not applicable. The event was considered as related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1721230 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-26
Onset:2021-09-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005288 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Internal haemorrhage, Purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (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: JPMODERNATX, INC.MOD20213

Write-up: Purpura in the lower leg; Internal hemorrhage in the right lower leg; Internal hemorrhage in the right thigh; This case was received via a regulatory authority (Reference number: JP-TAKEDA-2021TJP092463) on 10-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to a regulatory authority by a physician, was received via a regulatory authority (Ref, v21126217). Internal hemorrhage in the right thigh, Internal hemorrhage in the right lower leg was assessed as serious by a regulatory authority. The patient was taking With Hangame dead tree. On 26-Aug-2021, the patient received the 1st dose of the vaccine. On 04-Sep-2021, internal hemorrhage was found in the right thigh. On 06-Sep-2021, the symptom disappeared. After taking bath, the patient found internal hemorrhage in the right lower leg. On 07-Sep-2021, the patient visited a medical institution. Purpura was noted in the lower leg. Blood sampling was performed to find no abnormalities in platelets, prothrombin time (PT), APTT, or fibrinogen, etc. The outcome of internal hemorrhage in the right thigh was reported as recovered. The outcome of internal hemorrhage in the right lower leg and purpura in the lower leg was unknown. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 46-year-old, female patient with no relevant medical history, who experienced the unexpected events of internal hemorrhage and Purpura. The events occurred around 10-13 days after first dose of vaccine. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1721290 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2834 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Heart rate, Malaise, Oxygen saturation, Pallor
SMQs:, Anaphylactic reaction (broad), Hypotonic-hyporesponsive episode (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: Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Myocardial infarction (Had a heart attack 4 months ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:121/89 mmHg; Comments: Blood pressure controls stable and comparable; Test Date: 20210904; Test Name: pulse; Result Unstructured Data: Test Result:107; Test Date: 20210904; Test Name: Saturation; Test Result: 91 %
CDC Split Type: NLPFIZER INC202101216219

Write-up: Feeling unwell about 5 minutes after vaccination:; pressure on the chest.; pallor; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number NL-LRB-00677479. A 44-years-old male patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: FF2834) dose number unknown via an unspecified route of administration on 04Sep2021 (age at vaccination 44 years old) as dose number unknown, single for covid-19 immunisation. Medical history included ongoing tobacco user, aortic valve replacement from an unknown date and unknown if ongoing aortic valve replacement, myocardial infarction from May2021 to an unknown date Had a heart attack 4 months ago. The patient''s concomitant medications were not reported. On 04Sep2021 the patient was feeling unwell about 5 minutes after vaccination, pressure on the chest, pallor. Clinical course was reported as Five minutes after the vaccination, the patient started being unwell. He looked pale (pallor) and experienced chest pressure. They made him lay down and put his legs up but that did not help. The patient has had an aortic valve replacement in the medical history and has had a myocardial infarction 4 months before vaccination. His blood pressure was 121/89 and his pulse rate was 107. They treated him with nitro spray sublingual (1 puff) but that also did not help. His oxygen saturation was 91%. His blood pressure remained stable and comparable. The patient did not recover so he was taken to the hospital in an ambulance. According to the physician, the vaccine has triggered the symptoms but has not caused them. It is unknown whether this was the first or second corona vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: 121/89 mmhg on 04Sep2021 Blood pressure controls stable and comparable, heart rate: 107 on 04Sep2021, oxygen saturation: 91 % on 04Sep2021. The patient received treatment with laying down and legs up but that did not help. Then, the patient was treated with nitrospray sublingual (1 puff) but that also did not help. Next, the patient was transported to the hospital. The clinical outcome of the events was unknown. Therapeutic measures were taken as a result of feeling unwell about 5 minutes after vaccination: pressure on the chest, pallor. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: Summary of reporter''s comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): unknown Additional information ADR: Lying flat and legs up no effect. Taken to first aid room. Blood pressure 121/89 pulse 107. At 16.12 Nitrospray sublingual 1 puff: no effect. Ambulance service alerted. Saturation 91%. Blood pressure controls stable and comparable. aortic valve replacement and myocardial infarction in history, smoker Previous COVID-19 infection: No


VAERS ID: 1722110 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Uveitis
SMQs:, Ocular infections (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Acute uveitis; This case was received via RA (Reference number: GB-MHRA-ADR 25931094) on 14-Sep-2021 and was forwarded to Moderna on 14-Sep-2021. This regulatory authority case was reported by a nurse and describes the occurrence of UVEITIS (Acute uveitis) in a 26-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for Ill-defined disorder. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced UVEITIS (Acute uveitis) (seriousness criterion medically significant). At the time of the report, UVEITIS (Acute uveitis) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Patient experienced Bilateral Uveitis. Company comment: This case concerns a 26 year-old, female patient with no relevant medical history, who experienced the unexpected event of uveitis. The event occurred same day after the second dose of mRNA 1273 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as related to the product. The benefit-risk relationship of vaccine in not affected by this report.; Reporter''s Comments: The other outcome for Acute uveitis was: Bilateral uveitis; Sender''s Comments: This case concerns a 26 year-old, female patient with no relevant medical history, who experienced the unexpected event of uveitis. The event occurred same day after the second dose of mRNA 1273 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the event as related to the product. The benefit-risk relationship of vaccine in not affected by this report.


VAERS ID: 1723477 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101173193

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable other hcp via the Regulatory Authority. Regulatory authority report number is 617681. A 38-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction on 04Sep2021. The outcome of the event was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168389

Write-up: after the first vaccine; Swollen lymph nodes; the pain of the swelling is excessive.; This is a spontaneous report from a contactable consumer. This is report received from theregulatory authority report number is GB-MHRA-WEBCOVID-202109061143427610-YRKWI, Safety Report Unique Identifier number is (GB-MHRA-ADR 25899643). A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE8087) on 04Sep2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number unknown) both at single dose via an unspecified route of administration for COVID-19 immunization. Medical history included suspected COVID-19 from 12Mar2020, Unsure when symptoms stopped. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. It was informed that after the first vaccine, patient''s lymph nodes swelled painlessly, but after the second dose of the vaccine, the pain of the swelling was excessive. There were bumps covering her neck and collarbone on the side where patient received the vaccine, and every movement was painful. At the time of the reporting outcome for the event axillary mass was unknown, while the patient had not yet recovered from other reported events. It was also informed that patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724507 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FFZ153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Feeling of body temperature change, Inappropriate schedule of product administration, Lymphadenopathy, Pain, Pyrexia, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chills; Cold; Fever; Pain; Tiredness
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168335

Write-up: inappropriate schedule of vaccine administered; Swollen lymph nodes; Chills; hot/cold spells; Fever; aching; Tiredness; injection site strong pain; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109061206231990-ISL7Q. Safety Report Unique Identifier: GB-MHRA-ADR 25899888 A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 04Sep2021 (Lot Number: FFZ153) as dose 2, single at 23-year-old for COVID-19 immunization. Medical history included fatigue, chills, pyrexia, pain and cold. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medications included ibuprofen and paracetamol; both taken for an unspecified indication, start and stop date were not reported. The had inappropriate schedule of vaccine administered as he previously received the first dose of bnt162b2 on 08Jul2021. On 04Sep2021, first night after vaccine, the patient experienced injection site strong pain, fever, aching, and tiredness. On the day after the vaccination, on 05Sep2021, the patient had tiredness and hot/cold spells all day. Early morning of 06Sep2021, the patient woke up with chills, requiring warm clothes to be worn for hours before becoming feverishly warm until current (noon). He also noticed swollen lymph node in left underarm, injection side, roughly the size of a golf ball. The outcome of the event injection site pain, chills, tiredness, fever was recovering; lymph node swelling was not recovered; and feeling of hot and cold and aching was unknown. The events were assessed as medically significant. 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.


VAERS ID: 1724514 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug ineffective, Inappropriate schedule of product administration, Lymphadenopathy, Suspected COVID-19
SMQs:, Lack of efficacy/effect (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101168357

Write-up: inappropriate schedule of vaccine administered; suspected COVID-19; suspected COVID-19; Swollen lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109061902064960-W30S9, Safety Report Unique Identifier GB-MHRA-ADR 25902425. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Sep2021 (Lot Number: FE3380) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. The patient had inappropriate schedule of vaccine administered as she previously received dose 1 via an unspecified route of administration on 30Jun2021 (Lot Number: FD5613-L748) as dose 1, single for COVID-19 immunization. The patient experienced swollen lymph nodes and suspected COVID-19 on 04Sep2021. The outcome of the events was not recovered. The events were considered medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724515 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: Dizziness; Headache; Rash
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101168398

Write-up: dizziness; Skin rash/Rash on the arm of which I had the vaccine; Headache; Nausea; This is a spontaneous report from a contactable consumer. This report received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109061902303070-CQNLU. Safety Report Unique Identifier GB-MHRA-ADR 25902562. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Sep2021 with Batch/Lot Number: FF2153 as dose 2, single for COVID-19 immunization. Medical history included headache, dizziness and rash. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. On an unknown date, the patient experienced dizziness. On 04Sep2022, the patient had skin rash/rash on the arm of which he had the vaccine, headaches and nausea. The outcome of nausea and headache was recovered on 04Sep2021; the outcome of rash was not recovered and the outcome of dizziness was unknown. TH events were assessed as medically significant. The patient underwent lab tests and procedures which included negative COVID-19 virus test on an unspecified date. The patient had to take the day off work. 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.


VAERS ID: 1724560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Epistaxis, Fatigue, Headache, Pyrexia, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210828; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101182318

Write-up: Nosebleed; Dizzy; Weak; Sore head; Started feeling tired; Fever; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202109081022141370-A79TS, Safety Report Unique Identifier is GB-MHRA-ADR 25911224. A 26-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN, Expiry date not reported), via an unspecified route of administration on 02Sep2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history was not reported. It was unsure whether the patient had symptoms associated with COVID-19. The patient was not enrolled in the clinical trial. The patient was not pregnant and was not breastfeeding. Concomitant medications were not reported. On 28Aug2021, the patient underwent COVID-19 virus test and the result was negative. On an unknown date in 2021, the patient experienced fever. On 04Sep2021, the patient started feeling tired, weak and had sore head, unlike any symptoms the patient never had before. 07Sep2021, the patient experienced nosebleed for 5 minutes and felt dizzy afterwards. The patient had not tested positive for COVID-19, since having the vaccine. The clinical outcome of the events feeling tired and fever was resolving while the outcome of weak, sore head and dizzy was unknown. The clinical outcome of the event nosebleed was recovered with sequelae on 07Sep2021. The events tired, fever, nosebleed, weak, headache and dizziness was reported as serious for being medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstruation delayed, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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 INC202101182405

Write-up: Irregular periods; Heavy periods; Painful periods; late period; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109081615201810-9W9TI with Safety Report Unique Identifier of GB-MHRA-ADR 25913062. A 33-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history was not reported. The patient was not pregnant and not breastfeeding at the time of this report. The patient had no symptoms associated with COVID-19, and did not undergo a COVID-19 test. The patient was not enrolled in clinical trial. Past drug history included antihistamines from an unknown date for unspecified indication (also reported that the patient did not receive any other medication apart from antihistamines). Concomitant medications were not reported. On 04Sep2021, the patient experienced irregular periods. On an unknown date in 2021, the patient experienced heavy periods, late period and painful periods. The clinical course was reported as follows: The patient periods had been irregular since having the vaccine, and for the current month the periods were late by 3 and a half weeks. The periods were extremely heavy and painful periods to the point she thought she might be having a miscarriage. The patient had not tested positive for COVID-19 since having the vaccine. The case is serious (medically significant). The clinical outcomes of the events irregular periods, heavy periods, late period and painful periods were unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724639 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Bell's palsy, Hypoaesthesia oral, Pain, SARS-CoV-2 test
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191546

