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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 253 out of 8,010

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VAERS ID: 1724793 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-09-07
   Days after vaccination:246
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Drug ineffective, Hallucination, Hyperhidrosis, Polymerase chain reaction, SARS-CoV-2 test, Suspected COVID-19, Tremor
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: PCR; Test Result: Negative ; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Lateral flow test; Test Date: 20210907; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: Lateral flow test
CDC Split Type: GBPFIZER INC202101195014

Write-up: Hallucinations; Lack of efficacy for the Pfizer COVID vaccine; COVID-19; sweating; shaking; shivering; This is a spontaneous report from a non-contactable consumer or other non hcp. A adult female (45-50 years old)) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) dose 2 via an unspecified route of administration on 04Jan2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2, via an unspecified route of administration on an unspecified date in Dec2020 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On 07Sep2021 the patient experienced hallucinations, lack of efficacy for the pfizer covid vaccine, covid-19, sweating, shaking, shivering. Reporter stated that she experienced hallucinations, sweating, shaking, and shivering and experienced these symptoms on and off for 48 hours. She was still feeling unwell today, she learnt of this yesterday. She would let you know when she had fully recovered. The patient underwent lab tests and procedures which included polymerase chain reaction: negative, sars-cov-2 test: positive on an unknown date and sars-cov-2 test: negative on 07Sep2021 [Lateral flow test]. 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: 1724908 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Cold sweat, Hypoaesthesia, Investigation, Oropharyngeal discomfort, Oropharyngeal pain, Oxygen saturation, Vital signs measurement
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (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: 20210907; Test Name: No airway stenosis sound; Result Unstructured Data: Test Result:No airway stenosis sound; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210907; Test Name: SpO2; Result Unstructured Data: Test Result:normal; Test Date: 20210907; Test Name: vital sign; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101170721

Write-up: Abdominal pain; pharynx strange sensation of; pharyngodynia; cold sweat; numbness of left arm; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126112. A 25-year-old female patient received BNT162B2 (COMIRNATY, Lot number FF9942; and Expiration date 30Nov2021) at single dose on 07Sep2021 10:10 via an unknown date at 25-year-old for COVID-19 immunisation. Medical history was reported as "none". There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc.). Concomitant drug was not provided. Body temperature before vaccination was 36.2 degrees Centigrade. On 07Sep2021 at 10:18 (8 minutes after the vaccination), the patient experienced abdominal pain, pharynx strange sensation of, pharyngodynia, cold sweat and numbness of left arm. The course of event was as follows: The symptoms appeared after the vaccination. Vital sign, SpO2 normal. No airway stenosis sound. Saline IV drip and H1 H2 blocker administered. Patient improved and went home after 3 hours observation. Outcome of the events was resolving. The reporter commented as follows: nothing special. The reporter classified the event as non-serious and assessed the causality between the event and the bnt162b2 as related. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1724920 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Dysphoria, Feeling hot, Heart rate, Hyperhidrosis, Oxygen saturation, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Depression (excl suicide and self injury) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:77/33 mmHg; Comments: at 09:30; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210907; Test Name: pulse; Result Unstructured Data: Test Result:55; Comments: at 09:30; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %; Comments: at 09:30
CDC Split Type: JPPFIZER INC202101171234

Write-up: Vasovagal reflex; Blood pressure 77/33; Dysphoria; Sweaty; Feeling hot; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21127153. The patient was a 13-year and 11-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 07Sep2021 at 09:30 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FG0978, Expiration date 30Nov2021) (at age of 13 years old) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Sep2021 at 09:30 (the day of vaccination), the patient experienced vasovagal reflex. On 07Sep2021 (the day of vaccination), the outcome of the event was recovered. The course of the event was as follows: Immediately after vaccination, the patient experienced dysphoria, sweaty, feeling hot. Blood pressure 77/33, pulse 55, SpO2 98%. Atropine Sulfate 0.05%1ml intramuscular injection. About 30 minutes later the patient recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Immediately after the vaccination, there is a causal relationship.; Reporter''s Comments: Immediately after the vaccination, there is a causal relationship.


VAERS ID: 1724923 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FC9880 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood pressure decreased, Blood pressure measurement
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Blood pressure; Result Unstructured Data: Test Result:87/12
CDC Split Type: JPPFIZER INC202101171323

Write-up: Blood pressure decreased (87/12); Abdominal pain; This is a spontaneous report from a contactable other HCP received from the regulatory authority. Regulatory authority report number is v21126096. A 16-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration at the age of 16-year-old on 07Sep2021 11:56 (Lot Number: FC9880; Expiration Date: 30Sep2021) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was a 16-year and 9-month-old (at the time of vaccination) female. The patient had no family history. The patient experienced blood pressure decreased (87/12) (medically significant) on 07Sep2021 12:11, abdominal pain (medically significant) on 07Sep2021 12:11. The course of the event was as follows: The event onset date was 07Sep2021 at 12:11 (15 minutes after the vaccination). The outcome of the event was not provided. About 15 minutes after the vaccination, the patient experienced Abdominal pain. Blood pressure decreased (87/12), the patient received Adrenaline 0.3mg, intramuscular injection, and transported to the PRIVACY hospital. Physician Office Visit for events. The reporting other HCP classified the event as serious (Medically Significant) and assessed the causality between the event and bnt162b2 as unassessable. The patient underwent lab tests and procedures which included blood pressure measurement: 87/12 on 07Sep2021. Therapeutic measures were taken as a result of events. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724924 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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: Anaphylactic reaction, Blood pressure decreased, Body temperature, Chest discomfort, Conjunctival hyperaemia, Dyspnoea, Erythema, Hot flush, Lacrimation increased, Lip oedema, Rhinorrhoea, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? 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: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:35.08 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101171385

Write-up: anaphylaxis was strongly suspected; The patient experienced skin symptoms of Erythema and Hot flush; The patient experienced skin symptoms of Erythema and Hot flush; The cardiovascular symptoms of Blood pressure decreased and Tachycardia appeared; The cardiovascular symptoms of Blood pressure decreased and Tachycardia appeared; The respiratory symptoms of Nasal discharge, hard to breath , Dyspnoea, Chest discomfort appeared; The respiratory symptoms of Nasal discharge, hard to breath , Dyspnoea, Chest discomfort appeared; The respiratory symptoms of Nasal discharge, hard to breath , Dyspnoea, Chest discomfort appeared; The patient experienced digestive symptoms of Lip oedema; Eye symptoms of Conjunctival hyperaemia and Lacrimation; Eye symptoms of Conjunctival hyperaemia and Lacrimation; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126153. A 23-year and 8-month-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 07Sep2021 09:05 (at the age of 23-year and 8-month-old) (Lot Number: FF3620; Expiration Date: 30Nov2021) as single dose for COVID-19 immunisation. Medical history was none. The patient''s concomitant medications were not reported. Body temperature before vaccination was 35.08 degrees Centigrade. The patient experienced anaphylaxis was strongly suspected; the patient experienced skin symptoms of erythema and hot flush; the cardiovascular symptoms of blood pressure decreased and tachycardia appeared; the respiratory symptoms of nasal discharge, hard to breath, dyspnoea, chest discomfort appeared; the patient experienced digestive symptoms of lip oedema; eye symptoms of conjunctival hyperaemia and lacrimation; the events onset date was 07Sep2021 at 09:20 (15 minutes after the vaccination). On 07Sep2021 (the day of vaccination), the patient was admitted to the hospital. The course of the event was as follows: 15 minutes after vaccination, symptoms developed. It was sudden onset. With rapid symptoms. The patient experienced skin symptoms of Erythema and Hot flush. The cardiovascular symptoms of Blood pressure decreased and Tachycardia appeared. The respiratory symptoms of Nasal discharge, hard to breath, Dyspnoea, Chest discomfort appeared. The patient experienced digestive symptoms of Lip oedema, and Eye symptoms of Conjunctival hyperaemia and Lacrimation. From the above, anaphylaxis was strongly suspected. The outcome of the events was unknown. The reporting physician classified the event as serious (Hospitalized on 07Sep2021) and the causality between the event and bnt162b2 as not provided. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724926 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dysphoria, Nausea, Oxygen saturation, PO2, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopy (atopy as a child, no symptoms now)
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:130/80s; Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:120~130/80s; Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:100s; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination.; Test Date: 20210907; Test Name: SPO2(Oxygen saturation); Result Unstructured Data: Test Result:99; Test Date: 20210907; Test Name: PO2; Result Unstructured Data: Test Result:98
CDC Split Type: JPPFIZER INC202101171520

Write-up: Dysphoria; Queasy; Lower leg rash; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126146 and v21126156. A 17-year and 5-month-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Sep2021 14:40 (Lot Number: FF5357; Expiration Date: 30Nov2021) (at age of 17-year and 5-month-old) as single dose for covid-19 immunisation. Medical history included atopy as a child, no symptoms now. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees Centigrade. On 07Sep2021 at 14:40 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Intramuscular injection, Lot number FF5357, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. The event onset date/time was reported as 07Sep2021 at 14:50 (10 minutes after the vaccination). About 10 minutes after the vaccination, the patient experienced dysphoria and queasy, blood pressure was 100s, No problem of consciousness level. Lower leg rash. BOSMIN 0.3mg, via intramuscular injection in right lower leg, Saline 500 and Atarax-P. Blood pressure 130/80s, PO2(partial pressure of oxygen)98. The outcome of the events was unknown (as reported). The reporting physician classified the event as non-serious and the causality between the event and the vaccine was not provided. The reporting physician commented as follows: Blood pressure stabilized, SPO2(Oxygen saturation)99, BP(blood pressure)120-130/80s, and (event) onset disappeared. Prescribed antihistamines and anti-allergic drugs and went home. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Blood pressure stabilized, SPO2(Oxygen saturation)99, BP(blood pressure)120-130/80s, and (event) onset disappeared. Prescribed antihistamines and anti-allergic drugs and went home.


VAERS ID: 1724928 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Heart rate, Heart rate decreased, Oxygen saturation, Pallor, Presyncope, Syncope, Tension
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:88/48; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:46; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101171596

Write-up: Syncope; Vasovagal reflex; BP88/48; P46; complexion ill; tension; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126174. The patient was a 18-year and 2month old female. Body temperature before vaccination was 36.6 degrees Centigrade on 07Sep2021. 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). Concomitant medications were not reported. On 07Sep2021 at 15:40 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# FD0349, Expiration date 31Oct2021) at the age of 18years old via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Sep2021 at15:43(3 minutes after vaccination), the patient experienced Vasovagal reflex. The course of the event was as follows: 2-3 minutes after corona vaccination, syncope and complexion ill in the waiting area, but responding to the name, BP88/48, P46, SpO2 98%, recovered with fluid replacement and 1hour rest. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible causes of the event such as any other diseases were tension and no food intake. On 07Sep2021(the day of vaccination), the outcome of the event was recovered.


VAERS ID: 1724933 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Nausea, Rhinorrhoea, Sneezing, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to grains; Dermatitis atopic
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:170/105; Comments: at 15:00
CDC Split Type: JPPFIZER INC202101172042

Write-up: BP was 170/105; Wheals on both elbows; Abdominal pain lower; anaphylaxis-like symptom; Queasy; Sneezing; Nasal discharge; Vomiting; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21126203. A 39-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Sep2021 11:00 (Lot Number: FF5357; Expiration Date: 30Nov2021) at age of 39-year-old as single dose for covid-19 immunisation. 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 allergy to buckwheat noodles, Dermatitis atopic. The patient''s concomitant medications were not reported. On 07Sep2021 at 11:00 (the day of the vaccination), the patient received the first dose of bnt162b2. The event onset date was reported as 07Sep2021 at 11:10 (10 minutes after the vaccination). The course of the event was as follows: On 07Sep2021 at 11:00 (the day of the vaccination), the patient received the vaccination at PRIVACY clinic. 10 minutes later, the patient experienced Queasy, but the patient returned home. On this occasion, the patient also experienced Sneezing and Nasal discharge. The patient had been Vomiting repeatedly since returned home. From 07Sep2021 at around 12:00 (1 hour after the vaccination), the patient experienced Wheals on both elbows. The patient also experienced Abdominal pain lower. On 07Sep2021 at 15:00 (4 hours after the vaccination), the patient visited the reporting hospital to receive a medical examination. BP was 170/105, and there was no respiratory symptom. Olopatadine (ALLELOCK) was taken orally by the patient, Infusion 500mL and Metoclopramide (PRIMPERAN) were also administered, then the symptoms were recovering. On 07Sep2021 at 16:30 (5 hours and 30 minutes after the vaccination), the patient returned home. On 08Sep2021 morning (one day after the vaccination), it was confirmed that the symptoms were recovering. The outcome of the event was recovering. The reporter 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 reporter commented as follows: It was an anaphylaxis-like symptom. The patient visited the reporting hospital more than 3 hours after the symptoms were discovered, Blood pressure decreased was not observed, and the patient''s condition improved.


VAERS ID: 1724947 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FH0151 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Cold sweat, Dizziness, Heart rate, Hypoaesthesia, Muscle tightness, Oxygen saturation
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: bp; Result Unstructured Data: Test Result:143/124 mmHg; Comments: at 15:35; Test Date: 20210907; Test Name: bp; Result Unstructured Data: Test Result:76/43 mmHg; Comments: at 15:43; Test Date: 20210907; Test Name: bp; Result Unstructured Data: Test Result:83/44 mmHg; Comments: at 15:53; Test Date: 20210907; Test Name: p; Result Unstructured Data: Test Result:60; Comments: at 15:35; Test Date: 20210907; Test Name: p; Result Unstructured Data: Test Result:84; Comments: at 15:43; Test Date: 20210907; Test Name: p; Result Unstructured Data: Test Result:81; Comments: at 15:53; Test Date: 20210907; Test Name: SPO2; Test Result: 96 %; Comments: at 15:43; Test Date: 20210907; Test Name: SPO2; Test Result: 96 %; Comments: at 15:53; Test Date: 20210907; Test Name: SPO2; Test Result: 97 %; Comments: at 15:35
CDC Split Type: JPPFIZER INC202101175287

Write-up: Blood pressure fluctuation/blood pressure measurement: 143/124 mmhg on 07Sep2021 at 15:35, 76/43 mmhg on 07Sep2021 at 15:43, 83/44 mmhg on 07Sep2021 at 15:53; Swaying feeling; cold sweat; Numbness of left upper extremities; tightness on left upper extremities; This is a spontaneous report from a contactable pharmacist received via the RA. A 41-year-old female patient received bnt162b2 (COMIRNATY) dose 1 intramuscular, administered in arm left on 07Sep2021 15:30 (Lot Number: FH0151; Expiration Date: 31Dec2021) as dose 1, single for covid-19 immunisation. The patient was an unknown pregnancy status. 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. The patient had cephem antibiotics allergy. The patient''s concomitant medications were not reported. The patient experienced blood pressure fluctuation, swaying feeling, cold sweat, numbness of left upper extremities, tightness on left upper extremities on 07Sep2021 15:35 with outcome of recovered. On 07Sep2021 at 15:35 (5 minutes after the vaccination), the patient experienced Blood pressure fluctuation, Swaying feeling, cold sweat, Numbness of left upper extremities, and tightness on left upper extremities. At 15:35, BP was 143/124, P:60, SPO2: 96%. On 07Sep2021 at 15:43 (8 minutes after the vaccination), the symptoms of cold sweat, numbness of left upper extremities and tightness on left upper extremities disappeared. BP was 76/43, P was 84, SOP2 was 96%. Moreover, on 07Sep2021 at 15:53 (18 minutes after vaccination), BP was 83/44, P: 81, SPO2 was 97%. The reporter classified the events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered without treatment. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events BP fluctuation and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1724951 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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: Body temperature, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101177367

Write-up: Neurally mediated syncope; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21126179. A 26-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Sep2021 at 16:45 (Lot Number: FF2782; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.6 degrees Centigrade. On 07Sep2021 at 16:55 (10 minutes after the vaccination), the patient experienced neurally mediated syncope. 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. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1724957 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FG0978 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Oxygen saturation, Pruritus, Rash
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210907; Test Name: BP; Result Unstructured Data: Test Result:140/74; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:64; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101177665

