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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 260 out of 8,010

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VAERS ID: 1724891 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Computerised tomogram head, Headache, Hemiplegia, Migraine, Musculoskeletal pain, Musculoskeletal stiffness, Paralysis
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypersensitivity (narrow), Arthritis (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before second vaccination; Test Date: 20210816; Test Name: head CT; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202101164637

Write-up: Anaphylaxis; the same upper left limb began with a flexing and stiffening paralysis; Hemiplegia; the same upper left limb began with a flexing and stiffening paralysis/ Shoulder muscle stiffness; Throbbing headache; Migraine; Shoulder blade pain; This is a spontaneous report from a contactable physician received from the Regulatory Authority report number is v21126937. A 42-year and 3-month-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Sep2021 14:05 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 42 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took Comirnaty on 16Aug2021 for COVID-19 immunisation and experienced seizure, musculoskeletal stiffness, headache and arthralgia. The patient had no family history. 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) as follows: On 18Aug2021, even the first dose of COMIRNATY vaccine , lot number FD0889, Expiration date 30Sep2021, developed symptoms. Immediately after injection, within 10 minutes, convulsions and stiffness in the left half of the body occurred, then headache and shoulder pain occurred. Head CT no abnormalities. Diagnosed as Hemiplegic migraine, SELENICA-R 200 3 tablets parted at once, Migsis 5, 2 tablets parted at twice, Bayaspirin, 1 tablet, Takepron OD 15mg, 1 tablet taken orally. Visited to the hospital on 19Aug2021, 24th, 31th, and 06Sep2021. On 31Aug2021 (15 days after first vaccination), Paralysis remained. Because paralysis had slowed down the patient was inoculated for the second dose on the day. On 06Sep2021 14:10, the patient experienced anaphylaxis, the same upper left limb began with a flexing and stiffening paralysis, hemiplegia, throbbing headache, shoulder muscle stiffness, migraine and shoulder blade pain. On 06Sep2021 at 14:10 (5 minutes after the vaccination), the patient experienced Anaphylaxis, Hemiplegia and Migraine. The course of the event was as follows: Within 10 minutes immediately of the first vaccination, the patient suffered Paresis of left and headache, almost recovered completely within 3 weeks hospital visit. The same paralysis symptom was expected to occur in the second inoculation, but it was carried out because it was diagnosed as reversible disease state. The second time, injected, in less than five minutes, the same upper left limb began with a flexing and stiffening paralysis, then Throbbing headache, Shoulder muscle stiffness occurred. Solu-Cortef 100mg injected. left paralysis improved. Headache, Shoulder blade pain was observed by the Loxonin taken orally, and visited hospital. The patient underwent lab tests and procedures which included body temperature: 36.6 centigrade on 06Sep2021 before second vaccination, computerised tomogram head: no abnormalities on 16Aug2021. The reporting physician classified the event as serious (medically significant) 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: Both times occurred within few minutes after injection, and there was no thought of a reaction to the drug''s RNA making antigens in the body. It was considered that the solvent has vascular irritation and induced Coronary vasospasm. On 06Sep2021 (the same day of the vaccination), the outcome of the event was not recovered.


VAERS ID: 1724892 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anxiety, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NOLVADEX D
Current Illness: Breast cancer (right MMK)
Preexisting Conditions: Medical History/Concurrent Conditions: Iodine allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: BP; Result Unstructured Data: Test Result:136/82; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:35.6 Centigrade; Comments: before vaccination; Test Date: 20210906; Test Name: HR; Result Unstructured Data: Test Result:84; Test Date: 20210906; Test Name: SPO2; Test Result: 99 %; Test Date: 20210906; Test Name: SPO2; Result Unstructured Data: Test Result:98~100 %
CDC Split Type: JPPFIZER INC202101164649

Write-up: Anaphylaxis; hard to breathe; anxiety to allergies; This is a spontaneous report from a contactable other healthcare professional received from the regulatory authority, report number is v21126036. A 42-year-old female patient received BNT162b2 (COMIRNATY; lot number: FF2782; expiration date: 30Nov2021), via an unspecified route of administration on 06Sep2021 19:45 (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. 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) as follows: Right MMK (as reported), (nolvadex under taking orally) and iodo allergy. Concomitant medication included tamoxifen citrate (NOLVADEX D) taken for breast cancer from an unspecified start date and ongoing. Body temperature before vaccination was 35.6 degrees Centigrade. On 06Sep2021 at 19:45 (the day of vaccination), the patient received the first dose of BNT162B2. On 06Sep2021 at 19:50 (5 minutes after the vaccination), the patient experienced hard to breathe and anaphylaxis. The course of the event was as follows: About 5 minutes after vaccination, the patient complained about feeling of hard to breathe. The patient rested on the bed and vitals were measured: BP 136/82, HR 84, SPO2 99%, the symptoms gradually improved, progressed by SPO2 98~100%. The patient had anxiety to allergies and antihistamine drug 1 tablet was taken orally. The physician explained the possibility (allergy) of mild anaphylaxis. On 06Sep2021 (the same day of the vaccination), the outcome of the event was recovered. The reporting other healthcare professional 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. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1724903 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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: Blood pressure measurement, Fall, Heart rate, Loss of consciousness, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: Test Result:112/66 mmHg; Comments: no abnormality; Test Date: 20210906; Test Name: pulse; Result Unstructured Data: Test Result:74; Comments: /min(regular) no abnormality; Test Date: 20210906; Test Name: SpO2; Test Result: 97 %; Comments: no abnormality
CDC Split Type: JPPFIZER INC202101170628

Write-up: Loss of consciousness; fell forward; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126062. A 21-year-old female patient (21-year and 7-month-old female) received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF0843; Expiration Date: 31Oct2021), dose 1 via an unspecified route of administration on 06Sep2021 16:20 (at the age of 21-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient experienced loss of consciousness and fell forward on 06Sep2021 16:30. The course of the event was as follows: Immediately after the vaccination with the COVID-19, the patient was observed in the break room without any problems, but 10 minutes after the vaccination, the patient suddenly fell forward from where she had been sitting. The reporter Immediately rushed in and asked what happened, And the patient answered that she seemed to have lost consciousness and collapsed. At that stage, the consciousness was clear and there was no paralysis of the body. The patient was in the same condition as usual. Blood pressure 112/66 mmHg, SpO2 (Oxygen saturation) 97%, pulse 74 / min (regular), no abnormality on 06Sep2021. Outcome of the events was unknown. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: Recommended a medical center neurology consultation.


VAERS ID: 1724905 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure increased, Blood pressure measurement, Body temperature, Epilepsy, Oxygen saturation, Presyncope, Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (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), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210906; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/110 mmHg; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: before vaccination; Test Date: 20210906; Test Name: Spo2; Test Result: 98 %; Comments: room air
CDC Split Type: JPPFIZER INC202101170665

Write-up: Arrhythmia; Epilepsy; Blood pressure 150/110 mmHg; Convulsion for 30 seconds/hands and legs developed movement like Convulsion; Syncope; vasovagal reflex; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126088. A 24-year-old male patient (also reported as 24-year and 4-month-old) received BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 06Sep2021 at 13:30 (Batch/Lot Number: FF3622; Expiration Date: 30Nov2021) (at the age of 24-years-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 06Sep2021 at 13:35 (5 minutes after the vaccination), the patient experienced Convulsion for 30 seconds, Syncope, and vasovagal reflex. On 06Sep2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: The patient experienced Syncope several minutes after the vaccination and the same time, his hands and legs developed movement like Convulsion. Blood pressure 150/110 mmHg. Opened eyes in the normal position of the eyeball, lips and mouth were not seen. The patient recovered consciousness after reposed. SpO2 98% (room air), no symptoms. The events were considered as vasovagal reflex but with movement like Convulsion. The reporting physician classified the event as non-serious and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were Arrhythmia, Epilepsy. The reporting physician commented as follows: it was not sure whether the event was vasovagal reflex caused by vaccination or accidentally developed Convulsion. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: It was not sure whether the event was vasovagal reflex caused by vaccination or accidentally developed Convulsion.


VAERS ID: 1724910 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FE8206 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Depressed level of consciousness, Fall, Feeling abnormal, Presyncope
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gout
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: Test Result:78/60 mmHg; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101170752

Write-up: Anaphylaxis; had a slight reaction to the call; feels poorly; loss of posture; blood pressure 78/60mmHg; Vasovagal reflex (severe).; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126196. A 40-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 06Sep2021 16:44 (Batch/Lot Number: FE8206; Expiration Date: 31Oct2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included gout. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. On 06Sep2021 at 16:50 (6 minutes after the vaccination), the patient experienced anaphylaxis. On 06Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: On 06Sep2021 at 16:44, after receiving the first dose of COMIRNATY 0.3 mL via an intramuscular route of administration, the patient went to examining room from waiting room and took a seat by himself. About 5 minutes later, the patient wanted to go to the toilet, during the movement, the patient experienced feels poorly and sat down and was loss of posture. The patient was moved to bed and was in lying position. Oxygen 3L, blood pressure 78/60mmHg. The patient had a slight reaction to the call. The patient received drip of BOSMIN 0.3 ml (the first dose) and BOSMIN 0.2 ml (the second dose) via an intramuscular route of administration on right forearm. Vital was normal and recovered. Outcome of events was recovered on 06Sep2021. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was Vasovagal reflex (severe). The reporting physician commented as follows: On 08Sep2021 (reporting time), the patient was recovered and normal in daily life. No follow-up attempts possible. No further information expected.


VAERS ID: 1724915 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Heart rate increased, Loss of consciousness, Oxygen saturation, Seizure
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: RISPERIDONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Sleeplessness
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:158/90; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210906; Test Name: pulse rate; Result Unstructured Data: Test Result:112; Test Date: 20210906; Test Name: oxygen saturation; Test Result: 95 %
CDC Split Type: JPPFIZER INC202101171063

Write-up: after the vaccination of Comirnaty, about 2?3 minutes, Loss of consciousness, Seizure occurred; after the vaccination of Comirnaty, about 2?3 minutes, Loss of consciousness, Seizure occurred; blood pressure was 158/90; Pulse rate was 112; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21126087. A 31-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Sep2021 14:34 (Batch/Lot Number: FF2782; Expiration Date: 30Nov2021) at the age of 31-years-old as 0.3 ML SINGLE for covid-19 immunisation. Medical history included sleeplessness and anxiety. Concomitant medication included risperidone taken for anxiety and sleeplessness, start and stop date were not reported, the patient was currently treated (with medications, etc.) for other disease. Body temperature before vaccination was 36.7 degrees Centigrade. The patient took rebamipide, bio-three, ursodeoxycholic acid (URSO), belsomra 20mg, flunitrazepam 2mg, hydroxyzine embonate (ATARAX-P) 25g2p(as source reported), lorazepam 0.5mg. When anxiety, risperidone 6 mg, the patient took risperidone when sleeplessness and took risperidone around pm 12:00 of today (as source reported). On 06Sep2021 at 14:34 (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. The onset date of the event was reported as 06Sep2021 at 14:34 (the day of vaccination) (as reported). The course of the event was as follows: After the vaccination of Comirnaty, about 2, 3 minutes, loss of consciousness, seizure occurred. Oxygen saturation was 95%, blood pressure was 158/90 pulse rate was 112. On 06Sep2021 at 14:45 (11 minutes after the vaccination), emergency transported. Seriousness of the event and the causality between the event and bnt162b2 were not provided. Prevaccination Screening Questionnaire for COVID-19 vaccine was reported as follows: The patient was the first time to receive Coronavirus Disease 2019 vaccine. The patient had read Coronavirus Disease 2019 Vaccination Guide and understood its effect and potential side effects. The patient had basic diseases, the physician chosen "other" in immune disorder and treatment, but not provide a specific name. The patient was currently treated (with medications, etc.) for other disease. The patient had not been sick or had a fever in the past month. The patient was feeling sick today, and the symptom was Sleeplessness and took risperidone as need at pm 12:00 of today. The patient had been convulsions (seizures). The patient never had severed allergic reactions (anaphylaxis, etc.) to a medication or food. The patient never been sick after receiving vaccination. The patient was not possibly pregnant (e.g. late period) or currently breast-feeding. The patient had not received any other vaccines in the past two weeks. The vaccine dose was 0.3ml. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1724929 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Body temperature, Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram head, Dysarthria, Facial paralysis, Hypertension, Incontinence, Monoplegia, Paralysis, Putamen haemorrhage, Thalamus haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:200/121 mmHg; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210906; Test Name: CT scan of head; Result Unstructured Data: Test Result:hemorrhage in the right putamen, right thalamus, a; Comments: hemorrhage in the right putamen, right thalamus, and left putamen
CDC Split Type: JPPFIZER INC202101171634

Write-up: Stroke; Right side of the body flaccid paralysis; Dysarthria; Incontinence; Cerebral haemorrhage; hemorrhage in the right putamen, right thalamus, and left putamen; Thalamus haemorrhage; Paralysis of the right upper and lower limbs; right facial paralysis; consciousness disturbed; hypertension, Blood pressure at the time of admission was 200/121 mmHg; This is a spontaneous report from a contactable physician received from a regulatory authority. The regulatory authority report number is v21126148. The follow up report from a contactable physician received from a regulatory authority. The regulatory authority report number is v21126286. A 71-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 71-years-old on 06Sep2021 11:05 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FF2782, Expiration date 30Nov2021) on unknown date as single dose for covid-19 immunisation. On 06Sep2021 at 11:22 (17 minutes after the vaccination), the patient experienced stroke. On unspecified date, the patient was admitted to the hospital. The course of the event was as follows: There were Dysarthria, Right side of the body flaccid paralysis and Incontinence. The reporting physician classified the event as serious (hospitalized) and assessed that the causality between the event and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was stroke. As of 10Sep2021, a contactable physician reported that on 06Sep2021 at 11:25 (20 minutes after the vaccination), the patient experienced cerebral haemorrhage. On 08Sep2021 ( 2 days after the vaccination), the outcome of the event was not recovered. The course of the event was as follows: paralysis of the right upper and lower limbs, the right facial paralysis, and consciousness disturbed occurred. Blood pressure at the time of admission was 200/121 mmHg. CT scan of the head showed hemorrhage in the right putamen, right thalamus, and left putamen. The reporting physician classified the event as serious (disability) and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was hypertension etc. The outcome of the events cerebral haemorrhage, paralysis of the right upper and lower limbs, the right facial paralysis, and consciousness disturbed occurred, blood pressure at the time of admission was 200/121 mmHg (hypertension), hemorrhage in the right putamen, right thalamus, and left putamen was not recovered, of the other events was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724932 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Cough, Pruritus, Rash, Throat irritation
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
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: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101171952

Write-up: Anaphylaxis; itching of the whole body; cough; rash on limbs; Cough with irritating Pharynx; This is a spontaneous report from a contactable physician received from the Agency. Regulatory authority report number is v21126189. A 52-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration at the age of 52-year-old on 06Sep2021 13:57 (Lot Number: FE8162; Expiration Date: 30Nov2021) as single dose for COVID-19 immunisation. Medical history included none. There were no concomitant medications. The patient was a 52-year-old female (age at second vaccination). Body temperature before vaccination was 36.5 degrees Centigrade on 06Sep2021. 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 06Sep2021 at 14:07 (10 minutes after the vaccination), the patient experienced Anaphylaxis. On 06Sep2021 (the day of vaccination), the patient was admitted to the hospital. On 07Sep2021 (1 day after the vaccination), the patient discharged from hospital. On 07Sep2021 (1 day after the vaccination) (as reported), the outcome of the event was recovered. The course of the event was as follows: 10 minutes after Comirnaty vaccination, itching of the whole body and cough appeared. Itchy rash on limbs appeared. Cough with irritating Pharynx appeared. It was considered that it was Anaphylaxis due to Comirnaty, glycyrrhizin 20ml was Intravenous injected, Solu-Cortef 250mg drip was performed, and BOSMIN 0.3mg was Intramuscular injected into Right thigh, the patient was emergently transferred to hospital. The reporting physician classified the events as serious (hospitalized from 06Sep2021 to 07Sep2021) 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 was considered that it was Anaphylaxis due to Comirnaty. Emergency Room Visit and Physician Office Visit for events. The patient underwent lab tests and procedures which included body temperature: 36.5 centigrade on 06Sep2021 before the vaccination. Therapeutic measures were taken as a result of events. The outcome of events was recovered on 07Sep2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724952 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Anaphylactic shock, Body temperature, Cold sweat, Presyncope
SMQs:, Anaphylactic reaction (narrow), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101177406

Write-up: Anaphylactic shock; Anaphylaxis/ Anaphylactic reaction; Vasovagal reflex; cold sweat; This is a spontaneous report from a contactable other HCP received from the regulatory authority. Regulatory authority report number is v21126219. A 14-year and 1-month-old male patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3622, Expiration date 30Nov2021), via an unspecified route of administration On 06Sep2021 at 16:51 (at the age of 14-year and 1-month-old) as a single dose for COVID-19 immunisation. Body temperature before vaccination was 36.5 degrees Centigrade on 06Sep2021. 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). Medical history was none. The patient''s concomitant medications were not reported. On 06Sep2021 at 16:51 (the day of the vaccination), the patient experienced Anaphylactic shock, Vasovagal reflex and Anaphylaxis. On 06Sep2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: After the first dose of vaccination, the patient experienced Anaphylactic reaction. Shock with cold sweat and Vasovagal reflex. Fluid replacement and oxygenation with vitals. Blood pressure increased and respiratory condition recovered by using steroid. The reporting other HCP 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 other HCP commented as follows: the second dose of vaccination was cancelled. The outcome of the events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1724956 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Nausea, Rash pruritic, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101177641

Write-up: Anaphylaxis; vomiting; queasy; rash and itching; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126186. The patient was a 23-year-old female (age at vaccination). Body temperature before vaccination was 36.5 degrees Centigrade on 06Sep2021. The patient had medical history of allergy. On 06Sep2021 at 10:30 (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. Event onset date reported as 06Sep2021 at 10:30 (the same day of the vaccination). On 06Sep2021 (the day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: Gastrointestinal symptoms of vomiting occurred immediately after vaccination. And queasy continued afterwards. Since rash and itching also occurred after about 30-60 minutes, it was determined to be mind-moderate anaphylaxis. Outcome of the events was unknown. The reporting physician classified the events as serious (caused hospitalized from 06Sep2021) and assessed that the event was related to bnt162b2.