Write-up: Pain behind the ear and down the neck; Numbness of the tongue; loss of taste; Bell''s palsy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109100951210970-YQJNN, Safety Report Unique Identifier GB-MHRA-ADR 25922892. A 18-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FE3380), via an unspecified route of administration on 21Aug2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. On 04Sep2021, the patient experienced bell''s palsy and pain behind the ear and down the neck, numbness of the tongue, loss of taste on an unspecified date. The patient experienced Pain behind the ear and down the neck, Numbness of the tongue- loss of taste on one side, Can''t close one eye, Can''t move my mouth on one side. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test. Therapeutic measures were taken as a result of bell''s palsy, pain behind the ear and down the neck, numbness of the tongue. The clinical outcome of bell''s palsy was not recovered, and outcome of other events Pain behind the ear and down the neck, Numbness of the tongue, loss of taste was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724676 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-09-04
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness unilateral, Confusional state, Dizziness, Dysarthria, Transient ischaemic attack, Tremor, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191603

Write-up: went blind in one eye, blurry in other; My brother went blind in one eye, blurry in other; speech was slurred; hands shaking; dizzy; confused; Ministroke; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109102056022640-PVMYJ. Safety Report Unique Identifier GB-MHRA-ADR 25926270. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 14Aug2021, as DOSE 2, SINGLE for COVID-19 immunisation. The patients medical history and concomitant medications were not reported. Patient had no illnesses, fit and healthy. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced hands shaking, dizzy, confused, went blind in one eye, blurry in other, speech was slurred. On 04Sep2021, 21 days after second dose of vaccine, the patient experienced ministroke. The outcome of the event minstroke was resolving and outcome of remaining all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724677 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, SARS-CoV-2 test
SMQs:, Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191636

Write-up: Swollen lymph nodes; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109102102051230-4VAA6, Safety Report Unique Identifier GB-MHRA-ADR 25926189. A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration on 03Sep2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. It was stated that, on 04Sep2021 (after 1 day of vaccination), the patient experienced headache and on 10Sep2021 (after 7 days of vaccination), experienced swollen lymph nodes. Both the events were reported as serious with seriousness criteria as other medically important condition (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test (sars-cov-2 test) with negative result 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 for both the events was reported as not recovered, at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1724712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Costochondritis, Dizziness, Fungal infection, Inflammation, Nausea, SARS-CoV-2 test, Syncope
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), 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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191684

Write-up: heart inflammation; Mycosis; Fainting; Costochondritis; Nausea; Dizziness; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202109111120420070-GFVNM, Safety Report Unique Identifier GB-MHRA-ADR 25928016. A 27-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Aug2021 (Lot Number: FF2153) as DOSE 1, SINGLE for COVID-19 immunization. Patient is not pregnant at the time of vaccination. Patient is not currently breastfeeding. Medical history included anxiety. Concomitant medication(s) included citalopram (CITALOPRAM) taken for anxiety from 01Aug2016 to an unspecified stop date. The patient experienced heart inflammation on an unspecified date. The patient experienced costochondritis nausea, dizziness on 04Sep2021. The patient had fainting on 05Sep2021 and mycosis on 06Sep2021. The clinical course reported as follows, Still feeling inflammation across my chest and left side rib cage like costochondritis. Feeling heart beat as though I am out of breath but heart is not beating fast. Blood tests confirmed mild heart inflammation. 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. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome of event for heart inflammation, mycosis, nausea, dizziness, was recovering and for costochondritis was not recovered and for fainting was recovered on an unspecified date. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724791 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, Fatigue, Headache, Hyperhidrosis, Illness, Inappropriate schedule of product administration, Migraine, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101189767

Write-up: fainting; Sickness; temperature; hot and cold sweats; no appetite; headache; weakness in body; tiredness; migraine; Dose 1 on 10Jul2021 and dose 2 on 04Sep2021; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female (not pregnant at the time of vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Left arm on 04Sep2021 at 19:30 (age at vaccination 33-year-old, Batch/Lot Number: Ff2153) as dose 2, single for COVID-19 immunisation. The patient received most recent COVID-19 vaccine was administered at other. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient Historical vaccine include BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: Fd8813) dose 1 via unspecified route of administration, administered in left arm on 10 Jul2021 at 12:30 pm (33-year-old at the time of vaccination) for COVID-19 Immunization. The patient had not received any other vaccine within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient had not received other medications within 2 weeks of vaccination. On 05Sep2021 at 07:30, 12 hrs after vaccination, The patient experienced fainting, sickness, temperature, hot and cold sweats, no appetite, headache, weakness in body, tiredness, migraine. Patient visited Doctor or other healthcare professional office/clinic visit for adverse event. The patient had not received treatment for adverse event. The outcome of events were resolving. No follow-up attempts possible. No further information expected.


VAERS ID: 1724800 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-09-04
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Cerebrovascular accident, Dizziness, Headache, Hypoaesthesia, Migraine, Panic reaction, SARS-CoV-2 test, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LYRICA; OESTROGEN; NAPROXEN; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ehlers-Danlos syndrome type III; Fibromyalgia; Gender dysphoria; Klinefelter''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: Nasal Swab; Test Result: Negative ; Comments: Covid test name post vaccination=unknown (name)
CDC Split Type: GBPFIZER INC202101223521

Write-up: diagnosed stroke; severe headache; Felt dizzy; numb all over; not able to see; panic / anxiety; panic / anxiety; migraine; This is a spontaneous report from a contactable consumer. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in right arm on 14Aug2021 (Batch/Lot number was not reported) (at the age of 26 years old) as dose 2, single for COVID-19 immunisation. Medical history included Klinefelter''s syndrome, hypermobility EDS type 3, fibromyalgia and gender dysphoria. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included pregabalin (LYRICA); diethylstilbestrol (OESTROGEN); naproxen; and paracetamol; all taken for unspecified indication, start and stop date were not reported. The patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Sep2021, the patient experienced sudden onset severe headache, felt dizzy, numb all over, not able to see, and panic/anxiety. Diagnosed as migraine, but did not recover, returned to AE on 08Sep2021, and was diagnosed as stroke. The patient underwent lab tests and procedures which included Nasal Swab (COVID test name post vaccination=unknown (name)): negative on 08Sep2021. The events resulted in Emergency room/department or urgent care visit. The patient was sent home and was given sumatriptan and cyclizine as treatment for the events. Outcome of events was not recovered. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1724889 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure decreased, Blood pressure measurement, Body temperature, Depressed level of consciousness, Epilepsy, Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (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? 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: 20210904; Test Name: Auscultation; Result Unstructured Data: Test Result:No heart sounds problem and breast problem; Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:93/34; Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:92/52; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101164367

Write-up: unconsciously; Consciousness clouding; Epilepsy; fell; BP was 94/34/BP was 92/52; Vagal reflex; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). Regulatory authority report number is v21125936. The patient was an 18-year and 6-month-old (age at first vaccination) male. Body temperature before vaccination was 36.8 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 04Sep2021 at 11:08 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF9942, Expiration date 30Nov2021) via intramuscular as a single dose for COVID-19 immunization. The event onset date was reported as 04Sep2021 at 11:28 (20 minutes after the vaccination). On 04Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: After the intramuscular injection, the patient fell forward unconsciously. The patient was put to bed rest, but the patient experienced consciousness clouding. BP was 94/34. No heart sounds problem and breast problem were found from auscultation. Consciousness improved in a few minutes. 10 minutes later, BP was 92/52. Administration of Bosmin was ordered, but then it was canceled because the patient regained consciousness. The patient recovered completely with saline 500ml and Linolosal. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It seemed evident that the patient had vagal reflex. Epilepsy was also suspected. All events were reported recovered on 04Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724901 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101170606

Write-up: giddiness; headache; queasy; This is a spontaneous report from a contactable physician received from the regulatory authority . Regulatory authority report number is v21126057. The patient was a 51-year and 4-month-old female. Body temperature before vaccination was 36.9 degrees Centigrade. On 04Sep2021 at 14:50 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Patient age at vaccination was 51-year-old. The patient had a history of hypertension. The onset date of event was reported as 04Sep2021 at 15:00 (10 minutes after the vaccination). On 04Sep2021 (the day of vaccination), the outcome of the event was recovering. The course of the event was as follows: The patient experienced giddiness, headache and queasy, recovering after DIV. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1724902 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cold sweat, Pallor, Vital signs measurement
SMQs:, 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210904; Test Name: vital; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC202101170613

Write-up: Complexion ill; cold sweat; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and regulatory authority. Regulatory authority report number is v21126056. An 18-year-old (18-year and 5-month-old) male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FD1945; Expiration Date: 31Oct2021), via an unspecified route of administration on 04Sep2021 13:40 (at the age of 18 years old) as dose 1, single for COVID-19 immunisation. Medical history was none. There were no points to be considered on the vaccine screening questionnaire. The patient''s concomitant medications were not reported. Body temperature before vaccination (04Sep2021) was 36.4 degrees Centigrade. On 04Sep2021 14:37 (1 hour after the vaccination), the patient experienced complexion ill and cold sweat. The course of the event was as follows: Complexion ill, remarkable cold sweat. Vital was stable. Recovering with drip intravenous (DIV) + hydrocortisone sodium succinate (SOLU-CORTEF) 100mg. On 04Sep2021 (the day of the vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1724906 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-09-04
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Epilepsy, 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: Test Date: 20210904; Test Name: Brain CT; Result Unstructured Data: Test Result:No obvious abnormalities
CDC Split Type: JPPFIZER INC202101170673

Write-up: Generalised convulsion/convulsion; Epilepsy; This is a spontaneous report from a contactable Other HCP received from the Agency. Regulatory authority report number is v21126053. A 46-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Aug2021 (Batch/Lot number was not reported), at the age of 46-years-old, as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced epilepsy on 04Sep2021 15:40. On 04Sep2021 at about 15:40 (20 days after the vaccination), the patient experienced convulsion. On 04Sep2021 (20 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was not provided. The course of the events was reported as follows: Generalised convulsion occurred. The brain CT showed that No obvious abnormalities on 04Sep2021. The reporting other HCP classified the event as serious (caused hospitalization from 04Sep2021) and assessed the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was Epilepsy. The outcome of the events was unknown. The following information on the lot/batch number has been requested.