Write-up: Anaphylaxis; skin eruption with itching; skin eruption with itching; dyspnoea; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21126223. A 53-year-old (reported as 53-year and 7-month-old) female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FG0978; Expiration Date: 30Nov2021), via an unspecified route of administration on 07Sep2021 at 14:36 at age of 53-year-old as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees Centigrade. The patient had no family history. On 17Aug2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# not provided) as single dose for covid-19 immunisation, from 2 hours after the vaccination, abdominal pain, feeling queasy, numbness in hand and itching occurred. Itching disappeared in 1 hour, while Abdominal pain and feeling queasy disappeared the next morning. On 07Sep2021 at 14:50 (14 minutes after the vaccination), the patient experienced Anaphylaxis. The course of the event was as follows: 14 minutes after the second dose of Comirnaty on 07Sep2021, skin eruption with itching appeared from the neck to the anterior chest. The patient experienced mild dyspnoea. Vital signs were BP 140/74, P 64, SpO2 98%. No decrease in blood pressure or SpO2 was noted during follow-up observation. By taking ALLEGRA via oral and intravenous SOLU-CORTEF, feeling of dyspnoea disappeared in about 10 minutes. After 2 hours follow-up observation, symptoms recovered and the patient went home. The outcome of the events was recovered on 07Sep2021. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: because itching and gastrointestinal symptoms of first dose were delayed, it was difficult to determine whether it was Anaphylactic reaction. After explaining the risk of allergies, and with the patients wish and consent, the second dose was given.; Sender''s Comments: Linked Report(s) : 202101193977 same reporter/patient/product; different doses/AE


VAERS ID: 1725017 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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: Asthenia, Oropharyngeal discomfort
SMQs:, Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), 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: Allergy.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Weakness; Pharynx strange sensation; This case was received Regulatory Authority 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. On 07-Sep-2021, the patient received the 1st dose of this vaccine. Around 19:30, weakness developed after the vaccination. Pharynx strange sensation also developed. There were no other symptoms such as rash. Consciousness was clear, and there was no vital abnormality. The patient''s symptoms persisted, and the patient could not keep sitting, so emergency care was requested. Route was taken with 500 ml of saline. The outcome of weakness and pharynx strange sensation was reported as ongoing. 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 30-year-old, female patient with no relevant medical history, who experienced the unexpected events of Asthenia and Oropharyngeal discomfort. The events occurred the same day as the first dose of Spikevax. The rechallenge was unknown since no information about the second dose. The reporter assessed the events as related to the product. The benefit-risk relationship of Spikevax 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: 1725847 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300360812121 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Palpitations, SARS-CoV-2 test, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Asthma aggravated; Heart throbbing; Constriction throat; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25937667 ) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ASTHMA (Asthma aggravated), PALPITATIONS (Heart throbbing) and THROAT TIGHTNESS (Constriction throat) in a 39-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300360812121) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PALPITATIONS (Heart throbbing) (seriousness criterion medically significant) and THROAT TIGHTNESS (Constriction throat) (seriousness criterion medically significant). On 08-Sep-2021, the patient experienced ASTHMA (Asthma aggravated) (seriousness criterion medically significant). At the time of the report, ASTHMA (Asthma aggravated) had not resolved and PALPITATIONS (Heart throbbing) and THROAT TIGHTNESS (Constriction throat) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided. Throat/ Esophagus constricted. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Treatment medication was not provided. Company Comment: This case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected events of Palpitations, Asthma and Throat tightness. The events occurred approximately 2-3 days after the first dose of vaccine. The rechallenge was unknown since no information about the second dose was provided. The reporter assessed the events as related to the product. The benefit-risk relationship of vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 39-year-old, male patient with no relevant medical history, who experienced the unexpected events of Palpitations, Asthma and Throat tightness. The events occurred approximately 2-3 days after the first dose of vaccine. The rechallenge was unknown since no information about the second dose was provided. The reporter assessed the events as related to the product. The benefit-risk relationship of vaccine in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity


VAERS ID: 1728928 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FE3593 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Bronchial obstruction, Cough, Dysphonia, Pharyngeal disorder, Pruritus, Rash erythematous, Rash pruritic, Rhinorrhoea, Tachycardia, Vaccination site pain
SMQs:, Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Desloratadine; Vilanterol
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic dermatitis; atopic rhinitis; bronchial asthma.
Allergies: Food allergy (honey); hymenoptera sting allergy; peanut allergy
Diagnostic Lab Data:
CDC Split Type: CLPFIZER INC202101182061

Write-up: This is a spontaneous report from a contactable physician (patient). A 31-year-old female patient (non-pregnant) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# FE3593), intramuscularly, in left arm, on Sep 7, 2021, at 13:30, single dose, for COVID-19 immunisation. The patient''s medical history included atopic rhinitis, bronchial asthma, atopic dermatitis, peanut allergy, honey allergy and hymenoptera sting allergy. The patient''s concomitant medications included desloratadine and vilanterol. On Sep 7, 2021, at 19:30 (6 hours later post vaccination), patient experienced generalized itching, associated with erythematous and pruritic papillae in the neck, back, chest, extremities, rhinorrhea and pain in the inoculation area. On Sep 9, 2021, at 04:30 (39 hours later post vaccination), she experienced bronchial obstruction, persistent cough, hoarse voice, sensation of pharyngeal tightness and tachycardia. The patient had to use salbutamol inhaler 4 inhalations every 20 min. She had to use Fesema, famotidine 20mg, prednisone 60mg and desloratadine 5mg for one hour. The patient hospitalized for bronchial obstruction, persistent cough, hoarse voice, pharyngeal disorder and tachycardia from Sep 9, 2021 to an unknown date. Therapeutic measures taken as a result of the events (bronchial obstruction, persistent cough, hoarse voice, pharyngeal disorder and tachycardia): Treatment with salbutamol, famotidine, prednisone and desloratadine. The outcome of the events: recovering.


VAERS ID: 1729112 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EF3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Dermatitis atopic, Inflammation
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), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101191716

Write-up: stroke; inflammation; Atopic eczema; This is a spontaneous report from a contactable consumer received from a regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202109101550587590-IKIQP), Safety Report Unique Identifier (GB-MHRA-ADR 25924702). A female patient of an unspecified age received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EF3380, Expiry date was not reported), via an unspecified route of administration at dose 2, single on 04Sep2021 for COVID-19 immunization. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. I am homozygous for the MTHFR gene on c677t. I also have a diagnosis for ADHD-C (although was currently not on medication). The patient concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number, Expiry date was not reported) on unspecified date. The patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient experienced inflammation and stroke on an unspecified date and on 07Sep2021 atopic eczema . The reporter stated that it but felt best to report it. Also, it is worth noting my younger brother, who lives in another city, got taken to hospital a few days after his own vaccine with suspected stroke, but they now rule that out and think it is MS (they are still doing tests). Maybe an inflammation response and bad reaction with our genetics to this vaccine. Both of us had reactions after the 2nd one. The outcome of the events was inflammation, stroke was recovering, atopic eczema was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1729184 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004223 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: GBMODERNATX, INC.MOD20213

Write-up: chills; Vomiting; Feverish; Skin sensitization/if it rubbed against clothes/furniture etc.; Headache; This case was received via RA (Reference number: GB-MHRA-ADR 25939894) on 15-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of CHILLS (chills), VOMITING (Vomiting), PYREXIA (Feverish), SKIN SENSITISATION (Skin sensitization/if it rubbed against clothes/furniture etc.) and HEADACHE (Headache) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004223) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: SERTRALINE (Taking Sertraline 100mg daily). On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), SKIN SENSITISATION (Skin sensitization/if it rubbed against clothes/furniture etc.) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced CHILLS (chills) (seriousness criterion medically significant). On 07-Sep-2021, VOMITING (Vomiting) had resolved. On 10-Sep-2021, PYREXIA (Feverish) and HEADACHE (Headache) had resolved. On 11-Sep-2021, SKIN SENSITISATION (Skin sensitization/if it rubbed against clothes/furniture etc.) had resolved. At the time of the report, CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant product information were provided by the reporter. Patient was treated with paracetamol. Vomiting on awakening on the day after vaccination. Skin was painful to touch or if it rubbed against clothes/furniture. Patient had not tested positive for COVID-19 since having the vaccine. Company comment: This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the unexpected events of Vomiting, Feverish, Headache, Chills, Vomiting, Skin sensation. The events occurred approximately 1 day after the second dose of Moderna Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. 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 18-year-old, male patient with no relevant medical history, who experienced the unexpected events of Vomiting, Feverish, Headache, Chills, Vomiting, Skin sensation. The events occurred approximately 1 day after the second dose of Moderna Covid-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The reporter assessed the events as related to the product. 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: 1729546 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214019 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Myalgia, Paraesthesia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-782994) on 16-Sep-2021 and was forwarded to Moderna on 16-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PARAESTHESIA, ASTHENIA, PYREXIA and MYALGIA in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 vaccination. Concurrent medical conditions included Allergic rhinitis. On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 07-Sep-2021, the patient experienced PARAESTHESIA (seriousness criterion medically significant), ASTHENIA (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant) and MYALGIA (seriousness criterion medically significant). At the time of the report, PARAESTHESIA, ASTHENIA, PYREXIA and MYALGIA 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 medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. After vaccination patient were experienced fever, muscle pain asthenia and paresthesia of the hands. Company Comment: This case concerns a 43-year-old female with a medical history of allergic rhinitis, who experienced the unexpected events of paraesthesia, asthenia, pyrexia and myalgia 1 day after the first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translation received on 20-SEP-2021 contains No New Information; Sender''s Comments: This case concerns a 43-year-old female with a medical history of allergic rhinitis, who experienced the unexpected events of paraesthesia, asthenia, pyrexia and myalgia 1 day after the first dose of Spikevax. The rechallenge was not applicable. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1729590 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Hypoaesthesia, Limb discomfort, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101179378

Write-up: This is a spontaneous report from a contactable physician, received via the regulatory authority (report number: v21126213). A 39-year-old female patient received the first dose of BNT162B2 (Comirnaty, batch/lot# FG0978; expiration date: Nov 30, 2021), at the age of 39, via an unspecified route of administration, on Sep 7, 2021, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. The patient experienced pain in arm, sensation of heaviness (discomfort), numbness in arm and limb discomfort on Sep 7, 2021 (day of vaccination). The outcome of the events: unknown. The reporting physician classified the events serious (can lead to disability), and assessed the events were related to BNT162B2. There was no other possible cause (such as any other diseases). No follow-up attempts possible. No further information expected.


VAERS ID: 1729609 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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: Body temperature, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Urticaria; Wheezing
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101183900

Write-up: urticaria of the upper limbs/urticaria of both upper limbs; This is a spontaneous report from a contactable nurse received from The regulatory authority report number is v21126322. A 63-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 07Sep2021 (at the age of 63 years old) (Lot Number: FF3620; Expiration Date: 30Nov2021) as dose 1, single for COVID-19 immunisation. Medical history included wheezing and urticaria due to mackerel. The patient''s concomitant medications were not reported. Body temperature before vaccination was 35.7 degrees Centigrade. The patient''s history according to 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 Urticaria due to mackerel, Wheezing. On 07Sep2021 in the afternoon (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY). On 07Sep2021 at 19:00 (the day of vaccination), the patient experienced urticaria of both upper limbs. On 07Sep2021 (the day of vaccination), the outcome of the event was not provided. The course of the event was as follows: several tens of minutes after the first vaccination of COVID-19 vaccine (COMIRNATY), urticaria of the upper limbs appeared. There was itching. No dyspnoea. Polaramine 5 mg/ml of intramuscular injection was administrated. Fexofenadine hydrochloride OD tablet 60mg of 2 tablets for 2 or 3 days was prescribed. The patient returned home without exacerbation. The outcome of the events was unknown. The reporting nurse classified the event as non-serious and assessed that the event was related to BNT162B2. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1729621 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Choking sensation, Oxygen saturation, Sensory disturbance, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Test Date: 20210907; Test Name: Oxygen saturation; Test Result: 98 %
CDC Split Type: JPPFIZER INC202101184767

Write-up: urticaria appeared in both upper arms; Sensory aberrations of fingers in both hands; Pharynx strangled sensation of; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126282. The patient was a 16-year and 6 month-old female. Body temperature before vaccination was 35.9 degrees Centigrade. On 07Sep2021 at 14:45 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FH0151, Expiration date 31Dec2021) via an unspecified route of administration as a single dose for COVID-19 immunization. Relevant medical history included pyrexia of 38s centigrade and vaccination site swelling when receiving hepatitis B vaccination, Influenza vaccine, and Encephalitis vaccine. On 07Sep2021 (the day of vaccination) about 15:30 (as reported) While waiting for 15 minutes after vaccination, the patient experienced symptoms that Sensory aberrations of fingers in both hands and strangulation of pharynx. no Dyspnea was confirmed. Oxygen saturation was 98%(air room) . Then 7 minutes later, urticaria appeared in both upper arms, and no dyspnea was confirmed. The symptoms of Sensory aberrations in two hands and Pharynx strangled sensation of were alleviated. The doctor prescribed Anti Hcs. After 15 minutes, no aggravation of wheals or respiratory symptom was confirmed, the patient went home for observation. On 07Sep2021 (the day of vaccination), the outcome of the event was recovering. The reporting physician classified that the event was serious (medically significant) and related to bnt162b2. The reporting physician commented as follows: We need to discuss about the second dose of vaccination.


VAERS ID: 1729632 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FH0151 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Shock symptom, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101185733

Write-up: Shock-like symptom; Situational Syncope; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126339. A 27-year and 2-month-old male patient received BNT162B2 (COMIRNATY; Lot Number: FH0151; Expiration Date: 31Dec2021), via an unspecified route of administration on 07Sep2021 09:50 (at the age of 27-years-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 07Sep2021 at 09:50 (the day of vaccination), the patient received the first dose of bnt162b2. On 07Sep2021 at 10:15 (25 minutes after the vaccination), the patient experienced shock-like symptom. Immediate IV and O2 inhalation were performed. The patient rested and recovered tens of minutes later. At 14:30, immediately after the symptoms recovered, when the patient was about to go home, the same symptoms occurred and the same treatment was performed. Just in case, the patient was transported to the Hospital. On 07Sep2021 (the day of vaccination), the outcome of the event was recovered. 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 comment from the Hospital was "Situational Syncope."


VAERS ID: 1729647 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-07
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Vasculitis
SMQs:, Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101191135

Write-up: the blood vessel on the wrist of the struck arm was swelling; This is a spontaneous report from a contactable consumer or other non HCP (patient) received via Medical Information Team. A 41-year-old male received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown and Expiration date unknown) via an unspecified route of administration on 30Aug2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Details reported as follows: On 30Aug2021 (the day of vaccination), the patient received the first dose of BNT162B2 at the mass vaccination site. About a week later, the blood vessel on the wrist of the struck arm was swelling. There were blood vessels, or pulse points, around the wrist. On the back of blood vessel, or the place where took a pulse, the swelling had continued, about 1 cm in diameter. The patient had noticed the swelling since 4 days ago (07Sep2021). Seriousness and causality between the event and BNT162B2 were not provided. The outcome of event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1729663 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Feeling abnormal, Hypoaesthesia, Nausea, Neuropathy peripheral
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (narrow), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101192112

Write-up: Peripheral nerve disorder; Queasy; Feels poorly; Numbness of both hands and feet; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21126415. A 37-years and 7-months-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 07Sep2021 14:45 (Lot Number: FD0349; Expiration Date: 31Oct2021) at the age of 37-year-old as single dose for covid-19 immunization. Medical history included none. Body temperature before vaccination was 36.5 degrees Centigrade on 07Sep2021. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 07Sep2021 at 14:45 (the day of vaccination), the patient received the first dose of bnt162b2. On 07Sep2021 at 22:10 (7hours and 25minutes after the vaccination), the patient experienced peripheral nerve disorder. The course of the event was as follows: The patient experienced felt poorly, queasy and numbness of both hands and feet on 07Seo2021 22:10. On 08Sep2021 (1 day after the vaccination), the outcome of the events was recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2.There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: It was considered as an adverse reaction due to drugs contained in vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1730681 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; ADVIL [IBUPROFEN]
Current Illness:
Preexisting Conditions: Comments: No medical history information was provided.
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Fever 38.4 c
CDC Split Type: PHMODERNATX, INC.MOD20213