VAERS ID: 1724963 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF2782 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dysstasia
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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: JPPFIZER INC202101179184

Write-up: Feelings of weakness; not able to stand up; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126188. A 60-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: FF2782; Expiration Date: 30Nov2021), Dose 1 via an unspecified route of administration on 06Sep2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Sep2021 at 14:30 (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. Event onset date was reported as 06Sep2021 at 15:30 (the day of vaccination). On 06Sep2021 at 15:00, the patient experienced feelings of weakness (medically significant) and not able to stand up (non-serious). The outcome of the event was unknown. The course of the event was as follows: On 06Sep2021 at 14:30, the patient received the vaccination. On 06Sep2021 at 15:00 (as reported), feelings of weakness appeared, and the patient was not able to stand up. On 06Sep2021 at 16:30, as the symptoms did not improve, so the patient was emergently transported to hospital. The reporting physician did not provide seriousness 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: 1725018 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005293 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Presyncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), 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; Suspected vagal reflex; Fall; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP092508) on 11-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21126417). Loss of consciousness was assessed as serious by the regulatory authority. On 06-Sep-2021, the patient received the 1st dose of this vaccine. At 09:30, during follow-up, the patient suddenly staggered and fell while sitting. The patient regained consciousness immediately and vital signs were normal. The patient was diagnosed with suspected vagal reflex. After that, recovery of the patient''s symptoms was observed. The outcome of loss of consciousness, fall, suspected vagal reflex 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 refers to a 13-year-old female patient with no known medical history who experienced the unexpected event of Loss of Consciousness on the same day the first dose of COVID-19 Vaccine Moderna was administered. The reporter assessed the event as possibly related to COVID-19 Vaccine Moderna. The benefit-risk relationship of COVID-19 Vaccine Moderna is not affected by this report.


VAERS ID: 1726079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
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: 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 INC202101213383

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 620417. A 31-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number unknown), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medication were provided. On 06Sep2021, the patient developed pericarditis, serious as medically significant. 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: 1728565 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-09-06
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, 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: 20210906; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: 19.8
CDC Split Type: ATPFIZER INC202101189413

Write-up: vaccination failure; Coronavirus infection. Despite 2-fold vaccination Without symptoms Asymptomatic COVID-19; Coronavirus infection. Despite 2-fold vaccination Without symptoms Asymptomatic COVID-19/COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-043956. A 43-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), dose 2 via intramuscular route of administration on 17Jul2021 as dose 2, single, and dose 1 via an unspecified route of administration on 06Jun2021 (Batch/Lot number was not reported) as dose 1, single both taken for COVID-19 immunisation. No relevant medical history and no concomitant medications were reported. On 06Sep2021, the patient experienced vaccination failure, Asymptomatic COVID-19, and Coronavirus infection. Despite 2-fold vaccination Without symptoms Asymptomatic COVID-19/COVID-19 PCR test positive. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive 19.8 on 06Sep2021. The outcome of the events was unknown. No follow-up attempts were possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1728917 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-09-06
   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 - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dizziness, Eye pain, Hypoaesthesia, Muscle spasms, SARS-CoV-2 antibody test, SARS-CoV-2 test, Tremor
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Endometriosis; Fish allergy; Hysterectomy; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Covid-19 Rapid test; Result Unstructured Data: Test Result:Unknown; Test Date: 20210901; Test Name: Covid-19 Nasal Swab; Result Unstructured Data: Test Result:Negative
CDC Split Type: CAPFIZER INC202101191904

Write-up: Shakes - whole body; Left side of body numb; dizzy - non stop; Chest pain; Spasms throughout body; Eye balls hurt; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 03Aug2021 15:00 (Batch/Lot number was not reported) (at the age of 31 years old) as single dose for Covid-19 immunisation. Medical history included asthma, endometriosis, hysterectomy, sea food and fish allergy. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included melatonin taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took codeine. On 06Sep2021 at 02:30, the patient experienced shakes - whole body, left side of body numb (after 48 hours, as reported), dizzy - non stop, chest pain, spasms throughout body, and eye balls hurt. No headache, no chills, no fever. The adverse events resulted in emergency room/department or urgent care and admission to hospital. The patient did not receive any treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests which included Covid-19 Nasal Swab: negative on 01Sep2021, Covid-19 Rapid test: unknown on 09Sep2021. Outcome of the events was not recovered.


VAERS ID: 1729581 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF0843 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Nausea, Pallor, Peripheral coldness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 13:14; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before the vaccination
CDC Split Type: JPPFIZER INC202101172445

Write-up: Pallor facial; Blood pressure decreased; Cold extremities; Queasy; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21126049. A 27-year and 4-month-old (age at first dose of vaccination) female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number FF0843, Expiration date 31Oct2021) via an unspecified route of administration, on 06Sep2021 at 12:58 (at the age of 27-year and 4-month-old), as a single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 centigrade. Medical history was 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). The concomitant medications were not reported. The adverse event onset date was reported as on 06Sep2021 at 13:14 (the day of the vaccination). The course of the event was as follows: Pallor facial, Blood pressure decreased, Queasy, Cold extremities, etc. were seen. Queasy etc. were recovering with lower extremity elevation and supplemental fluids, but as there was no recovering in Cold extremities, etc. even 1 hour passed, the patient was transferred by ambulance. The outcome of the event "Queasy" was recovering; of other events was not recovered. The reporter classified the event as non-serious and the causality between the event and bnt162b2 as unassessable.


VAERS ID: 1729592 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Body temperature, Depressed level of consciousness, Feeling abnormal, Heart rate, Pulse abnormal, Vital signs measurement, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Specific allergy (drug)
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210906; Test Name: pulse; Result Unstructured Data: Test Result:feeble; Test Date: 20210906; Test Name: vital signs; Result Unstructured Data: Test Result:stable
CDC Split Type: JPPFIZER INC202101179671

Write-up: Anaphylaxis; consciousness status worsened; feels poorly; vomiting; blood pressure decreased; pulse was feeble; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21126249. A 30-year and 8-month-old male patient received first dose of bnt162b2 (COMIRNATY), solution for injection, lot number FE8162 and expiration date 30Nov2021, via an unspecified route of administration on 06Sep2021 at 12:19 (the day of vaccination) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.7 degrees Centigrade on 06Sep2021. 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 allergy to dental anesthesia. On 06Sep2021 at 12:35 (16 minutes after the vaccination), the patient experienced Anaphylaxis. On 06Sep2021 (the day of vaccination), the patient was admitted to the hospital. On 07Sep2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: About 15 minutes after receiving the vaccination on 06Sep2021 at 12:35, the patient experienced feels poorly and vomiting. The blood pressure decreased, the pulse was feeble, and the consciousness status worsened, so adrenaline was administered. The vital signs became stable afterwards; however, he was transferred to the below-mentioned hospital by an ambulance. The reporting physician classified the event as serious (caused hospitalization from 06Sep2021 to 07Sep2021) and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was not provided. The outcome of all the events was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1729660 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 EY0583 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101192036

Write-up: Cough; Skin red; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126533, v21126555. A 53-year-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: EY0583; Expiration Date: 31Oct2021), via an unspecified route of administration on 06Sep2021 15:00 (at age of 53 years old) as single dose for COVID-19 immunisation. Medical history included Anaphylaxis. The patient''s concomitant medications were not reported. The patient was a 53-year-old female. Body temperature before vaccination was 36.6 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) include Anaphylaxis. On 06Sep2021 at 15:00 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0583, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 06Sep2021 at 15:00 (the day of vaccination), the patient experienced the following events. The course of the events was reported as follows: cough, Skin red. The reporting physician classified the event as serious (caused hospitalization from 06Sep2021 to 07Sep2021). On 07Sep2021 (1 day after the vaccination), the outcome of the event was recovering. The causality between the event and the vaccine was not provided.


VAERS ID: 1729671 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Body temperature, Fall, Gaze palsy, Heart rate, Loss of consciousness, Mental impairment, Musculoskeletal stiffness, Oxygen saturation, Pain in extremity, Respiratory arrest, Vaccination site pain, Vital signs measurement
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:104/64; Comments: before the vaccination; Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:104/64; Comments: few minutes after the vaccination; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before the vaccination; Test Date: 20210906; Test Name: pulse rate; Result Unstructured Data: Test Result:54-58/normal; Comments: before the vaccination; Test Date: 20210906; Test Name: pulse rate; Result Unstructured Data: Test Result:58; Comments: few minutes after the vaccination; Test Date: 20210906; Test Name: Oxygen saturation; Test Result: 99 %; Comments: before the vaccination; Test Date: 20210906; Test Name: Oxygen saturation; Test Result: 99 %; Comments: few minutes after the vaccination; Test Date: 20210906; Test Name: vital signs; Result Unstructured Data: Test Result:no change; Comments: No change in vital signs was found before and after the vaccination no problem with vital signs.
CDC Split Type: JPPFIZER INC202101192512

Write-up: Loss of consciousness; Eyeball upturned; without breathing/Short-term respiratory arrest (about 20-30 seconds); stiffness/upper body stiff; the patient felt down; severe vaccination site pain; Pain in arm; mental dullness; twilight state; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126448. The patient was a 16-year and 9-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade. Patient''s history according to the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) included that the patient''s mother was allergic to cosmetics (skin redness), but no problem was found after she received the vaccination. For the patient, nothing in particular. On 06Sep2021 at 12:26, the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FE8206, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 06Sep2021at 12:26 (the day of the vaccination), the patient experienced loss of consciousness and stiffness. Clinical course of the events was reported as follows: Before the vaccination, vital was: blood pressure 104/64, pulse rate 54-58/normal, Oxygen saturation was 99%, the patient was in good health and have a good breakfast. On 06Sep2021 at 12:26 (the day of the vaccination), the patient received the vaccination. "It was quite painful" the patient said with a smile. Immediately after that, the patient felt down. Eyeball upturned and upper body stiff without breathing appeared. After 10-20 seconds, the patient said "buha" and resumed breathing. Oxygen administration, route maintenance. Vital signs in a few minutes: the blood pressure 104/64, pulse rate 58, Oxygen saturation was 99% (5L of Oxygen mask was used). No change in vital signs was found before and after the vaccination. The patient recovered consciousness after a few minutes, but the patient seemed like having mental dullness and in a twilight state. There was no problem with vital signs. Just in case, hydrocortone 100mg DIV administered. After returned consciousness, the patient complained about severe vaccination site pain felt. Although consciousness, pain in arm tended to improve gradually, considering there might be a recurrence. On 06Sep2021 at 13:30 (1hours 4 minutes after the vaccination), to prevent recurrence, the patient was taken to the emergency department of a Privacy hospital by ambulance. At the time of transportation, the patient was stable although he was in a slightly mental dullness state. During the whole process, there was no wheezing, sweaty, rash, urinary incontinence, feces incontinence of, lacrimation or any changes in abdominal peristalsis. It was not considered as typical anaphylaxis. In addition, from the before-after vital signs, body stiffness, and temporary respiratory arrest (about 10-20 seconds), it was hard to considered the symptoms as a simple vagal reflex. It was unknown whether the patient was hospitalized or not (Privacy hospital). On unspecified date, the outcome of events was unknown. The reporting physician classified the event serious (Medically significant) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporter''s comment: Immediately after the vaccination, loss of consciousness, stiffness, and short-term respiratory arrest appeared. From the symptoms, it was not considered simply as anaphylactic shock or vagal reflex. The situation after the patient was taken to the privacy hospital by ambulance was unknown.; Reporter''s Comments: Immediately after the vaccination, loss of consciousness, stiffness, and short-term respiratory arrest appeared. From the symptoms, it was not considered simply as anaphylactic shock or vagal reflex. The situation after the patient was taken to the privacy hospital by ambulance was unknown.


VAERS ID: 1729678 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4204 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haemorrhage subcutaneous
SMQs:, Haemorrhage terms (excl laboratory terms) (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 Date: 20210812; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before first vaccination.; Test Date: 20210902; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: before second vaccination.
CDC Split Type: JPPFIZER INC202101192771

Write-up: Bleeding spot/ Bleeding spot occurred on right front arm and a few days later on left front arm; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126522. A 55-year and 3-month-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration at age of 55-years, on 02Sep2021 11:00 (Lot Number: FF4204; Expiration Date: 31Oct2021) as single dose for covid-19 immunisation. The patient medical history was not reported. Body temperature before vaccination were 36.6 degrees Centigrade on 12Aug2021 (at first vaccination) and 36.8 degrees Centigrade on 02Sep2021 (at second vaccination). Concomitant medications were not reported. On 12Aug2021 at 11:00, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# FE8206, Expiration date 31Oct2021) as single dose for covid-19 immunisation. On 06Sep2021, the patient experienced Bleeding spot. Events resulted in "Physician Office Visit". The outcome of the event was unknown. 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 course of the event was as follows: Bleeding spot occurred on right front arm and a few days later on left front arm. No other part or bleeding tendency was found. The patient visited the reporting hospital on 10Sep2021 and was referred to other hospital. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729696 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Contusion, Dizziness postural, Fall, Loss of consciousness, Nausea, Skin laceration
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101198612

Write-up: Loss of consciousness; fall; Dizziness on standing up; No memory; bruises and lacerations on face and under nose; bruises and lacerations on face and under nose; mild queasy; This is a spontaneous report received from a contactable Physician via Pfizer sales representative. The patient was a 27-year-old male. The patient''s medical history and concomitant medications were not reported. On 06Sep2021 at the age of 27-year-old (the day of the vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration for COVID-19 immunisation. On 06Sep2021 (the day of the vaccination), the patient experienced loss of consciousness, fall, dizziness on standing up, no memory, bruises and lacerations on face and under nose, mild queasy. The details of the reaction were reported as follow: On 06Sep2021 (after the vaccination), the patient suddenly experienced loss of consciousness and fell when he went to the waiting room, had to lie down for blood collection because dizziness on standing up. The patient had no memory when he fell down. There were bruises and lacerations on face and under nose due to falling, he had mild queasy, then felt better. The outcome of the events was not provided. Seriousness and causality of the events were not provided.; Sender''s Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1729959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 LA / UN

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

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: lactose intolerance
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result: Fever
CDC Split Type: SEPFIZER INC202101191426

Write-up: This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received the 2nd dose of BNT162b2 (Comirnaty), via an unspecified route of administration in arm left on 06Sep2021 at 18 years (batch/lot number unknown) as dose 2, single for COVID-19 immunisation. Medical history included lactose intolerance. Patient was not pregnant and was not pregnant at time of vaccination. Concomitant medications were not reported. Previously the patient received the 1st dose of BNT162b2 (Comirnaty) in arm left on 09Aug2021 at 18 years for COVID-19 immunisation. The patient had not received any other vaccine within 4 weeks. The patient experienced severe cramping in the right leg (medically significant) on 06Sep2021 with outcome of recovered in Sep2021, fever (non-serious) on 06Sep2021 with outcome of recovered in Sep2021. The patient underwent lab tests and procedures which included body temperature: fever on 06Sep2021. No therapeutic measures were taken as a result of the events. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1730667 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-06
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Erythema, Pain in extremity, Rhinitis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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? 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: Allergy; Asthma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority(Reference number: IT-MINISAL02-783001) 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 PAIN IN EXTREMITY, ABDOMINAL PAIN, ERYTHEMA and RHINITIS in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Allergy. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced PAIN IN EXTREMITY (seriousness criterion hospitalization), ABDOMINAL PAIN (seriousness criterion hospitalization), ERYTHEMA (seriousness criterion hospitalization) and RHINITIS (seriousness criterion hospitalization). On 07-Sep-2021, PAIN IN EXTREMITY, ABDOMINAL PAIN, ERYTHEMA and RHINITIS had resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medication was provided. Company Comment: This case concerns a 51 year-old, female subject with a history of asthma and allergy who experienced the unexpected events of pain in extremity, abdominal pain, erythema and rhinitis. The events occurred 14 days after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was not applicable, as the events happened after the first dose of the vaccine. The events are consistent with the current understanding of the mechanism of action of the vaccine. The medical history of asthma and allergy remain as confounders. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Follow-up received on 16-Sep-2021 and does not contain any new information.; Sender''s Comments: This case concerns a 51 year-old, female subject with a history of asthma and allergy who experienced the unexpected events of pain in extremity, abdominal pain, erythema and rhinitis. The events occurred 14 days after the first dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was not applicable, as the events happened after the first dose of the vaccine. The events are consistent with the current understanding of the mechanism of action of the vaccine. The medical history of asthma and allergy remain as confounders. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report.