VAERS ID: 1724909 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-09-04
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral artery occlusion, Cerebral infarction, Computerised tomogram, Hemiplegia
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: CT; Result Unstructured Data: Test Result:confirmed right middle cerebral artery occlusion.; Comments: confirmed right middle cerebral artery occlusion. Diagnosed as acute phrase cerebral infarction.
CDC Split Type: JPPFIZER INC202101170723

Write-up: cerebral infarction/ acute phrase cerebral infarction; right middle cerebral artery occlusion; right hemiplegia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126051. A 79-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 21Jul2021, the patient previously received the first dose of bnt162b2 (COMIRNATY) as a single dose for COVID -19 immunisation. On 04Sep2021 at 04:00 (24 days after the vaccination), the patient experienced cerebral infarction. On 04Sep2021 (24 days after the vaccination), the patient was hospitalized. Outcome of the event was not reported. The course of event was as follows: On 04Sep2021 at 04:00, the patient experienced right hemiplegia when getting up and called the ambulance. From the CT, it was confirmed right middle cerebral artery occlusion. Diagnosed as acute phrase cerebral infarction. Intravascular treatment, performed thrombus retrieval treatment. The reporter classified the event as serious (hospitalization from 04Sep2021) and assessed the causality between the event and the bnt162b2 as unassessable. There was no other possible cause of the event such as any other diseases. Outcome of events was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1724912 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Coma scale, Cough, Oxygen saturation, Throat irritation, Type I hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to plants; Peanut allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: BP; Result Unstructured Data: Test Result:110/60s; Test Date: 20210904; Test Name: JCS; Result Unstructured Data: Test Result:0; Test Date: 20210904; Test Name: SPO2; Test Result: 99 %
CDC Split Type: JPPFIZER INC202101170826

Write-up: Anaphylaxis; throat itching; cough; Immediate hypersensitivity reaction; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126176. A 43-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Sep2021 11:10 (at the age of 43 years old) (Lot Number: FE8162; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation. Medical history included anaphylaxis due to bamboo shoot, peanuts and ISODINE. The patient''s concomitant medications were not reported. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included that the patient had anaphylaxis due to bamboo shoot, peanuts and ISODINE. The patient experienced anaphylaxis (medically significant) on 04Sep2021 11:40, immediate hypersensitivity reaction (medically significant) on 04Sep2021, throat itching on 04Sep2021 11:40, cough on 04Sep2021 11:40. On 04Sep2021 at 11:40 (30 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: After receiving the vaccination for 30 minutes, throat itching and cough appeared. SPO2 99%, BP 110/60s, JCS 0, no skin symptoms, no abdominal symptoms. No wheezing. This symptom carries the risk of progressing to anaphylaxis. Epinephrine 0.1 mg dermal injections were performed twice. On 04Sep2021 (the day of vaccination), the outcome of the event was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Immediate hypersensitivity reaction by vaccine was considered. The symptom disappeared by epinephrine 0.1mlx2 hypodermic injection. No follow-up attempts are needed. No further information is expected.~


VAERS ID: 1724919 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Cough, Pruritus, Pyrexia
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Allergy to plants (was allergic to ceda, rcypress and basu dakuto)
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade
CDC Split Type: JPPFIZER INC202101171223

Write-up: Anaphylaxis; itching in throat; cough; Pyrexia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126170. A 33-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Sep2021 16:00 (at age of 33 years old)(Lot Number: FF0843; Expiration Date: 31Oct2021) as DOSE 1, single for covid-19 immunisation. Medical history included allergy to plants. Body temperature before vaccination was 36.2 degrees Centigrade. 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. On 04Sep at 16:45 (45 minutes after the vaccination), the patient experienced Anaphylaxis. The outcome of the event was not provided. The course of the event was as follows: At 16:00 on 04Sep, the patient received second dose of COVID 19vaccination in the hospital. 15 minutes after receiving vaccination, took a follow up and without abnormalities in body , the patient went home. At about 16:45, the patient called hospital to complain the symptoms of itching in throat and cough by herself, and she hadn''t complained symptoms of feeling hot, rash and dyspnoea. There was no history of allergies recorded on the Prevaccination Screening Questionnaire but the history of allergies was found when reconfirmed, the patient was allergic to plants. Taking into account the possibility of adverse events for COVID19 vaccine ,the patients was advised to see a doctor in hospital. To confirm the symptoms, we called patient next day, After yesterday''s call, the patient went to Hospital with symptoms of itchy in throat ,cough and Pyrexia. It was diagnosed as an adverse reaction of COVID19 vaccine and prescribed oral medicine. Now the symptoms had been alleviated. The reporting physician classified the event as non-serious and there was no other possible cause of the event such as any other diseases.


VAERS ID: 1724925 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? 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: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202101171484

Write-up: Light-headed feeling; Queasy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126058. A 30-year-old female (reported as 30-year and 4-month-old female) patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Sep2021 14:45 (at the age of 30 years old) (Lot Number: FD1945; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.6 degrees Centigrade on 04Sep2021. The patient experienced light-headed feeling (medically significant) on 04Sep2021 14:45, queasy (medically significant) on 04Sep2021 14:45. The course of the event was as follows: DIV (intravenous drip) for queasy and light-headed feeling. The patient back home with symptoms recovering. On 04Sep2021 (the day of vaccination), the outcome of the events was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Gingival pain, Loose tooth, Musculoskeletal stiffness, Neck pain, Pain in extremity, Polymenorrhoea, Pyrexia, Tooth loss
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Gingival disorders (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fatigue; Pain
Allergies:
Diagnostic Lab Data: Test Name: Pyrexia; Result Unstructured Data: Test Result:7.2(as reported) Centigrade
CDC Split Type: JPPFIZER INC202101175036

Write-up: lost three teeth; pyrexia was 7.2 degrees Centigrade(as reported); the patient''s period came a week early; arm pain; Shoulder muscle stiffness; neck pain; Gum pain; Loose tooth; felt a little strange; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age 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 03Sep2021 (at unknown age) as single dose for COVID-19 immunisation. Medical history included Apr2021, the patient felt slightly tired and pain. The patient''s concomitant medications were not reported. On 03Sep2021 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at arm left as a single dose for COVID-19 immunization. On 03Sep2021, Friday, the patient was vaccinated on left arm. On Saturday''s evening (04Sep2021), after 24 hours, the patient couldn''t remember the time exactly, the patient experienced arm pain, Shoulder muscle stiffness, neck pain, gum pain and Loose tooth. The tooth itself were worn with a dental tray. The patient was about to take a bite of food on Saturday night, but the patient felt a little strange. It started to move vertically by about two millimeters. They were the second and third from the bottom on the far left, and the patient thought it was related to the vaccine. For there was arm pain, Shoulder muscle stiffness and neck muscle pain, it was after the first dose, the patient was a little nervous about the second dose. On unknown date, Pyrexia was 7.2 degrees Centigrade (as reported). This might not be relevant, but the patient''s period came a week early. The back teeth on the lower left side also need to be extracted, today two teeth which were the second and third from the bottom with a dental tray was extracted, and the patient went to the hospital as soon as possible on Monday. The patient was vaccinated on Friday and tooth moved on Saturday night, so the patient took some painkillers and put up with it because the hospital was not open on Sunday, and the patient went in the morning on Monday. The people around the patient said the second dose should be vaccinated, but the patient had lost three teeth. The first dose was received at the clinic, but they couldn''t make an appointment because there was no the second dose; The patient had an appointment at a mass vaccination site on 27Sep2021. The patient received the first dose and even had to extracted teeth to get partial denture. The teeth were installed with dental tray, about in spring. Treatment received for lost three teeth, Loose tooth. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1724973 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, 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? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101183251

Write-up: malaise; hyperthermia, Pyrexia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126261. The patient was a 15-year-old female (age at vaccination). Body temperature before vaccination was not provided. Medical history and concomitant medications were unknown. On unknown date, the patient received the first dose of bnt162b2 (COMIRNATY), Lot number EW0207, Expiration 30Sep2021 for Covid-19 immunisation. On 04Sep2021 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY), Solution for injection, Lot number FF0843, Expiration date 31Oct2021, via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 15-year-old. The course of the event was as follows: From the vaccination day (04Sep2021), hyperthermia appeared. The hyperthermia once subsided, but from 07Sep2021, pyrexia appeared again. In addition, the patient also experienced malaise since 07Sep2021; the patient visited clinic for the events (physician office).As of 08Sep2021 (4 days after vaccination), the did not recover from malaise and pyrexia. The reporting physician classified the events as serious (risk of disability) and assessed that the event was related to bnt162b2. The reporting physician commented as follows: Proper follow-up is necessary.


VAERS ID: 1724978 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Oral pain, Stevens-Johnson syndrome, Streptococcal infection
SMQs:, Severe cutaneous adverse reactions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Foreign body sensation in eyes (before vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: blood test; Result Unstructured Data: Test Result:AS level high; Comments: Streptococcal infection was confirmed
CDC Split Type: JPPFIZER INC202101183525

Write-up: Stevens-Johnson syndrome; Streptococcal infection; Oral pain; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This 45-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route, 03Sep2021 at single dose for COVID-19 immunisation. On 03Sep2021 (before vaccination), the patient had foreign body sensation in eyes. No additional medical history was provided. No relevant concomitant medications were provided. On 04Sep2021 (1 day after the vaccination), the patient visited the otorhinolaryngology nearby for she experienced oral pain. On 05Sep2021 (2 days after the vaccination), the patient was hospitalized cause the symptoms aggravated. Streptococcal infection was confirmed based on blood test result of AS level high. The patient received treatment of Steroid pulse and Globulin preparations but the symptoms were not recovered at the moment. The reporting physician considered that the Symptoms were Stevens-Johnson syndrome due to Streptococcal infection. It cannot be denied that it is a side effect of the vaccine. The patient had not recovered from the events ''Stevens-Johnson syndrome'' and ''Streptococcal infection'' while the outcome of oral pain was unknown. The reporter considered that the causality between Stevens-Johnson syndrome and BNT162B2 was possibly related. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Stevens-Johnson syndrome, Streptococcal infection, Oral pain and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1725023 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005273 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arrhythmia, Gaze palsy, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

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

Write-up: Loss of consciousness; Upward deviation of the eyes; Arrhythmia; Vagal reflex; This case was received (Reference number: JP-TAKEDA-2021TJP093048) on 11-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This case, initially reported to by a (physician), was received via the PMDA (Ref, v21126424). Loss of consciousness, upward deviation of the eyes, and arrhythmia was assessed as serious by the MAH. On an unknown date, body temperature before vaccination: 36.1 degrees Celsius. On 04-Sep-2021, at 18:00, the patient received the 1st dose of this vaccine. There was no problem immediately after the vaccination. At 18:15, vagal reflex developed in the standing position and the patient lost consciousness. Facial pallor and upward deviation of the eyes were observed. There was no memory at the time of loss of consciousness. Consciousness became clear at the examination. There was no weakness, and the patient was able to move for the instruction. Neurological findings were normal. ECG showed occasional arrhythmia. After 30 minutes of follow-up, improvement and recovery were confirmed and the patient returned home. The outcome of vagal reflex, loss of consciousness, upward deviation of the eyes, and arrhythmia was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 21-year-old, male patient with no relevant medical history, who experienced the unexpected events of Loss of consciousness, Gaze Palsy, Arrhythmia and Presyncope. The events occurred 15 minutes after the first dose of COVID-19 Vaccine Moderna. The rechallenge was not applicable, as the event happened after the first dose. The reporter assessed the events as related to the product. The benefit-risk relationship of COVID-19 Vaccine Moderna is not affected by this report.