Write-up: Joint pain; Headache; Fever 38.4 c; Muscle pain; This regulatory authority case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (Joint pain), HEADACHE (Headache), PYREXIA (Fever 38.4 c) and MYALGIA (Muscle pain) in a 29-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 immunization. No medical history information was provided. Concomitant products included PARACETAMOL and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication. On 06-Sep-2021, the patient received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 07-Sep-2021, the patient experienced ARTHRALGIA (Joint pain) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), PYREXIA (Fever 38.4 c) (seriousness criterion disability) and MYALGIA (Muscle pain) (seriousness criterion disability). At the time of the report, ARTHRALGIA (Joint pain), HEADACHE (Headache), PYREXIA (Fever 38.4 c) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 38.4 (abnormal) Fever 38.4 c. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: This case concerns a 29-year-old male patient with no relevant medical history ,who experienced the unexpected events of Arthralgia , Headache, Pyrexia and Myalgia . The events occurred one day after second dose of Spikevax.The rechallenge was unknown since no information about the first dose was disclosed . The events 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. 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 29-year-old male patient with no relevant medical history ,who experienced the unexpected events of Arthralgia , Headache, Pyrexia and Myalgia . The events occurred one day after second dose of Spikevax.The rechallenge was unknown since no information about the first dose was disclosed . The events 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. 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: 1730814 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-07
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Troponin; Result Unstructured Data: High
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Miopericarditis; This case was received via Agency Regulatory Authority (Reference number: ES-AEMPS-996596) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Miopericarditis) in a 19-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 08-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Sep-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced MYOCARDITIS (Miopericarditis) (seriousness criteria hospitalization and medically significant). On 12-Sep-2021, MYOCARDITIS (Miopericarditis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Troponin: 26.63 ng/l (High) High. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. Treatment information was unknown. Company comment: This case concerns a 19-year-old male patient with no relevant medical history, who experienced the expected serious event of Myocarditis. The event occurred approximately 28 days after the second dose of Spikevax. The rechallenge was not applicable. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: FU received on 22-Sep-2021. Stop date for the event of Myopericarditis added and outcome updated.; Sender''s Comments: This case concerns a 19-year-old male patient with no relevant medical history, who experienced the expected serious event of Myocarditis. The event occurred approximately 28 days after the second dose of Spikevax. The rechallenge was not applicable. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1730864 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Pericardite acuta post vaccinale; This case was received via regulatory authority (Reference number: IT-MINISAL02-783702) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of PERICARDITIS (Pericardite acuta post vaccinale) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. No Medical History information was reported. On 05-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 07-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced PERICARDITIS (Pericardite acuta post vaccinale) (seriousness criteria hospitalization and medically significant). At the time of the report, PERICARDITIS (Pericardite acuta post vaccinale) had resolved with sequelae. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient did not experience any adverse reaction after first dose. Lab data reported included Fragment D dimer, thorax CAT(computerized axial tomography), PCR (Polymerase chain reaction) performed on 07-Sep-2021 with inconclusive results. No concomitant medication information was reported. No treatment information was reported. Company Comment: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the expected event of Pericarditis. The event occurred three days after the second dose of mRNA-1273. The rechallenge was not applicable since only information about the second dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273is not affected by this report. After the first dose, the patient did not have any adverse reaction. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Follow up received contains no new information. On 17-Sep-2021: Translated document received on 21-Sep-2021 updated narrative with first dose details from reporter''s comment.; Sender''s Comments: This case concerns a 40-year-old, male patient with no relevant medical history, who experienced the expected event of Pericarditis. The event occurred three days after the second dose of mRNA-1273. The rechallenge was not applicable since only information about the second dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273is not affected by this report.


VAERS ID: 1732782 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood creatinine, Blood potassium, Blood sodium, Body temperature, C-reactive protein, Echocardiogram, Electrocardiogram, Glomerular filtration rate, Haemoglobin, International normalised ratio, Myocarditis, N-terminal prohormone brain natriuretic peptide, Platelet count, Prothrombin time, Troponin, White blood cell count
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy; Pneumococcal sepsis (pneumococcal sepsis in childhood)
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: CT angiography coronary; Result Unstructured Data: Test Result:No pericardial effusion; Comments: Coronary CT scan within normal limits taking into account kinetic artefacts. Probable lower basal subepicardial enhancement of left ventricle compatible with myocarditis; Test Name: Creatinine; Result Unstructured Data: Test Result:78 umol/l; Test Date: 20210910; Test Name: Creatinine; Result Unstructured Data: Test Result:67 umol/l; Test Name: Potassium; Result Unstructured Data: Test Result:4.5 mmol/L; Test Date: 20210910; Test Name: Potassium; Result Unstructured Data: Test Result:4.1 mmol/L; Test Name: sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20210910; Test Name: sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210910; Test Name: C-reactive protein; Result Unstructured Data: Test Result:28.6 mg/l; Test Date: 20210910; Test Name: Heart ultrasound; Result Unstructured Data: Test Result:Undilated left ventricle; Comments: Systolic function preserved. No disturbance of segmental kinetics. Initial non-dilated aorta. Left atrium non-dilated. No atrial septum defect and ventricular septic defect. No aortic or mitral valve disease. No exploitable tricuspid valve regurgitation flow, no reasons for a pulmonary arterial hypertension. Normal pericardium. Inferior vena cava fine and compliant.; Test Date: 20210910; Test Name: ECG; Result Unstructured Data: Test Result:Regular and sinus rhythm; Fine QRS; Comments: No repolarization disorder; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:124; Comments: mL / min / 1.73; Test Date: 20210910; Test Name: Glomerular filtration rate; Result Unstructured Data: Test Result:132; Comments: mL / min / 1.73; Test Name: hemoglobin; Result Unstructured Data: Test Result:16 g/dl; Test Date: 20210910; Test Name: hemoglobin; Result Unstructured Data: Test Result:15 g/dl; Test Name: INR; Result Unstructured Data: Test Result:1.11; Test Date: 20210910; Test Name: INR; Result Unstructured Data: Test Result:1.16; Test Name: NT PRO BNP; Result Unstructured Data: Test Result:81 pg/mL; Test Date: 20210910; Test Name: NT PRO BNP; Result Unstructured Data: Test Result:222 pg/mL; Test Name: platelets; Result Unstructured Data: Test Result:286 g/l; Test Date: 20210910; Test Name: platelets; Result Unstructured Data: Test Result:203 g/l; Test Name: prothrombin time; Test Result: 85 %; Test Date: 20210910; Test Name: prothrombin time; Test Result: 80 %; Test Name: Troponin; Result Unstructured Data: Test Result:168 pg/mL; Test Date: 20210910; Test Name: Troponin; Result Unstructured Data: Test Result:555 pg/mL; Test Name: Leucocytes; Result Unstructured Data: Test Result:7.30 g/l; Test Date: 20210910; Test Name: Leucocytes; Result Unstructured Data: Test Result:9.30 g/l
CDC Split Type: FRPFIZER INC202101228454

Write-up: Myopericarditis/cardiac pericarditis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-PA20211674. A 20-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via intramuscular on 07Sep2021 at patient age of 20-year-old (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. The patient relevant medical history included pneumococcal sepsis in childhood, Allergy: penicillin. The patient had none cardiovascular risk factors. The patient concomitant medication was not provided. The patient experienced myopericarditis. The clinical course was reported: On 07Sep2021, the patient presented immediately after a plateau fever more than 38.5 which is poorly tolerated, and severe asthenia. From 09Sep2021, the patient had appearance of retro-sternal pain. Consultation at the surgical admission unit on 10Sep2021 for persistent pain. The patient had hospitalization at the coronary care unit from 10Sep2021 to 14Sep2021. Lab data included: Entry clinical examination on 10Sep2021: Regular heart sounds, no breath. No right or left signs of cardiac insuffiency. No cough, no sputum. No fever for suspecting infection. ECG on entry on 10Sep2021: Regular and sinus rhythm; Fine QRS, no repolarization disorder. Heart ultrasound on entry on 10Sep2021: undilated left ventricle, systolic function preserved. No disturbance of segmental kinetics. Initial non-dilated aorta. Left atrium non-dilated. No atrial septum defect and ventricular septic defect. No aortic or mitral valve disease. No exploitable tricuspid valve regurgitation flow, no reasons for a pulmonary arterial hypertension. Normal pericardium. Inferior vena cava fine and compliant. Coronary CT angiography on 10Sep2021: No pericardial effusion. Coronary CT scan within normal limits taking into account kinetic artefacts. Probable lower basal subepicardial enhancement of left ventricle compatible with myocarditis. Assessment on entry on 10Sep2021: Hemoglobin 15 g / dL; Leukocytes 9.30 G / L; 203 G / L platelets; TP (prothrombin time) 80%; INR (international normalized ratio) 1.16; Sodium 139 mmol / L; Potassium 4.1 mmol / L; Creatinine 67 umol / L; GFR (glomerular filtration rate) 132 mL / min / 1.73; CRP(C-reactive protein) 28.6 mg / L; NT PRO BNP 222 pg / mL; Troponin 555 pg / mL. Final assessment: Hemoglobin 16 g / dL; Leukocytes 7.30 G / L; Platelets 286 G / L; TP 85%; INR 1.11; Sodium 141 mmol / L; Potassium 4.5 mmol / L; Creatinine 78 umol / L; GFR 124 mL / min / 1.73; NT PRO BNP 81 pg / mL; Troponin 168 pg / mL. No sport for a month - cardiologist consultation in a month with a cardiologist being close to the home. Favorable outcome. In summary, occurrence of cardiac pericarditis in a 20-year-old patient with no particular history, 2 days after 2nd dose of COMIRNATY. The case was reported as life-threatening and hospitalization. The patient was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1732908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema multiforme, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101208078

Write-up: Erythema multiforme; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number GB-MHRA-WEBCOVID-202109091034023390-Q9D5C. Safety Report Unique Identifier GB-MHRA-ADR 25917110. A 17-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 05Sep2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced erythema multiforme on 07Sep2021. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unspecified date. The outcome of event was not recovered.


VAERS ID: 1732927 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004225 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Haemorrhage, Hypomenorrhoea, Maternal exposure during breast feeding
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neonatal exposures via breast milk (narrow), Fertility disorders (broad)

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

Write-up: maternal exposure during breast feeding; bleeding; after having the vaccine; Light periods; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25927632) on 12-Sep-2021 and was forwarded to Moderna on 12-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (bleeding) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3004225) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast feeding. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced HYPOMENORRHOEA (Light periods). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding), HAEMORRHAGE (bleeding) (seriousness criterion medically significant) and FATIGUE (after having the vaccine). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (maternal exposure during breast feeding) and FATIGUE (after having the vaccine) had resolved and HYPOMENORRHOEA (Light periods) and HAEMORRHAGE (bleeding) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment information was provided. Patient reported after having the vaccine, her period had stopped within hours. It normally last 5-7days and can spot up to 2 days after finishing her period (Upto 9 days of bleeding). She had only come on her period on Sunday 5th sept and it stopped after the vaccine on tuesday 7th September. Patient has not tested positive for COVID-19 since having the vaccine. Company Comment: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during breastfeeding and other non serious events (Fatigue, Hypomenorrhea, and Bleeding). The hypomenorhea occurred the same day of the 2nd dose of Moderna vaccine, for the rest of the events onset date was not provided. assessment. The benefit-risk relationship of Spikevax in not affected by this report. This case was linked to MOD-2021-317646 (Parent-Child Link). See case MOD-2021-317646 for details regarding the child case.; Sender''s Comments: This case concerns a 34-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during breastfeeding and other non serious events (Fatigue, Hypomenorrhea, and Bleeding). The hypomenorhea occurred the same day of the 2nd dose of Moderna vaccine, for the rest of the events onset date was not provided. assessment. The benefit-risk relationship of Spikevax in not affected by this report.


VAERS ID: 1732955 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-07
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Decreased appetite, Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101196504

Write-up: Heart racing; Anxiety; Appetite lost; This is a spontaneous report from a contactable consumer (patient). This report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109121141216900-HUZ1I. Safety Report Unique Identifier GB-MHRA-ADR 25928982. A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), via an unspecified route of administration on 24Aug2021 (lot number: FE8087) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. Patient was not had symptoms associated with COVID-19. On 07Sep2021, the patient experienced heart racing, anxiety and appetite lost. It was reported that her heart started racing and gives her anxiety. The events were assessed as medically significant. Patient was not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, No - Negative COVID-19 test. The outcome of the events was reported as not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1733016 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-07
   Days after vaccination:3
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: Angioedema, Erythema, Pain, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? 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 INC202101196533

Write-up: Small hives; Painful; red; Giant hives; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109122230077350-KHCUE. Safety Report Unique Identifier GB-MHRA-ADR 25929463. A 39-year-old male patient received second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 04Sep2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 as BNT162B2 with an unspecified start an stop date for covid-19 immunization. The patient not had symptoms associated with COVID-19. The patient did not have a COVID-19 test. The patient had not tested positive for COVID-19 since having the vaccine. The patient was not enrolled in clinical trial. The patient experienced giant hives on 07Sep2021, small hives, painful and red. Small hives on nose and one giant hive between top lip and nose. Painful and red. Have not sought treatment. The events were reported as eventually medically significant for giant hives and non-serious for small hives, painful, red. The outcome of the events were not recovered for Giant hives, unknown for Small hives, Painful, red. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1733035 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-07
   Days after vaccination:17
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: Menstruation delayed, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101205443

Write-up: many/Nausea; Late period; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109130907478750-KEHCT, Safety Report Unique Identifier GB-MHRA-ADR 25930621. A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on 21Aug2021, as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as single dose for COVID-19 immunization. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, after second dose of vaccine, the patient experienced many/nausea. On 07Sep2021, 17 days after second dose of vaccine, the patient experienced late period. Events were reported as serious, medically significant. Patient''s period was always accurate to the day. Many, if not a majority, of patient''s female friends said that the vaccine has had significant effects on their menstrual cycle. Adverse reaction did not occur as a result of an exposure during pregnancy. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative, on an unspecified date. The clinical outcome of the event many/nausea was reported as unknown and clinical outcome of the event late period was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733081 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Chest discomfort, Headache, Illness, Pain, Pain of skin, Somnolence, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101205509

Write-up: Asthma; skin pain/sore skin; Sickness; Sleepy; Tight chest; Headache; wheezing; Aching all over; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109131935020760-0ENP7 and Safety Report Unique Identifier is GB-MHRA-ADR 25933942. A 16-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number unknown),via an unspecified route of administration on 07Sep2021 (at the age of 16-year-old) as dose 1, single for COVID-19 immunization. Medical history included asthmatic. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. It was reported that adverse reaction did not occur as a result of an exposure during pregnancy. On an unspecified date in 2021, the patient experienced wheezing and aching all over. On 07Sep2021, she experienced headache, sickness, sleepy and tight chest (needed her inhaler for the asthma as wheezing). On 08Sep2021, the patient experienced asthma and skin pain/sore skin. The outcome of event wheezing and aching all over was unknown. The patient had not yet recovered from asthma, skin pain and had recovered in 2021 from events sickness and sleepy and patient was resolving from rest of the events. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-09-07
   Days after vaccination:17
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: Blood test, Hypoaesthesia, Muscle spasms, Myalgia, Paraesthesia, SARS-CoV-2 test, Sciatica
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:no blood clot; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101205489

Write-up: muscle pain; Pins and needles; Leg cramps; Numbness in leg; Sciatica; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109132248167660-NEIWN, Safety Report Unique Identifier GB-MHRA-ADR 25935500. A 22-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for Injection Batch/Lot Number were not reported), dose 2 via an unspecified route of administration on 21Aug2021 as dose 2, single for COVID-19 immunization. Medical history included clinical trial participant from an unknown date and unknown if ongoing. Historical vaccine included BNT162B2 for dose 1 for COVID-19 Immunisation on an unspecified date. The patient has not had symptoms associated with COVID-19. The patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient was referred to hospital to check for blood clots. Hospital reluctant to Scan so only took bloods which were all fine. Told to go home and rest and told its nots vaccine related. Muscle pain started after vaccine and has been ongoing ever since but week 3 was when it for unbearable pain. The patient experienced muscle pain on an unspecified date, pins and needles, leg cramps, numbness in leg on 12Sep2021, sciatica on 07Sep2021. The patient underwent lab tests and procedures which included COVID-19 virus test was no - negative covid-19 test, blood test with no blood clot. The outcome of the events muscle pain was recovering, pins and needles, leg cramps, numbness in leg was not recovered, sciatica was recovered with sequel. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1733118 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA NOT KNOWN / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Cyanosis, Dyspnoea, Influenza like illness, SARS-CoV-2 test, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210908; 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: increased work of breathing; Blue lips; felt unwell; flu like; high temp; This case was received via regulatory authority (Reference number: GB-MHRA-ADR 25954993) 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 DYSPNOEA (increased work of breathing) and CYANOSIS (Blue lips) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. Not known) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Suspected COVID-19 from 07-Sep-2021 to 10-Sep-2021. On 07-Sep-2021, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced CYANOSIS (Blue lips) (seriousness criterion medically significant), VACCINATION COMPLICATION (felt unwell), INFLUENZA LIKE ILLNESS (flu like) and BODY TEMPERATURE INCREASED (high temp). On an unknown date, the patient experienced DYSPNOEA (increased work of breathing) (seriousness criterion medically significant). On 07-Sep-2021, CYANOSIS (Blue lips) had resolved. At the time of the report, DYSPNOEA (increased work of breathing), VACCINATION COMPLICATION (felt unwell), INFLUENZA LIKE ILLNESS (flu like) and BODY TEMPERATURE INCREASED (high temp) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Sep-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication information not provided. Body temperature was reported as 38.5. Treatment information not provided. Company comment: This case concerns a 18-year-old male patient with no relevant medical history, who experienced the unexpected events of Cyanosis and Dyspnea. The events occurred on the same day after receiving a dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.; Sender''s Comments: This case concerns a 18-year-old male patient with no relevant medical history, who experienced the unexpected events of Cyanosis and Dyspnea. The events occurred on the same day after receiving a dose of mRNA-1273 (Moderna CoviD-19 Vaccine). The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) in not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however there was no information in the source document supporting that the events resulted in a persistent or permanent incapacity.