VAERS ID: 1730680 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
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: 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? 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: 20210906; Test Name: Blood Pressure; Result Unstructured Data: 230/120
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Elevated Blood Pressure 230/120; This regulatory authority case was reported by another health care professional and describes the occurrence of BLOOD PRESSURE INCREASED (Elevated Blood Pressure 230/120) in a 37-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3004960) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 06-Sep-2021 at 2:10 PM, the patient experienced BLOOD PRESSURE INCREASED (Elevated Blood Pressure 230/120) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 06-Sep-2021 due to BLOOD PRESSURE INCREASED. At the time of the report, BLOOD PRESSURE INCREASED (Elevated Blood Pressure 230/120) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Blood pressure measurement: 230/120 (High) 230/120. 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. No treatment information reported. Company Comment: This case concerns a 37-year-old male subject with no relevant medical history who experienced the serious event of blood pressure increased. The event occurred approximately 14 hours after the first dose of Spikevax. There was no re-challenge as at the time of the event, as the patient was yet to receive the second dose of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.; Sender''s Comments: This case concerns a 37-year-old male subject with no relevant medical history who experienced the serious event of blood pressure increased. The event occurred approximately 14 hours after the first dose of Spikevax. There was no re-challenge as at the time of the event, as the patient was yet to receive the second dose of the vaccine. Causality was not provided by the reporter. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1730873 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 immunisation, Electrocardiogram, Myocarditis, Troponin I
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: C-reactive protein; Result Unstructured Data: Elevated.; Test Date: 20210907; Test Name: ECG; Result Unstructured Data: ECG findings consistent with pericarditis.; Test Date: 20210907; Test Name: Cardiac troponin I; Result Unstructured Data: 8000 ng/L (nanogram per litre)
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00049867) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) and MYOCARDITIS in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for Vaccination. Previously administered products included for Vaccination: Comirnaty. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) (seriousness criterion hospitalization). On 07-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, COVID-19 IMMUNISATION (REVACCINATION WITH DIFFERENT COVID-19 VACCINE) and MYOCARDITIS was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, C-reactive protein: elevated. (High) Elevated.. On 07-Sep-2021, Electrocardiogram: abnormal (abnormal) ECG findings consistent with pericarditis.. On 07-Sep-2021, Troponin I: 8000 (High) 8000 ng/L (nanogram per litre). For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Company Comment: This case concerns an 18 year old female with no medial history who experienced the listed event of Myoarditis 2 days after the second dose of Spikevax. Re-challenge is unknown as there is no information about the first dose. The events 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 20 Sep 2021 contains no new information.; Sender''s Comments: This case concerns an 18 year old female with no medial history who experienced the listed event of Myoarditis 2 days after the second dose of Spikevax. Re-challenge is unknown as there is no information about the first dose. The events 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: 1731054 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
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 INC202101213036

Write-up: Myocarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 619462. A 31-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 06Sep2021. 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: 1731059 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
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 INC202101213635

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 620907. A 39-year-old female 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 06Sep2021, troponin increased on 06Sep2021. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1731428 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   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 FF2153 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Pain, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gedarel 30/150 contraceptive pill
Current Illness: Covid on August 5, 2021
Preexisting Conditions: No
Allergies: Sulpha antibiotics
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever, body aches and chills, fatigue


VAERS ID: 1732899 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Appendicitis perforated, Appendix disorder, Inflammation, Localised infection
SMQs:, Gastrointestinal perforation (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Fear of needles
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101243205

Write-up: Ruptured appendix; Infection localised; Inflammation; Appendix pains; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-EYC 00260762. Safety Report Unique Identifier GB-MHRA-ADR 25964602. A 30-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via parenteral on 02Sep2021 (Batch/Lot Number: FE8087) as single dose for COVID-19 immunization. Medical history included ongoing fear of needles, fear of hospitals. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced appendix pains (appendix disorder) on 06Sep2021, ruptured appendix on an unspecified date, infection localized on an unspecified date, inflammation on an unspecified date. Patient went for his second dose, ended up with infection in his appendix that ruptured while he was at work, suffered sociological harm from dealing with his fear of hospitals and needles and fearing for his life, getting the vaccine was the worst thing. Patient had done always been healthy before and now patient had lost his appendix. Sent to hospital for appendix removal, caused inflammation and infection. Operation to remove appendix. Case was reported as serious, life threatening, caused/prolonged hospitalization, other medically important condition. Outcome of events were unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1732976 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
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 upper, Diarrhoea, Migraine, Nausea, Pyrexia, SARS-CoV-2 test, Tension headache
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: HYDROCORTISON [HYDROCORTISONE]
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 INC202101196528

Write-up: Nausea; Headache tension; Migraine headache; Fever; Diarrhea; Stomach cramps; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109121840450960-8JLJO, Safety Report Unique Identifier GB-MHRA-ADR 25929318. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on 04Sep2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) on unspecified date for COVID-19 immunisation. Concomitant medication included hydrocortison [hydrocortisone] (HYDROCORTISON [HYDROCORTISONE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced diarrhea, stomach cramps on 06Sep2021, nausea, headache tension, migraine headache and fever on an unspecified date. All events are medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test negative on unspecified date, No-Negative COVID-19 test. The outcome of the event headache tension, migraine headache, fever was recovered on unspecified date, events nausea and diarrhea was not recovered and recovering for stomach cramps. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Axillary pain, Burning sensation, Chest pain, Fatigue, Feeling hot, Lymphadenopathy, Nausea, Pain in extremity, Pyrexia, SARS-CoV-2 test, Somnolence
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tendinopathies and ligament 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196381

Write-up: felt hot; both armpits were burning; fell asleep midday; Swollen lymph nodes; Fever; Chest pain; Armpit pain; Fatigue; Nausea; left arm the one injected was sore and achy/ both arms hurt; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109122152119910-L1W4J, Safety Report Unique Identifier GB-MHRA-ADR 25929444. A 45-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 in left arm on 04Sep2021 as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 15Jan2020 to unspecified date, not ongoing (unsure when symptoms stopped). Concomitant medications were not reported. The patient did not have symptoms associated with COVID-19. The patient was not enrolled in clinical trial. The patient was not pregnant at the time of vaccination and was not currently breastfeeding. On 06Sep2021, 2 days after vaccination the patient experienced swollen lymph nodes, fever, chest pain, armpit pain, fatigue, nausea and left arm the one injected was sore and achy. On 07Sep2021, the patient experienced felt hot, both armpits were burning and fell asleep midday. The clinical course was reported as follows: It was reported that on the day of vaccination the patient felt absolutely fine until 06Sep2021 (Monday), morning when she felt nausea and fatigued. Under left arm pit hurt, left arm the one injected was sore and achy. On 07Sep2021 in the morning, she woke and both arms hurt, felt like had been kicked in the chest and both armpits were burning, and felt hot. She also fell asleep midday which was odd. The patient had not tested positive for COVID-19 since having the vaccine. On an unknown date, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events fever, chest pain, fatigue and nausea was resolved on an unknown date in Sep2021; while that of the event swollen lymph nodes and armpit pain was resolving. The clinical outcome of the event left arm the one injected was sore and achy, felt hot, both armpits were burning and fell asleep midday was unknown at the time of this report. The events swollen lymph nodes, fever, chest pain, armpit pain, fatigue, nausea were 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: 1733054 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 FF2153 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Muscle spasms, Myalgia, Pain assessment, Spinal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Pain scale; Result Unstructured Data: Test Result:sometimes up to an 8; Test Date: 2021; Test Name: Pain scale; Result Unstructured Data: Test Result:2/10
CDC Split Type: GBPFIZER INC202101205401

Write-up: Back muscle spasms; Muscle ache/ severe muscle paint on left side; Started in arm as a ''dead arm'' feeling, but has spread over the course of a week into back and neck.; turning head can cause shooting pains down spine and in shoulders/joint paint on left side; turning head can cause shooting pains down spine and in shoulders; This is a spontaneous report from a contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202109131246027380-ZD1YK, Safety Report Unique Identifier GB-MHRA-ADR 25931678. A 29-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration in left arm on 06Sep2021 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have symptoms associated with COVID-19 and not had a COVID-19 test. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 06Sep2021, the patient experienced back muscle spasms and muscle ache/ severe muscle paint on left side; on an unknown date in 2021, he experienced joint pain on left side, "dead arm" feeling in arm, but had spread over the course of a week into back and neck and turning head caused shooting pains down spine and in shoulders; all reported as serious for being medically significant. Clinical course was reported as follows: the patient had severe muscle / joint paint on left side, in arm and upper back (vaccine was given in left arm); started in arm as a ''dead arm'' feeling, but then spread over the course of a week into back and neck. The pain came in waves, it was always a consistent 2/10, but sometimes up to 8, even when not moving; turning head could cause shooting pains down his spine and in shoulders, sending into short-lived muscular spasms. The chronic feeling was a lot like had ''pulled a muscle'', but the severity of the pain fluctuated and the location of the pain changed throughout the course of the day. There was no position or medication found that would dull the pain. It had then been 7 days and only seemed to be getting worse. Treatment included paracetamol (manufacturer unknown) for muscle pain from 06Sep2021. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events back muscle spasms and muscle ache/ severe muscle paint on left side was not resolved while that of the other events was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733363 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-09-06
   Days after vaccination:35
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: Muscle spasms, Pharyngeal oedema, Pyrexia
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Oropharyngeal allergic 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? 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: This case was received via a regulatory authority (Reference number: IT-MINISAL02-781748) 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 PHARYNGEAL OEDEMA, MUSCLE SPASMS and PYREXIA in a 47-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced PHARYNGEAL OEDEMA (seriousness criterion hospitalization), MUSCLE SPASMS (seriousness criterion hospitalization) and PYREXIA (seriousness criterion hospitalization). At the time of the report, PHARYNGEAL OEDEMA, MUSCLE SPASMS and PYREXIA had resolved. No concomitant medication information was provided. No treatment medication information was provided. First dose of SPIKEVAX lot 3004235 on 02-Aug-2021. Company comment: This case concerns a 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Pharyngeal oedema, Muscle spasms and expected event of Pyrexia. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The event of Pyrexia is consistent with the current understanding of the mechanism of action of the study medication. The events were considered related to the product per the reporter''s assessment. 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: Significant FU appended. seriousness criteria updated to Hospitalization On 17-Sep-2021: Follow-up information included about dose 1 (Lot no. mentioned in sender''s comment updated in the I-narrative section).; Reporter''s Comments: 02.08.2021; Sender''s Comments: This case concerns a 47-year-old, female patient with no relevant medical history, who experienced the unexpected events of Pharyngeal oedema, Muscle spasms and expected event of Pyrexia. The events occurred the same day as the first dose of Moderna Covid-19 vaccine. The event of Pyrexia is consistent with the current understanding of the mechanism of action of the study medication. The events were considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.


VAERS ID: 1733459 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Oxygen saturation; Test Result: 99 %; Comments: after inhaling oxygen, Spo2 recovered to 99%.; Test Date: 20210906; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:decreased slightly
CDC Split Type: JPPFIZER INC202101193672

Write-up: vagal reflex; This is a spontaneous report from a contactable physician via . A 16-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration on 06Sep2021 (the day of vaccination, at the age of 16-year-old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 06Sep2021 (the day of vaccination), the patient experienced vagal reflex. The reporter classified the event as non-serious and assessed that the event related to the BNT162B2. On 06Sep2021, the outcome of event was recovered. The course of the event was as follows: After receiving the COMIRNATY, the patient experienced vagal reflex. Because the SpO2 had decreased slightly, giving Oxygen inhalation for the patient. And after inhaling oxygen, SpO2 recovered to 99%. After 15 minutes of observation, the patient went home. It was judged that patient was recovered because she had a normal meal at night. 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 known safety profile of the vaccine BNT162B2, a temporal relation between the event Presyncope and the administration of the vaccine 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: 1733460 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness unilateral
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101198479

Write-up: Deafness unilateral; This is a spontaneous report from a contactable physician via a sales representative. A 7-decade-old (in her 60s) female patient received BNT162B2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration in Sep2021 (the day of vaccination) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On about 06Sep2021 (about 2 days after vaccination), the patient experienced Deafness unilateral. The patient was immediately referred to a nearby otolaryngologist, took steroids at the otolaryngologist, and recovered shortly later. As therapeutic measures steroids were taken as a result of deafness unilateral. The outcome of the event was recovered on about 08Sep2021. Reporter considered that the event was non-serious and the causality between the suspect drug and event 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 limited information provided, a causal association between BNT162B2 and the reported unilateral deafness cannot be completely excluded. Patient''s medical history and concomitant medications are needed in determining the risk factors that may have led to the event. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1733511 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005236 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness, 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:
Preexisting Conditions: Comments: No medical history was provided
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Feeling of loss of consciousness; Vasovagal reflex; This case was received via regulatory authority (Reference number: 2021TJP092437) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, reported by a physician, was received by Moderna''s adverse reaction reporting site (TASK0021584), and reported to the regulatory authority by a physician, was received via the PMDA (Ref, v21126207). Feeling of loss of consciousness was assessed as serious by the RA. The patient had a history of multiple feels poorly in blood collection. On an unknown date, body temperature before the vaccination: 36.8 degrees Celsius. On 06-Sep-2021, at 14:21, the patient received the 1st dose of this vaccine. At 14:30, about 10 minutes after the vaccination, vasovagal reflex developed while waiting in a sitting position. The patient complained of feeling of loss of consciousness. Facial pallor developed. In a supine position, BP: 97/53, PR: 66, and Sp02: 97% (RA). The patient improved rapidly. After about 30 minutes of bed rest, BP: 111/80, PR: 64, and Sp02: 98% (RA). The patient returned home after confirming that there was no relapse of symptoms in a sitting or standing position. On 07-Sep-2021, it was reconfirmed by telephone examination that there was no significant change. The recovery of the symptoms was also confirmed. The outcome of feeling of loss of consciousness and vasovagal reflex was reported as resolved. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 38 year old male patient with no relevant medical history, who experienced theun expected events of depressed level of consciousness and presyncope. The events occurred approximately 7 minutes after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The events are considered related to the product per the reporter''s assessment. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report


VAERS ID: 1733724 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-09-06
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: TRPFIZER INC202101200235

Write-up: positive COVID-19 test with symptoms (runny nose, nasal congestion and sore throat); positive COVID-19 test with symptoms (runny nose, nasal congestion and sore throat); This is a spontaneous report from a non-contactable consumer (patient) received by Pfizer from regulatory authority. A 26-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not reported; Expire date: Unknown), on 22Jul2021 (at the age of 25-years-old) as dose 2, single and on 19Jun2021 (at the age of 25-years-old) as dose 1, single, both via intramuscular route of administration, administered in Deltoid Left for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications were None. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other additional vaccines. There were no adverse events after previous vaccinations. On 06Sep2021, the patient started to experience symptoms of runny nose, nasal congestion and sore throat. It was learned that as a result of the COVID-19 PCR test performed routinely by the workplace, it was positive on 10Sep2021. (PCR swab sample was taken at the company''s health centre on 10Sep2021. However, since the health centre in the company was not opened at the weekend, the information that the patient was positive was entered into the system on 13Sep2021). The patient was not currently receiving treatment with Favipiravir. Since there were 2 doses of vaccine and mild symptoms were present, this referral was made from the District Health. Since the symptoms did not cease, he has been using Redoxon (vitamin C + vitamin D + zinc) effervescent twice a day, Imuneks 10 mg capsules once a day and 500 mg Minoset tablets as needed since Saturday (11Sep2021) as a precaution (Minoset tablet has been used only once so far). In addition, with the advice of District Health, he started to use 100 mg Coraspin once a day for 1 week (13Sep2021). The patient''s nasal congestion, runny nose and sore throat continue. The patient has no other symptoms other than these. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737736 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-09-06
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: echocardiography; Result Unstructured Data: Test Result:severely restricted ejection fraction of 25%; Test Name: ejection fraction; Test Result: 25 %
CDC Split Type: DEPFIZER INC202101194238

Write-up: Myocarditis; Flu like symptoms; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100184683. A 45-year-old female patient received BNT162B2 (COMIRNATY 0.3 mL), intramuscular on 16Aug2021 (Batch/Lot Number: Unknown) at the age of 45 years old as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 06Sep2021, the patient experienced myocarditis and flu like symptoms. Medical report not available. This case was assessed by RA and meets the Brighton Collaboration Case Definition Level 4: Reported case of myocarditis with insufficient evidene to meet level 1, 2 or 3 of the case definition. The patient underwent echocardiography a severely restricted ejection fraction of 25%. Outcome of events was unknown. This report is serious - hospitalization. Relatedness of drug to reactions/events, Source of assessment: RA , Result of Assessment: D. Unclassifiable Sender comment: Patient has no pre-existing conditions, after the 2. vaccination flu-like symptoms. Now at the echocardiography a severely restricted ejection fraction of 25%. The following differential diagnoses were ruled out: Coronary heart disease. Was outpatient treatment necessary? None. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1737856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210947887

Write-up: PARESTHESIA; This spontaneous report received from a consumer by a Regulatory Authority (DE-PEI-202100194940) was received on 24-SEP-2021 and concerned a male of unspecified age. The patient''s weight was 112 kilograms, and height was 193 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 dosage forms, 1 total administered on 03-SEP-2021 for drug used for unknown indication. No concomitant medications were reported. On 06-SEP-2021, the patient experienced paresthesia. On an unspecified date, the patient was hospitalized, number of days hospitalized and discharge information was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from paresthesia. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: IInitials [redacted] no age provided


VAERS ID: 1737977 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Myocarditis
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? 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: DEJNJFOC20210945574

Write-up: Perimyocarditis; Retrosternal pain; This spontaneous report received from a consumer via Regulatory Authority (DE-PEI-CADR2021177228) was received on 23-SEP-2021 and concerned a 31 year old male of unspecified race and ethnicity. The patient''s weight was 107 kilograms, and height was 188 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 03-SEP-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-SEP-2021, the patient experienced perimyocarditis, retrosternal pain and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from perimyocarditis, and retrosternal pain on 07-SEP-2021. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1738532 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial; Type II diabetes mellitus
Preexisting Conditions: Comments: METFORMINE 500mg BENAZEPRIL 10mg HYDROCHLOROTHIAZIDE 12.5mg
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: FRJNJFOC20210944916

Write-up: Vaccination failure; This spontaneous report received from a pharmacist via a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-PB20216247) was received on 23-SEP-2021 and concerned a 90 year old male of unknown race and ethnic origin. The patient''s weight was not reported and height was 170 centimeters. The patient''s concurrent conditions included: hypertension arterial, and type 2 diabetes mellitus, and other pre-existing medical conditions included: METFORMINE 500mg BENAZEPRIL 10mg HYDROCHLOROTHIAZIDE 12.5mg. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C11-02 expiry: UNKNOWN) 1 dosage forms, frequency 1 total, administered on 08-JUN-2021 for covid-19 vaccination. No concomitant medications were reported. On 06-SEP-2021, the patient experienced vaccination failure, and was hospitalized (date unspecified). On 07-SEP-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Positive (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vaccination failure. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1738818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-09-06
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Antineutrophil cytoplasmic antibody, Biopsy kidney, Blood test, Glomerulonephritis rapidly progressive, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis prophylaxis; Pain; Polydipsia; Shoulder pain ((had a course of NSAID in July))
Allergies:
Diagnostic Lab Data: Test Date: 202109; Test Name: ANCA; Result Unstructured Data: Test Result:Raised ANCA; Test Date: 202109; Test Name: MPO; Result Unstructured Data: Test Result:Raised MPO; Test Date: 202109; Test Name: Renal biopsy; Result Unstructured Data: Test Result:Found to have crescentic glomerulonephritis; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:found to have an acute kidney injury; Test Date: 20201025; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211293