VAERS ID: 1725097 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:190/100 mmHg
CDC Split Type: PHPFIZER INC202101183212

Write-up: Elevated BP (190/100 mmHg); This is a spontaneous report from a contactable other Health Professional received from the regulatory authority report number PH-PHFDA-300104276. A 69-year-old male patient received a dose of BNT162b2 (COMIRNATY), intramuscular on 04Sep2021 (Lot Number: FD0350) (at the age of 69-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced elevated BP (blood pressure) on 04Sep2021 at 09:33. The patient underwent lab tests and procedures which included blood pressure measurement: 190/100 mmHg on 04Sep2021. The patient outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1725098 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0350 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:210/100 mmHg
CDC Split Type: PHPFIZER INC202101183213

Write-up: Elevated BP (210/100 mmHg); This is a spontaneous report from a contactable other health professional received from the regulatory authority. Regulatory authority report number PH-PHFDA-300104280. A 64-year-old male patient received a dose of BNT162b2 (COMIRNATY), intramuscular on 04Sep2021 (Lot Number: FD0350) (at the age of 64-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced elevated BP (blood pressure) on 04Sep2021 at 09:49. The patient underwent lab tests and procedures which included blood pressure measurement: 210/100 mmHg on 04Sep2021. The patient outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1725961 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-09-04
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram, Dizziness, Facial paralysis, Gait disturbance, Oculomotor study, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided
Allergies:
Diagnostic Lab Data: Test Name: Computer tomography; Result Unstructured Data: no obvious infarction or hemorrhage; Test Name: oculomotor palsy; Result Unstructured Data: oculomotor palsy of the right eye was diagnosed
CDC Split Type: TWMODERNATX, INC.MOD20213

Write-up: Facial palsy; unstable gait; blurred vision in the right eye; dizziness; This regulatory authority case was reported by a pharmacist and describes the occurrence of FACIAL PARALYSIS (Facial palsy) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided. Concomitant products included HYDROCORTISONE for an unknown indication. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced FACIAL PARALYSIS (Facial palsy) (seriousness criterion medically significant), GAIT DISTURBANCE (unstable gait), VISION BLURRED (blurred vision in the right eye) and DIZZINESS (dizziness). At the time of the report, FACIAL PARALYSIS (Facial palsy), GAIT DISTURBANCE (unstable gait), VISION BLURRED (blurred vision in the right eye) and DIZZINESS (dizziness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) no obvious infarction or hemorrhage. On an unknown date, Oculomotor study: abnormal (abnormal) oculomotor palsy of the right eye was diagnosed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment product was not provided by the reporter Company comment: This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the unexpected events of Gait disturbance, Vision blurred and Dizziness and expected event of facial paralysis. The events occurred approximately 2 months after the first dose of Spikevax. The rechallenge was unknown since only information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity; Sender''s Comments: This case concerns a 68-year-old, male patient with no relevant medical history, who experienced the unexpected events of Gait disturbance, Vision blurred and Dizziness and expected event of facial paralysis. The events occurred approximately 2 months after the first dose of Spikevax. The rechallenge was unknown since only information about the first dose was disclosed. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1726038 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-04
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Test Result:33.8; Comments: 33.8
CDC Split Type: ATPFIZER INC202101189401

Write-up: Drug ineffective; inappropriate schedule of vaccine administered; the patient experienced Asymptomatic COVID-19, COVID-19 PCR test positive; This is a non-serious spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-043955. A 76-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Jun2021 as dose 1, single for COVID-19 immunisation. On 04Sep2021 the patient experienced Asymptomatic COVID-19, COVID-19 PCR test positive and on an unknown date the patient experienced drug ineffective and inappropriate schedule of vaccine administered. The patient underwent lab tests and procedures which included sars-cov-2 test positive: 33.8 on 04Sep2021 33.8. Outcome of events was unknown. Follow-up activities not possible. No further information expected. Batch/LOT number cannot be obtained.


VAERS ID: 1726040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210904; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: 27.7
CDC Split Type: ATPFIZER INC202101188341

Write-up: Positive PCR, no symptoms; Positive PCR, no symptoms; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number AT-BASGAGES-2021-044002. A 76-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 27Mar2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. On 04Sep2021 the patient experienced COVID-19 PCR test positive, Asymptomatic COVID-19. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 04Sep2021 (27.7). This report was reported as non-serious. The event outcome was unknown. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1727533 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCUE1 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Lip swelling
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: Medical History/Concurrent Conditions: Drug allergy (Patient has also reacted to therapy with ACE inhibitors with swelling of the lips); Swelling lips (Patient has also reacted to therapy with ACE inhibitors with swelling of the lips)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101196341

Write-up: exclusively a swelling of the lips/After 6 days, the swelling returned after the everything had previously subsided; exclusively a swelling of the lips; This is a spontaneous report received from a contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 85882, license party for Comirnaty]. A male patient of an unspecified age received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Sep2021 (Batch/Lot Number: SCUE1) as single dose, for COVID-19 immunization. Medical history included drug allergy and swelling of the lips (Patient had also reacted to therapy with ACE inhibitors with swelling of the lips). The patient''s concomitant medications were not reported. The patient experienced exclusively a swelling of the lips on 04Sep2021. It was reported the primary care physician vaccinated a patient who developed lip swelling after 2 days, exclusively a swelling of the lips, which was not described in the professional information. He treated the patient with the antihistamine cetirizine. The swelling persisted for 36 hours under treatment with cetirizine and then subsided. After 6 days on 08Sep2021, the swelling returned after the everything had previously subsided. The swelling of the lips was much more pronounced than the first time. The patient was again treated with high doses of cetirizine and prednisolone 2 x 50 mg, which led to an almost complete reduction within 24 hours on yesterday, 09Sep2021. In the past, the patient had also reacted to therapy with ACE inhibitors with swelling of the lips. The reaction was exactly the same as with vaccination. The outcome of events was recovered on 09Sep2021.; Sender''s Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Lip Swelling, Disease recurrence and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1728662 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity, SARS-CoV-2 test
SMQs:, 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: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ache
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Leg pain; This case was received via Regulatory Authority MHRA (Reference number: GB-MHRA-ADR 25896487) on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Leg pain) in a twenty-seven-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Ache. Concomitant products included SERTRALINE from 01-Mar-2021 to 01-Jun-2021 for Depression. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced PAIN IN EXTREMITY (Leg pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Leg pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jul-2021, SARS-CoV-2 test: Negative COVID-19 test. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication details was reported. Company comment: This case concerns a twenty-seven-year-old, female patient with relevant medical history of Ache, who experienced the unexpected event of Pain in extremity. The event occurred approximately one day after the first dose of Moderna COVID-19 Vaccine. The reporter assessment of the event was not provided. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a twenty-seven-year-old, female patient with relevant medical history of Ache, who experienced the unexpected event of Pain in extremity. The event occurred approximately 1 day after the first dose of Moderna COVID-19 Vaccine. The reporter assessment of the event was not provided. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1728664 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101194222

Write-up: Menstrual cycle shortened; This is a spontaneous report from a contactable consumer (patient) downloaded from the Regulatory Authority-WEB, regulatory authority number GB-MHRA-WEBCOVID-202109051047574340-ECULO. Safety Report Unique Identifier is GB-MHRA-ADR 25897037. A 41-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 04Sep2021 (age at the vaccination was 41-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not enrolled in clinical trial. Patient was not breastfeeding. Patient not had symptoms associated with COVID-19. The patient had not any other illnesses and not taken any other medications. Patient was a healthy and fit woman. The patient never had an issue like this in her life. The patient experienced menstrual cycle shortened on 04Sep2021. The patient always had normal and predictable periods. The patient period started the morning of her second dose. It was heavy, as it always was on the first day. Her flow stopped abruptly a couple of hours after she got the vaccination. This had never happened to her before in her life. It was truly extraordinary. Patient was extremely concerned given that nothing was ever tested on women, so there was no way of knowing how this was interfering with our bodies. Totally unacceptable. The patient lab test and procedures which included COVID-19 virus test was no-negative COVID-19 test on an unspecified date. The outcome of the event was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1728676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bloody discharge, Discharge, Hypersomnia, Muscle spasms, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTAIR; VENTOLIN [SALBUTAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191635

Write-up: cramping; discharge was dark, lumpy; Bleeding vaginal; Bloody discharge; slept for a long time; drained of energy; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109101002585930-DM5GO., Safety Report Unique Identifier GB-MHRA-ADR 25923003. A 32-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 04Sep2021 (Batch/Lot Number: FE8087) as dose 2,single for covid-19 immunization. The patient''s Medical history included suspected covid-19 from 01Jan2020 to 05Mar2021, asthmatic. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The Concomitant medication included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for asthmatic start and stop date were not reported; salbutamol (VENTOLIN [SALBUTAMOL]) taken for asthmatic, start and stop date were not reported.The patient experienced drained of energy, slept for a long time on 04Sep2021, bleeding vaginal, bloody discharge on 05Sep2021, cramping and discharge was dark, lumpy on an unspecified date. The day of the vaccine she felt completely drained of energy and slept for a long time. When she woke up the next morning, she found she was bleeding vaginally (2 weeks before my expected period). The discharge was dark, lumpy and bloody. Over the next 2 days it turned to fresh blood and for the remaining days (until today, 10Sep2021) it reverted to being brown and textured. she experienced some light cramping on and off.The symptoms were still here today, but have lessened enough that she expected they would cease by tomorrow. she had never experienced anything quite like this before. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial.The patient underwent lab tests and procedures which included COVID-19 virus test:No - Negative COVID-19 test on unspecified date. The outcome of drained of energy and cramping was recovered on unspecified date, bleeding vaginal and bloody discharge was recovering and discharge was dark, lumpy and slept for long time was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729169 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation irregular, Neck pain, Pain, SARS-CoV-2 test, Vaccination site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), Arthritis (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205593

Write-up: first dose received on 19Jun2021 and second dose received on 04Sep2021; Irregular periods; Prolonged heavy periods; Headache dull; Tiredness; Generalized aching; Neck pain; Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109132222344300-ECZ1J. Safety Report Unique Identifier: GB-MHRA-ADR 25935082. A 28-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 04Sep2021 (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number, Expiry date was not reported), via an unspecified route of administration on 19Jun2021 as dose 1, single for COVID-19 immunization. Patient has not had symptoms associated with COVID-19. Patient was not breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. The patient experienced headache dull, tiredness, generalized aching, neck pain, injection site pain on 04Sep2021, irregular periods and prolonged heavy periods on 06Sep2021 and First dose received on 19Jun2021 and second dose received on 04Sep2021 on an unspecified date. The events caused medically significant. Reporter stated that she have the contraceptive implant and never have periods. Since having her second vaccine a period has started and is lasting a long time. The patient underwent lab tests and procedures which included sars-cov-2 test was negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the events was irregular periods and prolonged heavy periods was not recovered. The outcome of the events was headache dull, generalized aching, neck pain was recovered on 06Sep2021. The outcome of the events was tiredness and vaccination site pain was recovered on 07Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729200 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Myalgia, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

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

Write-up: tight and painful chest; Sore arm for 4 days; Body achy and sore (neck, back, arms, chest); Chest pain; Ache; This case was received via a regulatory authority (Reference number: GB-MHRA-ADR 25946182) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tight and painful chest), CHEST PAIN (Chest pain) and PAIN (Ache) in a 31-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 information was reported. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion medically significant) and PAIN (Ache) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (tight and painful chest) (seriousness criterion medically significant), PAIN IN EXTREMITY (Sore arm for 4 days) and MYALGIA (Body achy and sore (neck, back, arms, chest)). At the time of the report, CHEST DISCOMFORT (tight and painful chest), PAIN IN EXTREMITY (Sore arm for 4 days) and MYALGIA (Body achy and sore (neck, back, arms, chest)) outcome was unknown and CHEST PAIN (Chest pain) and PAIN (Ache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were not reported. The patient had sore arm for 4 days with body ache and sore neck, back, arms and chest. No treatment information was provided. Company Comment: This case concerns a 31-year-old, female subject, with no relevant medical history, who experienced the serious unexpected events of Chest pain, Pain and Chest discomfort. The events Chest pain and Pain occurred approximately 1 day after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna), and the occurrence of the event Chest discomfort was unknown after second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Sender''s Comments: This case concerns a 31-year-old, female subject, with no relevant medical history, who experienced the serious unexpected events of Chest pain, Pain and Chest discomfort. The events Chest pain and Pain occurred approximately 1 day after the second dose of mRNA-1273 (COVID-19 Vaccine Moderna), and the occurrence of the event Chest discomfort was unknown after second dose of mRNA-1273 (COVID-19 Vaccine Moderna). The rechallenge was unknown as there''s no information available about the first dose. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.