VAERS ID: 1733364 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Hyperpyrexia
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: Allergy to animal (Allergic to cat hair); Grass allergy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: 40.5 at 4 am; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: 39; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: 38.5; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: 39
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via a regulatory authority (Reference number: IT-MINISAL02-781751) 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 HYPERPYREXIA in a 12-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. Concurrent medical conditions included Grass allergy and Allergy to animal (Allergic to cat hair). On 06-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced HYPERPYREXIA. The patient was treated with PARACETAMOL for Hyperpyrexia, at an unspecified dose and frequency. At the time of the report, HYPERPYREXIA was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 40.5 (High) 40.5 at 4 am, 39 (High) 39, 38.5 (High) 38.5 and 39 (High) 39. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. At the time of this report, the patient''s body temperature was 37.8. Company Comment: This is a RA report of Hyperpyrexia (IME listed, but reported as non-serious by RA as per recovered), in a 12 year-old male; a few hours after first dose administration. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Translation document received on 22 Sep 2021 included dose number, medical history, lab data and treatment medication.; Sender''s Comments: This is a RA report of Hyperpyrexia (IME listed, but reported as non-serious by RA as per recovered), in a 12 year-old male; a few hours after first dose administration. The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report


VAERS ID: 1733452 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-05
Onset:2021-09-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9873 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Platelet count decreased
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101192948

Write-up: Platelets decreased; This is a spontaneous report from a non-contactable pharmacist received via Regulatory Authority. A non-pregnant 48-year-old female received on 05Sep2021 at 12:00 (the day of vaccination), the patient received the second single dose of BNT162b2(COMIRNATY, Solution for injection, Lot number FC9873, Expiration date 30Sep2021) for COVID-19 immunization at the age of 48-years. It was unknown that whether the patient received medicine within 4 weeks prior to the COVID vaccine or not. Prior to vaccination, whether the patient was diagnosed with COVID-19 or not was unknown. Medical history and concomitant medications were not reported. On an unspecified date, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown) for COVID-19 immunization. On 07Sep2021(2 days after the vaccination), the patient experienced platelets decreased. The reporter classified the event as serious (hospitalization) and stated the event resulted in hospitalized (Sep2021). The outcome of the event was unknown. Weather the patient received treatment or not was unknown. Since the vaccination, whether the patient has not been tested for COVID-19 or not was unknown. No follow up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Platelets decreased. 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: 1733508 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005685 / 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? 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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Anaphylaxis; This case was received via RA (Reference number: 2021TJP092098) on 08-Sep-2021 and was forwarded to Moderna on 20-Sep-2021. This case, initially reported to the Regulatory Agency (RA) by a pharmacist, was received via the PMDA (Ref, v21126149). A patient with allergic history: Grilled fish and fish fat, Ragweed On 07-Sep-2021, at 11:00, the patient received the 1st dose of this vaccination. At 11:10, anaphylaxis developed. Itching in the head and dyspnea were found. Queasy and urticaria was not noted. At 11:15, BP 95/80 mmHg, P 105 times/min, SpO2 99%. At 11:28, BP 161/111 mmHg. Adrenaline 0.3 mg was injected intramuscularly. Subjective symptoms did not improve, so the patient requested an ambulance. At 12:03, the patient arrived at the hospital. BP 161/84 mmHg, P80 times/min, SpO2 100% (oxygen 4 mL/min). The patient had a dyspnea and fairly small hoarse. The patient was not able to breathe deeply. Wheezing was present. A slight productive cough was noted. The face was slightly flushed, and there is no conspicuous skin eruption on the trunk. At 12:10, d-chlorpheniramine maleate was intravenously injected. At 12:25, subjective symptoms markedly improved. The patient was able to talk as usual. BP 160/93 mmHg, P 75 times/min, SpO2 99% (oxygen 4 mL/min). At 12:30, oxygen was changed to 3mL/min. At 12:33, SpO2 98 to 99% (oxygen 1.5 mL/min). At 12:35, SpO2 96 to 98% (without oxygen). No dyspnea was found. At 14:00, symptomatic recovery was confirmed. The patient returned home without recurrence of the symptom. The outcome of anaphylaxis was reported as recovered. 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 51 year old female patient with medical history of allergies, who experienced the expected event of anaphylactic reaction. The event occurred approximately 5 minutes after the first dose of the Moderna COVID-19 vaccine. The rechallenge was not applicable. The event is considered related to the product per the reporter''s assessment. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report.


VAERS ID: 1738082 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4721 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Angiogram, Angiogram cerebral, Auscultation, Blood glucose, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, Brain herniation, Brain injury, C-reactive protein, Cerebral disorder, Cerebral haematoma, Cerebral haemorrhage, Cerebral ventricle collapse, Coma, Computerised tomogram, Drug screen, Emergency care examination, Heart rate, Hypotonia, Intracranial aneurysm, Irregular breathing, Miosis, Muscle spasms, Neurological decompensation, Neurological examination, SARS-CoV-2 test, Screaming, Stertor, Subarachnoid haemorrhage, Tongue biting, Vomiting, Weight
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (broad), Dystonia (broad), Drug abuse and dependence (broad), 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 (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke (father suffered a stroke at age 40)
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Cranial CT angiography; Result Unstructured Data: Test Result:large intraparenchymal hematoma; Comments: large intraparenchymal hematoma with temporal extension and white matter of semioral centers, centered on left basal ganglia with signs of active bleeding. No drainage or dilation of veins is observed. It associates contralateral deviation of the midline of 8 mm, with displacement and collapse of the left lateral ventricle. Obliteration of the cisterns of the base with signs of left uncal herniation. It impresses a fusismatic aneurysmal dilation of 8 mm in the left middle cerebral artery in M2 portion. An arteriovenous malformation is not ruled out.; Test Date: 20210907; Test Name: cranial angiographic study; Result Unstructured Data: Test Result:dissecting aneurysm of the middle cerebral artery; Test Date: 20210907; Test Name: auscultation; Result Unstructured Data: Test Result:Rhythmic heart auscultation not murmurs; Test Date: 20210907; Test Name: Auscultation; Result Unstructured Data: Test Result:sternous breathing with irregular breathing patter; Comments: sternous breathing with irregular breathing pattern; Test Date: 20210907; Test Name: blood glucose; Test Result: 215 mg/dl; Test Date: 20210907; Test Name: potassium; Result Unstructured Data: Test Result:2.7 mEq/l; Test Date: 20210907; Test Name: blood pressure; Result Unstructured Data: Test Result:117/85; Test Date: 20210907; Test Name: sodium; Result Unstructured Data: Test Result:140; Test Date: 20210907; Test Name: urea; Test Result: 24 mg/dl; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Test Date: 20210907; Test Name: Computed axial tomography; Result Unstructured Data: Test Result:large intraparenchymal hemorrhage; Comments: large intraparenchymal hemorrhage centered on left basal ganglia, of 5.9x4.4x3.1cm (Anteroposterior, Cerebellum and Thalasmic respectively) with component of subarachnoid hemorrhage in ipsolateral frontoparietal cortical grooves and more doubtful in both Silvian valleys. Probable underlying injury is observed.; Test Date: 20210907; Test Name: c-reactive protein; Result Unstructured Data: Test Result:<0.54 mg/dl; Test Date: 20210907; Test Name: Drug abuse screening; Test Result: Negative ; Test Date: 20210907; Test Name: emergency care examination; Result Unstructured Data: Test Result:Soft and depressible abdomen; Comments: Soft and depressible abdomen without masses or megalias. otolaryngology: bite of the tongue in the right lateral area. Nondescript rest.; Test Date: 20210907; Test Name: heart rate; Result Unstructured Data: Test Result:70; Comments: bpm; Test Date: 20210907; Test Name: neurological examination; Result Unstructured Data: Test Result:Pointed pupils with arreactive miosis.; Comments: Pointed pupils with arreactive miosis. Glasgow 7 (ocular 2, verbal 2, motor 3).; Test Date: 20210907; Test Name: Polymerase chain reaction SARS-COV2; Test Result: Negative ; Test Date: 20210907; Test Name: weight; Test Result: 55 kg
CDC Split Type: ESPFIZER INC202101228423

Write-up: Cerebral haemorrhage; dissecting aneurysm of the middle cerebral artery; subarachnoid hemorrhage; left uncal herniation; neurological depression; coma; has woken up from the nap screaming; hypotonia; agitation; spasmodic movements; food vomit; large intraparenchymal hematoma/large intraparenchymal hemorrhage centered on left basal ganglia, of 5.9x4.4x3.1cm; computed axial tomography (CT) of the central nervous system showed probable underlying injury; arreactive myosis; sternous breathing; irregular breathing pattern; tongue bite on the right side; contralateral deviation of the midline of 8 mm; collapse of the left lateral ventricle; fusiform aneurysmal dilation of 8 mm in the left middle cerebral artery; This is a spontaneous report from two contactable physicians downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number ES-AEMPS-1002203. A 13-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unknown route of administration at age of 13-years, on 07Sep2021 (Lot Number: FE4721) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Her father suffered a stroke at age 40. Historical Vaccine included the first dose of bnt162b2 (COMIRNATY) via intramuscular on 14Aug2021 (Lot Number: FG4442) as single dose for covid-19 immunisation. The patient experienced cerebral haemorrhage (life threatening), dissecting aneurysm of the middle cerebral artery, subarachnoid hemorrhage, left uncal herniation, neurological depression, coma, has woken up from the nap screaming, hypotonia, agitation, spasmodic movements, food vomit, large intraparenchymal hematoma/large intraparenchymal hemorrhage centered on left basal ganglia, of 5.9x4.4x3.1cm, probable underlying injury, arreactive myosis, sternous breathing, irregular breathing pattern, tongue bite on the right side, contralateral deviation of the midline of 8 mm, collapse of the left lateral ventricle, fusiform aneurysmal dilation of 8 mm in the left middle cerebral artery, all on 07Sep2021. The patient was hospitalized for above events. Therapeutic measures were taken. Events outcome was not recovered. The clinical course was reported as follows: The patient received the second dose of Comirnaty on 07Sep2021 and hours later presents a sudden episode of neurological depression and coma. The mother explains that she has woken up from the nap screaming, and alternating episodes of agitation with hypotonia. She has made some spasmodic movements and a food vomit. Upon arrival at the emergency room, computed axial tomography (CT) of the central nervous system is performed, showing a large intraparenchymal hemorrhage centered on left basal ganglia, of 5.9x4.4x3.1cm (Anteroposterior, Cerebellum and Talamic respectively) with component of subarachnoid hemorrhage in ipsilateral frontoparietal cortical grooves and more doubtful in both Silvian valleys. Probable underlying injury is observed. Physical examination: Estimated weight 55 kg, Blood pressure 117/85, Heart rate 70 bpm Temperature 36.4 C. Pointed pupils with arreactive myosis. Glasgow 7 (ocular 2, verbal 2, motor 3). Rhythmic heart auscultation not murmurs, Respiratory ausculatacion sternous breathing with irregular breathing pattern. Soft and depressible abdomen without masses or megalias. otolaryngology: bite of the tongue in the right lateral area. Nondescript rest. Complementary studies: Screening drugs abuse: negative, glucose 215 mg/dl, urea 24 mg/dl, c-reactive protein less than 0.4 mg/dl, potassium 2.7 mEq/l, sodium 140. Polymerase chain reaction SARS-COV2 negative. She is stabilized and referred to the intensive care-pediatric unit of tertiary hospital where emergency decompressive craniotomy is performed. Cranial angiographic study shows a dissecting aneurysm of the middle cerebral artery. Cranial CT angiography: large intraparenchymal hematoma with temporal extension and white matter of semioral centers, centered on left basal ganglia with signs of active bleeding. No drainage or dilation of veins is observed. It associates contralateral deviation of the midline of 8 mm, with displacement and collapse of the left lateral ventricle. Obliteration of the cisterns of the base with signs of left uncal herniation. It impresses a fusismatic aneurysmal dilation of 8 mm in the left middle cerebral artery in M2 portion. An arteriovenous malformation is not ruled out. The patient continues with hemodynamic ventilation, ionotropic support and intracranial pressure monitoring. The prognosis is very serious. The outcome will be monitored. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1738149 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-09-07
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101204457

Write-up: thrombus in leg; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 40-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 27Jul2021 for COVID-19 immunization. It was reported that patient received the "last dose" of vaccine. The patient medical history and concomitant medications were not reported. On 07Sep2021, the patient was detected a thrombus in leg. The patient asked if It is possible that it has some kind of relationship with respect to vaccine. The outcome of the event was unknown. The lot number for [BNT162B2], was not provided and will be requested during follow up


VAERS ID: 1738824 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Headache, Nausea, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101211308

Write-up: Diarrhea; Nausea; Sneezing excessive; Headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202109141649173220-C0VS7, Safety Report Unique Identifier GB-MHRA-ADR 25939965. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3380) via an unspecified route of administration on 06Sep2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications were not reported. On 07Sep2021, 1 day after vaccination, the patient experienced headache; on 09Sep2021, 3 days after vaccination, the patient experienced sneezing excessive, on 13Sep2021, 7 days after vaccination, the patient experienced diarrhea and nausea; all the events were reported as serious for being medically significant. On 14Sep2021, the patient underwent COVID-19 virus test and the result was negative. The clinical outcome of the events headache and sneezing excessive was not recovered, diarrhea was recovering whereas that of the event nausea was recovered on 14Sep2021, after a duration of 1 day at the time of this report. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1739024 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

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

Write-up: Fever; Headache; Chills; Generalised aching; This case was received via a Regulatory Authority (Reference number: GB-MHRA-ADR 25965268) on 19-Sep-2021 and was forwarded to Moderna on 19-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), HEADACHE (Headache), CHILLS (Chills) and PAIN (Generalised aching) in a 42-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant) and PAIN (Generalised aching) (seriousness criterion medically significant). On 08-Sep-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. On 09-Sep-2021, HEADACHE (Headache) and PAIN (Generalised aching) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Concomitant medication was not provided by the reporter. Patient did not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient did not test positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Treatment medications was not provided by the reporter. Company Comment: This case concerns a 42-year-old, female patient with no relevant medical history, who experienced the unexpected event of pain, and the expected events pyrexia, headache and chills. The events occurred 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events pyrexia, headache and chills are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. 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 42-year-old, female patient with no relevant medical history, who experienced the unexpected event of pain, and the expected events pyrexia, headache and chills. The events occurred 1 day after the second dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the first dose was disclosed. The events pyrexia, headache and chills are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. 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: 1739242 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FG4686 / 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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101194063

Write-up: syncopal episode(loss of consciousness and faint/absence of pulse for about 40 seconds. after stimulation the patient regains his senses and consciousness).For further comments sent to Emergency Room; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-781574. A 19-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG4686, Expiry date was not reported), via intramuscular route of administration, administered in left deltoid on 07Sep2021 at 10:30 (at the age of 19-years-old) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 07Sep2021, after vaccination, the patient experienced syncopal episode (loss of consciousness and faint/absence of pulse for about 40 seconds. after stimulation the patient regains his senses and consciousness) for further comments sent to emergency room. The event resulted in hospitalization. Patient had stimulation and control of vital parameters. The clinical outcome of the event was recovering at the time of report. No follow-up attempts possible. No further information expected.