Write-up: Crescentic glomerulonephritis; acute kidney injury; This is a spontaneous report from a contactable health care professional. This is a report received from a Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109141510513550-RPUMW with Safety Report Unique Identifier of GB-MHRA-ADR 25939699. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 13May2021 as a single dose for COVID-19 immunisation. Medical history included shoulder pain, polydipsia, pain and gastritis prophylaxis. It was reported that patient had a painful shoulder and had a course of NSAID in July. On 25Oct2020, the patient underwent COVID-19 virus test and the result was negative. The patient had no symptoms associated with COVID-19. It was unsure if the patient was enrolled in the clinical trial. Concomitant medications included codeine phosphate, paracetamol (CO-CODAMOL) and naproxen (MANUFACTURER UNKNOWN) both were taken for pain from 05Jul2021, unknown if ongoing and omeprazole (MANUFACTURER UNKNOWN) taken for gastritis prophylaxis from 05Jul2021 and unknown if ongoing. On an unknown date in 2021, the patient experienced acute kidney injury and on 06Sep2021, the patient experienced crescentic glomerulonephritis; both the events were reported as serious for being medically significant and causing hospitalization. The clinical course reported was as follows: The patient had blood test checked by GP (general practitioner) following a 2-week history of polydipsia and was found to have an acute kidney injury. The patient was not diabetic. The patient was then referred to specialist renal unit. On an unknown date in Sep2021, the patient underwent lab tests included ANCA (Antineutrophil cytoplasmic antibodies) and MPO (Myeloperoxidase antibodies test) on immunology screen and the both resulted in raised levels and the renal biopsy result was found to have crescentic glomerulonephritis. It was reported that, there were no possible blood clots or low platelet counts. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events crescentic glomerulonephritis was not resolved and acute kidney injury was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1738830 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cold urticaria, Dyspnoea, Fatigue, Gait disturbance, Inappropriate schedule of product administration, SARS-CoV-2 test, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211456

Write-up: This is a spontaneous report from a contactable Consumer or other non-Health Care Professional. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109141819333500-3RQK1, Safety Report Unique Identifier GB-MHRA-ADR 25940521. A 23-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number unknown) via an unspecified route of administration on 05Sep2021 as dose 2, single for COVID-19 immunization. The patient previously received first dose of historical vaccine BNT162B2 on 29Jun2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced shortness of breath on 06Sep2021 and events tight chest, shortness of breath, unable to walk far, extreme fatigue, tiredness, Urticaria (swelling of hands mouth and tongue when they become cold) and inappropriate schedule of vaccine administered on an unspecified date. All the events caused disability and were medically significant. On 07Sep2021, the patient underwent lab tests and procedures which included sars-cov-2 test (no-negative COVID-19 test). Unsure if patient has had symptoms associated with COVID-19, Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event experienced shortness of breath was not recovered, while another events outcome was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1739048 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-09-06
   Days after vaccination:149
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: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: He tested negative on 23Aug2021.; Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: His specimen collected on 06Sep2021 tested positive for COVID-19
CDC Split Type: GBPFIZER INC202101210343

Write-up: tested positive for COVID-19 and he remains asymptomatic; tested positive for COVID-19 and he remains asymptomatic; This is a spontaneous report from a contactable other Healthcare Professional. A 16-years-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 20Mar2021 (age at vaccination was unknown) as dose 1, single and second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Apr2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had received two doses of COVID-19 vaccination. On 06Sep2021, the patient tested positive for COVID-19 and he remained asymptomatic (vaccination failure). It was reported that the patient traveled on 26Aug2021. He tested negative on 23Aug2021. His specimen collected on 06Sep2021 tested positive for COVID-19 and he remained asymptomatic. The RA was notified of a confirmed case on 09Sep2021. The patient underwent lab tests which included COVID-19 virus test: negative on 23Aug2021 and COVID-19 virus test: positive on 06Sep2021. It was unknown whether the Health authority was notified. The outcome of the event was unknown. Information about Lot/Batch number requested.; Sender''s Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of RA (vaccination failure,asymptomatic covid-19).


VAERS ID: 1739292 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Dehydration, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Diabetes; Retinopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: high fever up to 39 C
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received (Reference number: IT-MINISAL02-782271) 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 PYREXIA, DEHYDRATION and VOMITING in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 prophylaxis. Concurrent medical conditions included Retinopathy and Diabetes. On 06-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 06-Sep-2021, the patient experienced PYREXIA (vomito ripetuto, febbre elevata fino a 39?C, disidratazione in paziente diabetico insulinodipendente) (seriousness criterion medically significant), DEHYDRATION (vomito ripetuto, febbre elevata fino a 39?C, disidratazione in paziente diabetico insulinodipendente) (seriousness criterion medically significant) and VOMITING (vomito ripetuto, febbre elevata fino a 39?C, disidratazione in paziente diabetico insulinodipendente) (seriousness criterion medically significant). At the time of the report, PYREXIA (vomito ripetuto, febbre elevata fino a 39?C, disidratazione in paziente diabetico insulinodipendente), DEHYDRATION (vomito ripetuto, febbre elevata fino a 39?C, disidratazione in paziente diabetico insulinodipendente) and VOMITING (vomito ripetuto, febbre elevata fino a 39?C, disidratazione in paziente diabetico insulinodipendente) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: high fever up to 39 c (Inconclusive) high fever up to 39 C. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The concomitant medications were not provided by the reporter. Treatment information was not provided by the reporter. Labs included O2 saturation, Body temperature, Heart rate, Glycaemia control, Blood pressure on 07-sep-2021 with unknown results. This case concerns a 35 year-old, male with a history of Diabetes (insulin dependent) who experienced the unexpected events of Vomiting, Dehydration and Pyrexia. The event occurred the same day after a dose of mRNA-1273 Moderna vaccine (SD doesn?t clarify if it is 1st or 2nd). The medical history of Diabetes could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. The reporter states that the patient had experienced repeated vomiting and high fever up to 39?C, dehydration and patient is insulin-dependent diabetic. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Translation Received on 23-SEP-2021, event verbatim were added in narrative.; Sender''s Comments: This case concerns a 35 year-old, male with a history of Diabetes (insulin dependent) who experienced the unexpected events of Vomiting, Dehydration and Pyrexia. The event occurred the same day after a dose of mRNA-1273 Moderna vaccine (SD doesn?t clarify if it is 1st or 2nd). The medical history of Diabetes could be a potentially confounder. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report.


VAERS ID: 1739305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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: Asthenia, Blood test, Body temperature, Chest pain, Dyspnoea, Electrocardiogram, Full blood count, Headache, Heart rate, Hyperventilation, Oxygen saturation, Pain assessment, Paraesthesia, Pharyngeal erythema, Physical examination, Pyrexia, Seizure, Sopor, Tonsillar erythema, Tonsillar hypertrophy
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: Blood test; Result Unstructured Data: Test Result:isolated increase in PCR with normal blood count a; Comments: isolated increase in PCR with normal blood count and indices of myocardial damage; Test Date: 20210906; Test Name: Body temperature; Result Unstructured Data: Test Result:max 38.5 Centigrade; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Name: ecg; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: Heart rate; Result Unstructured Data: Test Result:108; Test Date: 20210908; Test Name: O2 saturation; Result Unstructured Data: Test Result:98; Test Name: Physical exam; Result Unstructured Data: Test Result:good overall condition, alert, responsive, respond; Comments: good overall condition, alert, responsive, responds to questions with the same tone. At chest, good air entry, no pathological noise. Heart is normal, rhythmic with normal sounds. Pain on pressing with finger on ribs in left parasternal area, nothing on right parasternal area. Abdomen normal without pain, organs in the hypochondriac region within limits. Pharynx reddened on the arch, slightly hypertrophied tonsils, slight redness when cleared. Not laterocervical lymphadenomegaly. Final clinical diagnosis: transient chest pain during hyperventilation seizure.; Test Date: 20210906; Test Name: headache; Result Unstructured Data: Test Result:9; Test Date: 20210906; Test Name: pain in proximal sternal region; Result Unstructured Data: Test Result:7-8
CDC Split Type: ITPFIZER INC202101195433

Write-up: difficulty in breathing/Dyspnoea; Red tonsils; She complains of headache; Pharynx redness of; difficulty in breathing.; Fever from 06Sep2021 in the evening (CT max 38.5 C); Paraesthesia; slightly hypertrophied tonsils; hyperventilation seizure; At around 01: 30-2 she presented with chest pain/pain in the proximal sternum region; Sopor; Asthenia; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-782348. A 16-year-old female patient received bnt162b2 (COMIRNATY) dose 2 intramuscular administered in left arm on 06Sep2021 (Lot Number: FG7387) as 0.3 mL single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced at around 01: 30-2 she presented with chest pain, pain in the proximal sternum region, sopor, asthenia, difficulty in breathing, red tonsils, she complains of headache, pharynx redness of, dyspnea, difficulty in breathing, fever from 06sep2021 in the evening (ct max 38.5 C), paraesthesia on 06Sep2021. All events were serious as medically significant. Accessed in the Emergency Room today at 3:35 AM for hyperpyrexia and reported post-vaccine dyspnea. 8:30 PM. Orosoluble tachipirina [paracetamol] 1000 mg. Pediatric visit at 08:11 AM: Fever since the evening of 06Sep2021 (max 38.5C), last Tachipirina [paracetamol] 1000 mg taken at 08:30 PM. 2nd dose of bnt162b2 was on 06Sep2021 at around 5 pm. At around 01:30 - 02:00 AM, she presented with chest pain and breathing difficulties. She wasn''t sleeping because she was drowsy/asthenic during the day. She now complains of headache (pain 9/10), pain in proximal sternal region (pain 7-8/10). At home, hyperventilation seizures with paresthesias in the extremities. Wellness in previous days. No problems after the first dose of vaccine on 02Aug2021 at 05:22 PM, Batch FF7481 Expiry date 30Nov2021, performed in the left deltoid. Seen at another hospital in the Region that referred him/her to our institution for expertise. Physical exam: good overall condition, alert, responsive, responds to questions with the same tone. At chest, good air entry, no pathological noise. Heart was normal, rhythmic with normal sounds. Pain on pressing with finger on ribs in left parasternal area, nothing on right parasternal area. Abdomen normal without pain, organs in the hypochondriac region within limits. Pharynx reddened on the arch, slightly hypertrophied tonsils, slight redness when cleared. Not laterocervical lymphadenomegaly. Final clinical diagnosis: transient chest pain during hyperventilation seizure. - Measures taken included Pediatric visit. 4:00 AM: ECG, blood tests are repeated. Ibuprofen 600 mg was administered. 7:00 AM: ECG normal, isolated increase in PCR with normal blood count and indices of myocardial damage 8:00 AM. At re-evaluation, good general conditions, quiet, no more pain. She rested. She was discharged. Follow-up on 08Sep2021. Patient referred to treating physician for knowledge and further evaluation. Brufen 400 mg tablets: 1 tablet in the case of pain, it can be repeated maximum every 8 hours. Return to the emergency department if clinical conditions worsen. Control by the attending doctor according to clinical progress.). On 08Sep2021 37.8C; ECG normal; heart rate 108; O2 saturation 98; on examination, isolated increase in PCR with normal blood count and indices of myocardial damage. The outcome of events was recovering.


VAERS ID: 1739318 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   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 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101195381

Write-up: two consecutive fainting; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. WEB IT-MINISAL02-782495. A 43-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 06Sep2021 08:25 (Lot Number: FG6273; Expiration Date: 30Nov2021) (at age of 43-year-old) as DOSE 2, 0.3 ML, SINGLE for covid-19 immunisation. Patient took the first dose of bnt162b2 (COMIRNATY), administered in right shoulder on 02Aug2021 08:57 AM (lot FF2752, expiry date 30Nov2021) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced two consecutive fainting (hospitalization) on 06Sep2021 with outcome of recovering. Measures taken included drank water, ate a sugary snack, lifted legs. Sender''s comments: Syncope after administration of the second dose of Comirnaty. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739844 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: This case was received via Regulatory Authority (Reference number: SE-MPA-2021-082444) 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 PAIN, NAUSEA, HEADACHE and CHILLS in a 38-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced PAIN (seriousness criterion disability), NAUSEA (seriousness criterion disability), HEADACHE (seriousness criterion disability) and CHILLS (seriousness criterion disability). At the time of the report, PAIN and NAUSEA had not resolved and HEADACHE and CHILLS was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. No relevant concomitant medications were reported No treatment information was provided. Company comment: This case concerns a 38-year-old male patient with no relevant medical history,who experienced the unexpected events of Pain, Nausea, Headache and Chills .The events occurred on the same day after first dose of Spikevax . The rechallenge was not applicable since only information about the first dose was disclosed. The events , Nausea, Headache and Chills 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. Events 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 38-year-old male patient with no relevant medical history,who experienced the unexpected events of Pain, Nausea, Headache and Chills .The events occurred on the same day after first dose of Spikevax . The rechallenge was not applicable since only information about the first dose was disclosed. The events , Nausea, Headache and Chills 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. Events 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: 1740463 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
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: Back pain, Blood pressure measurement, Body temperature, Chills, Coma scale, Diarrhoea, HIV test, Headache, Heart rate, Investigation, Lower respiratory tract infection, Oxygen saturation, Pain, Palpitations, Respiratory distress, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient had no history of allergies and had no pre-existing medical conditions and no hospitalization in last 30 days. The patient had no previous reaction or adverse events after immunization and had no pre-existing acute illness 30 days prior to vaccination and was not tested positive for covid-19 prior to vaccination. The patient had currently no medical condition and had no family history of any allergies and any diseases.
Allergies:
Diagnostic Lab Data: Test Date: 20210916; Test Name: Blood pressure; Result Unstructured Data: 161/99 mmHg; Test Date: 20210916; Test Name: Body temperature; Result Unstructured Data: 35 C; Test Date: 20210916; Test Name: Oxygen saturation; Result Unstructured Data: 100 %; Test Date: 20210916; Test Name: Glasgow coma scale; Result Unstructured Data: 15/15; Test Date: 20210916; Test Name: Investigation; Result Unstructured Data: 6.9; Test Date: 20210916; Test Name: Heart rate; Result Unstructured Data: 123; Test Date: 20210916; Test Name: Respiratory rate; Result Unstructured Data: 32; Test Date: 20210916; Test Name: HIV test; Result Unstructured Data: uninfected
CDC Split Type: ZAJNJFOC20210941810

Write-up: RESPIRATORY DISTRESS; LOWER RESPIRATORY TRACT INFECTION (COUGH, NASAL FLARING, SHORTNESS OF BREATH, MOIST MUCOUS MEMBRANES, CHEST PAIN, CHEST MILD CREPITATIONS); BACK PAIN; PALPITATIONS; PAIN; CHILLS; DIARRHOEA; HEADACHE; This spontaneous report received from a health care professional concerned a 28 year old female of an unspecified race and ethnic origin. . The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient had no history of allergies and had no pre-existing medical conditions and no hospitalization in last 30 days. The patient had no previous reaction or adverse events after immunization and had no pre-existing acute illness 30 days prior to vaccination and was not tested positive for covid-19 prior to vaccination. The patient had currently no medical condition and had no family history of any allergies and any diseases. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE430 expiry: UNKNOWN) dose was not reported, administered 1 total on 06-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. Since vaccination on 06-SEP-2021, the patient experienced respiratory distress and lower respiratory tract infection (cough, nasal flaring, shortness of breath, moist mucous membranes, chest pain, chest mild crepitations). back pain palpitations, pain, chill, diarrhea (with negative abdominal pain) headache. Time of first symptom was reported as 19:00 on 06-SEP-2021. The patient took paracetamol and headache resolved but respiratory distress continued. The patient not experienced confusion, dehydration, active bleeding and injuries. On 16-SEP-2021, Laboratory data included: Blood pressure (NR: not provided) 161/99 mmHg, Body temperature (NR: not provided) 35 C, Glasgow coma scale (NR: not provided) 15/15, HIV test (NR: not provided) uninfected, Heart rate (NR: not provided) 123, HGT Investigation (NR: not provided) 6.9, Oxygen saturation (NR: not provided) 100 %, and Respiratory rate (NR: not provided) 32. On SEP-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on SEP-2021, and had not recovered from back pain, diarrhea, respiratory distress, lower respiratory tract infection (cough, nasal flaring, shortness of breath, moist mucous membranes, chest pain, chest mild crepitations), palpitations, chills, and pain. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210941810-covid-19 vaccine ad26.cov2.s -Respiratory distress and Lower respiratory tract infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1742284 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Herpes simplex, Polymerase chain reaction
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Herpes simplex (first episode); PCR positive (first episode for herpes simplex)
Allergies:
Diagnostic Lab Data: Test Date: 202005; Test Name: PCR for herpes simplex.; Result Unstructured Data: Test Result:positive
CDC Split Type: ESPFIZER INC202101209437

Write-up: recurrent herpes simplex on her left cheek; recurrent herpes simplex on her left cheek; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB with regulatory authority number ES-AEMPS-998736. A 14-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Sep2021 (Lot Number: FG6273) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included first episode in May2020 was PCR+ for herpes simplex. The patient''s concomitant medications were not reported. On 06Sep2021, the patient experienced herpes simplex which was considered serious medically significant. It was reported that the patient had recurrent herpes simplex on her left cheek. The last episode was 3 days after receiving the vaccine. The outcome of the event was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1742576 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood test, Chest pain, Magnetic resonance imaging, Muscular weakness, Musculoskeletal disorder, Myelitis transverse, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Contrast MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: MRI; Result Unstructured Data: Test Result:unknown results; Test Date: 20201231; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101217545

Write-up: Back pain; Chest pain; Myelitis transverse; Leg weakness; Loss of leg function; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202109152217354620-QQK7O with Safety Report Unique Identifier GB-MHRA-ADR 25948565. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Aug2021 as a single dose for COVID-19 immunisation. Medical history included suspected COVID-19 from 24Dec2020 and it was unsure when the symptoms stopped. It was reported that the patient was normally healthy and active. The patient was not enrolled in a clinical trial. On 31Dec2020, the patient underwent a COVID-19 virus test and the result was positive. Concomitant medications were not reported. On 06Sep2021, the patient experienced back pain, chest pain, myelitis transverse and events were reported as serious for causing hospitalisation, disability and for being medically significant. On an unknown date in 2021, the patient experienced leg weakness and loss of leg function. It was reported that the patient was still in hospital and had occasional chest pain. On an unknown date in Sep2021, the patient underwent MRI (magnetic resonance imaging), blood test and contrast MRI and the results were unknown. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the events back pain, leg weakness and loss of leg function was unknown while the outcome of events chest pain and myelitis transverse was not resolved 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: 1742716 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Maternal exposure during pregnancy, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Anaemic; Asthma; Gestational diabetes; Pregnancy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test .
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: fever; shivering; Maternal exposure during pregnancy; Vomiting; This case was received via regulatory authority (Reference number: ADR 25966427) on 20-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This regulatory authority pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (shivering), VOMITING (Vomiting) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Gestational diabetes, Pregnancy, Anaemic, Asthma and Pregnancy. Concomitant products included FOLIC ACID for Folic acid supplementation. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 06-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced PYREXIA (fever) (seriousness criterion medically significant), CHILLS (shivering) (seriousness criterion medically significant) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. On 07-Sep-2021, VOMITING (Vomiting) had resolved. At the time of the report, PYREXIA (fever) and CHILLS (shivering) had resolved and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test .. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were provided Patient had blood cloth in previous pregnancy. Patient had no symptoms associated with COVID-19 and was not breastfeeding . Patient was 31 weeks and 2 days pregnant during second dose. Patient had gone to hospital due to no movement of baby and also it was found that baby heart rate was raised. Patient was exposed to the medicine on her Second-trimester (13-28 weeks). Company Comment: This case concerns a 30-year-old, female patient with a medical history of gestational diabetes, anemia and asthma, who experienced the unexpected events of maternal exposure during pregnancy and expected events of pyrexia, chills and vomiting. The patient received the second dose of vaccine at 31 weeks of gestation.. The reporter''s assessment was also not provided. The benefit-risk relationship of the 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 30-year-old, female patient with a medical history of gestational diabetes, anemia and asthma, who experienced the unexpected events of maternal exposure during pregnancy and expected events of pyrexia, chills and vomiting. The patient received the second dose of vaccine at 31 weeks of gestation.. The reporter''s assessment was also not provided. The benefit-risk relationship of the 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: 1743066 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3622 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia
SMQs:, Guillain-Barre 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Dermatitis atopic; Eosinophilic granulomatosis with polyangiitis; Food allergy (allergy to honey, fruits, latex.); Latex allergy (allergy to honey, fruits, latex.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101206978