VAERS ID: 1729526 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Fatigue, Hypertension, Malaise, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), 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: Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:178/95 mmHg; Comments: at 14:30; Test Date: 20210904; Test Name: Blood pressure; Result Unstructured Data: Test Result:167/84 mmHg; Comments: at 3:00 pm
CDC Split Type: ITPFIZER INC202101184950

Write-up: Lipothymia and general malaise; 178/95 mmHg at 14:30; 167/84 mmHg at 3:00 pm; fatigue; Lipothymia and general malaise; Lipothymia; This is a spontaneous report from contactable Pharmacist downloaded from the WEB IT-MINISAL02-780982. A 68-year-old female patient received bnt162b2 (COMIRNATY), at same age, dose 1 intramuscular on 04Sep2021 (Batch/Lot Number: FG7387; Expiration Date: 30Nov2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lipothymia and general malaise (syncope) on 04Sep2021 with outcome of recovering, fatigue on 04Sep2021 with outcome of unknown. On 04Sep2021, patient experienced 178/95 mmHg at 14:30; 167/84 mmHg at 3:00 pm with outcome of unknown. The treatment was received for all events. Reporter''s comments: In the medical history no pathology and therapy to report. A few minutes after administration of the vaccine fatigue episode. The patient is cannulated and Flebocortid and trimeton are administered (at 2:40 pm). At 3:40 pm she was left with general malaise: she was sent back to her home. No follow-up attempts possible. No further information expected.; Reporter''s Comments: In the medical history no pathology and therapy to report. A few minutes after administration of the vaccine fatigue episode. The patient is cannulated and Flebocortid and trimeton are administered (at 2:40 pm). At 3:40 pm she was left with general malaise: she was sent back to her home.


VAERS ID: 1729544 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Headache, Menstruation irregular, Mental impairment
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), 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: Medical History/Concurrent Conditions: Aortic disorder; Gilbert''s syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101188486

Write-up: 02Sep: start of menstruation; 04Sep: 1 Pfizer / anti-covid dose; after 3 h sudden increase in flow (haemorrhage type), immediately after it stopped, to date (07Sep) it has not reappeared; 02Sep: start of menstruation; 04Sep: 1 Pfizer / anti-covid dose; after 3 h sudden increase in flow (haemorrhage type), immediately after it stopped, to date (07Sep) it has not reappeared.; 02Sep: start of menstruation; 04Sep: 1 Pfizer / anti-covid dose; after 3 h sudden increase in flow (haemorrhage type), immediately after it stopped, to date (07Sep) it has not reappeared; 02Sep: start of menstruation; 04Sep: 1 Pfizer / anti-covid dose; after 3 h sudden increase in flow (haemorrhage type), immediately after it stopped, to date (07Sep) it has not reappeared; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-781882. A 42-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 04Sep2021 (Batch/Lot Number: FG7387) (at the age of 42-year-old) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included Gilbert''s syndrome, Valvola aortica bicuspide. The patient''s concomitant medications were not reported. On 04Sep2021 patient experienced irregular menstrual cycle after administration of the vaccine associated with headache, mental apathy and asthenia that persist for 4 days. bleeding cycle that suddenly increased further a few hours after the vaccine (non-absorbents were not enough to contain the flow) and then just as suddenly stopped; the 2 day cycle never lasted and patient never had these sudden blocks. Reporter thought it was closely linked to the administration of the vaccine, together with asthenia and headache. The outcome of events was unknown.; Reporter''s Comments: reported on the acceptance form: gilbert, bicuspid aorta valve with mild insufficiency; bleeding cycle that suddenly increased further a few hours after the vaccine (non-absorbents were not enough to contain the flow) and then just as suddenly stopped; to me the 2 day cycle never lasted and I never had these sudden blocks


VAERS ID: 1729556 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chest pain, Cold sweat, Cough, Dyspepsia, Headache, Hypotension, Paraesthesia
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BRUFEN
Current Illness: Chronic migraine
Preexisting Conditions: Medical History/Concurrent Conditions: Arachnoid cyst; Cardiac murmur
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: blood pressure; Result Unstructured Data: Test Result:80/48 mmHg; Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade
CDC Split Type: ITPFIZER INC202101228409

Write-up: Wet cough; Excessive cold sweating; Chest pain; Hypotension; Pain on the back of the head; Severe heartburn; Severe tingling in both arms; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-787020. A 21-year-old male patient received first dose of bnt162b2 (COMIRNATY, solution for injection) via intramuscular route of administered at right arm on 04Sep2021 13:40 (Lot number: FG7387; Expiration Date: Nov2021, at the age of 21-year-old) as 0.3 ml single dose for COVID-19 immunisation. Medical history included Arachnoid cyst between brain and cerebellum, chronic migraine and Light murmur on the right side of the heart. Concomitant medication included ibuprofen (BRUFEN) taken for Chronic migraine from 28Aug2021 to 28Aug2021. It was reported that on 04Sep2021 18:00 the symptoms started and patient experienced severe heartburn, hypotension, excessive cold sweating, severe tingling in both arms, chest pain, wet cough. Pain on the back of the head, helped by some Red Cross volunteers accompanied by a doctor, who recommended taking Gaviscon. At 7.30 pm, he went home and measured his blood pressure which gave result of 80/48 mmHg and a body temperature of 38.3 C. On 15Sep2021 made visited his general practitioner who diagnosed inflammation of the stomach. Neurological examination and Computed Tomography of the cranium were also prescribed. History of arachnoid cyst between brain and cerebellum and headache. The patient would take Brufen 600mg as needed to treat migraine, the last administration occurred the week before the vaccination date. The patient underwent lab tests and procedures which included blood pressure measurement: 80/48 mmhg on 04Sep2021, body temperature: 38.3 centigrade on 04Sep2021. Patient visited physician office for severe heartburn. All events considered as life-threatening. Patient did not receive any treatment for the events except severe heartburn for this event patient received treatment. Outcome of all events was not recovered. Health authority comment: Arachnoid cyst located between the brain and cerebellum. Light murmur on the right side of the heart Chronic migraine. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Arachnoid cyst located between the brain and cerebellum. Light murmur on the right side of the heart Chronic migraine


VAERS ID: 1729631 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Hypoaesthesia, Nausea, Throat irritation, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma; Seafood allergy; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101185659

Write-up: Anaphylaxis; numbness in left upper limbs; queasy; vomiting; abdominal pain; Pharyngeal itching; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21127572. A 15-year-old female patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 04Sep2021 at 16:59 (Batch/Lot number was not reported) (at the age of 15-year-old) as single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus, asthma bronchial and food allergy (seafood), all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. On 04Sep2021 at 16:59 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY). On 04Sep2021 at 17:15 (16 minutes after the vaccination), the patient experienced anaphylaxis. On 04Sep2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: the patient complained of numbness in left upper limbs from a few minutes after vaccination on 04Sep2021. Queasy appeared from around 17:15. Queasy aggravated from around 17:30. Vomited in the bathroom. Vomited in medical office at 17:50. Vomited a few times in the bathroom at 18:00. Drank water but vomited. POLARAMINE was administered at 18:35. Fluid infusion was initiated. Queasy improved at 18:39. Our hospital was requested for exam at 18:54. The patient was transported to our hospital and hospitalized. After administering POLARAMINE, queasy improved but abdominal pain persisted. Around 22:00, because abdominal pain and queasy improved, the patient had food but vomited a few times from 10 minutes after. No blood pressure decreased. No upper respiratory stenosis. Pharyngeal itching. Hydrocortisone was administered. The patient had breakfast next morning but vomited. No vomiting after lunch and dinner. The last vomit was 05Sep at 14:00. Symptoms improved and discharged on 06Sep2021. On 09Sep2021 (5 days after the vaccination), the outcome of the events was recovering. The reporting pharmacist classified the event as serious (Hospitalized from 04Sep2021 to 06Sep2021) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101207833 same reporter/patient; different product/AE


VAERS ID: 1729718 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Auditory disorder, Blood pressure measurement, Bradycardia, Heart rate, Oxygen saturation, Presyncope
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: 88/41; Test Name: Blood pressure; Result Unstructured Data: 90/52; Test Name: Pulse rate; Result Unstructured Data: 47; Test Name: Pulse rate; Result Unstructured Data: 60; Test Name: SPO2; Test Result: 98 %; Result Unstructured Data: 98; Test Name: SPO2; Test Result: 98 %; Result Unstructured Data: 98
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Bradycardia; Complete hearing loss; Suspicion of vagal reflex; This case was received via Regulatory Authority (Reference number: 2021TJP087646) on 06-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This case was reported by a physician via a medical representative. Bradycardia was assessed as serious by the Regulatory Authority. On 04-Sep-2021, at 12:09, the patient received the 1st dose of this vaccine. At 12:18, after the vaccination, the patient experienced complete hearing loss, giddiness, and feels poorly. Vagal reflex was suspected. The patient was about to fall down due to lightheadedness and lay down in the first-aid room for 20 minutes, after which the symptoms improved. Initial vital signs revealed bradycardia and hypotension. Blood pressure 88/41, pulse rate 47, and SPO2 98%. The patient sat for about 5 minutes and did not feel poorly. At 12:45, the follow-up was finished. Blood pressure 90/52, pulse rate 60, and SPO2 98%. The outcome of complete hearing loss, suspicion of vagal reflex, and bradycardia was reported as recovered. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. This case concerns an adult male patient with no relevant medical history, who experienced the unexpected event of bradycardia. The event occurred approximately 9 minutes after the second dose of Moderna COVID-19 Vaccine. The patient experienced complete hearing loss, giddiness, and felt poorly. Vagal reflex was suspected. The patient was about to fall down due to lightheadedness and laid down, after which the symptoms improved. Initial vital signs revealed bradycardia and hypotension.The rechallenge was not applicable, as the events happened after the first dose and action taken was reported as not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reporter''s Comments: Vagal reflex suspected based on the patient''s symptoms after the vaccination. The symptom improved in 20 minutes, and there was no problem after the follow-up for 5 minutes, so the patient was allowed to go home. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns an adult male patient with no relevant medical history, who experienced the unexpected event of bradycardia. The event occurred approximately 9 minutes after the second dose of Moderna COVID-19 Vaccine. The patient experienced complete hearing loss, giddiness, and felt poorly. Vagal reflex was suspected. The patient was about to fall down due to lightheadedness and laid down, after which the symptoms improved. Initial vital signs revealed bradycardia and hypotension.The rechallenge was not applicable, as the events happened after the first dose and action taken was reported as not applicable. The reporter assessed the events as related to the product. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1729783 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-09-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: MXPFIZER INC202101197744

Write-up: Pericarditis problems; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received BNT162B2 via an unknown route of administration on 23Aug2021 as single dose (dose number unknown), at an unspecified age, for covid-19 immunisation. Medical history reported as none. The patient''s concomitant medications were not reported. The patient was request guidance due to the fact that she present secondary symptoms after the vaccination. The patient had not suffered from any disease for which she considered that. They did not specify at the time of vaccinating this situation. The patient would like to receive correct guidance and know what to do. The patient experienced pericarditis problems on 04Sep2021 with outcome of unknown. The lot number for BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1730678 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-04
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210904; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: Fever 38C; Test Date: 20210909; Test Name: O2 SAT; Test Result: Inconclusive ; Result Unstructured Data: 82 90%
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: DYSPNEA; COUGH; Fever; COLD; This regulatory authority case was reported by an other health care professional and describes the occurrence of NASOPHARYNGITIS (COLD) in a 51-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced NASOPHARYNGITIS (COLD) (seriousness criterion hospitalization prolonged). The patient was treated with AZITHROMYCIN on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency and CEFIXIME TRIHYDRATE on 04-Sep-2021 for Adverse event, at a dose of 200 mg. At the time of the report, NASOPHARYNGITIS (COLD) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Body temperature: 38 (Inconclusive) Fever 38C. On 09-Sep-2021, Oxygen saturation: 82 90% (Inconclusive) 82 90%. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. Company Comment: This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected events of nasopharyngitis, cough, dyspnea and pyrexia. The events occurrence is unknown with respect to the unknown dose of mRNA-1273 vaccine. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 51-year-old, male patient with no relevant medical history, who experienced the unexpected events of nasopharyngitis, cough, dyspnea and pyrexia. The events occurrence is unknown with respect to the unknown dose of mRNA-1273 vaccine. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1730831 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214021 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Pain in extremity, Type I hypersensitivity
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Immediate hypersensitivity reaction; Pain in arm; Asthenia; This case was received via regulatory authority (Reference number: FR-AFSSAPS-NT20213819) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) in a 13-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214021) for SARS-CoV-2 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arm) and ASTHENIA (Asthenia). At the time of the report, TYPE I HYPERSENSITIVITY (Immediate hypersensitivity reaction) had resolved and PAIN IN EXTREMITY (Pain in arm) and ASTHENIA (Asthenia) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company Comment: This case concerns a 13 year-old, male patient with no relevant medical history, who experienced the unexpected event of Type I hypersensitivity reaction. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine) requiring hospitalization. The rechallenge was not applicable since the event occurred after the first dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 21-Sep-2021 and contain no new information.; Sender''s Comments: This case concerns a 13 year-old, male patient with no relevant medical history, who experienced the unexpected event of Type I hypersensitivity reaction. The event occurred on the same day after the first dose of Spikevax (Moderna COVID-19 vaccine) requiring hospitalization. The rechallenge was not applicable since the event occurred after the first dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.