VAERS ID: 1739307 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature decreased, Headache, Heart rate, Heart rate decreased, Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:drop; Test Date: 20210907; Test Name: Heart rate; Result Unstructured Data: Test Result:drop
CDC Split Type: ITPFIZER INC202101195201

Write-up: Same day: Asthenia, arm pain, drop in body temperature and heart rate. Next day: headache and lower limb numbness is added; Same day: Asthenia, arm pain, drop in body temperature and heart rate. Next day: headache and lower limb numbness is added; Same day: Asthenia, arm pain, drop in body temperature and heart rate. Next day: headache and lower limb numbness is added; Same day: Asthenia, arm pain, drop in body temperature and heart rate. Next day: headache and lower limb numbness is added; Same day: Asthenia, arm pain, drop in body temperature and heart rate. Next day: headache and lower limb numbness is added; Same day: Asthenia, arm pain, drop in body temperature and heart rate. Next day: headache and lower limb numbness is added; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-782351. A 30-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG6273, Expiration date not reported) via intramuscular route, administered in left arm on 07Sep2021 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Same day, on 07Sep2021, the patient experiencedi asthenia, arm pain, drop in body temperature and heart rate, headache and lower limb numbness. Impact on quality-of-life 6/10. The outcome of all events was not recovered. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: None


VAERS ID: 1739319 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Hypoaesthesia, Investigation, Myalgia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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:
Allergies:
Diagnostic Lab Data: Test Name: Screening test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101195982

Write-up: lower limb hypoesthesia (anterior femoral cutaneous region); injection site pain; Chills; twin muscle soreness; Headache; This is a spontaneous report from a contactable physician downloaded from the regulatory authority IT-MINISAL02-782499. A 29-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscularly administered in left arm at the age of 29-years-old on 07Sep2021 10:20 (Lot Number: FG6273; Expiration Date: 30Nov2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced lower limb hypoesthesia (anterior femoral cutaneous region), injection site pain, chills, twin muscle soreness and headache on 07Sep2021. The events were medically significant. The outcome of the events was recovering. The patient underwent lab tests and procedures which included screening test: unknown results. Therapeutic measures were taken as a result of the events. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739383 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FF5357 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypertension (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psoriatic arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Blood pressure; Result Unstructured Data: Test Result:172/114; Test Date: 20210907; Test Name: Blood pressure; Result Unstructured Data: Test Result:175/106; Test Date: 20210908; Test Name: Blood pressure; Result Unstructured Data: Test Result:158/106; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210908; Test Name: Body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Test Date: 20210907; Test Name: heart rate; Result Unstructured Data: Test Result:121; Test Date: 20210907; Test Name: heart rate; Result Unstructured Data: Test Result:103; Test Date: 20210908; Test Name: heart rate; Result Unstructured Data: Test Result:87; Test Date: 20210908; Test Name: SpO2; Test Result: 97 %
CDC Split Type: JPPFIZER INC202101193710

Write-up: Anaphylaxis; blood pressure 172/114; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. Regulatory authority report number is v21126559. A 44-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FF5357; Expiration Date: 30Nov2021), via an unspecified route of administration on 07Sep2021 14:00 at the age of 44-year-old as dose 1, single for covid-19 immunisation. Medical history included patient had a history of psoriatic arthritis and anaphylaxis caused by a contrast medium for CT (IOPAMIRON) (about two years ago). On 07Sep2021 at 14:05 (the day of vaccination), the patient experienced anaphylaxis. The course of the event was as follows: At five minutes after the vaccination of BNT162B2, the patient experienced palpitations, queasy, feels poorly, eyelid oedema, redness of eyelid, itchy sensation of upper and lower limbs and tingling sensation of upper and lower limbs. Feeling of dyspnoea appeared. No blood pressure immeasurable (high values). After intramuscular injection of adrenaline 0.3 mg, blood pressure: 172/114, and heart rate: 121. After intravenous infusion of SOLU-MEDROL 125 mg (+ saline 100 mL) and intravenous injection of POLARAMINE 5 mg (+ saline 20 mL), blood pressure: 175/106, and heart rate: 103. Numbness of limbs and feels poorly were improved, but the patient was admitted to hospital on 07Sep2021 for observation. During the morning on the following day, the patient was discharged on 08Sep2021 without relapse of the symptoms. Blood pressure: 158/106, heart rate: 87, body temperature: 35.4 degrees Centigrade, and SpO2: 97%. The reporting pharmacist classified the events as serious(caused hospitalization from 07Sep2021 to 08Sep2021) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The outcome of event was recovered on 08Sep2021. The reporting pharmacist commented as follows: Possible anaphylactic symptoms due to Comirnaty vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739392 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FD0349 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Auscultation, Body temperature, Cough, Erythema, Hypersensitivity, Pruritus, Rales, Respiratory rate increased, Scratch, Tachycardia
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Accidents and injuries (narrow), Hypersensitivity (narrow), 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? 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: Drug allergy (drug allergy with several sorts of drugs such as NIFLAN, PL, and other.)
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: neck Auscultation; Result Unstructured Data: Test Result:continuous rales was audible; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101198399

Write-up: Anaphylaxis; cough/Cough aggravated; continuous rales; redness and itching occurred on the neck and the precordial chest; redness and itching occurred on the neck and the precordial chest; scratched the neck, precordial chest, trunk, and lower limbs; respiratory rate increased; tachycardia tendency; Type-1 allergy skin symptoms; This is a spontaneous report from a contactable physician received from the Regulatory authority; report number is v21126595. The patient was a 61-year and 2-month-old female. Body temperature before vaccination was 36.6 degrees Centigrade. The patient has a medical history suggestive of drug allergy with several sorts of drugs such as NIFLAN, PL, and other. On 17Aug2021, the 1st vaccination against Novel Coronavirus (Pfizer) was performed. On 17Aug2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot# number and Expiration date were unknown) at single dose for COVID-19 immunization, without adverse event. On 07Sep2021 at 14:20 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FD0349, Expiration date 31Oct2021) via an unspecified route of administration as a single dose for COVID-19 immunization (61-year-old at the time of vaccination). On 07Sep2021 at 14:48 (28 minutes after the vaccination), the patient experienced Anaphylaxis. On 07Sep2021 (the day of vaccination), the patient was admitted to the hospital. On 08Sep2021 (1 day after the vaccination), the outcome of the event was recovering. The course of the event was as follows: On 07Sep2021, a while after the 2nd vaccination against Novel Coronavirus, the patient presented with cough. Persistent cough with occasional, several episodes was present. Slight, continuous rales was audible on an auscultation of neck, and the vital signs were carefully followed up, but apparent redness and itching occurred on the neck and the precordial chest. The patient frequently scratched the neck, precordial chest, trunk, and lower limbs and presented with respiratory rate increased and tachycardia tendency. Type-1 allergy skin symptoms occurred almost systemically, and slight continuous rales were audible at an auscultation of neck. Persistent cough with aggravating tendency developed. Those findings were judged to be consistent with the diagnostic criteria of anaphylaxis. The patient underwent therapy with Bosmin 0.3mg intramuscular injection, isotonic sodium chloride solution (500) IV with an infusion access secured, polaramine (5) 1A intravenous injection (IV), famotidine 1A IV, and another Bosmin 0.5 mg, which slowly alleviated the symptoms. The reporting physician classified the event as serious (Hospitalized from 07Sep2021 to 08Sep2021) 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: 1739394 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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 INC202101198492

Write-up: Deafness unilateral; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. A 7-decade-old (in her 60s) female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. About 07Sep2021 (after the vaccination), the patient experienced deafness unilateral. The patient went to a nearby otolaryngologist. The patient was given steroids at the otolaryngologist and recovered shortly thereafter. The outcome of the event was resolved about 09Sep2021. 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 temporal association, a possible contributory role of BNT162B2 to the development of deafness unilateral 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: 1739663 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-09-07
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF8871 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pain, Pyrexia, SARS-CoV-2 test, Throat irritation
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210910; Test Name: Covid-19 PCR Test; Test Result: Positive
CDC Split Type: PHPFIZER INC202101219766

Write-up: fever; loss of smell; General body pain; Itchy throat; COVID-19 PCR test positive; COVID-19 PCR test positive; loss of taste; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300105104. A 24-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FF8871), via intramuscularly, administered on 17Aug2021 (age at vaccination was 24 years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient experienced loss of taste on 07Sep2021 at 11:00. On 10Sep2021 the patient had Covid-19 PCR test positive (medically significant). On an unspecified date the patient experienced general body pain, fever, itchy throat and loss of smell and loss of taste. The patient underwent lab tests which included Covid-19 PCR Test: positive on 10Sep2021. Outcome of the events general body pain and fever was recovered on an unspecified date and other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1739841 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-07
   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 - / 2 - / -

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? 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: Common cold; Rhinorrhoea; Sinus disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101195636

Write-up: Myopericarditis; chest pain; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB SE-MPA-2021-082437. A 18-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Sep2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included symptoms of a common cold with rhinorrhoea and swollen sinuses. The patient''s concomitant medications were not reported. Three days post second dose of vaccination (on 07Sep2021), the man had symptom debut of heavy chest pain, which was worsened with breathing or change of position. There was a minor release of Troponin, but no affect on the cardiac pump function or an increased amount of pericardial effusion. The symptoms were assessed as myopericarditis. Report assessed as serious (hospitalization). The outcome of the events was recovering. The statement of the reporting physician read: "The myopericarditis probably has an infectious genesis, however an adverse reaction can not be ruled out." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1740462 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE430 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure decreased, Blood pressure measurement, Blood pressure systolic, Body temperature, Dizziness, Haemoglobin, Heart rate, Heart rate irregular, Hyperhidrosis, Loss of consciousness, Nausea, Oxygen saturation, Pallor, Respiratory rate, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (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: Comments: Patient did not have any history of similar event. Patient did not have any previous reactions or adverse event after immunisation. Patient did not have any history of allergy (vaccine, food, drugs). Patient did not have any family history of any allergies and any disease (relevant to AEFI). Patient had no pre-existing medical condition/congenital disorder and any pre-existing acute illness (30 days) prior to vaccination. Patient had not suffering from any medical condition currently. Patient did not have any history of hospitalization in last 30 days. Patient was not tested for covid-19 positive prior to vaccination. The patient used cannabis and unknown drug prior to the vaccination.
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: Blood pressure; Result Unstructured Data: 70/40 mmHg; Test Date: 20210907; Test Name: Respiratory rate; Result Unstructured Data: 12 {breaths}/min; Test Date: 20210907; Test Name: Heart rate; Result Unstructured Data: 89 {beats}/min; Test Date: 20210907; Test Name: Blood glucose; Result Unstructured Data: 4.8; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: 36.5 degree celcius; Test Date: 20210907; Test Name: Haemoglobin; Result Unstructured Data: 10.9 g/dL; Test Date: 20210907; Test Name: Oxygen saturation; Result Unstructured Data: 97 %; Test Date: 20210907; Test Name: Systolic blood pressure; Result Unstructured Data: 106/68 mmHg
CDC Split Type: ZAJNJFOC20210936907

Write-up: LOSS OF CONSCIOUSNESS; FAINT AFTER COVID VACCINE/COLLAPSED/SHOCK-LIKE STATE; BLOOD PRESSURE DECREASED/NO BLOOD PRESSURE; IRREGULAR HEARTBEAT; DIZZINESS; SWEATY; PALE; VOMITING; NAUSEA; This spontaneous report received from a health care professional concerned a 19 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: Patient did not have any history of similar event. Patient did not have any previous reactions or adverse event after immunisation. Patient did not have any history of allergy (vaccine, food, drugs). Patient did not have any family history of any allergies and any disease (relevant to AEFI). Patient had no pre-existing medical condition/congenital disorder and any pre-existing acute illness (30 days) prior to vaccination. Patient had not suffering from any medical condition currently. Patient did not have any history of hospitalization in last 30 days. Patient was not tested for covid-19 positive prior to vaccination. The patient used cannabis and unknown drug prior to the vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE430, expiry: 23-MAY-2023) dose was not reported, 1 total, administered on 07-SEP-2021 11:00 for prophylactic vaccination. No concomitant medications were reported. On 07-SEP-2021, patient was faint after covid vaccine/collapsed/shock-like state within 10 minutes after administrating of vaccine, had loss of consciousness, no blood pressure (BP) after 5 minutes, blood pressure after 10 minutes was 70/40 mmHg (blood pressure decreased). Further reported that, 15 minutes after vaccination, patient had dizziness, nausea and vomiting. The patient also had irregular heartbeat, pale and sweating oriented to time and place. Patient was hospitalized on 07-SEP-2021. Number of days of hospitalization was not reported. It was unknown if patient was discharged. Laboratory data included: Blood glucose (NR: not provided) 4.8, Blood pressure (NR: not provided) 70/40 mmHg, Body temperature (NR: not provided) 36.5 degree celcius, Haemoglobin (NR: not provided) 10.9 g/dL, Heart rate (NR: not provided) 89 (beats)/min, Oxygen saturation (NR: not provided) 97 percent, Respiratory rate (NR: not provided) 12 (breaths)/min, and Systolic blood pressure (NR: not provided) 106/68 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from faint after covid vaccine/collapsed/shock-like state, vomiting, nausea, blood pressure decreased/no blood pressure, irregular heartbeat, dizziness, pale and sweaty, and loss of consciousness. This report was serious (Hospitalization Caused / Prolonged, and Disability or Permanent Damage). This case, from the same reporter is linked to 20210936890.; Sender''s Comments: V0: 20210936907-covid-19 vaccine ad26.cov2.s-faint after covid vaccine/collapsed/shock-like state, blood pressure decreased/no blood pressure, irregular heartbeat, dizziness, pale and sweaty, and loss of consciousness. 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: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY 20210936907- covid-19 vaccine ad26.cov2.s-vomiting, nausea. The case causality is considered NOT RELATED. Rationale: There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, MEDICAL HISTORY


VAERS ID: 1740498 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005694 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Depressed level of consciousness
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Decrease in consciousness; This case was received via Regulatory Authority (Reference number: JP-TAKEDA-2021TJP094378) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the Agency by a physician, was received via the RA (Ref, v21126700). Decrease in consciousness was assessed as serious. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 07-Sep-2021, at 14:40, the patient received the 1st dose of this vaccine. After the vaccination, decrease in consciousness developed. BP was 77/42, P was impalpable, and there was consciousness. Drip infusion was started at bed rest with leg elevation. Thereafter, the patient was awake and alert, and BP was 111/68 with P 80 and Sp02 98%. After receiving an explanation, the patient went home. The outcome of decrease in consciousness was reported as recovered. 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. Company Comment: This case refers to a 30-year-old female patient with no known medical history who experienced the unexpected event of Depressed Level of Consciousness on the same day after receiving the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is assessed as possibly related by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender''s Comments: This case refers to a 30-year-old female patient with no known medical history who experienced the unexpected event of Depressed Level of Consciousness on the same day after receiving the first dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable since only information about the first dose was disclosed. The event is assessed as possibly related by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.


VAERS ID: 1740499 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005289 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fall, Loss of consciousness, Presyncope, Wound
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Loss of consciousness; Vasovagal reflex; Fall; Mouth haemorrhage; This case was received via (Reference number: JP-TAKEDA-2021TJP094394) on 15-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This case, initially reported to the by a (physician), was received via the (Ref, v21126793). Loss of consciousness was assessed as serious by the . The patient had a history of pyrexia of 38 degrees Celsius after influenza vaccination 5 years ago On an unknown date, body temperature before the vaccination: 35.9 degrees Celsius. On 07-Sep-2021, at 14:50, the patient received the 1st dose of this vaccine. Loss of consciousness developed 4 to 5 minutes after the vaccination. At 14:56, vasovagal reflex developed, and the patient fell on the face while sitting. Mouth haemorrhage developed. The patient responded when the name was called. The patient was followed up in bed, and the facial complexion improved. Bleeding in the mouth also stopped. The physician at the scene instructed to keep the patient in bed for observation. At 16:20, the symptoms were resolving. The patient was picked up by the family member and returned home. The outcome of loss of consciousness, vasovagal reflex, fall, and mouth haemorrhage was reported as resolving. 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 25-year-old, male patient with no relevant medical history, who experienced the unexpected events of loss of consciousness, presyncope, fall, and wound. The events occurred on the same day after the first dose of Moderna vaccine. The reporter assessed the events as not related to the product. The benefit-risk relationship of Moderna vaccine is not affected by this report. Event loss of consciousness assessed as serious per Regulatory Authority reporting and auto-IME, however based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, it is deemed non-serious.