Write-up: Weakness; This is a spontaneous report from a contactable physician received via COVID-19. A 31-years-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: FF3622; Expiration Date: 30Nov2021), via intramuscular route, administered in left arm on 06Sep2021 at 15:00 (the day of vaccination, at the age of 31 years old) as dose 1, single for COVID-19 immunisation. Other medical history included eosinophilic granulomatosis with polyangiitis, asthma and dermatitis atopic from an unknown date. The patient had allergies to honey, fruits, latex. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included montelukast sodium, prednisolone acetate (PREDONINE), tacrolimus, hydrocortisone acetate (CORTRIL) all taken for an unspecified indication, start and stop date were not reported. On 06Sep2021 at 15:15 (15 minutes after vaccination), the patient experienced weakness. The outcome of the event was recovered on an unspecified date in 2021 with treatment including intravenous injection. The reporter stated the event results in emergency room/department or urgent care. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected. Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of asthenia 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: 1743212 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

Administered by: Unknown       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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Food allergy (yam); Seafood allergy (shrimp, crab)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via Pharmaceutical Company(Reference number: JP-TAKEDA-2021TJP095062 ) on 15-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This case, initially reported to the Regulatory Authority by a physician, was received via the Regulatory Authority (Ref, v21126830). On an unknown date, the patient received 1st dose of the vaccine. On 06-Sep-2021, at 10:04, the patient received 2nd dose of the vaccine. In about 5 minutes, the patient complained of itching of the face and abdomen. At 10:10, the patient experienced anaphylaxis. The patient experienced itchy throat and cough. There was a difficulty in blood pressure measurement. Adrenaline was administered to the right thigh. At 10:18, peripheral intravenous route was secured, and bolus administration of normal saline was initiated. At 10:22, methylprednisolone sodium succinate 125 mg and d-chlorpheniramine maleate 5 mg were infused intravenously. Thereafter, the symptoms gradually improved. At 10:58, the patient was urgently taken to the reporting hospital. At this time, the symptoms had almost disappeared. The patient was hospitalized overnight for observation. On 07-Sep-2021, the symptoms were confirmed to be resolving. At 10:00, the patient was discharged from the hospital. The outcome of anaphylaxis was reported as resolving. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 42 year old female patient with medical history of food allergy (seafood), who experienced the expected serious event of anaphylaxis, within the same day after the second dose of mRNA-1273 vaccine. The patient''s medical history of food allergy confounds causality assessment. Rechallenge is not applicable. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1744787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-09-06
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101189419

Write-up: No symptoms; vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the Agency WEB. The regulatory authority report number is AT-BASGAGES-2021-044000. A 55-year-old female patient received BNT162B2 (COMIRNATY), Intramuscular on 16Jun2021 as DOSE 2, SINGLE for COVID-19 immunisation. No medical history reported. No concomitant medication reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 05May2021 for COVID-19 immunisation. On 06Sep2021 the patient experienced Asymptomatic COVID-19/ No symptoms, COVID-19 PCR test positive. Outcome of the event was unknown. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.


VAERS ID: 1746074 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 215020 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema induratum
SMQs:, Vasculitis (narrow), Opportunistic 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: ESMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: ES-AEMPS-999691) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ERYTHEMA INDURATUM in a 12-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 215020) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced ERYTHEMA INDURATUM (seriousness criterion medically significant). At the time of the report, ERYTHEMA INDURATUM was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment medications were not reported. Company Comment: This case concerns a 12-year-old male patient with no reported medical, who experienced Erythema induratum 2 days after the unspecified dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable The benefit-risk relationship of Spikevax in not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation received on 24-Sep-21 contains No NewInformation.; Sender''s Comments: This case concerns a 12-year-old male patient with no reported medical, who experienced Erythema induratum 2 days after the unspecified dose of Spikevax. The reporter did not provide causality assessment. The rechallenge was not applicable The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1746437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram, Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Capillary nail refill test, Chest pain, Dizziness, Dyspnoea exertional, Ear, nose and throat examination, Fibrin D dimer, Full blood count, Haemoptysis, Heart rate, Investigation, Nausea, Oxygen saturation, Physical examination, Prothrombin time, Pyrexia, Respiratory disorder, Respiratory rate, Tachycardia, Troponin, Ultrasound scan
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Medical History/Concurrent Conditions: Depression; Functional bowel syndrome (on Fluoxetine 30 mg per day); Irritable bowel syndrome; Non-smoker; Strabismus correction (Strabismus surgery)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: Chest CT angiography; Result Unstructured Data: Test Result:no abnormality visible on the chest CT scan; Comments: with intravenous injection of contrast agent in particular, nothing suggestive of a pulmonary embolism.; Test Date: 20210906; Test Name: blood pressure; Result Unstructured Data: Test Result:114/78 mmHg; Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 2021; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:unknown results; Test Date: 20210906; Test Name: capillary refill time; Result Unstructured Data: Test Result:less than 2sec; Test Date: 2021; Test Name: CRP; Result Unstructured Data: Test Result:unknown results; Test Date: 20210906; Test Name: ear, nose and throat examination; Result Unstructured Data: Test Result:normal ear drums, clean throat; Test Date: 2021; Test Name: D-Dimers; Result Unstructured Data: Test Result:unknown results; Test Date: 2021; Test Name: complete blood count; Result Unstructured Data: Test Result:unknown results; Test Date: 20210906; Test Name: heart rate; Result Unstructured Data: Test Result:120 bpm; Comments: regular heart beats, tachycardia, max systolic murmur at aortic area, peripheral and femoral pulses felt; Test Date: 20210906; Test Name: abdomen examination; Result Unstructured Data: Test Result:Abdomen soft, not tender, no guarding,; Comments: no hepatosplenomegaly; Test Date: 20210906; Test Name: saturation; Test Result: 98 %; Test Date: 20210906; Test Name: PHYSICAL EXAMINATION; Result Unstructured Data: Test Result:No diarrhea, No urinary symptoms,; Comments: No recent travel, no plane travel. No prolonged time in bed. No pain in the calves, Non-smoker; Test Date: 2021; Test Name: prothrombin time; Result Unstructured Data: Test Result:unknown results; Test Date: 20210906; Test Name: respiratory rate; Result Unstructured Data: Test Result:28 breaths per minute; Comments: eupneic on ambient air, breath sounds bilateral and symmetrical, no crackles, no wheezing; Test Date: 2021; Test Name: troponin; Result Unstructured Data: Test Result:normal; Test Date: 2021; Test Name: 4-point ultrasound; Result Unstructured Data: Test Result:no incompressibility of the veins
CDC Split Type: FRPFIZER INC202101216220

Write-up: pain in the middle of the chest; nausea; dizzy; respiratory discomfort; heart rate 120 bpm/tachycardia; Sputum bloody/coughing up blood; Fever 38.1 C with chills; Dyspnea exertional; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PV20212696. A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 01Sep2021 (lot number and expiry date: unknown) as dose 2, 0.3 ml single, for Covid-19 immunisation; fluoxetine hydrochloride oral from an unspecified date (number and expiry date: unknown) to an unspecified date, at 30 mg, 1x/day for anxiety depression. Medical history included functional bowel syndrome, depression, strabismus surgery, irritable bowel syndrome, and non-smoker. The patient had no allergies/ no health log. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), for Covid-19 immunisation. On 06Sep2021, the patient experienced sputum bloody/coughing up blood, respiratory discomfort, fever 38.1 c with chills, dyspnea exertional, pain in the middle of the chest, nausea, dizzy, and heart rate 120 bpm/tachycardia. The clinical course was reported as follows: On 06Sep2021, the patient was practicing sports at school (middle-distance running); progressive respiratory discomfort followed by coughing up blood (bottom of a glass). Persistence of sensation of dyspnea with pain in the middle of the chest; nausea. No vomiting; fever 38.1 C with chills; felt nauseated and dizzy. Physical Examination: No diarrhea, no urinary symptoms, no recent travel, no plane travel, no prolonged time in bed, no pain in the calves. Non-smoker. Fever of 38.1 C, Upper airways clear and certain. No cyanosis, no sign of distress, saturation 98%, respiratory rate 28 breaths per minute, eupneic on ambient air, breath sounds bilateral and symmetrical, no crackles, no wheezing, no mottling, blood pressure 114/78 mmHg, heart rate 120 bpm, regular heart beats, tachycardia, max systolic murmur at aortic area, peripheral and femoral pulses felt, capillary refill time < 2 sec, extremities warm, no hepatomegaly. Abdomen soft, not tender, no guarding, no hepatosplenomegaly, ear, nose and throat: normal ear drums, clean throat, no skin rash, no purpura, no neck stiffness, soft and painless calves. Additional tests: 4-point ultrasound: no incompressibility of the veins. Chest CT angiography: no abnormality visible on the chest CT scan with intravenous injection of contrast agent in particular, nothing suggestive of a pulmonary embolism. Blood Tests: CBC (complete blood count), CRP, PT (prothrombin time), APTT (Activated partial thromboplastin time), D-Dimers, BNP (brain natriuretic peptide), troponin normal. In summary: dyspnea with coughing up blood on exertion, fever on Day 5 following the second dose of COMIRNATY in a 15-year-old adolescent also taking FLUOXETINE; resolving. Action taken with fluoxetine was dose not changed. Outcome of the event heart rate 120 bpm/tachycardia was unknown, for the remaining events was recovering. Note on accountability: accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures Therapie/1985; 40:111-68". No follow-up attempts are needed. Information on batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1746521 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: GBPFIZER INC202101190609

Write-up: Fainting; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109090851561130-MZSQF, Safety Report Unique Identifier GB-MHRA-ADR 25916512. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2153) via an unspecified route of administration on 06Sep2021 (at the age of 21-years-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 had not undergone a COVID-19 test. The patient was not enrolled in clinical trial. On 06Sep2021, the patient experienced fainting. The patient had not tested positive for COVID-19 since having the vaccine. The clinical outcome of the event fainting was recovered on 06Sep2021 at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746597 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-09-06
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Dysmenorrhoea, Heavy menstrual bleeding, Muscle spasms, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: GBPFIZER INC202101217682

Write-up: cramps; Period was much heavier than usual; longer than usual; Drug ineffective; Menstrual cramp; Menstrual flooding; SARS-CoV-2 infection; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109151425521670-VUWN0, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25945605. A 45-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was FE8087)vi a an unspecified route of administration on 13Aug2021 as Dose 1, Single for COVID-19 immunization. The patient is not currently breastfeeding.Medical history included suspected covid-19 from 28Dec2019 to an unknown date Unsure when symptoms stopped. The patient''s concomitant medications were not reported. The patient did not had COVID-19 test. The patient experienced cramps on an unspecified date, sars-cov-2 infection on 06Sep2021, menstrual cramp on 08Sep2021 with outcome of recovered on 11Sep2021, menstrual flooding on 08Sep2021 with outcome of recovered on 11Sep2021, period was much heavier than usual on an unspecified date, longer than usual on an unspecified date, drug ineffective on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Sep2021. The outcome of events cramps, period was much heavier than usual, longer than usual, drug ineffective was unknown and for others was recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Chest pain, Electrocardiogram, Migraine, Nightmare, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data: Test Name: Blood Test; Result Unstructured Data: Test Result:Unknown; Test Name: cxr; Result Unstructured Data: Test Result:Unknown; Test Name: ecg; Result Unstructured Data: Test Result:Unknown; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101224978

Write-up: Migraine/ series of migraine headaches; Chest pain; Palpitation; nightmares; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109161113403390-L4TBX, Safety Report Unique Identifier is GB-MHRA-ADR 25951896. A 60-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FE8087), via an unspecified route of administration, on 03Sep2021, as dose 2, single for COVID-19 immunization. Medical history included stroke (stroke 11 years ago. took clopidogrel, artarvostatin, lansaprazole, sumatriptan). Patient has not had symptoms associated with COVID-19. The patient previously took clopidogrel, sumatriptan, lansoprazole, atorvastatin. The patient''s concomitant medications were not reported. The patient experienced chest pain, palpitation and nightmares on 06Sep2021; migraine/ series of migraine headaches on 13Sep2021. Clinical information included gripping chest pain especially at night, heart palpitations, nightmares, series of migraine headaches. Patient has not tested positive for COVID-19 since having the vaccine. Patient visited emergency room due to events. The patient underwent lab tests and procedures which included blood test with result unknown, chest x-ray with result unknown, electrocardiogram with result unknown and sars-cov-2 test/ COVID-19 virus test was negative (No - Negative COVID-19 test) on an unspecified date. Outcome of the events was unknown. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-29
Onset:2021-09-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Choking sensation, Musculoskeletal discomfort, SARS-CoV-2 test, Thyroid function test, Thyroid function test abnormal, Thyroid pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hashimoto''s disease; Hypothyroidism; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Date: 2021; Test Name: thyroid labs; Result Unstructured Data: Test Result:worsened
CDC Split Type: GBPFIZER INC202101225350

Write-up: Pain thyroid; choking feeling in neck thyroid area; discomfort in neck; thyroid labs worsened; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Regulatory Agency. Regulatory authority report number (GB-MHRA-WEBCOVID-202109161915378230-QRJE7). Safety Report Unique Identifier (GB-MHRA-ADR 25954926). A female patient of an unspecified age received first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 29Aug2021 (Batch/Lot Number: unknown) as DOSE 1, SINGLE for covid-19 immunization. Medical history included Hashimoto (Hashimoto''s disease), hypothyroidism, suspected covid-19 from 01Nov2020 (not ongoing, unsure when symptoms stopped), immunodeficiency (has an illness or condition, not listed above, which reduces the immune response); and COVID-19 on unspecified date (laboratory test was reported with sars-cov-2 test on unspecified date with result of YES - positive covid-19 test on an unknown date). The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. The patient experienced pain thyroid on 06Sep2021. Event was considered as serious (medically significant). On unspecified date in 2021, the patient also experienced choking feeling in neck thyroid area, discomfort in neck, and thyroid labs worsened. Patient has not been tested positive for COVID-19 since having the vaccine. Outcome of event pain thyroid and thyroid labs worsened was not recovered, while outcome of the events choking feeling in neck thyroid area and discomfort in neck was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Hypoaesthesia, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Blood pressure; Result Unstructured Data: low; Test Date: 20210904; Test Name: heart rate; Result Unstructured Data: high; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Numbness; Swollen arm; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25968636) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness) and PERIPHERAL SWELLING (Swollen arm) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. 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 06-Sep-2021, the patient experienced HYPOAESTHESIA (Numbness) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swollen arm) (seriousness criterion medically significant). At the time of the report, HYPOAESTHESIA (Numbness) had resolved with sequelae and PERIPHERAL SWELLING (Swollen arm) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Sep-2021, Heart rate: high (High) high. On 06-Sep-2021, Blood pressure measurement: low (Low) low. On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medication reported. No treatment medication provided. Laboratory test included blood glucose on 06-Sep-2021, result unknown. Patient has not had symptoms associated with COVID-19. Used aspirin to bring down heart rate during the first week. Patient has 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 unknonwage, with no relevant medical history, who experienced the unexpected events of numbness, swollen arm. The events occurred approximately 3 days after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report. 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 female patient of unknonwage, with no relevant medical history, who experienced the unexpected events of numbness, swollen arm. The events occurred approximately 3 days after the second dose of Moderna covid -19 vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Moderna covid -19 vaccine, is not affected by this report. 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: 1746896 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Hypomenorrhoea, Inappropriate schedule of product administration, Muscle spasms, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Dystonia (broad), Fertility disorders (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 test; Result Unstructured Data: Test Result:Has not tested positive for COVID-19; Comments: Patient has not tested positive for COVID-19 since having the vaccine.
CDC Split Type: GBPFIZER INC202101237775

Write-up: Inappropriate schedule of vaccine administered; cramps; Since having the vaccine I have had constant bleeding for the past 3 months, sometimes light, sometimes heavy; Since having the vaccine I have had constant bleeding for the past 3 months, sometimes light, sometimes heavy; This is a spontaneous report from a contactable consumer. This is the second of two reports. The first report is a report downloaded from The regulatory authority report number is GB-MHRA-WEBCOVID-202109161356049270-DHCII, Safety Report Unique Identifier is GB-MHRA-ADR 25952929. A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on 06Sep2021, at single dose, for COVID-19 immunisation. Relevant medical history was unknown. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient previously, on 12Jun2021, received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not known), via an unspecified route of administration, at single dose, for COVID-19 immunization. On an unspecified date, in 2021, the patient experienced cramps, light periods, heavy periods described and menorrhagia. Concomitant medication included contraceptive medication (unspecified). On an unspecified date, in 2021, the patient experienced cramps, light periods, and heavy periods described as "since having the vaccine patient had constant bleeding for the past 3 months, sometimes light, sometimes heavy, will only stop for a day before bleeding again. Light cramps too". Patient was on contraceptive medication but it was not stopping the bleeding. Patient has not tested positive for COVID-19 since having the vaccine. The patient did not recover from light periods, and heavy, while recovered from cramps on an unspecified date. The events, cramps, light periods, and heavy periods, were assessed as serious (medically significant). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101225068 Same patient/drug and different dose/events


VAERS ID: 1747042 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-06
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Hypertensive end-organ damage; Neoplasm
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 PCR test; Test Result: Negative; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Negative; Test Date: 20210830; Test Name: COVID-19 PCR test; Test Result: Negative; Test Date: 20210901; Test Name: COVID-19 PCR test; Test Result: Negative; Test Date: 20210906; Test Name: COVID-19 PCR test; Test Result: Positive; Test Date: 20210901; Test Name: COVID-19 antigen test positive; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232691

Write-up: Paucysymptomatic/ positive molecular test; Paucysymptomatic/ positive molecular test; Rhinitis; This is a spontaneous report from a contactable other hcp from the Regulatory Authority. The regulatory authority number IT-MINISAL02-787125. A 91-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EK9788; Expiration Date: 31May2021), dose 2 via intramuscular, administered in Arm Left on 04Feb2021 as dose 2, 0.3 ml single, dose 1 via intramuscular, administered in Arm Left on 14Jan2021 (Batch/Lot Number: EJ6797; Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for covid-19 immunisation. The patient medical history included hypertensive end-organ damage from 07Apr2000 to an unknown date, hypertension from 21Nov1991 to an unknown date and neoplasm from 18Mar1991 to an unknown date. The patient concomitant medications were not reported. On 06Sep2021, the patient experienced positive molecular test, paucysymptomatic, and rhinitis. Conclusion for lot EK9788 was the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. Conclusion for lot EJ6797 was the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root causes were identified as the complaint was not confirmed. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 23Aug2021, 25Aug2021, 30Aug2021, and 01Sep2021. COVID-19 antigen test positive on 01Sep2021 and sars-cov-2 test positive on 06Sep2021. The outcome of positive molecular test, paucysymptomatic, and rhinitis was not recovered whereas vaccination failure was unknown.