VAERS ID: 1731049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101212597

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 619077. A 23-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 04Sep2021 with outcome of not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1731057 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213135

Write-up: Myocarditis; Troponin increased; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 619823. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant) on 04Sep2021, troponin increased on 04Sep2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1731060 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101213766

Write-up: Myocarditis; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 621692. A 30-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocarditis (medically significant) on 04Sep2021. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Breast pain, Myocarditis, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Lipodystrophy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: DEJNJFOC20210942480

Write-up: Myocarditis; Breast pain; Tachycardia; This spontaneous report received from a consumer via a Regulatory Authority (DE-PEI-CADR2021177747) on 22-SEP-2021 concerned a 28 year old male of unknown race and ethnicity. The patient''s weight was 112 kilograms, and height was 183 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) 1 total, dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-SEP-2021, the patient experienced myocarditis, breast pain, tachycardia and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from myocarditis, breast pain, and tachycardia. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: Sender comment- Are you or the affected person aware of allergies? If so, which ones? No. Information on risk factors or pre-existing conditions: Obesity / Presentation in the central emergency room of the hospital. There is detection of increased myocardial necrosis parameters. In the MRI proof of Myocarditis.


VAERS ID: 1732862 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
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? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via a regulatory authority (Reference number: FR-AFSSAPS-ST20213373) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (Myopericarditis) in a 20-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDITIS (Myopericarditis) had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not reported. Company comment: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation Received on 21-SEP-2021, Dosage text translation was updated.; Sender''s Comments: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the expected event of Myocarditis. The event Myocarditis occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1733136 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Pain in extremity, SARS-CoV-2 test
SMQs:, Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210902; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101191492

Write-up: Painful arm; Tired all the time; This is a solicited report from the Regulatory Authority program from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-YCVM-202109022119254640-FWIQJ, Safety Report Unique Identifier GB-MHRA-ADR 25925375. A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 03Sep2021 (Lot Number: FE8087) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On 04Sep2021, the patient experienced painful arm and tired all the time. The events were medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative COVID-19 test on 02Sep2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the painful arm was recovered on 05Sep2021 and tired all the time was recovered on 06Sep2021. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on available information and the close drug event temporal association, a possible contributory role of suspect product BNT162B2 to the development of events pain in extremity and fatigue cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1733137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Maternal exposure during pregnancy, Pain in extremity, SARS-CoV-2 test, Scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy (Estimated due date: 04Feb2022)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: 12 weeks scan; Result Unstructured Data: Test Result:ok
CDC Split Type: GBPFIZER INC202101191659

Write-up: Maternal exposure during pregnancy/exposed to the vaccine Second-trimester; Tiredness; Painful arm; Headache; This is a solicited report from a Monitor program from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-YCVM-202109041453125650-0QZRZ, safety report unique identifier is GB-MHRA-ADR 25928668. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Sep2021 (Lot Number: FE3380) as dose 1, single for COVID-19 immunization (at the age of 35-years). Medical history included ongoing pregnancy with an estimated due date of 04Feb2022. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient had IVF to become pregnant. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. On 04Sep2021, the patient experienced painful arm and headache. On 05Sep2021, the patient had tiredness. The outcome of the events was recovered on 06Sep2021. The events were assessed as medically significant. It was also reported that the patient had maternal exposure during pregnancy on an unspecified date. The patient underwent lab tests and procedures which included 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. Patient did not think vaccination had an adverse effect on any aspect of the pregnancy. Patient was exposed to the vaccine Second-trimester (13-28 weeks). Details of scans or investigations: 12 weeks scan ok. No causality was provided for the events. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events pain in extremity, headache, fatigue and the suspect drug BNT162B2 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 product and on the conduct of the study 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: 1733155 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Back pain, Blood urine present, Dizziness, Dysuria, Feeling abnormal, Pain, Pollakiuria, Pyrexia, Syncope, Urine odour abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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:
CDC Split Type: GBPFIZER INC202101217424

Write-up: faint; Pain during urination; peeing pure blood; Needing to pee often; vomiting; Severe pain in stomach, back, sides; fever; Bad smelling urine; dizzy; Felt like I was going to die; Severe pain in stomach, back, sides; Severe pain in stomach, back, sides; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: FE3380), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Sep2021, the patient was faint and had experienced pain during urination, was peeing pure blood, needing to pee often, vomiting, severe pain in stomach; back and sides, fever, had bad smelling urine, dizzy, the patient felt like she was going to die. The patient visited emergency room/department or urgent care due to the events. Doctors could not confirm any trace of bacteria or infection. As corrective treatment the patient received antibiotics although there was no confirmed infection. The outcome was reported as recovering for the reported events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733316 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Cyanosis, Dizziness, Heart rate, Heart rate increased, Hypotension, Nausea, Pain in extremity, Pallor, Rash erythematous, Respiratory rate, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: Blood pressure; Result Unstructured Data: Test Result:blood pressure low; Comments: blood pressure low; Test Date: 20210905; Test Name: Pulse rate; Result Unstructured Data: Test Result:pulse rate high, was checked a few times and it ca; Comments: pulse rate high, was checked a few times and it came down after 3 checks to normal; Test Date: 20210905; Test Name: breathing; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: IEPFIZER INC202101239773

Write-up: Weakness; Blue lips; Pale; Felt faint; Painful arm; High pulse rate; Vomited; Blood pressure low; Nausea; red rash on her belly and back; urticaria flare up; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number IE-HPRA-2021-083906 and Sender''s (Case) Safety Report Unique Identifier IE-HPRA-2021-083906. A 13-year-old female patient received BNT162B2 (COMIRNATY) dose 2 via an unspecified route of administration on 04Sep2021 (at the age of 13 years old) (Lot Number: FG3716) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient was not taking any concomitant medication. On 14Aug2021, patient was previously vaccinated with her first dose of Comirnaty (lot number FE7053) for COVID-19 immunisation. Later on 04Sep2021, the patient experienced a urticaria flare up with a red rash on her belly and back. The patient took Zirtek before going to bed. The following morning on 05Sep2021, the patient had a sore arm and felt weak (like she was going to faint). The patient went pale, had blue lips, felt nauseous and got sick (vomited). This reaction lasted 30 minutes. The reporter was fearful of an anaphylactic shock reaction. The patient went to the doctors and her breathing, blood pressure and pulse rate were checked. The patient''s blood pressure was low and their pulse rate was high (came down to normal after three checks). It was reporter that the patient was prescribed steroids in case needed and advised to take Piriton for 3 days with close monitoring. The patient was treated with Nurofen and Piriton. At the time of reporting the patient''s symptoms were continuing. The outcome of events was not recovered. Events were reported as life-threatening. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1733370 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-09-04
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Incorrect route of product administration, Myocarditis
SMQs:, Drug abuse and dependence (broad), Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Miopericardite acuta; Inappropriate route of vaccination (Intra Venous Otherwise Not Specified); This case was received via Regulatory Agency (Reference number: IT-MINISAL02-782110) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intravenous) dosage was changed to .5 milliliter in total. On 04-Sep-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination (Intra Venous Otherwise Not Specified)). On 05-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). On 04-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination (Intra Venous Otherwise Not Specified)) had resolved. At the time of the report, MYOCARDITIS outcome was unknown. For mRNA-1273 (Spikevax) (Intravenous), the reporter did not provide any causality assessments. Patient had Acute Myocarditis. No concomitant medication details was reported. No treatment medication details was reported. Company comment: This case concerns a 38-year-old male patient with no relevant medical history, who experienced the expected serious events of Myocarditis. The event occurred approximately 01 days after the second dose of Spikevax. The rechallenge was not applicable. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translated document received on 22-Sep-2021. Event verbatim updated in narrative supplement. On 21-Sep-2021: Follow-up received provided no new information.; Sender''s Comments: This case concerns a 38-year-old male patient with no relevant medical history, who experienced the expected serious events of Myocarditis. The event occurred approximately 01 days after the second dose of Spikevax. The rechallenge was not applicable. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1733467 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-28
Onset:2021-09-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nephrotic syndrome, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Proteinuria (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: Helicobacter pylori infection (From August 27th to September 3rd, the patient had eradication treatment of Helicobacter pylori.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101199883

Write-up: Nephrosis; Oedema; This is a spontaneous report received from a contactable physician. The patient was a 50-year-old female. Other medical history included helicobacter pylori. And from August 27th to September 3rd, the patient had eradication treatment of helicobacter pylori. Concomitant medications were unknown. On 28Aug2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY), Solution for injection, Lot number unknown, Expiration date unknown, via an unspecified route of administration for COVID-19 immunization. On 04Sep2021 ( 7 days after vaccination), the patient experienced oedema and nephrosis. The outcome of the events was not provided. The events were found after using the product. Seriousness and causality of the events were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: As there is limited information in the case provided, the causal association between the events and the suspect BNT162B2 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: 1733520 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Back pain, Hypoacusis, Loss of consciousness, Somnolence
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), Retroperitoneal fibrosis (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20210945567

Write-up: TRANSIENT LOSS OF CONSCIOUSNESS WITH HEARING IMPAIRMENT; HEARING IMPAIRED; DROWSINESS; BACK PAIN; WEAKNESS; This spontaneous report received from a consumer by a Regulatory Authority (LT-SMCA-4295) on 23-SEP-2021 and concerned a 24-year-old female of unspecified race and ethnicity. The patient''s weight was 58 kilograms, and height was 174 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 04-SEP-2021 for covid-19. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 04-SEP-2021, the patient experienced transient loss of consciousness with hearing impairment, drowsiness, back pain, weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from drowsiness, transient loss of consciousness with hearing impairment, weakness, and back pain. This report was serious (Other Medically Important Condition).