VAERS ID: 1740505 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-07
   Days after vaccination:4
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: 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: SEMODERNATX, INC.MOD20213

Write-up: ; This case was received (Reference number: SE-MPA-2021-082716) on 17-Sep-2021 and was forwarded to Moderna on 17-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS in a 19-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 second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment medication were provided. Company Comment - This case concerns a 19-year-old, male patient, with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 4 days after the second dose of Spikevax. The rechallenge was not applicable since no events were reported after the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Initial Source translation received (Contains significant info with regards to dosage text ); Sender''s Comments: This case concerns a 19-year-old, male patient, with no relevant medical history, who experienced the expected event of Myocarditis. The event occurred approximately 4 days after the second dose of Spikevax. The rechallenge was not applicable since no events were reported after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1742846 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-09-07
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (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: Lymphoma; Mesenteric vein thrombosis (idiopathic mesenteric vein thrombosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202101222854

Write-up: Thrombus formationdeveloped non-occlusive cerebral sinus venous thrombosis in 3 venous sinuses: namely sup sagittal sinus, left lateral and left sigmoid sinus extending to left internal jug vein.; This is a spontaneous report from a contactable physician downloaded. This is a report received from HPRA, regulatory authority number IE-HPRA-2021-084284, Safety Report Unique Identifier IE-HPRA-HMARR-2021091311048. A 38-year-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, Batch/Lot number was not reported) subcutaneous route of administration on 08Aug2021 as dose number unknown, single for COVID-19 immunization. Medical history included idiopathic mesenteric vein thrombosis, CNS lymphoma (her father had an idiopathic mesenteric vein thrombosis at old age, and he was also diagnosed with CNS lymphoma). There were no concomitant medications. The reporter described the patient as a physically active lady who competes as a triathlete (nothing unusual regarding training or competition recently, compliance with hydration). Not on contraception, no severe dehydration episode. No family history of diagnosed thrombophilia diseases. No history of pregnancy or miscarriage. No history of recent travel. The patient was not on contraception. One month later, on 07Sep2021, a thrombus formation was developed as non-occlusive cerebral sinus venous thrombosis in three venous sinuses, namely sup sagittal sinus, left lateral and left sigmoid sinus extending to left internal jug vein. The patient was hospitalized for the event. The patient was treated with therapeutic Clexane. Outcome of the event was reported as not recovered at this time of the report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1742905 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FG3739 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034; Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (last attack in July 2021); Panic attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101209447

Write-up: After 15 minutes after vaccination, tonic-clonic seizures with 3 subentrant accesses in 10 minutes; This is a spontaneous report from a contactable physician downloaded from the regulatory authority number is IT-MINISAL02-783746. A 53-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FG3739; Expiration Date: 30Nov2021) via intramuscular, administered in Arm Left on 07Sep2021 at 15:26 (at the age of 53-year-old) as dose 2, 0.3ml single for COVID-19 immunisation. Medical history included epilepsy for many years (last attack in July 2021) and panic attack. Concomitant medications included carbamazepine (TEGRETOL), lamotrigine (LAMICTAL). On 07Sep2021, the patient experienced after 15 minutes after vaccination, tonic-clonic seizures with 3 subentrant accesses in 10 minutes. Outcome of the event was recovering. Health Authority Comment: The patient has a history of epilepsy for many years, last attack in Jul2021, lives alone, possible non-adherence to therapy. During the pre-vaccination visit she stated that she has no allergies. It is reasonable to assume that the event is not related to vaccination. No follow-up attempts are possible, no further information is expected. ; Sender''s Comments: Based on current information available, the event tonic-clonic seizures mostly represented intercurrent condition in this patient with relevant history, unrelated to Bnt162b2.


VAERS ID: 1743040 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram thorax, Hypoxia, Interstitial lung disease, Lung opacity, Malaise, Pyrexia, SARS-CoV-2 test
SMQs:, Asthma/bronchospasm (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Pfizer, Inc. EUA 027034
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210907; Test Name: body temperature; Result Unstructured Data: Test Result:Pyrexia of 38.5-39 degrees Centigrade; Comments: From noon; Test Date: 20210907; Test Name: Chest CT; Result Unstructured Data: Test Result:interstitial shadow in the right lung; Test Date: 20210907; Test Name: covid19 PCR; Test Result: Negative
CDC Split Type: JPPFIZER INC202101199099

Write-up: General malaise; Pyrexia of 38.5-39 degrees Centigrade; Chest CT showed interstitial shadow in the right lung; Interstitial pneumonia; Hypoxaemia; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21126630. A 57-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration on 06Sep2021 at 16:00 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination (06Sep2021) was 36.5 degrees centigrade. The patient''s medical history was not reported. The patient''s concomitant medications included triazolam (HALCION), oral from unspecified date and ongoing. The patient''s history according to 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 HALCION which was being taken orally. The course of the event was as follows: on 06Sep2021, the vaccination was received. From the morning of 07Sep2021 (reported as 07Sep2021 at 9:00), general malaise appeared: from noon, the patient had pyrexia of 38.5-39 degrees centigrade, and the patient also had hypoxaemia, so the patient visited a medical center. Chest computed tomography (CT) showed interstitial shadow in the right lung and COVID-19 polymerase chain reaction (PCR) was negative. After being hospitalized, antibiotic treatment was started. On 08Sep2021, after administration of 100 mg of acetaminophen, the pyrexia had disappeared. General malaise disappeared. The patient was admitted to the hospital on 07Sep2021 (1 day after the vaccination) and he was discharged on 11Sep2021. The reporting physician classified the event as serious (Interstitial pneumonia, caused hospitalization from 07Sep2021 to 11Sep2021) and assessed that the event was related to bnt162b2. The outcome of the events was resolved on 08Sep2021 for pyrexia and general malaise and resolving for the other events. The reporting physician commented as follows (reporter''s comment): Pneumonia bacterial was unlikely to be improved by administration of antibiotics for about 4 days, and it was highly likely that it might be caused by disorder of COVID-19 vaccine.; Reporter''s Comments: Pneumonia bacterial was unlikely to be improved by administration of antibiotics for about 4 days, and it was highly likely that it might be caused by disorder of COVID-19 vaccine.


VAERS ID: 1743079 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FF4204 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Malaise, Neuropathy peripheral, Off label use, Product use issue, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Medication errors (broad), Immune-mediated/autoimmune disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast feeding.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101207324

Write-up: Peripheral nerve disorder; Abnormal sensation; numbness from the left back to the lumbar area; malaise in left upper body; off-label use; drug use in unapproved population; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21127824. A 40-year-old female patient received first dose bnt162b2 (COMIRNATY; Lot Number: FF4204; Expiration Date: 31Oct2021) via intramuscular route, administered in upper left arm on 07Sep2021 at 15:30 (the day of vaccination, age at vaccination 40 years old) as dose 1, single for covid-19 immunisation. Body temperature before vaccination was not provided. Patient medical history includes breast feeding. The patient''s concomitant medications were not reported. On 07Sep2021 (the day of vaccination), the patient experienced peripheral nerve disorder and abnormal sensation. The off-label use and drug use in unapproved population was reported on 07Sep2021. The course of the event was as follows: The patient received the vaccination via intramuscular in upper left arm. After that, the patient felt numbness from the left back to the lumbar area, with malaise in left upper body on 07Sep2021. The symptoms did not improve after a week and even got aggravated, so the patient came for consultation. The patient was introduced to Neurology Department in another private hospital due to hard evaluation. There was no swelling of the lymph nodes from the body, and the symptoms were not noticeable in the upper limbs. The reporting physician commented as follows: Reported since there was no other risk except the vaccination. Still waiting for the causality assessment from the hospital. On 14Sep2021 (7 days after the vaccination), the outcome of the events was not recovered. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101228200 baby case


VAERS ID: 1743086 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FD0349 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood pressure systolic increased, Body temperature, Eye pruritus, Feeling abnormal, Heart rate, Ocular hyperaemia, Oxygen saturation, Pruritus, Pyrexia, Rash, Throat irritation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol allergy; Drug allergy (allergic to gelatin (such as Gummi),)
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:144/103; Comments: 15:14; Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:109/73; Comments: 15:26; Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:113/79; Comments: 15:39; Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:114/68; Comments: 15:52; Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:119/75; Comments: 16:00; Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:111/75; Comments: 16:10; Test Date: 20210907; Test Name: BP; Result Unstructured Data: Test Result:113/80; Comments: 16:20; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Comments: 15:26; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: 15:39; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: 16:00; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: 15:52; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: 16:10; Test Date: 20210907; Test Name: Body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Comments: 16:20; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:98; Comments: 15:14; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:80; Comments: 15:26; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:81; Comments: 15:39; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:76; Comments: 15:48; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:71; Comments: 15:52; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:70; Comments: 15:52; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:68; Comments: 16:00; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:71; Comments: 16:10; Test Date: 20210907; Test Name: P; Result Unstructured Data: Test Result:67; Comments: 16:20; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %; Comments: 15:14; Test Date: 20210907; Test Name: SpO2; Test Result: 99 %; Comments: 15:20; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %; Comments: 15:26; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %; Comments: 15:39; Test Date: 20210907; Test Name: SpO2; Test Result: 100 %; Comments: 15:48; Test Date: 20210907; Test Name: SpO2; Test Result: 99 %; Comments: 15:52; Test Date: 20210907; Test Name: SpO2; Test Result: 99 %; Comments: 15:52; Test Date: 20210907; Test Name: SpO2; Test Result: 95 %; Comments: 16:00; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %; Comments: 16:10; Test Date: 20210907; Test Name: SpO2; Test Result: 98 %; Comments: 16:20
CDC Split Type: JPPFIZER INC202101207955

Write-up: 37.7 degrees centigrade; Eye itching/ left Eye itching; Ocular hyperaemia; Itchy throat; feels poorly; BP 144/103; Rash/Scalp rash/itching occurred in neck, rash occurred; Itchy scalp/Itching/itching occurred in neck; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21126702. A 30-year and 5-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: FD0349, Expiration date: 31Oct2021) via an unspecified route of administration on 07Sep2021 at 15:09 (the day of vaccination, at the age of 30-year and 5-month-old), as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.5 degrees centigrade on 07Sep2021. 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: alcohol allergy, allergic to gelatin (such as Gummi). Concomitant medications were not reported. The patient previously received an influenza vaccine for influenza immunisation and experienced dyspnoea and urticaria. At the time of consultation had explained the situation with the patient but took the vaccination under the strong will of the patient. The event onset date was reported as on 07Sep2021 (the same day of vaccination). The course of the events was reported as follows: At 15:14 BP (Blood pressure)144/103 P (Heart rate) 98, SpO2 (Oxygen saturation) 98%, Itchy scalp, rash occurred. At 15:20 99%, feels poorly, Scalp rash, itching continued. At 15:26 BP 109/73, P 80, SpO2 98%, T (Body temperature) 37.4, Itchy throat occurred, itching worsen as reported above. At 15:34 no Dyspnoea, no asthma. At 15:39 BP 113/79, P 81, SpO2 98%, T37.0, Ocular hyperaemia. At 15:48 kept route took SOLITA-T No.3 G 200ml, SpO2 100%, P76. At 15:52 took Saline 20 and HYDROCORTONE 100ml, no Dyspnoea, SpO2 99%, P71. BP 114/68, no feels poorly, P70, Itchy scalp, Eye itching. No abnormalities, SpO2 99%, T 37.6. At 16:00, BP 119/75, P 68, SpO2 95% no Dyspnoea, no queasy, no headache, Eye itching occurred, itching occurred in neck, rash occurred. At 16:10 BP 111/75, P 71, SpO2 98% T37.7, itching decreased. At 16:20 BP 113/80, P67, SpO2 98%, T37.6, left Eye itching, itching in neck, rash decreased. At 16:25 DIV Needle Out. D2 diagnosis. Permitted to go home. Went home. Therapeutic measures were received for the events. On 07Sep2021 (the day of vaccination), the outcome of all the events was recovering while outcome of feels poorly was recovered on 07Sep2021 at 15:52. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1744883 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-07
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Electrocardiogram, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hives
Allergies:
Diagnostic Lab Data: Test Name: Blood analysis; Result Unstructured Data: Test Result:everything ok; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:everything ok
CDC Split Type: BEPFIZER INC202101222285

Write-up: Palpitations; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number BE-FAMHP-DHH-N2021-106497. A 15-year-old male patient received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 24Aug2021 as dose 2, single for COVID-19 immunisation. Medical history included hives. Concomitant medication included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported. The patient experienced palpitations on 07Sep2021. Event was considered serious, disability. The patient underwent lab tests and procedures which included blood test and electrocardiogram: everything ok on an unspecified date. Outcome of the event was recovered on 07Sep2021. Reporter''s comments: Treatment - Evolution of the ADR - Restored: several hours. Examinations - electrocardiogram: everything ok blood analysis : everything ok. ADR description - palpitations No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reporter''s Comments: Treatment - Evolution of the ADR - Restored: several hours Examinations - electrocardiogram: everything ok blood analysis: everything ok ADR description - palpitations


VAERS ID: 1744888 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Chills, Extensive swelling of vaccinated limb, Fatigue, Injection site reaction, Malaise, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via regulatory authority (Reference number: BE-FAMHP-DHH-N2021-106518) 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 ANAPHYLACTIC REACTION in a 68-year-old female patient who received mRNA-1273 (Spikevax) (batch no. Code: Vc87a3644d977423) for COVID-19. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced ANAPHYLACTIC REACTION (seriousness criterion medically significant), MALAISE (Malaise), EXTENSIVE SWELLING OF VACCINATED LIMB, INJECTION SITE REACTION, FATIGUE, PYREXIA, CHILLS and MYALGIA. At the time of the report, ANAPHYLACTIC REACTION, MALAISE, EXTENSIVE SWELLING OF VACCINATED LIMB INJECTION SITE REACTION, FATIGUE, PYREXIA, CHILLS and MYALGIA was resolving. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter. Treatment information was not provided. Company Comment: A 68-year-old female developed a serious expected anaphylactic reaction, and non-serious malaise, extensive swelling of vaccinated limb, injection site reaction, fatigue, pyrexia, chills, and myalgia. Latency within 24 hours after second dose. Events resolving. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translation document received on 27 Sep 2021, contains no new information; Reporter''s Comments: Treatment - Evolution of the ADR - Herstellende; Sender''s Comments: A 68-year-old female developed a serious expected anaphylactic reaction, and non-serious malaise, extensive swelling of vaccinated limb, injection site reaction, fatigue, pyrexia, chills, and myalgia. Latency within 24 hours after second dose. Events resolving. Rechallenge not applicable. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.


VAERS ID: 1745852 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-09-07
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Back pain, COVID-19, Dyspnoea, Fatigue, Gait inability, Headache, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (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:
Allergies:
Diagnostic Lab Data: Test Date: 20210909; Test Name: Covid test; Test Result: Positive
CDC Split Type: COPFIZER INC202101240329

Write-up: she informed that she had covid-19; COVID-19; back pain; unable to walk; Lost the sense of taste; fatigue; breathing difficulty; headache; lost the sense of smell; This is a spontaneous report from a contactable consumer (patient). This patient reported for two products. This is the second of two reports. A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on 02Jul2021 (at the age of 52-year-old), as dose 2, single for COVID-19 immunization. The patient also received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown), via an unspecified route of administration on 09Jun2021 (at the age of 52-year-old), as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient experienced back pain, unable to walk, lost the sense of taste, fatigue, breathing difficulty, headache, lost the sense of smell. On 09Sep2021, the patient experienced covid-19 (medically significant), The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 09Sep2021. The clinical outcome of the events covid-19, back pain, unable to walk, lost the sense of taste, fatigue, breathing difficulty, headache, lost the sense of smell were recovered on an unspecified date in 2021. The clinical outcome of the event she informed that she had covid-19 was unknown. Batch number and expiration date have been requested.


VAERS ID: 1746109 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

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

Write-up: Miscarriage; Maternal exposure during pregnancy; This case was received via Regulatory Authority (Reference number: FI-FIMEA-20214665) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 07-Sep-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). 07-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) (seriousness criterion medically significant). The delivery occurred on an unknown date, which was reported as Abortion NOS. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (Miscarriage) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) was resolving. The action taken with mRNA-1273 (Intramuscular) was unknown. No concomitant and treatment medication were provided Company Comment: This case concerns a pregnant female of unknown age with no relevant medical history, who experienced the unexpected non-serious events of maternal exposure during pregnancy and spontaneous abortion. The event spontaneous abortion occurred 5 days after the first dose of Moderna mRNA-1273 vaccine. The gestational age of pregnancy/LMP was not reported. The rechallenge is not applicable as the events occurred after the first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine in not affected by this report.; Sender''s Comments: This case concerns a pregnant female of unknown age with no relevant medical history, who experienced the unexpected non-serious events of maternal exposure during pregnancy and spontaneous abortion. The event spontaneous abortion occurred 5 days after the first dose of Moderna mRNA-1273 vaccine. The gestational age of pregnancy/LMP was not reported. The rechallenge is not applicable as the events occurred after the first dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA vaccine in not affected by this report.