VAERS ID: 1747043 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-06
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Rhinitis, SARS-CoV-2 test, SARS-CoV-2 test positive, 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: 20210906; Test Name: SARS-CoV-2 molecular test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232711

Write-up: Positive molecular swab in vaccinated 14Jan and 04Feb. Symptomatic with rhinitis; vaccination failure; Positive molecular swab in vaccinated 14Jan and 04Feb. Symptomatic with rhinitis; This is a spontaneous report received from a contactable other hcp from the Regulator Authority. The regulatory authority report number is IT-MINISAL02-787132. A 94-year-old female patient received second dose on bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: EK9788, Expiration Date: 31May2021), via intramuscular, administered in arm right (shoulder) on 04Feb2021 as dose 2, 0.3 mL single (at the age of 94-year-old) for COVID-19 immunization and first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot Number: EL1484, Expiration Date: 30Apr2021), via intramuscular, administered in arm right (shoulder) on 14Jan2021 as dose 1, 0.3 mL single (at the age of 94-year-old) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 06Sep2021, the patient experienced positive molecular swab in vaccinated 14Jan and 04Feb. Symptomatic with rhinitis. On 06Sep2021, the patient underwent lab tests and procedures which included SARS-CoV-2 molecular test positive. The outcome of the events was not recovered. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1484. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root causes were identified as the complaint was not confirmed. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1747303 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-09-06
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood alkaline phosphatase, Blood creatinine, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Catheterisation cardiac, Chest X-ray, Echocardiogram, Electrocardiogram, Gamma-glutamyltransferase, Glomerular filtration rate, Haematocrit, Haemoglobin, Magnetic resonance imaging heart, Myocarditis, Platelet count, Respiratory rate, Troponin T, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Thoracic pain (atypical, no abnormalities observed)
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:31 IU/l; Test Name: AST; Result Unstructured Data: Test Result:73 IU/l; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:68 IU/l; Test Name: creatinine; Result Unstructured Data: Test Result:81 umol/l; Test Name: glucose; Result Unstructured Data: Test Result:7.3 mmol/L; Test Name: potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Name: NIBP; Result Unstructured Data: Test Result:139/68 (92) mmHg; Test Name: sodium; Result Unstructured Data: Test Result:136 mmol/L; Test Name: Urea; Result Unstructured Data: Test Result:5.8 mmol/L; Test Name: Temp; Result Unstructured Data: Test Result:37.3 Centigrade; Test Name: CAG; Result Unstructured Data: Test Result:the patient is free of symptoms; Comments: The patient is free of symptoms. The coronary arteries show no obstruction; myocardial bridging and ws intramyocardial course of the distal segment of the LAD.; Test Date: 20210906; Test Name: X-thorax; Result Unstructured Data: Test Result:increased heart size; Comments: Compared to 29Mar2011. Increased heart size. No overfilling. No defined consolidations.; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:33 mg/l; Test Date: 20210906; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210906; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:33 mg/l; Test Date: 20210906; Test Name: TTE ZGT; Result Unstructured Data: Test Result:Normal systolic LV function; Comments: Normal systolic LV function, autoEF 55.6%, GLS -18.8% RV normal. No significant valve disease.; Test Name: ECG; Result Unstructured Data: Test Result:ST elevation; Comments: ST elevation II III aVF, slightly V5V6, depression aVL. STEMI; Test Date: 20210906; Test Name: ECG; Result Unstructured Data: Test Result:ST elevation; Comments: ST elevation II III aVF, slightly V5V6, depression aVL. STEMI; Test Date: 20210906; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 80/min; Comments: Sinus rhythm 80/min, intermediate cardiac axis, narrow QRS (95ms), clockwise rotation R-top, bowl-shaped ST elevation inferolaterally with slight ST depression in aVL, QTc 405ms. NB: PTA depression visible particularly inferior.; Test Date: 20210909; Test Name: ECG; Result Unstructured Data: Test Result:HF 58/min; Comments: HF 58/min, PQ 170ms, QRS 94ms, QTC (Bazett) 396ms, R axis 57gr, Sinus bradycardia with sinus arrhythmia. Evolution of negative T waves. Sinus rhythm 80/min, intermediate cardiac axis, narrow QRS (95ms), clockwise rotation R-top, bowl-shaped ST elevation inferolaterally with slight ST depression in aVL, QTc 405ms. NB: PTA depression visible particularly inferior.; Test Name: Gamma GT; Result Unstructured Data: Test Result:35 IU/l; Test Name: eGFR CKD-epi; Result Unstructured Data: Test Result:$g90~ml/min/1,73m2; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.43; Comments: Units:L/L; Test Date: 20210906; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.43; Comments: Units:L/L; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.9 mmol/L; Test Date: 20210906; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.9 mmol/L; Test Name: MRI cardio; Result Unstructured Data: Test Result:myocarditis; Comments: Mild dilatation, good function. Picture of myocarditis. DD sarcoidosis, including Anderson Fabry (no wall thickening); Test Date: 20210907; Test Name: MRI cardio; Result Unstructured Data: Test Result:myocarditis; Comments: Mild dilatation, good function. Picture of myocarditis. DD sarcoidosis, including Anderson Fabry (no wall thickening); Test Name: Trombocytes; Result Unstructured Data: Test Result:226 ng/L; Test Name: RESP; Result Unstructured Data: Test Result:18; Comments: Units:{breaths}/min; Test Name: hsTroponin T; Result Unstructured Data: Test Result:increased to 1203 ng/L; Test Name: hsTroponin T; Result Unstructured Data: Test Result:999 ng/L; Test Date: 20210906; Test Name: hsTroponin T; Result Unstructured Data: Test Result:1265 ng/L; Test Date: 20210906; Test Name: hsTroponin T; Result Unstructured Data: Test Result:999 ng/L; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.29 ng/L
CDC Split Type: NLPFIZER INC202101216235

Write-up: patient was diagnosed with myocarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB [NL-LRB-00683079] and Safety Report Unique Identifiers NL-LRB-00684236 andNL-LRB-00686275. A 22-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Aug2021 (Lot Number: FG4509) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thoracic pain (atypical, no abnormalities observed from 2020). The patient''s concomitant medications were not reported. The patient did not have COVID-19 prior the vaccination. Historical vaccine includes dose 1 of Comirnaty received on 10Jul2021. On 06Sep2021, the patient experienced fatigue which developed into acute chest pain later on during the evening/night. He woke up during the night with chest pain which was radiating towards his left arm. He also experienced palpitations. The patient experienced symptoms only for 1 day. The patient was hospitalised for 5 days. When he arrived in the hospital he looked pale, sweaty and looked painful. The patient was suspected of suffering from a ST-elevated myocardial infarction. However, cardiac catheterisation showed no obstructed coronary arteries. A blood test showed elevated troponin T. The patient was diagnosed with myocarditis which was confirmed by a cardiac MRI. He was treated accordingly. When the patient did no longer experience symptoms, the treatment with NSAIDs was withdrawn. Treatment was continued with colchicine and perindopril. Risk factors: The patient has not experienced myocarditis before. The patient did not have an infection prior to onset of myocarditis. The patient does not have underlying health conditions and did not use comedication. He had never used drugs and has no familial risk factor. He has no allergies. Relevant tests: body temperature (37.3 degr. Celc.), respiratory rate (18/min), blood pressure (139/68(92) mmHg), ECG (day 1 of hosp: ST elevations in II, III and aVF with a depression in aVL, something around V5V6, STEMI; day 4 of hosp: HF: 58/min, sinusbrachycardia with sinus arrhythmia), thorax X ray (enlarged heart, no cardiac tamponade), blood test (troponin T: first: 999 ng/L, later: 1265 ng/L; CRP: first: 33 mg/L, later: 30 mg/L; leukocyte count: 7.29 ng/L; thrombocyte count: 226 ng/L, AST: 73 U/L), echocardiography (day 2 of hosp: normal systolic LV function, ejection fraction: 55.6%, RV normal, no significant valve dysfunction), cardiac MRI (mild dilation, good function. Signs of myocarditis, DD sarcoidosis, among others anderson fabry (no wall thickening)), cardiac catheterisation (patient experiences no symptoms anymore. No obstruction in coronary arteries). Blood test: Hemoglobin 8.9 millimoles per liter, Hematocrit 0.43 liter/liter, C-Reactive Protein 33 milligram/liter, Leukocytes 7.29 10^9/l, Thrombocytes 226 10^9/l, Alkaline phosphatase 68 U/l, Gamma GT 35 U/liter, Aspartate transaminase 73 U/l, Alanine aminotransferase 31 U/l, hsTroponine T 999, anogram/liter increased to 1203, Urea 5.8 millimoles per liter, Ceatinine 81 micromol/liter, Estimated Glomerular Filtration Rate (Chronic Kidney Disease Epidemiology Collaboration) $g90 ml/min/1.73m2, Sodium 136 millimoles per liter, Potassium 3.7 millimoles per liter, Glucose GLUCOSE 7.3 millimoles per liter, Magnetic resonance imaging: Mild dilatation, good function. Image of myocarditis. Differential diagnosis sarcoidosis, including Anderson Fabry (no wall thickening). Coronary Angiography: Patient is symptom-free here. The coronaries show no obstruction; myocardial bridging and wall stress intramyocardial course of the distal segment of the left anterior descending artery. Left ventricle angiogram was performed. The patient recovered from myocarditis after unknown duration. Therapeutic measures were taken as a result of the event (Myocarditis is treated with colchicine (for 3 months), metoprolol, enalapril, ibuprofen and pantoprazole). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Summary of reporter''s comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Adverse drug reactions: no. Date: 10Jul2021 Additional information on ADR available Previous COVID-19 infection: No


VAERS ID: 1747354 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Cough, Dyspnoea, Oxygen saturation, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: COVID-19 PCR test; Result Unstructured Data: POSITIVE; Test Date: 20210913; Test Name: Oxygen saturation; Result Unstructured Data: 89 %
CDC Split Type: PHJNJFOC20210945232

Write-up: OCCASIONAL DYSPNEA; BODY WEAKNESS; DRY COUGH; FEVER; CONFIRMED COVID- 19 INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300106387] concerned a 72-year-old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient had no known allergies. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 27-JUL-2021 for an unspecified indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On unspecified date, patient got exposed to his COVID-19 positive wife. on 06-SEP-2021, the patient experienced dry cough, fever (confirmed covid-19 infection). On 10-SEP-2021, still with above symptoms the patient experienced weakness and occasional dyspnea. On 11-SEP-2021, patient tested positive for COVID-19 infection (PCR test) (confirmed clinical vaccination failure). On 12-SEP-2021 a teleconsultant gave azithromycin once a day (OD) as treatment drug. On 13-SEP-2021 patient experienced progression of cough and dyspnea. Laboratory data included: Oxygen saturation decreased to 89%. On 14-SEP-2021 patient was consulted at hospital and hence hospitalized for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dry cough, fever, body weakness, and occasional dyspnea, and the outcome of confirmed Covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with a product quality complaint: 90000194530. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender''s Comments: V0: 20210945232-covid-19 vaccine ad26.cov2.s-dry cough, fever, occasional dyspnea, confirmed covid- 19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210945232-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. 20210945232-covid-19 vaccine ad26.cov2.s-body weakness. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1748033 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA156571 / 2 GM / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Product administered at inappropriate site
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRINA
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: AFPFIZER INC202101226419

Write-up: cerebral thrombosis; vaccine location=Left buttocks; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on Gluteus Medius Left (also reported as left buttocks) on 06Sep2021 08:45 (Batch/Lot Number: PAA156571) as DOSE 2, SINGLE for COVID-19 immunization at the Hospital. Medical history was none. Concomitant medication included acetylsalicylic acid (ASPIRINA) taken for unspecified indication and therapy dates. The patient received the first dose of received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) on 15Aug2021 10:15 (lot #PAA156571) administered on the left buttocks for COVID-19 immunization. Then, the patient received the 2nd dose on 06Sep2021 08:45 administered on the left buttocks. On 14Sep2021 20:00, the patient had cerebral thrombosis. The patient was hospitalized in 2021 for 3 days. The event cerebral thrombosis resulted to emergency room/department or urgent care. The patient had not received any treatment for the event of cerebral thrombosis. The patient had no COVID-19 prior vaccination and not tested for COVID-19 post vaccination. Outcome of cerebral thrombosis was not recovered.


VAERS ID: 1749041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-09-06
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, 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)

Life 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: Atrial fibrillation; Hyperlipidaemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101229220

Write-up: stroke; Ischemic infarction in the left cerebral artery and in the right cerebellum (PICA flow area) and subcortically in the left frontal gyrus; This is a spontaneous report from a contactable consumer (patient''s partner) and physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-044060. A 73-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 10Jun2021 as Dose 2, single for covid-19 immunisation. Medical history included atrial fibrillation, hypertension arterial, hyperlipidaemia; all from an unknown date and unknown if ongoing. There were no concomitant medications reported. On 06Sep2021, the patient experienced stroke; ischemic infarction in the left cerebral artery and in the right cerebellum (pica flow area) and subcortically in the left frontal gyrus resulting hospitalization. The outcome of the event was unknown. Sender Comment: The report is for my partner. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1749301 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-09-06
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214016 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Adnexa uteri pain, Diarrhoea, Dizziness, Headache, Intermenstrual bleeding
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: EUTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Authority (Reference number: 997020) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING in a 34-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3005888 and 214016) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (EUTHYROX) from 01-Aug-2016 to 08-Sep-2021 for Hypothyroidism. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced DIARRHOEA, ADNEXA UTERI PAIN (Ovarian pain), DIZZINESS (Dizziness) and HEADACHE (Headache). On 07-Sep-2021, the patient experienced INTERMENSTRUAL BLEEDING (seriousness criterion medically significant) and ABDOMINAL PAIN (Abdominal pain). At the time of the report, INTERMENSTRUAL BLEEDING, DIARRHOEA, ADNEXA UTERI PAIN (Ovarian pain), DIZZINESS (Dizziness), ABDOMINAL PAIN (Abdominal pain) and HEADACHE (Headache) had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 07-Aug-2021. Treatment information was not provided. This case concerns a 34-year-old, female subject with no relevant medical history reported, who experienced the unexpected event of Intermenstrual bleeding. The event three days after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 27-SEP-2021 Includes Updated dosage text - administration site -left arm, Concomitant medication indication updated, Relevant history updated.; Sender''s Comments: This case concerns a 34-year-old, female subject with no relevant medical history reported, who experienced the unexpected event of Intermenstrual bleeding. The event three days after the second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1749310 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005790 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Myopericarditis; This case was received via regulatory authority (Reference number: ES-AEMPS-999451) on 22-Sep-2021 and was forwarded to Moderna on 22-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) (batch no. 3005790) for COVID-19 vaccination. The patient''s past medical history included COVID-19. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced MYOCARDITIS (Myopericarditis) (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS (Myopericarditis) was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided. Treatment information was not provided. Company Comment: This case concerns a 20-year-old male patient with relevant medical history of COVID-19, who experienced serious, unlisted event of myocarditis. The serious event occurred 4 days after 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the date for the first dose of Moderna COVID-19 Vaccine was provided. The history of history of COVID-19 remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 26-Sep-2021 include no new information.; Sender''s Comments: This case concerns a 20-year-old male patient with relevant medical history of COVID-19, who experienced serious, unlisted event of myocarditis. The serious event occurred 4 days after 1st dose of Moderna COVID-19 Vaccine. The rechallenge was unknown as the date for the first dose of Moderna COVID-19 Vaccine was provided. The history of history of COVID-19 remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1750749 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-09-06
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Embolism pulmonary; Tibial vein thrombosis; This case was received via Regulatory Authority(Reference number: FR-AFSSAPS-NT20213969) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM (Embolism pulmonary) and DEEP VEIN THROMBOSIS (Tibial vein thrombosis) in a 48-year-old male patient who received mRNA-1273 for SARS-CoV-2 vaccination. No Medical History information was reported. On 27-Aug-2021, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced PULMONARY EMBOLISM (Embolism pulmonary) (seriousness criteria hospitalization and medically significant) and DEEP VEIN THROMBOSIS (Tibial vein thrombosis) (seriousness criteria hospitalization and medically significant). At the time of the report, PULMONARY EMBOLISM (Embolism pulmonary) and DEEP VEIN THROMBOSIS (Tibial vein thrombosis) was resolving. The action taken with mRNA-1273 (Intramuscular) was unknown. For mRNA-1273 (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 48-year-old male patient, with no relevant medical history, who developed the serious and unexpected events of pulmonary embolism and deep vein thrombosis, 11 days after receiving the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.; Sender''s Comments: This case concerns a 48-year-old male patient, with no relevant medical history, who developed the serious and unexpected events of pulmonary embolism and deep vein thrombosis, 11 days after receiving the first dose of Moderna COVID-19 vaccine. The rechallenge was not applicable since no information about the second dose was disclosed. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1750884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2153 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Incorrect dose administered, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Guillain-Barre syndrome (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101226999