VAERS ID: 1733579 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Echocardiogram, Electrocardiogram, Myocarditis, Troponin T
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: Test Date: 20210904; Test Name: C-reactive protein; Result Unstructured Data: Slightly increased; Test Date: 20210904; Test Name: Echocardiography; Result Unstructured Data: Normal; Test Date: 20210904; Test Name: Electrocardiogram; Result Unstructured Data: Findings consistent with perimyocarditis; Test Date: 20210904; Test Name: Troponin T; Result Unstructured Data: 378
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: NO-NOMAADVRE-E2B_00049197) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 20-year-old male patient who received mRNA-1273 (batch no. 3003604) for Vaccination. Co-suspect product included non-company product BNT162B2 for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received second dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient started BNNT162B2 (unknown route) at an unspecified dose. On 04-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, C-reactive protein: high (High) Slightly increased. On 04-Sep-2021, Echocardiogram: normal (normal) Normal. On 04-Sep-2021, Electrocardiogram: perimyocarditis (abnormal) Findings consistent with perimyocarditis. On 04-Sep-2021, Troponin T: 378 (abnormal) 378. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. The patient had Perimyocarditis, troponin-t increase to 378. No treatment information was provided. Company Comment: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 3 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as limited information was provided about the first dose. The event was considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation Received on 22-Sep-2021, Narration was updated.; Sender''s Comments: This case concerns a 20-year-old, male patient with no relevant medical history, who experienced the unexpected event of Myocarditis. The event occurred approximately 3 days after the second dose of Moderna Covid-19 vaccine. The rechallenge was not applicable, as limited information was provided about the first dose. The event was considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the study medication The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1733659 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210904; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210944588

Write-up: DRUG INEFFECTIVE; ASYMPTOMATIC COVID-19; This spontaneous report received from a health care professional via a Regulatory (EVHUMAN Vaccines, PT-INFARMED-B202109-620) on 23-SEP-2021 and concerned a 40 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C16-03 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 26-AUG-2021 for covid-19 immunisation. Duration of drug administration 0 days. No concomitant medications were reported. On 04-SEP-2021, the patient had asymptomatic COVID-19 and experienced drug ineffective (Possible vaccine failure). Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Positive Iu international unit (s). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug ineffective and asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Reporter''s Comments: Other information: RT PCR test positive on 04-Sep-2021; Asymptomatic


VAERS ID: 1733660 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Not reported
CDC Split Type: PTJNJFOC20210945119

Write-up: VACCINE FAILURE; COVID-19; This spontaneous report received from a health care professional by a Regulatory Authority (Regulatory Authority, PT-INFARMED-B202109-741)on 23-SEP-2021 and concerned a 20 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE423 expiry: UNKNOWN) 0.5 ml,1 total administered on 11-AUG-2021 for covid-19 immunisation. No concomitant medications were reported. On 04-SEP-2021, the patient experienced vaccine failure and covid-19. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Not reported. The dose of covid-19 vaccine ad26.cov2.s was not changed. The outcome of the vaccine failure and covid-19 was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product Quality Complaint.; Reporter''s Comments: Other information: Positive RT PCR test on 04-Sep-2021; Odynophagia


VAERS ID: 1736291 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Application site pain, Fatigue, Headache, Neck pain, Vertigo
SMQs:, Vestibular disorders (narrow), Arthritis (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: ATMODERNATX, INC.MOD20213

Write-up: Application site pain; Fatigue; Headache. This case was received via European Medicines Agency (Reference number: AT-BASGAGES-2021-043723) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VERTIGO (Starker in a 43-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced VERTIGO (seriousness criterion medically significant), NECK PAIN and HEADACHE (Headache). On 05-Sep-2021, the patient experienced APPLICATION SITE PAIN (Application site pain) and FATIGUE (Fatigue). At the time of the report, VERTIGO , APPLICATION SITE PAIN (Application site pain), FATIGUE (Fatigue) and HEADACHE (Headache) had resolved. No concomitant medications reported by reporter. Patient developed Severe dizziness with the feeling of walking on cotton and had Severe pain in the back of the head and neck. No treatment medications provided by the reporter. Company Comment: This case concerns a 43 year-old, male with no relevant medical history, who experienced the unexpected events of vertigo . The event occurred within 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 22-Sep-2021 includes dosage text and Action taken updated accordingly; Sender''s Comments: This case concerns a 43 year-old, male with no relevant medical history, who experienced the unexpected events of vertigo . The event occurred within 1 and 2 days after the second dose of mRNA-1273 Moderna vaccine. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.


VAERS ID: 1736388 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bell's palsy, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASCORBIC ACID; CETIRIZINE; VITAMIN D NOS; GENTALYN BETA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 respiratory infection; Fibromyalgia; Headache
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: Bell''s palsy with House-Brackmann classification grade 2; Bell''s palsy with House-Brackmann classification grade 2; This case was received via regulatory authority (Reference number: IT-MINISAL02-782186) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of VISION BLURRED (Bell''s palsy with House-Brackmann classification grade 2) and BELL''S PALSY (Bell''s palsy with House-Brackmann classification grade 2) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. The patient''s past medical history included COVID-19 respiratory infection, Headache and Fibromyalgia. Concomitant products included ASCORBIC ACID, CETIRIZINE, VITAMIN D NOS and BETAMETHASONE VALERATE, GENTAMICIN SULFATE (GENTALYN BETA) for an unknown indication. On 04-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Sep-2021, the patient experienced VISION BLURRED (Bell''s palsy with House-Brackmann classification grade 2) (seriousness criterion medically significant) and BELL''S PALSY (Bell''s palsy with House-Brackmann classification grade 2) (seriousness criterion medically significant). At the time of the report, VISION BLURRED (Bell''s palsy with House-Brackmann classification grade 2) and BELL''S PALSY (Bell''s palsy with House-Brackmann classification grade 2) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No treatment information was provided. It was reported that the patient experienced bell''s palsy with House-Brackmann classification grade 2 and had blurred vision. Company comment: This case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected event of vision blurred and expected event of Bell''s palsy. The events occurred same day after the dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The causality was not provided by the reporter. The event of Bell''s palsy is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation received on 22-Sep-2021 contains significant event verbatim.; Sender''s Comments: This case concerns a 48-year-old, female patient with no relevant medical history, who experienced the unexpected event of vision blurred and expected event of Bell''s palsy. The events occurred same day after the dose of Spikevax. The rechallenge was unknown as there''s no information available about the first dose. The causality was not provided by the reporter. The event of Bell''s palsy is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1737851 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E021A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase MB, Chest pain, Echocardiogram, Electrocardiogram, Investigation, Myocarditis, N-terminal prohormone brain natriuretic peptide
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CK-MB; Result Unstructured Data: Test Result:Unknown results; Test Name: cardiac echo; Result Unstructured Data: Test Result:Unknown results; Test Name: ECG; Result Unstructured Data: Test Result:Unknown results; Test Name: laboratory diagnostics; Result Unstructured Data: Test Result:Unknown results; Test Name: TropT; Result Unstructured Data: Test Result:Unknown results; Test Name: nt-proBNP; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: DEPFIZER INC202101195465

Write-up: Myocarditis; Thorax pain; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number DE-PEI-202100187238. A 13-year-old male patient received BNT162B2 (COMIRNATY) dose 2 via an unspecified route of administration on 01Sep2021 (at the age of 13 years old, Lot Number: 1E021A) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of Comirnaty on 09Aug2021 0.3 ml for COVID-19 vaccination. The patient experienced thorax pain on 04Sep2021 with outcome of recovered on 05Sep2021, myocarditis on 05Sep2021 with outcome of not recovered. The patient was hospitalized due to events thorax pain and myocarditis. ECG, TropT, ntproBNP, CK-MB, other laboratory diagnostics, cardiac echo, all with unknown results. Causality of Comirnaty for events Thorax pain, Myocarditis was reported as Unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1737853 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / 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: DEMODERNATX, INC.MOD20213

Write-up: Myocarditis; This case was received (Reference number: DE-PEI-202100187378) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS (Myocarditis) in a 20-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. Based on ECG and laboratory results. First dose on 27.07.2021. No concomitant medications were reported. Treatment information was not provided. This case concerns a 20 year-old male patient with no reported history, who experienced the listed event of Myocarditis. The event occurred 4 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translated document received on 21 Sep 2021 include initials of patient, lab details and date of first dose.; Sender''s Comments: This case concerns a 20 year-old male patient with no reported history, who experienced the listed event of Myocarditis. The event occurred 4 days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1738146 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-04
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood bilirubin, Blood glucose, Blood potassium, Blood sodium, Body temperature, Diarrhoea, Gamma-glutamyltransferase, Gastroenteritis, Haemoglobin, Heavy menstrual bleeding, Intermenstrual bleeding, Investigation, Liver function test, Pelvic pain, Persistent depressive disorder, Platelet count, Polymerase chain reaction, Pregnancy test negative, Pyrexia, Renal function test, SARS-CoV-2 test, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bundle branch block left; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:9 IU/l; Test Name: AST; Result Unstructured Data: Test Result:18 IU/l; Test Name: FA; Result Unstructured Data: Test Result:60 IU/l; Test Name: BR; Result Unstructured Data: Test Result:3 umol/l; Test Name: glucose; Result Unstructured Data: Test Result:5''1 mmol/L; Test Name: K; Result Unstructured Data: Test Result:4''09; Test Name: Na; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210904; Test Name: peak fever; Result Unstructured Data: Test Result:38 Centigrade; Test Name: GGT; Result Unstructured Data: Test Result:17 IU/l; Test Name: HB; Result Unstructured Data: Test Result:120 g/l; Test Name: TAR SARS-CoV-2; Test Result: Negative ; Test Name: Hepatic function; Result Unstructured Data: Test Result:Normal; Test Name: Platelets; Result Unstructured Data: Test Result:Normal x10 9/l; Test Date: 20210904; Test Name: Platelets; Result Unstructured Data: Test Result:332 x10 9/l; Test Name: PCR; Result Unstructured Data: Test Result:2 mg/l; Test Name: pregnancy test; Result Unstructured Data: Test Result:Negative; Test Name: Renal funtion; Result Unstructured Data: Test Result:Normal; Test Name: PCR SARS-CoV-2; Result Unstructured Data: Test Result:Unknown; Comments: Pending result; Test Name: Leucocytes; Result Unstructured Data: Test Result:Analytical leukocytosis
CDC Split Type: ESPFIZER INC202101194776

Write-up: right and pelvic hypochondrium pain; right and pelvic hypochondrium pain; diarrheal stool; Anticipation of the menstrual cycle 2 weeks and heavier bleeding; dysthermic sensation; Gastroenteritis; Metrorrhagia; peak fever of 38?C; This is a spontaneous report from a contactable physician downloaded from the Agency WEB, regulatory authority number ES-AEMPS-997703. A 27-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 12Aug2021 (Lot Number: FG4442) as dose 1, 0.3 ml single for covid-19 immunization. Medical history included varicose veins of lower extremities, right fascicular block. The patient''s concomitant medications were not reported. The patient experienced gastroenteritis (medically significant) and metrorrhagia (medically significant) on 04Sep2021. On 04Sep2021 the patient went to the hospital emergency room for right and pelvic hypochondrium pain, dysthermic sensation not thermometered and diarrheal stools without pathological products or respiratory problems. No nausea, vomiting or oral intolerance. Anticipation of the menstrual cycle 2 weeks and heavier bleeding. In recovery. Upon arrival at the emergency room peak fever of 38 Centigrade on 04Sep2021 well tolerated. Analytical leukocytosis, normal platelets. Normal kidney and hepatic function. Biochemistry: glucose: 5''1mmol/L, Na (Sodium): 139mmol/L, K (Potassium): 4''09, ALT (Alanine Aminotransferase): 9U/L, AST (aspartate aminotransferase): 18U/L, BR (Bilirubin): 3umol/L, FA (alkaline phosphatase):60 U/L, GGT (gamma-glutamyl transferase): 17U/L, PCR (Polymerase chain reaction): 2mg/L, HB (hemoglobin): 120g/L, Platelets: 332 x10E9/L, Negative pregnancy test, TAR (transformation-associated recombination) SARS-CoV-2: negative, PCR SARS-CoV-2: Pending. It is oriented as acute gastroenteritis without warning signs is discharged with standards of re consultation with standards of isolation until PCR result. Outcome of the events gastroenteritis and metrorrhagia was recovering, of other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-04
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: covid test; Test Result: Positive
CDC Split Type: FIPFIZER INC202101193625

Write-up: Positive covid test result. Despite two vaccines.; Positive covid test result. Despite two vaccines.; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20214537. A 63-year-old male patient received bnt162b2 (COMIRNATY; Lot Number: FE7051 and expiration date was not reported), intramuscular, administered in Left upper Arm on 13Aug2021 at dose 2, single and via administered on 12May2021 (lot number: FA4598 and expiration date was not reported) at dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After vaccinated, patient was tested positive for covid despite 2 vaccines. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738421 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Conjunctival haemorrhage, Electrocardiogram ambulatory, Ophthalmological examination
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Conjunctival disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: blood pressure holter; Result Unstructured Data: Test Result:monitoring; Test Name: ophthalmologic consultation; Result Unstructured Data: Test Result:normal examination
CDC Split Type: FRPFIZER INC202101194896