VAERS ID: 1746310 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-09-07
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial test, Blood alkaline phosphatase, Blood calcium, Blood creatinine, Blood magnesium, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Body temperature, C-reactive protein, Cytomegalovirus test, Echocardiogram, Ejection fraction, Epstein-Barr virus antibody, HIV test, Liver function test, Multisystem inflammatory syndrome in children, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Procalcitonin, SARS-CoV-2 antibody test, SARS-CoV-2 test, Thyroxine, Tri-iodothyronine, Troponin T, Ultrasound abdomen, Ultrasound scan, Viral test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Toxic-septic shock conditions (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210915; Test Name: Blood culture; Test Result: Positive ; Comments: for gram negative bacillus and Gram + cocci; Test Date: 20210915; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:124 IU/l; Comments: slightly reduced; Test Date: 20210914; Test Name: calcium; Result Unstructured Data: Test Result:hypocalcaemia; Test Date: 20210914; Test Name: serum creatinine; Result Unstructured Data: Test Result:106 umol/l; Comments: renal failure; Test Date: 20210916; Test Name: serum creatinine; Result Unstructured Data: Test Result:36 umol/l; Test Date: 20210914; Test Name: magnesium; Result Unstructured Data: Test Result:hypomagnesemia; Test Date: 20210916; Test Name: magnesium; Result Unstructured Data: Test Result:normal; Test Date: 20210914; Test Name: potasssium; Result Unstructured Data: Test Result:hyperkalaemia; Test Date: 20210916; Test Name: potasssium; Result Unstructured Data: Test Result:normal; Test Date: 20210914; Test Name: sodium; Result Unstructured Data: Test Result:hyponatremia; Test Date: 20210916; Test Name: sodium; Result Unstructured Data: Test Result:normal; Test Date: 20210915; Test Name: TSH; Result Unstructured Data: Test Result:normal; Test Date: 20210908; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Test Date: 20210916; Test Name: body temperature; Result Unstructured Data: Test Result:no fever Centigrade; Test Date: 20210914; Test Name: CRP; Result Unstructured Data: Test Result:102 mg/l; Test Date: 202109; Test Name: CRP; Result Unstructured Data: Test Result:45 mg/l; Test Date: 20210915; Test Name: CRP; Result Unstructured Data: Test Result:91.6 mg/l; Test Date: 20210916; Test Name: CRP; Result Unstructured Data: Test Result:33 mg/l; Test Date: 202109; Test Name: cytomegalovirus; Test Result: Negative ; Test Date: 20210914; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:overall left ventricular dysfunction with LVEF = 3; Comments: overall left ventricular dysfunction with LVEF = 35%, without segmental kinetics disorder, lowered cardiac output.; Test Date: 20210915; Test Name: left ventricular ejection fraction; Result Unstructured Data: Test Result:35 to 40 %; Test Date: 20210916; Test Name: left ventricular ejection fraction; Test Result: 48 %; Test Date: 202109; Test Name: Epstein-Barr virus IgG; Test Result: Positive ; Test Date: 20210915; Test Name: HIV serology; Test Result: Negative ; Test Date: 20210915; Test Name: liver function; Result Unstructured Data: Test Result:No hepatic cytolysis or cholestasis; Test Date: 202109; Test Name: polynuclear neutrophil; Result Unstructured Data: Test Result:10 g/l; Test Date: 20210915; Test Name: NT-proBNP; Result Unstructured Data: Test Result:9554 ng/L; Test Date: 202109; Test Name: procalcitonine; Result Unstructured Data: Test Result:1.2; Test Date: 20210915; Test Name: Covid-19 serology; Result Unstructured Data: Test Result:IgM anti S + ; IgG anti-S + ; IgG anti-N +; Test Date: 20210914; Test Name: PCR COVID-19; Test Result: Negative ; Test Date: 20210915; Test Name: T4; Result Unstructured Data: Test Result:diminished; Test Date: 20210915; Test Name: T3; Result Unstructured Data: Test Result:diminished; Test Date: 20210915; Test Name: Troponin T-Hs; Result Unstructured Data: Test Result:140 ng/L; Test Date: 202109; Test Name: Abdominal ultrasound; Result Unstructured Data: Test Result:mesenteric adenolymphitis; Test Date: 202109; Test Name: Cervical lymph node ultrasound; Result Unstructured Data: Test Result:infra-centimetric lymphadenopathy; Test Date: 20210915; Test Name: HCV serology; Test Result: Negative ; Test Date: 20210915; Test Name: HHV6 DNA and adenovirus DNA test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101239538

Write-up: Multisystem inflammatory syndrome in children; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority report number is FR-AFSSAPS-MP20217534. A 12-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 22Aug2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Person was not considered to be at risk of developing a severe form of COVID-19 disease. The patient experienced multisystem inflammatory syndrome in children (hospitalization, life threatening) on 07Sep2021. On 07Sep2021 headache and fever. Vomiting of food and bloodless diarrhea. On 08Sep2021 emergency consultation with fever at 40C not reduced by doliprane. Blood test : hyperleukocytosis polynuclear neutrophil 10 G/L, CRP 45 mg/l, procalcitonine, 1,20, serology Epstein-Barr virus IgG positive, cytomrgalovirus serology negative. Abdominal ultrasound: mesenteric adenolymphitis. Cervical lymph node ultrasound: infra-centimetric lymphadenopathy. Treatment by intravenous rehydration and return home. On 09Sep2021: new emergency room consultation for persistent fever with associated vomiting. Oral rehydration and treatment with Vogalene metopimazine then return home. On 14Sep2021: Emergency consultation for hypotension at home with prodrome of malaise without loss of consciousness in this context of persistent diarrhea despite the cessation of vomiting. In emergencies: hypotension, pallor, acute renal failure (serum creatinine = 106 umol / L), hyponatremia, hypomagnesemia, hypocalcaemia, hyperkalaemia (without ECG sign), and inflammatory syndrome with CRP = 102 mg/l. Cardiac ultrasound: overall left ventricular dysfunction with LVEF = 35%, without segmental kinetics disorder, lowered cardiac output. Myocarditis assessment taken. Persistent hypotension. Suspicion of paediatric inflammatory multisystem syndrome. Other contributive additional examinations included on 14Sep2021: PCR Covid negative. On 15Sep2021: anti-Covid-19 serology : IgM anti S + ; IgG anti-S + ; IgG anti-N +. Negative HIV and HCV serologies. HHV6 DNA and adenovirus DNA test negative. TSH normal but T3 and T4 diminished. NT-proBNP = 9554 ng/L. Troponin T-Hs = 140 ng/L. CRP = 91,6 mg/L. No hepatic cytolysis or cholestasis but slightly reduced alkaline phosphatase (124 iU/l). On 15Sep2021: Transfer to pediatric intensive care unit with introduction of noradrenaline. Multisystem inflammatory syndrome in children protocol implementation (double antibiotic therapy: amoxicillin / clavulanic acid and azithromycin + IV corticosteroid) and myocarditis assessment. Curative anticoagulation by unfractionated heparin in front of renal failure. During the day, left ventricular ejection fraction = 35-40%. Blood cultures taken in emergency room positive for gram negative bacillus and Gram + cocci, modification of antibiotic therapy amoxicillin / clavulanic acid and azithromycin for cefotaxime and metronidazole. Improvement of neurological condition16Sep2021 : Normalization of natremia, kalaemia, magnesemia. Creatinine = 36 umol/L. Left ventricular ejection fraction = 48%. No fever. CRP = 33 mg/L. Discontinuation of antibiotic therapy with cefotaxime and metronidazole. The patient was hospitalized for multisystem inflammatory syndrome in children from Sep2021 to an unknown date. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1746442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-09-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LODOZ; INEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness: Asthenia; Coagulation disorder; Gamma GT increased; Hyperbilirubinaemia; Hypertension arterial; Obesity; Steatohepatitis; Thrombocytopenia
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20210952644

Write-up: Vaccination failure; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, FR-AFSSAPS-RE20212610) on 27-SEP-2021 and concerned a 65 year old female of unknown race and ethnicity. The patient''s weight was 72 kilograms and height was 166 centimeters. The patient''s concurrent conditions included: steatohepatitis, obesity, hypertension arterial, asthenia, gamma gt increased, thrombocytopenia, hyperbilirubinaemia and coagulation disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 1 dosage forms, 1 total, administered on 15-APR-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Drug start period and last period was 146 days. Duration of drug administration was reported 1 days. Concomitant medications included bisoprolol fumarate/hydrochlorothiazide and esomeprazole magnesium. On 07-SEP-2021, the patient experienced vaccination failure. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 15-APR-2021. The patient had not recovered from vaccination failure. This report was serious (Life Threatening). This case was associated with product quality complaint.


VAERS ID: 1746653 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FE8087 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dysmenorrhoea, Pain in extremity
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (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:
CDC Split Type: GBPFIZER INC202101225256

Write-up: Period pains; Chest pain; Leg pain; Painful arm; This is a spontaneous report from a contactable consumer (patient). This is a report received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109160931472550-DGQEX, Safety Report Unique Identifier GB-MHRA-ADR 25951309. A 32-year-old female patient (not pregnant, not currently breastfeeding; age at vaccination: 32-year-old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FE8087), via an unspecified route of administration in left arm on 07Sep2021 as dose 1, single for COVID-19 immunisation. The patient''s medical history was not reported, and the patient was not taking any medication. On 07Sep2021, the patient reported that left arm ached immediately which lasted approximately 5 days (immunized in left arm), her chest and leg pain started within hours of vaccine both on left side of body, her period pains started within 3/4 hours of being immunized and continue on/off daily. The events were reported as serious medically significant. The outcome of painful arm was recovered on 12Sep2021; for other events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1746699 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-30
Onset:2021-09-07
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation irregular, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-CYPRINDIOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Chronic disease, ulcerative colitis)); Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101225301

Write-up: Vaginal bleeding; Irregular periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109161143356120-FFTMY, and Safety Report Unique Identifier is GB-MHRA-ADR 25952077. A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Aug2021 (batch/lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included suspected COVID-19 from 01Jun2021 to an unknown date, unsure when symptoms stopped; and inflammatory bowel disease from an unknown date and unknown if ongoing, taking medicines for inflammatory bowel disease (Chronic disease, ulcerative colitis). Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included cyproterone acetate, ethinylestradiol (CO-CYPRINDIOL) taken as contraceptive. The patient experienced vaginal bleeding on 07Sep2021 with outcome of not recovered, and irregular periods on 07Sep2021 with outcome of not recovered. The events were considered serious as other medically important condition. Additional Information: Patient takes Co-Cyprindiol 2000/35 tablets as a contraceptive and have for a couple of years. She has never had any issues with irregular periods or random vaginal bleeding when taking this medication before. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab test which included COVID-19 virus test: Yes - Positive COVID-19 test on 02Jun2021. No follow-up attempts are possible; information about batch/lot number cannot be obtained.


VAERS ID: 1747001 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005689 / UNK - / OT

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

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

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-784253) 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 URTICARIA in a 49-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for COVID-19 vaccination. Concurrent medical conditions included Nail infection. Concomitant products included KETOPROFEN LYSINE and AMOXICILLIN for an unknown indication. On 04-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 07-Sep-2021, after starting mRNA-1273 (Spikevax), the patient experienced URTICARIA (seriousness criterion medically significant). At the time of the report, URTICARIA had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: This case concerns a 49 year-old, male patient with reported concomitant use of ketoprofen and amoxicillin, who experienced the unexpected event of urticaria. The event occurred approximately 3 days after vaccination with Spikevax, dose number not specified. The rechallenge is unknown since dose number was not specified. The use of concomitant medication ketoprofen and amoxicillin, remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Predisposing conditions: nail infection. The reporter reports that the male patient is in apparent good health. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up received: No new information On 21-Sep-2021: Translation received on 24-SEP-2021, contains senders comment and reporters comment.; Reporter''s Comments: On 12-Sep: request for information on the case from the reporter. In data 12/09. Sender''s Comments: This case concerns a 49 year-old, male patient with reported concomitant use of ketoprofen and amoxicillin, who experienced the unexpected event of urticaria. The event occurred approximately 3 days after vaccination with Spikevax, dose number not specified. The rechallenge is unknown since dose number was not specified. The use of concomitant medication ketoprofen and amoxicillin, remain a confounder. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1747021 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-09-07
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101223149

Write-up: VACCINATION FAILURE: FEVER; VACCINATION FAILURE: COUGH; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB IT-MINISAL02-785179. A 36-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FC5089), intramuscular, administered in right arm on 19Jul2021 09:56 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient historical vaccine included first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: not reported, expiration date: 22Jun2021), administered in right arm on 22Jun2021 17:21 for COVID-19 immunisation. The patient experienced vaccination failure fever and vaccination failure cough on 07Sep2021. The outcome of all the events was recovered on an unspecified date in 2021 Follow-up attempts are completed. No further information is expected.


VAERS ID: 1747029 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005687 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Hyperpyrexia
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:
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-MINISAL02-785294) 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 HYPERPYREXIA in a 15-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005687) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 07-Sep-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and HEADACHE (seriousness criterion medically significant). On 08-Sep-2021, HYPERPYREXIA and HEADACHE had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported by the reporter. No treatment information was provided by the reporter. This case concerns a 15-year-old female patient with no relevant medical history who experienced serious unexpected events of Hyperpyrexia and Headache. The events occurred on the same day after the dose of Spikevax. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. Very limited information regarding clinical course of the event Hyperpyrexia has been provided at this time. The event Headache 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.; Sender''s Comments: This case concerns a 15-year-old female patient with no relevant medical history who experienced serious unexpected events of Hyperpyrexia and Headache. The events occurred on the same day after the dose of Spikevax. The rechallenge was unknown as it was not provided whether the patient received the first or the second dose of the vaccine. Very limited information regarding clinical course of the event Hyperpyrexia has been provided at this time. The event Headache 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: 1747034 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005689 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pyrexia, Tachycardia
SMQs:, Anaphylactic reaction (broad), 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 (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-785509) 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 CHEST PAIN, TACHYCARDIA, DYSPNOEA and PYREXIA in an 18-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005689) for COVID-19 immunisation. No Medical History information was reported. On 07-Sep-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 07-Sep-2021, the patient experienced CHEST PAIN, TACHYCARDIA (seriousness criterion hospitalization), DYSPNOEA (seriousness criterion hospitalization) and PYREXIA (seriousness criterion hospitalization). At the time of the report, CHEST PAIN, TACHYCARDIA, DYSPNOEA and PYREXIA had not resolved. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided. Company Comment : This case concerns a 18-year-old female patient with no reported medical history who experienced Chest pain, Tachycardia, Dyspnoea and pyrexia 1 day after 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 22-Sep-2021: Non -significant Follow up received included no new information.; Sender''s Comments: This case concerns a 18-year-old female patient with no reported medical history who experienced Chest pain, Tachycardia, Dyspnoea and pyrexia 1 day after 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: 1747044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: 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: Hypertensive end-organ damage
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232782

Write-up: vaccination failure; Cellini cluster. Molecular swab positive in vaccinated. Paucysymptomatic; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB IT-MINISAL02-787166. A 83-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EK9788; Expiration Date: 31May2021)via intramuscular route of administration, administered in left arm on 03Feb2021 as Dose 2, 0.3ml Single and first dose received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL1484; Expiration Date: 30Apr2021)via intramuscular route of administration, administered in on 13Jan2021 left arm Dose 1, 0.3ml Single for COVID-19 immunization. Medical history included hypertensive end-organ damage from 07Aug2000 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced cellini cluster. molecular swab positive in vaccinated. Paucysymptomatic on 07Sep2021 where he was exposed to vaccination failure on unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Sep2021. The outcome of cellini cluster molecular swab positive in vaccinated. Paucysymptomatic was not recovered. The outcome of vaccination failure was Unknown. Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE INJECTABLE lot EL1484 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 lots of the reported lot EL1484 and 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1747046 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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, Cough, Pyrexia, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232850

Write-up: Covid-19; positive molecular and antigenic swab at vaccinated.; Mildly symptomatic (cough, fever).; Mildly symptomatic (cough, fever).; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787177. A 91-year-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EK9788; Expiration Date: 31May2021), via intramuscular route of administration, on 03Feb2021 as dose 2, 0.3 ml single in left arm; and received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EL1484; Expiration Date: 30Apr2021), via intramuscular route of administration, on 13Jan2021 as dose 1, 0.3 ml single in left arm for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient was mildly symptomatic with cough and fever and was positive molecular and antigenic swab at vaccinated. The patient underwent lab tests and procedures which included COVID-19 antigen test with result positive and COVID-19 PCR test with result positive on 07Sep2021. The outcome of events was not recovered. Conclusion of Previously completed investigation report received from the PQC Group included: 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 EK9788 and 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. System concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The system process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed.