Write-up: Heavy Period; Pins and Needles in arms, hands and feet; 0.5 mL, single; This is a spontaneous report from a contactable consumer from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-EYC 00260816; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25951835. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 parenteral on 06Sep2021 (Lot Number: FF2153) as 0.5 mL, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 08Sep2021, the patient experienced pins and needles in arms, hands and feet, medically significant. On 09Sep2021, the patient experienced heavy period, medically significant. The outcome of the events pins and needles in arms, hands and feet and heavy period was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1750963 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-09-06
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Headache, SARS-CoV-2 test, Sinus headache
SMQs:, Dementia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 09/15/2021; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202101226596

Write-up: This is a spontaneous report from a contactable consumer, via the regulatory authority (report number: GB-MHRA-WEBCOVID-202109170907165940-KICAU; safety report unique identifier: GB-MHRA-ADR 25957733). A female patient, of an unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on Aug 25, 2021, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19. Patient not enrolled in a clinical trial. Reportedly, patient had a headache that won''t go away (unspecified date). The patient had another sinus headache on Sep 6, 2021. Since the vaccination, patient has not tested positive for COVID-19. The lab test included: COVID-19 virus test (negative) on Sep 15, 2021. The outcome of the events: not resolved. No follow-up attempts possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1751363 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005698 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bone pain, Confusional state, Diarrhoea, Fatigue, Feeling hot, Headache, Hyperpyrexia, Pain in extremity, Vertigo
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Osteonecrosis (broad), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-785902) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA , VERTIGO , CONFUSIONAL STATE , FEELING HOT , BONE PAIN , DIARRHOEA , PAIN IN EXTREMITY , HEADACHE and FATIGUE in a 43-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005698) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 500 microliter in total. On 06-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criteria disability and medically significant), VERTIGO (seriousness criterion disability), CONFUSIONAL STATE (seriousness criterion disability), FEELING HOT (seriousness criterion disability), BONE PAIN (seriousness criterion disability), DIARRHOEA (seriousness criterion disability), PAIN IN EXTREMITY (seriousness criterion disability), HEADACHE (seriousness criterion disability) and FATIGUE (seriousness criterion disability). At the time of the report, HYPERPYREXIA , VERTIGO , CONFUSIONAL STATE , FEELING HOT , BONE PAIN , DIARRHOEA , PAIN IN EXTREMITY , HEADACHE and FATIGUE outcome was unknown. Concomitant medication was not provided by the reporter. The patient had severe fever (38.5-39?C), headache (as if the head was about to burst), pains in the bones, feeling hot (body burning), maximum confusional state, dizziness, diarrhea, pains in the legs and tiredness. Treatment medications was not provided by the reporter. The events were considered serious (Disability) as per Regulatory Authority?s report. Company comment: This case concerns a 43-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hyperpyrexia, vertigo, confusional state, feeling hot, bone pain, diarrhoea, pain in extremity, headache and fatigue. The event occurred approximately on the same day after the first dose of Spikevax. The rechallenge was unknown since this was first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation recieved on 28-Sep-2021, narrative updated. On 23-Sep-2021: Follow up received, contains no new information.; Sender''s Comments: This case concerns a 43-year-old, male patient with no relevant medical history, who experienced the unexpected serious events of hyperpyrexia, vertigo, confusional state, feeling hot, bone pain, diarrhoea, pain in extremity, headache and fatigue. The event occurred approximately on the same day after the first dose of Spikevax. The rechallenge was unknown since this was first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1751367 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-31
Onset:2021-09-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005244 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, 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? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA and LYMPHADENOPATHY in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005244) for COVID-19 prophylaxis. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 06-Sep-2021, the patient experienced URTICARIA (seriousness criterion disability) and LYMPHADENOPATHY (seriousness criterion disability). At the time of the report, URTICARIA and LYMPHADENOPATHY outcome was unknown. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. The concomitant medications were not reported. The treatment information was not provided. One week after the second dose of the moderna COVID 19 vaccine, patient had hives and her axillary lymph nodes were swollen. One week after the second dose of the moderna COVID 19 vaccine, she had hives and her axillary lymph nodes were swollen. Company Comment : This case concerns a 25-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Urticaria and Lymphadenopathy. The events occurred approximately 07 days after the dose of Spikevax (not specific after 1st or 2nd dose.) The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a disability. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation document received on 28-Sep-2021, added translated event verbatim in I-narrative.; Sender''s Comments: This case concerns a 25-year-old female patient with no relevant medical history, who experienced the serious unexpected event of Urticaria and Lymphadenopathy. The events occurred approximately 07 days after the dose of Spikevax (not specific after 1st or 2nd dose.) The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Events seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a disability.


VAERS ID: 1751368 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214014 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haematuria, Nephritis
SMQs:, Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: IgA post SARS-COV-2 (dose Moderna); IgA post SARS-COV-2 (dose Moderna); This case was received via Regulatory Authority (Reference number: IT-MINISAL02-786051) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NEPHRITIS (IgA post SARS-COV-2 (dose Moderna)) and HAEMATURIA (IgA post SARS-COV-2 (dose Moderna)) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214014) for COVID-19 immunisation. No Medical History information was reported. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 06-Sep-2021, the patient experienced NEPHRITIS (IgA post SARS-COV-2 (dose Moderna)) (seriousness criteria hospitalization and medically significant) and HAEMATURIA (IgA post SARS-COV-2 (dose Moderna)) (seriousness criterion hospitalization). At the time of the report, NEPHRITIS (IgA post SARS-COV-2 (dose Moderna)) and HAEMATURIA (IgA post SARS-COV-2 (dose Moderna)) was resolving. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication was given. No treatment medication was given. Company comment - This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Nephritis and Haematuria. The events occurred around 2 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 27-Sep-2021 does not contain any new information.; Reporter''s Comments: Contacted the reporter who will send the clinical documentation of the vists performed.; Sender''s Comments: This case concerns a 29-year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Nephritis and Haematuria. The events occurred around 2 days after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1751374 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

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

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

Write-up: This case was received via Agency (Reference number: IT-MINISAL02-786236) on 22-Sep-2021 and was forwarded to Moderna on 22-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY in a 59-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 06-Sep-2021, the patient experienced LYMPHADENOPATHY (seriousness criterion disability). At the time of the report, LYMPHADENOPATHY had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medication were not provided Treatment medication were not reported. Patients lymph nodes were visibly enlarged in the neck and the armpit which tendered the patient to touch. Company Comment: This case concerns a 59-year-old male subject, with no relevant medical history, who experienced the unexpected serious event of lymphadenopathy. The event occurred 6 days after the administration of a Spikevax dose. The rechallenge is not applicable as there is only information about one dose. The benefit-risk relationship of the vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 28 SEP 2021 contains: Event verbatim updated in narrative.; Sender''s Comments: This case concerns a 59-year-old male subject, with no relevant medical history, who experienced the unexpected serious event of lymphadenopathy. The event occurred 6 days after the administration of a Spikevax dose. The rechallenge is not applicable as there is only information about one dose. The benefit-risk relationship of the vaccine is not affected by this report.


VAERS ID: 1751389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-09-06
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, SARS-CoV-2 test positive, 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: 20210823; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210830; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210906; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:weakly Positive
CDC Split Type: ITPFIZER INC202101232745

Write-up: Vaccination failure; Asymptomatic COVID-19; Operator with positive molecular buffer; This is a spontaneous report from a contactable other health care professional downloaded from the regulatory authority number IT-MINISAL02-787145. A 59-year-old male patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: unknown; Expiration Date: 07Sep2021), via an intramuscular route of administration in left arm on 03Mar2021 as DOSE 2, 0.3 mL SINGLE for covid-19 immunization and also received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot number: EL0725; Expiration Date: 31Mar2021), via an intramuscular route of administration in left arm on an 10Feb2021 as DOSE 1, 0.3 mL SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Sep2021, the patient experienced operator with positive molecular buffer (medically significant), asymptomatic covid-19 (medically significant), vaccination failure (medically significant). The patient underwent lab tests and procedures which included Covid-19 PCR test: negative on 23Aug2021, negative on 25Aug2021, negative on 30Aug2021 and weakly positive on 06Sep2021. The outcome of the events was not recovered. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1751467 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Novel COVID-19 infection; This case was received (Reference number: JP-TAKEDA-2021TJP090304 ) on 15-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case was reported by a person in charge of workplace vaccination. Novel COVID-19 infection was assessed as serious. This case was reported without any patient identifiers. On 03-Sep-2021, the patient received the 1st dose of this vaccine. On 06-Sep-2021, in the presence of a public health center, the patient was confirmed to be COVID-19 positive. The outcome of novel COVID-19 infection was unknown. Follow-up investigation was attempted, but was impossible due to the reporter''s non-cooperation.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a patient of unknown age and sex with no relevant medical history, who experienced the unexpected serious events of Covid-19. The event occurred 3 days after receiving the first dose of Moderna mRNA-1273 vaccine. The rechallenge is not applicable as the second dose was not given by the time this event was reported. The reporter assessed the event as related to the product. The benefit-risk relationship of mRNA-1273 vaccine in not affected by this report.


VAERS ID: 1752918 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-09-06
   Days after vaccination:77
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: Delayed period; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25981040) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (Delayed period) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. No Medical History information was reported. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2021, the patient experienced MENSTRUATION DELAYED (Delayed period) (seriousness criterion medically significant). At the time of the report, MENSTRUATION DELAYED (Delayed period) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. No treatment medications were reported. It was reported that the patient was 2 weeks late on period and no period at all this month and not on the contraceptive pill. It was also reported that the patient always usually have regular periods The patient did not have symptoms associated with COVID-19 and did not have a COVID-19 test and was not enrolled in clinical trial. The patient did not test positive for COVID-19 since having the vaccine. Company comment: This case concerns a patient 25-year-old female patient with no previous relevant medical history who experienced the serious unexpected event of menstruation delayed. The event occurred 21 days after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event seemed to be serious by medical judgement and from a clinical or regulatory standpoint.; Sender''s Comments: This case concerns a patient 25-year-old female patient with no previous relevant medical history who experienced the serious unexpected event of menstruation delayed. The event occurred 21 days after the second dose of COVID-19 Vaccine Moderna (mRNA-1273). The rechallenge was unknown since no information about the first dose was disclosed. The benefit-risk relationship of COVID-19 Vaccine Moderna (mRNA-1273) is not affected by this report. Event seriousness was assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the event seemed to be serious by medical judgement and from a clinical or regulatory standpoint.


VAERS ID: 1752930 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blister, Burning sensation, Headache, Hemiparesis, Loss of consciousness, Paralysis
SMQs:, Torsade de pointes/QT prolongation (broad), Severe cutaneous adverse reactions (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy (allergy to cat fur); Food allergy (Lamb, snails); Grass allergy; House dust mite allergy; Hypertension; Insulin resistance; Metabolic syndrome (Homocysteine metabolic syndrome); MTHFR gene mutation; Obesity; Thrombophilia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: ; .; .; .; .; .; This case was received via European Medicines Agency (Reference number: IT-MINISAL02-786877) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of BLISTER (), HEADACHE (.), BURNING SENSATION (.), LOSS OF CONSCIOUSNESS (.), HEMIPARESIS (.) and PARALYSIS (.) in a 42-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. Concurrent medical conditions included Insulin resistance, Hypertension, Thrombophilia, Food allergy (Lamb, snails), Metabolic syndrome (Homocysteine metabolic syndrome), Allergy (allergy to cat fur), Obesity, MTHFR gene mutation, House dust mite allergy and Grass allergy. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 06-Sep-2021, the patient experienced BLISTER () (seriousness criterion life threatening), HEADACHE (.) (seriousness criterion life threatening), BURNING SENSATION (.) (seriousness criterion life threatening), LOSS OF CONSCIOUSNESS (.) (seriousness criteria medically significant and life threatening), HEMIPARESIS (.) (seriousness criteria medically significant and life threatening) and PARALYSIS (.) (seriousness criteria medically significant and life threatening). At the time of the report, BLISTER (), HEADACHE (.), BURNING SENSATION (.), LOSS OF CONSCIOUSNESS (.), HEMIPARESIS (.) and PARALYSIS (.) had resolved with sequelae. Concomitant product use was not provided. Treatment information was not provided. It was reported that 10 minutes after the first dose of the Moderna vaccine patient had severe burning in head, blisters on face, paralysis on the right side of body, loss of consciousness and a pulsating headache. This case concerns a 42-year-old female patient with relevant medical history of Hypertension, Hypercoagulation, Obesity with Metabolic syndrome and multiple allergies, who experienced the unexpected serious events of Loss of consciousness, Hemiparesis, Paralysis, Blister, Headache, Burning sensation. The events occurred approximately 1 day after the first dose of Moderna COVID-19 Vaccine administration. Blister, Headache and Burning sensation were assessed by the reporting RA as Life threatening; however, the was no clinical evidence provided to justify this seriousness. Therefore, events Blister, Headache and Burning sensation considered as non-serious. The rechallenge was unknown as no information on the second dose available. The benefit-risk relationship is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translation document received on 27 Sep 2021 contains translated verbatim. On 24-Sep-2021: Follow up information received wherein relevant medical history, updated batch number and new event On 24-Sep-2021: Translation document received on 29 Sep 2021, updated medical history comments, updated translated event verbatim information in I-narrative. On 28-Sep-2021: Follow up information received contains no new information; Sender''s Comments: This case concerns a 42-year-old female patient with relevant medical history of Hypertension, Hypercoagulation, Obesity with Metabolic syndrome and multiple allergies, who experienced the unexpected serious events of Loss of consciousness, Hemiparesis, Paralysis, Blister, Headache, Burning sensation. The events occurred approximately 1 day after the first dose of Moderna COVID-19 Vaccine administration. Blister, Headache and Burning sensation were assessed by the reporting RA as Life threatening; however, the was no clinical evidence provided to justify this seriousness. Therefore, events Blister, Headache and Burning sensation considered as non-serious. The rechallenge was unknown as no information on the second dose available. The benefit-risk relationship is not affected by this report.


VAERS ID: 1752939 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-09-06
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Body temperature, Chest discomfort, Chest pain, Chills, Headache, Hypothermia, Nausea, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test, Sinusitis
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210906; Test Name: Body temperature; Result Unstructured Data: 39.8; Test Date: 20210920; Test Name: Body temperature; Result Unstructured Data: 35 and 37; Test Date: 20210909; Test Name: SARS COV-2 test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Hypothermia; Chest distress; Nausea; Sinusitis; Throat pain; Chest pain; Back pain; Pyrexia; Chills; Headache; This case was received via regulatory authority (Reference number: 2021TJP095040) on 21-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case was reported by the family member of a vaccine recipient via the Drug Information Center. Hypothermia was assessed as serious by the MAH. On Aug-2021, the patient received the 1st dose of the vaccine. On 06-Sep-2021, around 13:00, the patient received 2nd dose of the vaccine. In the middle of the night, the patient experienced pyrexia of 39.8 degrees Celsius and took antipyretic. The patient experienced chills, headache, chest pain, and back pain. On an unknown date, the patient experienced throat pain. On 09-Sep-2021, the patient visited an internal medicine department and an ophthalmology department. The patient was diagnosed with sinusitis. Due to throat pain, a test for coronavirus infection was performed, and the result was negative. On 20-Sep-2021, the patient experienced nausea, chest pain, hypothermia (35-degree level in Celsius), chills, low-grade fever (37 degrees in Celsius), and chest distress. The outcome of pyrexia, chills, headache, chest pain, back pain, sinusitis, throat pain, nausea, hypothermia, and chest distress was not resolved. Follow-up investigation is impossible due to lack of cooperation from the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 13-year-old male patient with no medical history reported, who experienced the serious (medically significant) unexpected event of Hypothermia and other non-serious events. The events occurred approximately 14 days after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. The rechallenge was considered unknown because it was not reported whether the same/similar events had occurred after the first dose. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1754433 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-09-06
   Days after vaccination:182
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Coronavirus SARS-CoV-2 PCR; Test Result: Positive
CDC Split Type: DEPFIZER INC202101229692

Write-up: SARS-CoV-1 test positive; SARS-CoV-1 test positive; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB via Regulatory Authority. The Regulatory Authority Report Number is DE-PEI-202100189678. A 88-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: ER2659), via an unspecified route of administration on 08Mar2021 as dose 2, single; received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EJ6789), via an unspecified route of administration on 13Feb2021 as dose 1, single for covid-19 immunization. On 06Sep2021, the patient had sars-cov-1 test positive (medically significant). The patient underwent lab test on 06Sep2021 which included sars-cov-2 test positive. The outcome of the events was unknown at the time of report. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-09-06
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Sars-cov-2 molecular test; Test Result: Positive.
CDC Split Type: DEPFIZER INC202101229687

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a non-contactable consumer or other non hcp from the Regulatory Authority. The regulatory authority number DE-PEI-202100189680. A 92-year-old female patient received BNT162B2 (COMIRNATY; solution for injection, Lot Number: ER2659), via unspecified route of administration, on 09Mar2021 as a dose 2, single and first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6789), via unspecified route of administration, on 13Feb2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient not sick. On 06Sep2021 the patient experienced vaccination failure and COVID-19. On 06Sep2021 the patient underwent lab tests and procedures which included sars-cov-2 molecular test positive. Outcome of the reported events was unknown. Event assessment SARS-CoV-2 molecular test positive, Indeterminate. No follow-up attempts possible. No further information expected.


VAERS ID: 1754448 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-09-06
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

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

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: DEPFIZER INC202101228704

Write-up: Pulmonary embolism; Thoracic pain; Dyspnoea; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority number DE-PEI-202100190452. A 38-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 03Aug2021 (Lot Number: FE8405) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 on 06Jul2021 as dose 1, 0.3 ml single for COVID-19 vaccination. On 06Sep2021 the patient experienced thoracic pain, dyspnoea and pulmonary embolism. The patient was hospitalized due to the events on Sep2021. The outcome of the events was recovered on an unknown date in Sep2021. Causality assessment for the suspect drug Comirnaty and the events thoracic pain, dyspnoea and pulmonary embolism via PEI was unclassifiable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1754659 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-06
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101229042

Write-up: Leg venous thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-1001407. A male patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: unknown) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccine administration. The patient experienced leg venous thrombosis on 06Sep2021 which caused hospitalization. The outcome of the event was recovering. No follow-up attempts are possible, information about lot/batch number cannot be obtained.