Write-up: Conjunctiva hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20213529. A 38-years-old female patient received bnt162b2 (COMIRNATY), intramuscular at the age of 38 years old on 02Sep2021 (Batch/Lot Number: FG4493) as dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 04Sep2021, the patient experienced conjunctival haemorrhage leading to an ophthalmologic consultation, normal examination. Placement of a blood pressure Holter. The outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738895 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Lymphadenopathy, Tonsillitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101217582

Write-up: tonsillitis was diagnosed/tonsils were all enlarged; lacking energy; Felt tired; Enlarged lymph nodes (excl infective); This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109151239149970-ZZQZE with Safety Report Unique Identifier GB-MHRA-ADR 25945094. A 34-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 02Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have symptoms associated with COVID-19 and did not undergo a COVID-19 test. The patient was not enrolled in the clinical trial. Concomitant medication was not reported. On 04Sep2021, 2 days after the vaccination the patient experienced enlarged lymph nodes (excl infective) on the right side of the neck, felt tired and lacking energy. On 07Sep2021 (Tuesday), 5 days after vaccination the patient''s tonsils were all enlarged. On 09Sep2021, 7 days after vaccination they were all white and tonsillitis was diagnosed. Events enlarged lymph nodes (excl infective) and tonsillitis was reported as serious for being medically significant. The patient had not been tested positive for COVID-19 since having the vaccine. The clinical outcome of the events enlarged lymph nodes (excl infective) and tonsillitis were recovering while that of the events lacking energy and felt tired were unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1739188 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Throat tightness, Tongue pruritus
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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: Anaphylaxis; Contrast media allergy (Contrast agent for CT scan, with immediate-like symptoms of anaphylaxis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101195987

Write-up: she complains of an itchy feeling in the tongue; constriction in the throat; This is a spontaneous report from a contactable other HCP downloaded from the regulatory authority-WEB regulatory authority IT-MINISAL02-780584. A 39-year-old female patient received the second dose of BNT162B2 (COMRINATY) via intramuscular on the left arm (reported as: left shoulder) on 04Sep2021 at 17:00 (Lot Number: FG7387) at the age of 39-year-old as single dose for COVID-19 immunization. Medical history included Contrast media allergy (Contrast agent for CT scan, with immediate-like symptoms of anaphylaxis) and unknown ongoing and anaphylaxis. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 31Jul2021 as single dose for COVID-19 immunization and no adverse drug reaction. On 04Sep2021, the patient complained of an itchy feeling in the tongue and constriction in the throat. The patient performed phleboclysis 250 + flebocortid 1 gr. The outcome of event was recovered.


VAERS ID: 1739272 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Loss of consciousness, Pain, Pyrexia
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via regulatory authority case (Reference number: IT-MINISAL02-781861) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS, FATIGUE and PYREXIA. At the time of the report, LOSS OF CONSCIOUSNESS, PAIN, FATIGUE and PYREXIA was resolving. No concomitant and treatment information was provided. This case concerns a 62-year-old female patient with no relevant medical history who experienced serious unexpected event of Loss of consciousness, non-serious unexpected event of Pain and non-serious expected events of Fatigue and Pyrexia. The events occurred one day following the dose of Spikevax. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. The event Loss of consciousness was classified as non-serious by RA, however, as per IME list was upgraded to serious and retained as such based on medical judgment. The events Fatigue and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 62-year-old female patient with no relevant medical history who experienced serious unexpected event of Loss of consciousness, non-serious unexpected event of Pain and non-serious expected events of Fatigue and Pyrexia. The events occurred one day following the dose of Spikevax. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. The event Loss of consciousness was classified as non-serious by RA, however, as per IME list was upgraded to serious and retained as such based on medical judgment. The events Fatigue and Pyrexia are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1739323 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Limb discomfort, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101195546

Write-up: This is a spontaneous report from a contactable other HCP (patient), downloaded via the regulatory authority (IT-MINISAL02-782563). A 32-year-old female patient received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# FG4686; expiration date: Nov 30, 2021), intramuscularly, in left arm, on Aug 31, 2021, single dose, for COVID-19 immunisation. The patient received the first dose of BNT162B2 (Comirnaty), on Aug 10, 2021, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. On Sep 4, 2021, patient experienced heaviness in the lower limbs (medically significant), with outcome of not recovered; nausea (medically significant), with outcome of not recovered; and severe disabling dizziness (medically significant), with outcome of not recovered. The reported reaction was the most serious patient had, but she had other symptoms at the same time. Patient experienced medical consultation and subsequent examination in the emergency room. Reporter''s comments: "This reported reaction is the most serious I had, but I have other symptoms at the same time." Sender''s comments: Sep 6, 2021: information on the remaining symptom requested from the reporter. A clinical record of the emergency room accompanied by therapies administered and a follow-up of the case. No follow-up attempts possible. No further information expected.


VAERS ID: 1739351 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Physical examination, 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: Test Name: General examination; Result Unstructured Data: Test Result:Pupils are isochoric/isocyclic normoreactive; Comments: Pupils are isochoric/isocyclic normoreactive, no nystagmus, no strength deficits in all four limbs. Good, rhythmic tones, no murmurs. Vesicular breath normotransmitted, no added noises.
CDC Split Type: ITPFIZER INC202101209477

Write-up: Syncope; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-783790. A 23-years-old male patient received BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FG6273, Expiration date: 30Nov2021), dose 1 via intramuscular, administered in Arm Left on 04Sep2021, at 13:12 (at the age of 23-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Sep2021, the patient experienced syncope. Pupils are isochoric/isocyclic normoreactive, no nystagmus, no strength deficits in all four limbs. Good, rhythmic tones, no murmurs. Vesicular breath normotransmitted, no added noises. patient was administered physiological solution 500 ml and performed general examination. The patient underwent lab tests and procedures which included physical examination: pupils are isochoric/isocyclic normoreactive on an unspecified date. The outcome of the event was recovering. No follow-up attempts possible. No further information expected.; Reporter''s Comments: General examination: Pupils are isochoric/isocyclic normoreactive, no nystagmus, no strength deficits in all four limbs. Good, rhythmic tones, no murmurs. Vesicular breath normotransmitted, no added noises.


VAERS ID: 1739417 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cardiomyopathy, Chest pain, Painful respiration, Pericarditis, Troponin I, Troponin I increased, Troponin T
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: CRP; Test Result: 9.91 mg/dl; Test Date: 20210906; Test Name: CRP; Test Result: 9.45 mg/dl; Test Date: 20210913; Test Name: CRP; Test Result: 0.57 mg/dl; Test Date: 20210905; Test Name: troponin I; Result Unstructured Data: Test Result:308.2 pg/mL; Comments: The initial Troponin I could be fake positive.; Test Date: 20210906; Test Name: Troponin T; Result Unstructured Data: Test Result:0.008 ng/dL
CDC Split Type: JPPFIZER INC202101199864

Write-up: troponin I 308.2 pg/ml; Pericarditis; chest pain; very slight Myocardial disorder; chest pain occurred/ got worsen when breathed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126625. A 38-year-old (reported as 38-year and 0-month-old) male patient received bnt162b2 (COMIRNATY, solution for injection, lot number FE8162, expiration date 30Nov2021) via an unspecified route of administration on 02Sep2021 (at the age of 38-year-old, as reported) as dose 2, single for COVID-19 immunization. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 12Aug2021, the patient previously received the first dose of bnt162b2 (COMIRNATY). On 04Sep2021 at 08:00 (2 days after the vaccination), the patient experienced chest pain (suspected to be pericarditis). The course of the event was as follows: on 02Sep2021, took the second dose (first dose on 12Aug2021). On 04Sep2021 in the morning, front chest pain occurred, sleep and sit position, got worsen when breathed. On 05Sep2021, in other hospital, C-Reactive Protein (CRP) 9.91 mg/dl, troponin I 308.2 pg/dl (normal is 0-28.7). On 06Sep2021, went to this hospital, CRP 9.45 mg/dl, troponin T 0.008 ng/dl (less than 0.014), was normal. Chest pain was suspected caused by pericarditis, recovering after took analgesic. On 13Sep2021, CRP 0.57 mg/dl, recovering (as reported). The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. On 13Sep2021 (11 days after the vaccination), the outcome of the events was resolved. The reporting physician commented as follows (reporter''s comment): troponin I in other hospital and troponin T in this hospital were hard to quantify could be wrong. Very slight myocardial disorder became normal after 7 days (as reported). The initial Troponin I could be fake positive. Follow-up attempts are completed. Further information is not expected.; Reporter''s Comments: Troponin I in other hospital and troponin T in this hospital were hard to quantify could be wrong. Very slight myocardial disorder became normal after 7 days. The initial Troponin I could be fake positive.


VAERS ID: 1739716 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-04
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210947819

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-650) on 24-SEP-2021 concerned a 41 year old male. The patient''s weight was 86 kilograms, and height was 171 centimeters. No past medical history and concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 and expiry: unknown) 0.5 ml, 1 total administered on 25-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 04-SEP-2021, patient tested positive IU (international unit) (s) for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) and experienced vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from vaccination failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.


VAERS ID: 1740482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005696 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Appendicitis, Drug hypersensitivity, Flatulence, Palpitations, SARS-CoV-2 test
SMQs:, Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; NUROFEN [IBUPROFEN]
Current Illness:
Preexisting Conditions: Comments: No Medical History information was reported.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Drug hypersensitivity; Palpitations; Gas; Appendicitis; This case was received (Reference number: GB-MHRA-ADR 25966185) on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis), DRUG HYPERSENSITIVITY (Drug hypersensitivity), PALPITATIONS (Palpitations) and FLATULENCE (Gas) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3005696) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) from 15-Sep-2021 to an unknown date for Constipation, IBUPROFEN (NUROFEN [IBUPROFEN]) for Pain inflammation activated. On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced DRUG HYPERSENSITIVITY (Drug hypersensitivity) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and medically significant) and FLATULENCE (Gas) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in September 2021 due to APPENDICITIS. At the time of the report, APPENDICITIS (Appendicitis) and DRUG HYPERSENSITIVITY (Drug hypersensitivity) had not resolved and PALPITATIONS (Palpitations) and FLATULENCE (Gas) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. The patient started having the belly full of gas on the right side, hard time releasing feces and gas, stings of pain - right lower abdominal region. Took different meds that caused palpitations and other secondary effects. Patient had done X-ray showed mass of gas on the right side. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Company Comment : This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected events of Palpitations, Flatulence, Appendicitis, and Drug hypersensitivity. The event of Appendicitis occurred one day after the second dose of mRNA-1273 vaccine, and the events of Palpitations, Flatulence and Drug hypersensitivity occurred an unknown number of days after the second dose. The reporter noted that unspecified medications were taken which may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender''s Comments: This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected events of Palpitations, Flatulence, Appendicitis, and Drug hypersensitivity. The event of Appendicitis occurred one day after the second dose of mRNA-1273 vaccine, and the events of Palpitations, Flatulence and Drug hypersensitivity occurred an unknown number of days after the second dose. The reporter noted that unspecified medications were taken which may have contributed to the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1740774 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 282318D / UNK LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101204492

Write-up: Bell''s palsy; earaches; This is a spontaneous report from a contactable consumer (patient) received through regulatory authority portal. A 16-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left at the age of 16 years old on 31Aug2021 (Batch/Lot Number: 282318d) as dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced earaches on 04Sep2021 and Bell''s palsy on 10Sep2021. The events were considered serious (medically significant). The outcome of the events was recovering.


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