VAERS ID: 1754726 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: Myocarditis; This case was received via regulatory authrity (Reference number: FI-FIMEA-20214705) on 23-Sep-2021 and was forwarded to Moderna on 23-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) was resolving. 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 medications were not reported. Company Comment: This case concers a 18 year old male patient with no medical history reported, who experience the expected event of myocarditis after the first dose of mRNA-1273- The event occurred 4 days after received mRNA-1273. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concers a 18 year old male patient with no medical history reported, who experience the expected event of myocarditis after the first dose of mRNA-1273- The event occurred 4 days after received mRNA-1273. The rechallenge was not applicable, as the events happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1754871 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-09-06
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Renal colic
SMQs:

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

Write-up: Renal colic; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NC20214284) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RENAL COLIC (Renal colic) in a 39-year-old male patient who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 06-Sep-2021, after starting mRNA-1273, the patient experienced RENAL COLIC (Renal colic) (seriousness criterion medically significant). At the time of the report, RENAL COLIC (Renal colic) had resolved. Concomitant medication was not provided. Treatment medication was not provided. Company comment: This case concerns a 39 year old male patient with no relevant medical history ,who experienced the serious unexpected event of Renal colic. The event occurred approximately 26 days after first . The rechallenge was not applicable since only information about the first dose was disclosed.. The benefit-risk relationship of is not affected by this report.; Sender''s Comments: This case concerns a 39 year old male patient with no relevant medical history ,who experienced the serious unexpected event of Renal colic. The event occurred approximately 26 days after first. The rechallenge was not applicable since only information about the first dose was disclosed.. The benefit-risk relationship of is not affected by this report.


VAERS ID: 1755313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-09-06
   Days after vaccination:121
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Test Result:38; Comments: for two days
CDC Split Type: ITPFIZER INC202101229108

Write-up: Vaccination failure: fever 38 for two days; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number IT-MINISAL02-785944. A 21-year-old female patient received BNT162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: FA5831) Booster dose number (2), via an intramuscular, administered in the left arm on 08May2021 08:32 as dose 2, single for COVID-19 immunisation. The patient''s medical history included asthma from an unknown date and unknown if ongoing. The patient previously received Historical Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EX0893) Booster dose number (1), via intramuscular route of administration, administered in left shoulder on time of administration 10:05 as dose 1, single for COVID-19 immunization. The patient''s concomitant medications were not reported. The patient experienced vaccination failure: fever 38 for two days on 06Sep2021. The patient underwent lab tests and procedures which included body temperature: 38 on 2021 for two days. The clinical outcome of the event was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1755368 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-09-06
   Days after vaccination:138
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Rhinitis, 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: 20210823; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210830; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210906; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232677

Write-up: vaccination failure; PRIVACY cluster. Positive molecular swab in vaccinated 31Mar2021 and 21Apr2021. Paucisymptomatic with rhinitis; Rhinitis; This is a spontaneous report from a contactable other health care professional downloaded from the Regulatory Authority WEB IT-MINISAL02-787117. An 81-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, quantity: 0.3 ml; Lot Number: EX0893, expiration date: 31Jul2021) administered intramuscularly in left arm on 21Apr2021 as dose 2, 0.3 ml single for covid-19 immunization and bnt162b2 (COMIRNATY, formulation: solution for injection, quantity: 0.3 ml; Lot Number: ER9470, expiration date: 31Jul2021) administered via an unspecified route of administration in left arm on 31Mar2021 as dose 1, 0.3 mL single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 06Sep2021, the patient experienced privacy cluster. positive molecular swab in vaccinated 31mar2021 and 21apr2021. Pauci symptomatic with rhinitis, Rhinitis and Vaccination failure. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER9470. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root were identified as the complaint was not confirmed. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 23Aug2021, COVID-19 PCR test: negative on 25Aug2021, COVID-19 PCR test: negative on 30Aug2021 and COVID-19 PCR test: positive on 06Sep2021. The outcome of events rhinitis and covid-19 as not recovered. No follow-up attempts are possible. No further information is expected


VAERS ID: 1755369 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-09-06
   Days after vaccination:145
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Name: oxygen saturation; Test Result: 80 %; Test Date: 20210802; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210809; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210823; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210830; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210906; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101229011

Write-up: COVID-19; COVID-19; Oxygen saturation decreased; COVID-19 PCR test positive; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787131. A 94-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number: EW2246; Expiration Date: 07Sep2021), intramuscular, administered in deltoid left on 14Apr2021 as 0.3 ml, single dose, first dose via intramuscular, administered in Deltoid Right on 24Mar2021 (Batch/Lot Number: ET3620; Expiration Date: 30Jun2021) as 0.3 ml single dose for COVID-19 immunisation. Medical history included neoplasm from 11Nov2019 to an unknown date and unknown if ongoing, diabetes mellitus from 22Sep2017 to an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 06Sep2021, the patient experienced covid-19, oxygen saturation decreased, covid-19 pcr test positive. The patient underwent lab tests and procedures which included oxygen saturation: 80 % on an unspecified, sars-cov-2 test: negative on 02Aug2021, sars-cov-2 test: negative on 09Aug2021, sars-cov-2 test: negative on 23Aug2021, sars-cov-2 test: negative on 25Aug2021, sars-cov-2 test: negative on 30Aug2021, sars-cov-2 test: positive on 06Sep2021. The outcome of the events was not recovered. New information received from product quality complaint team regarding other hcp''s complaint about Comirnaty (lot: ET3620, expiration date: 30Jun2021). Investigational report conclusion from division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5824348 (see File attachment in this investigation record). The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET3620. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. New information received from product quality complaint team regarding other hcp''s complaint about Comirnaty (lot: EW2246, expiration date: 31Jul2021). Investigational report conclusion from Puurs division was: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5882945 (see File attachment in this investigation record). The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EW2246. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1755370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-09-06
   Days after vaccination:214
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus (Continuing: asked, but unknown)
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Negative; Test Date: 20210825; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Negative; Test Date: 20210830; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Negative; Test Date: 20210906; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232716

Write-up: positive COVID-19 test with no symptoms; positive COVID-19 test with no symptoms; Paucisymptomatic with rhinitis; This is a spontaneous report from a contactable other hcp from the Regulatory Authority. The regulatory authority number IT-MINISAL02-787133. A 92-years-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EK9788, Expiry date: 31May2021) via intramuscularly, administered in Arm Left on 04Feb2021 as dose 2, 0.3ml single and dose 1 intramuscularly, administered in Arm Right on 14Jan2021 (Lot Number: EL1484; Expiration Date: 30Apr2021) as dose 1, 0.3ml single for COVID-19 immunisation. Medical history included diabetes mellitus from 16Apr2020 to an unknown date Continuing: asked, but unknown and concomitant medications were not reported. On 06Sep2021 the patient experienced positive covid-19 test with no symptoms and paucisymptomatic with rhinitis. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 23Aug2021, on 25Aug2021 and on 30Aug2021, sars-cov-2 test positive on 06Sep2021. The outcome of the events were not recovered. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1484and EK9788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root causes were identified as the complaint was not confirmed. Follow up (22Sep2021). This is a follow-up report from Product Complaint Team. New information provided includes narrative updated, expiry date added for both doses. No follow-up attempts possible. No further information expected.


VAERS ID: 1755540 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Echocardiogram, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Echocardiography; Result Unstructured Data: A small amount of pericardial fluid.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Perikarditt; This case was received via regulatory authority (Reference number: NO-NOMAADVRE-E2B_00050957) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PERICARDITIS (Perikarditt) in a 28-year-old male patient who received mRNA-1273 (Spikevax) for Vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 06-Sep-2021, the patient experienced PERICARDITIS (Perikarditt) (seriousness criteria hospitalization and medically significant). At the time of the report, PERICARDITIS (Perikarditt) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Echocardiogram: abnormal (abnormal) A small amount of pericardial fluid.. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Reporter provided by Suspect drug batch No 3004224 . Concomitant products were not provided. Treatment medication were not reported. Company Comment: This case concerns a 28-year-old, male patient with a no relevant medical history, who experienced the serious, expected event of Pericarditis. The event occurred three days after the first dose of mRNA-1273. However, in the Source document it was also reported that there is a discrepancy between the reported date of vaccination and what is in the vaccination register (batch number 3004224 given on 27th of august 2021. (10 days after the first dose). The rechallenge is unknown as only the first dose was received. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 30-SEP-2021 and updated with suspect drug batch number in narrative of SD.; Sender''s Comments: This case concerns a 28-year-old, male patient with a no relevant medical history, who experienced the serious, expected event of Pericarditis. The event occurred three days after the first dose of mRNA-1273. However, in the Source document it was also reported that there is a discrepancy between the reported date of vaccination and what is in the vaccination register (batch number 3004224 given on 27th of august 2021. (10 days after the first dose). The rechallenge is unknown as only the first dose was received. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1757820 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Arthralgia, Asthenia, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Vaccination adverse reaction (Patient reported having severe reaction to the COVID -19 vaccine Comirnaty and pyrexia after influenza vaccine)
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTJNJFOC20211002567

Write-up: CARDIAC PAIN; TEMPERATURE 38 C; MUSCLE ACHE; JOINT ACHE; WEAKNESS GENERALISED; This spontaneous report received from a consumer by a Regulatory Authority(LT-SMCA-6010N) on 01-OCT-2021 concerned a 59 year old female. The patient''s weight was 65 kilograms, and height was 168 centimeters. The patient''s past medical history included: vaccination adverse reaction to COVID -19 vaccine Comirnaty and pyrexia after influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) .5 ml, 1 total administered on 06-SEP-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 06-SEP-2021, the patient experienced cardiac pain, temperature 38 c, muscle ache, joint ache and weakness generalised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from temperature 38 c on 09-SEP-2021, and was recovering from muscle ache, joint ache, cardiac pain, and weakness generalised. This report was serious (Other Medically Important Condition).


VAERS ID: 1757837 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005238 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Headache, Malaise, Nausea, Syncope, Vaccination site pain, Vaccination site swelling
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), Arthritis (broad), Hypoglycaemia (broad)

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

Write-up: This case was received via regulatory authrority (Reference number: SE-MPA-2021-082743) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE, MALAISE, NAUSEA, DIZZINESS, ARTHRALGIA, VACCINATION SITE SWELLING, HEADACHE and VACCINATION SITE PAIN in a 17-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005238) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Sep-2021, the patient experienced VACCINATION SITE PAIN (seriousness criteria hospitalization and disability). On 07-Sep-2021, the patient experienced SYNCOPE (seriousness criteria hospitalization, disability and medically significant), MALAISE (seriousness criteria hospitalization and disability), NAUSEA (seriousness criteria hospitalization and disability), DIZZINESS (seriousness criteria hospitalization and disability), ARTHRALGIA (seriousness criteria hospitalization and disability), VACCINATION SITE SWELLING (seriousness criteria hospitalization and disability) and HEADACHE (seriousness criteria hospitalization and disability). On 07-Sep-2021, MALAISE, NAUSEA, DIZZINESS, ARTHRALGIA and HEADACHE had resolved. At the time of the report, SYNCOPE had resolved with sequelae and VACCINATION SITE SWELLING and VACCINATION SITE PAIN (was resolving. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. Company Comment: This case concerns a 17-year-old male patient with no previous relevant medical history, who experienced the serious unexpected events of Syncope, Malaise, Dizziness, Headache, Nausea, Arthralgia, Vaccination site swelling and Vaccination site pain after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event Vaccination site pain occurred on the day after the first dose of Spikevax and the rest of the events approximately 1 day after the first dose. The rechallenge is unknown since only information about the first dose was disclosed. Headache, Nausea, Arthralgia, Vaccination site swelling and Vaccination site pain are consistent with the known safety profile of the vaccine for adult patients. However, since the patient is younger than 18 years of age and the events had a serious outcome, they are considered unexpected. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The seriousness criteria of the events was assessed as per regulatory authority report. Further information is needed regarding Hospitalization. There is insufficient evidence in SD to support Disability. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow-up received on 24-sep-2021 contains no new information.; Sender''s Comments: This case concerns a 17-year-old male patient with no previous relevant medical history, who experienced the serious unexpected events of Syncope, Malaise, Dizziness, Headache, Nausea, Arthralgia, Vaccination site swelling and Vaccination site pain after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event Vaccination site pain occurred on the day after the first dose of Spikevax and the rest of the events approximately 1 day after the first dose. The rechallenge is unknown since only information about the first dose was disclosed. Headache, Nausea, Arthralgia, Vaccination site swelling and Vaccination site pain are consistent with the known safety profile of the vaccine for adult patients. However, since the patient is younger than 18 years of age and the events had a serious outcome, they are considered unexpected. The benefit-risk relationship of Spikevax vaccine is not affected by this report. The seriousness criteria of the events was assessed as per regulatory authority report. Further information is needed regarding Hospitalization. There is insufficient evidence in SD to support Disability.


VAERS ID: 1758150 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-09-06
   Days after vaccination:181
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anosmia, Body temperature, COVID-19, Conjunctivitis, Drug ineffective, Migraine, Pyrexia
SMQs:, Severe cutaneous adverse reactions (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Hypercholesteremia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: Fever 37.5; Result Unstructured Data: Test Result:37.5
CDC Split Type: ITPFIZER INC202101229353

Write-up: VACCINATION FAILURE; VACCINATION FAILURE; Migraine; Anosmia; Pinkeye; Fever 37.5; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-785943. A 55-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EP2166), dose 2 intramuscular, administered in Deltoid Left on 09Mar2021 15:58 as dose 2, single, and dose 1 intramuscular, administered in Deltoid Left on 16Feb2021 15:23 (Lot Number: EL0725) as dose 1, single for covid-19 immunisation. Medical history included hypercholesterolaemia and hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 06Sep2021 the patient experienced vaccination failure, migraine, anosmia, pink eye and fever 37.5 for two days. The patient underwent lab tests and procedures which included body temperature was 37.5 on 06Sep2021. Outcome of the events was recovered in Sep2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1758164 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-09-06
   Days after vaccination:157
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive end-organ damage
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210823; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210825; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210830; Test Name: COVID-19 PCR test negative; Test Result: Negative ; Test Date: 20210906; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232705

Write-up: PRIVACY cluster. Positive molecular swab in vaccinated 11Mar and 02Apr.; vaccination failure; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority number IT-MINISAL02-787128. A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ET1831, expiry date: 30Jun2021), via intramuscular, administered in arm right on 11Mar2021 as dose 1, 0.3 ml single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER9470, expiry date: 30Jun2021), via intramuscular, administered in arm right on 02Apr2021 as dose 2, 0.3 ml single for COVID-19 immunization. Patient had no known allergies. The patient''s medical history includes hypertensive end-organ damage. The patient concomitant medications were not reported. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET1831 and ER9470. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or were identified as the complaint was not confirmed. On 06Sep2021, the patient had Positive molecular swab in vaccinated 11Mar2021 and 02Apr2021. The patient also had vaccination failure. The patient underwent lab test: COVID-19 PCR test positive on 30Jul2021, 23Aug2021, 25Aug2021, 30Aug2021 with result negative and on 06Sep2021 with result positive. The outcome of SARS-CoV-2 test positive was not recovered and vaccination failure was unknown. No Follow-up attempts are possible. No information is expected further.


VAERS ID: 1758169 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005294 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Hyperpyrexia, Hypoacusis, Lymphadenopathy, Migraine, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hearing impairment (narrow), Hypersensitivity (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via Regulatory Agency (Reference number: IT-MINISAL02-787422) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MIGRAINE , HYPERPYREXIA, HYPOACUSIS WHEEZING, LYMPHADENOPATHY and ARTHRALGIA non responsive in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005294) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 06-Sep-2021, the patient experienced MIGRAINE (seriousness criterion medically significant), HYPERPYREXIA (seriousness criterion medically significant), HYPOACUSIS (seriousness criterion medically significant), WHEEZING (seriousness criterion medically significant), LYMPHADENOPATHY(seriousness criterion medically significant) and ARTHRALGIA (seriousness criterion medically significant). At the time of the report, MIGRAINE HYPERPYREXIA, HYPOACUSIS, WHEEZING, LYMPHADENOPATHY and ARTHRALGIA had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. After vaccination Patient were experienced with Unresponsive fever of 39.5, axillary lymphadenopathy, migraine, polyarthralgia for 3 days. After lowering of fever, reported worsening of tinnitus (acoustic neuroma) and was suffered with hearing loss. Company Comment: This case concerns a 43-year-old, female subject with no relevant medical history reported, who experienced the unexpected events of MIGRAINE, HYPERPYREXIA, HYPOACUSIS, WHEEZING, LYMPHADENOPATHY and ARTHRALGIA. The events occurred on the same day of the first dose of Spikevax. The rechallenge was unknown as no information about second dose is available. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Additional information received on 30-SEP-2021 that contains updated Narrative.; Sender''s Comments: This case concerns a 43-year-old, female subject with no relevant medical history reported, who experienced the unexpected events of MIGRAINE, HYPERPYREXIA, HYPOACUSIS, WHEEZING, LYMPHADENOPATHY and ARTHRALGIA. The events occurred on the same day of the first dose of Spikevax. The rechallenge was unknown as no information about second dose is available. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1758231 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2832 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Dizziness, Headache, Heavy menstrual bleeding, Hormone level abnormal, Hot flush, Muscular weakness, Nausea, Oral herpes, Polymenorrhoea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101229409

Write-up: Dizziness; Diarrhea; Herpes on lip; Weakness muscle; Ache stomach; Headache; Hot flashes; Fever; Period has been advanced with more blood/ menorrhagia; Churning of stomach; Lack of appetite; Hormonal changes; My period has been advanced; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number ES-AEMPS-1001138. A 31-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 06Sep2021 (at the age of 31-year-old) (Lot Number: FF2832) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (COMIRNATY), intramuscular, on 16Aug2021 (Lot Number: FF2832) as dose 1, single for COVID-19 immunization. The patient experienced dizziness, diarrhea, herpes on lip, weakness muscle, ache stomach, headache, hot flashes, fever, churning of stomach, lack of appetite, hormonal changes, period has been advanced with more blood/ menorrhagia on 06Sep2021. Therapeutic measures were taken as a result of the events with paracetamol (took paracetamol on day 6 and day 7 because of the fever. The rest of the days the patient had not taken it again but she still feel quite bad and the situation did not improve). The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


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