VAERS ID: 1747047 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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, 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232894

Write-up: Cellini cluster. Positive molecular swab in vaccinated. Paucisymptomatic.; vaccination failure; This is a spontaneous report from a contactable other healthcare professional from the Regulatory Authority IT-MINISAL02-787180 received via regulatory authority. A 81-years-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EK9788 and expiry dates: 31May2021), via Intramuscular, in Arm Left, on 03Feb2021, as single dose, 0.3 ml, for COVID-19 immunisation and first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: EL1484 and expiry dates: 30Apr2021), via Intramuscular, in Arm Left, on 13Jan2021, as single dose, 0.3 ml, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient experienced Cellini cluster. Positive molecular swab in vaccinated. Paucisymptomatic and vaccination failure. The patient underwent lab test and procedure included COVID-19 PCR test with positive result on 07Sep2021. Outcome of the events was not recovered. The product complaint included the conclusion as 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 and 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.


VAERS ID: 1747424 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005238 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache, Myalgia, Nausea, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via the RA (Reference number: SE-MPA-2021-082200) 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 HEADACHE, PYREXIA, MYALGIA, FATIGUE, CHILLS, DIZZINESS, ARTHRALGIA, VOMITING and NAUSEA in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3005238) for COVID-19 vaccination. The patient''s past medical history included Migraine and COVID-19. Concurrent medical conditions included Penicillin allergy since 2015. On 07-Sep-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (seriousness criterion hospitalization), MYALGIA (seriousness criterion hospitalization) and FATIGUE (seriousness criterion hospitalization). On 08-Sep-2021, the patient experienced HEADACHE (seriousness criterion hospitalization), CHILLS (seriousness criterion hospitalization), DIZZINESS (seriousness criterion hospitalization), ARTHRALGIA (seriousness criterion hospitalization), VOMITING (seriousness criterion hospitalization) and NAUSEA (seriousness criterion hospitalization). On 08-Sep-2021, MYALGIA had resolved with sequelae, FATIGUE, CHILLS, ARTHRALGIA, VOMITING and NAUSEA had resolved. At the time of the report, HEADACHE had not resolved, PYREXIA was resolving and DIZZINESS had resolved. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company Comment: This case concerns a 50-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of headache, pyrexia, myalgia, fatigue, chills, dizziness, arthralgia, vomiting and nausea . The events occurred 1 day after except pyrexia, myalgia, fatigue which occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Translated document contains no new information.; Sender''s Comments: This case concerns a 50-year-old, female patient with no previous relevant medical history, who experienced the unexpected events of headache, pyrexia, myalgia, fatigue, chills, dizziness, arthralgia, vomiting and nausea . The events occurred 1 day after except pyrexia, myalgia, fatigue which occurred on the same day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.


VAERS ID: 1749205 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-09-07
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7011 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Borrelia test, Facial paralysis, Interchange of vaccine products, Lumbar puncture, Off label use
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Medication errors (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: Borrelia serology; Result Unstructured Data: Test Result:pending; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:pending
CDC Split Type: DEPFIZER INC202101228998

Write-up: Vaxzevria on 01Jul2021/Pfizer vaccine on 30Jul2021; Vaxzevria on 01Jul2021/Pfizer vaccine on 30Jul2021; Facial palsy; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100190431. A 37 year old male patient received BNT162B2 (COMIRNATY Formulation: Solution for injection Batch/Lot Number: FE7011) via an unspecified route of administration on 30Jul2021 (at the age of 37 years) as dose 2 (initial pfizer dose), single for COVID-19 immunization. The patient medical history was not reported. The patient''s historical vaccines include Vaxzevria (lot# ABX3182) on 01Jul2021. The patient''s concomitant medications were not reported. The patient experienced facial palsy on 07Sep2021, Vaxzevria on 01Jul2021/Pfizer vaccine on 30Jul2021. The patient underwent lab tests and procedures which included borrelia serology test: pending, lumbar puncture: pending. The outcome of event was not recovered. Sender Comment: Lumbar puncture, Borrelia serology (pending) DIFERENTIAL DIAGNOSIS (DD): Meningitis, Borreliosis. No follow-up attempts are possible. No further information expected.


VAERS ID: 1749309 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-09-07
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214006 / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Atrial flutter
SMQs:, Supraventricular tachyarrhythmias (narrow)

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

Write-up: Flutter atrial; This case was received via Regulatory Authority (Reference number: ES-AEMPS-999391) 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 ATRIAL FLUTTER (Flutter atrial) in a 29-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 214006 and 3005703) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced ATRIAL FLUTTER (Flutter atrial) (seriousness criterion medically significant). On 07-Sep-2021, ATRIAL FLUTTER (Flutter atrial) had resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 01-Sep-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not provided. Treatment information was not provided. Company Comment: This case concerns a 29 year-old male subject with no relevant medical history reported, who experienced the serious unexpected event of ATRIAL FLUTTER. The event occurred approximately 7 days after receiving the second dose of spikevax Time to onset from the fist dose were 55 days. Rechallenge was not applicable since the event occurred after the second 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: Translated document received on 27-Sep-2021, include anatomical Location.; Sender''s Comments: This case concerns a 29 year-old male subject with no relevant medical history reported, who experienced the serious unexpected event of ATRIAL FLUTTER. The event occurred approximately 7 days after receiving the second dose of spikevax Time to onset from the fist dose were 55 days. Rechallenge was not applicable since the event occurred after the second dose. The benefit-risk relationship of spikevax is not affected by this report.


VAERS ID: 1750712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-09-07
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, C-reactive protein, CSF glucose, Ear pain, Facial paralysis, Full blood count, Headache, Investigation, Myalgia, Photophobia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic; Maturity-onset diabetes of the young (Maturity-Onset Diabetes of the Young placed on a healthy living and healthy plan); Penicillin allergy; Tonsillectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood glucose; Result Unstructured Data: Test Result:6.5 mmol/L; Test Date: 20210908; Test Name: c-reactive protein; Result Unstructured Data: Test Result:27 mg/l; Test Date: 20210908; Test Name: Cerebrospinal fluid glucose; Result Unstructured Data: Test Result:4.6 mmol/L; Test Date: 20210908; Test Name: complete blood count; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210908; Test Name: ionogram; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210908; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101222740

Write-up: Facioplegia; Headaches; fever; Myalgia; photophobia; otalgia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB FR-AFSSAPS-GR20214057. A 14-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number: FE7051) intramuscular on 18Aug2021 as dose 1, 0.3ml single for COVID-19 immunization. The patient''s medical history included tonsillectomy in May2021, maturity-onset diabetes of the young placed on a healthy living and healthy plan and allergic to cephalosporin (Quincke edema) and penicillin. On 07Sep2021, the patient experienced onset of fever, myalgia, otalgia and photophobia. On 08Sep2021, patient also experienced onset of left facial paralysis, consulted at the emergency room and hospitalization and headache on an unknown date. The lad data included C-reactive protein was 27 mg/L, Glucose (Cerebrospinal Fluid) at 4.6 mmol/L, Blood glucose: 6.5 mmol/L, Complete blood count and ionogram showed no anomalies, SARS-CoV-2 test was negative on 08Sep2021. Differential diagnostic included no recent travel, no evidence she had been bitten by ticks but strolls a lot in the forest, no infectious contact, no motor deficit, no pyramidal or cerebellar syndrome, no ocular motor impairment. Tests for infectious diseases was serology underway. Conclusion was reported as patient had left peripheral facial palsy with symmetrical damage to the 2 territories. On 09Sep21, initiation of a steroid therapy at 1mg/kg for 7 days and no additional imaging. Disappearance of the headaches, and left otalgia, afebrile. Persistence of left peripheral facial palsy, no other cranial nerve deficit; no photo/phonophobia. The outcome of the event left facial paralysis was not recovered, headache was resolved on an unspecified date while for the other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1751139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-07
   Days after vaccination:6
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: Flat affect, Oligospermia, SARS-CoV-2 test
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Fertility 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101226734

Write-up: My sperm is watery; Affect loss; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202109181123352420-Q1ZBA, Safety Report Unique Identifier GB-MHRA-ADR 25964598. A 39-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 01Sep2021 as single dose for COVID-19 immunisation. Medical history included clinical trial participant from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced affect loss (disability) on 07Sep2021 and my sperm was watery (disability) on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative COVID-19 test on an unspecified date. The clinical outcome of affect loss was not resolved and my sperm was watery was unknown. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1751383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-09-07
   Days after vaccination:149
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Diabetes mellitus, Hypertension, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (POSITIVE SWAB ON 08Jan2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: Nasal swab; Test Result: Positive
CDC Split Type: ITPFIZER INC202101228727

Write-up: Hypertension; Diabetic; Ischaemia cerebral; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB. This is a report received from Regulatory authority report number IT-MINISAL02-787032 with Safety Report Unique Identifier IT-MINISAL02-787032. A 78-years-old female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch no: not reported/Lot Number: EW2246; Expiration Date: 31Jul2021) via intramuscularly in Deltoid Left (also reported as left shoulder) on 11Apr2021 as dose 1 0.3 ml, single for COVID-19 immunization. Medical history included COVID-19 from 08Jan2021 to an unknown date (positive swab on 08Jan2021). The patient''s concomitant medications were not reported. On 07Sep2021, patient experienced hypertension, diabetic and ischemia cerebral (medically significant)and events caused hospitalization for patient. The patient had not received the second dose yet. The patient underwent lab tests and procedures which included SARS-CoV-2 nasal swab test on 08Jan2021 and result positive for covid-19. Outcome of the events were not recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1751390 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-09-07
   Days after vaccination:176
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232799

Write-up: covid-19; vaccination failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB Kliknij IT-MINISAL02-787169 received via regulatory authority. A 83-year-old elderly female patient received (COMIRNATY, formulation: Solution for injection, lot/batch number was not reported and expiry date 08Sep2021), via an intramuscular route of administration at left shoulder/left arm, on 19Feb2021, as a dose 1, 0.3ml single dose (Booster dose number 1) for COVID-19 immunization and (COMIRNATY, formulation: Solution for injection, lot number: ET1831 and expiry date 30Jun2021), via an intramuscular route of administration at left shoulder/left arm, on 15Mar2021, as a dose 2, 0.3ml single dose (Booster dose number 2) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient had COVID-19 and vaccination failure. On 07Sep2021, the patient was tested positive for COVID-19 PCR test. 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''. 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 Puurs 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. The outcome was not recovered for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1751391 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: 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: Glaucoma; Hypertensive end-organ damage
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 antigen test positive; Result Unstructured Data: Test Result:positive; Test Date: 20210908; Test Name: COVID-19 PCR test positive; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC202101232839

Write-up: vaccination failure; Cellini cluster. Molecular swab in vaccine. Paucisymptomatic (pyrexia). Positive antigenic 07Sep2021; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-787175. A 90-years-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EK9788, Expiration date: 31May2021), intramuscular, administered in Arm Left on 03Feb2021 as dose 2, 0.3 ml single for COVID-19 immunization and received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EL1484, Expiration date: 30Apr2021) intramuscular, administered in Arm Left on 13Jan2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient''s medical history included hypertensive end-organ damage from 09May2001 and glaucoma from 20Oct2005 to an unknown date. The patient''s concomitant medications were not reported. On 07Sep2021 the patient experienced cellini cluster. molecular swab in vaccine. paucisymptomatic (pyrexia). positive antigenic 07sep2021 and on an unspecified date the patient experienced vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test positive which showed positive result on 07Sep2021 and sars-cov-2 test positive which showed positive result on 08Sep2021. The outcome of the event cellini cluster. molecular swab in vaccine. paucisymptomatic (pyrexia). positive antigenic 07sep2021 was not recovered. The outcome of the event vaccination failure was unknown. 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 and 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. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. Follow-up (22Sep2021): This is a follow-up spontaneous report received from a Regulatory Authority record received with summary investigation from the site RA. Information obtained: expiration date EK9788 31May2021, EL1484 30Apr2021 unknown and investigation results.


VAERS ID: 1751549 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003604 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Arthralgia, Fatigue, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: NOMODERNATX, INC.MOD20213

Write-up: This case was received via(Reference number: NO Regulatory Authority-NOMAADVRE-E2B_00049685) 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 in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003604) for Vaccination. No Medical History information was reported. On 06-Sep-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No relevant concomitant medications were provided. Patient developed intense pain in abdomen, fever, nausea, muscle and joint pain. No treatment information was provided. Company comment: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected event of abdominal pain. The event abdominal pain occurred 24 hours after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since only information about the this unknow dose number was disclosed. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Translation received on 27-SEP-2021 , does not contain any new information.; Reporter''s Comments: The suspected product was changed from Paracet tab 500 mg to Spikevax due to available information in (RA). The patient reported the Outcome of ABDOMINAL PAIN as Recovering/Resolving. The Patient also reported Cessation Date as 08/Sep/2021 for the ABDOMINAL PAIN. In addition, the patient answered "No" to the reaction still being ongoing. Contact with healthcare professionals: Physician.; Sender''s Comments: This case concerns a 25-year-old, female patient with no relevant medical history, who experienced the unexpected event of abdominal pain. The event abdominal pain occurred 24 hours after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since only information about the this unknow dose number was disclosed. No product report assessment was given from the reporter. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.


VAERS ID: 1751590 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: SARS-CoV-2 test; Result Unstructured Data: Positive Iu international unit(s)
CDC Split Type: PTJNJFOC20210957429

Write-up: VACCINATION FAILURE; This spontaneous report received from a health care professional via a Regulatory Authority (EVHUMAN Vaccines, PT-INFARMED-T202109-1119) on 29-SEP-2021 concerned a 32 year old male. The patient''s weight was 82 kilograms, and height was 182 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 08-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 07-SEP-2021, the patient experienced vaccination failure. Laboratory data included: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) test (NR: not provided) Positive Iu international unit (s). 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 (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1751617 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
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: Dizziness, Dyspnoea, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

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

Write-up: This case was received via regulatory authority (Reference number: SE-MPA-2021-083003) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DIZZINESS, DYSPNOE and NAUSEA in an 18-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 07-Sep-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced DIZZINESS (seriousness criterion medically significant), DYSPNOEA (seriousness criterion medically significant) and NAUSEA (seriousness criterion medically significant). At the time of the report, DIZZINESS, DYSPNOEA and NAUSEA outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medications were provided. The events are assessed as serious by the Regulatory Authority; however, based on medical judgement and the lack of evidence of seriousness from a clinical or regulatory standpoint, the events are not considered serious. Company Comment: This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Dizziness, Dyspnoea and the serious expected event of Nausea (the event Nausea is unexpected as it is retained as serious per the source document Authority reporting). The events occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable since the events occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Translated document received on 28-SEP-2021, contain no newsignificant information.; Sender''s Comments: This case concerns a 18-year-old, male patient with no relevant medical history, who experienced the serious unexpected events of Dizziness, Dyspnoea and the serious expected event of Nausea (the event Nausea is unexpected as it is retained as serious per the source document Authority reporting). The events occurred on the same day after the second dose of Spikevax. The rechallenge was not applicable since the events occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1752962 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-07
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210959703

Write-up: NON PRODUCTIVE COUGH; SHORTNESS OF BREATH; INTERMITTENT FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300107792] concerned a 74 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, 1 total, administered on 28-JUN-2021 for drug used for unknown indication. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 07-SEP-2021, the patient experienced non productive cough, shortness of breath (SOB), and intermittent fever. On 13-SEP-2021, the patient experienced progression of events and was hospitalized. The number of days hospitalized and the discharge information were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from non productive cough, intermittent fever, and shortness of breath. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210959703-COVID-19 VACCINE AD26.COV2.S-non productive cough, shortness of breath. 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). 20210959703-COVID-19 VACCINE AD26.COV2.S-intermittent fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1753202 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-09-07
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-10-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SA8721 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Peripheral swelling, Seizure
SMQs:, Cardiac failure (broad), Angioedema (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101240375

Write-up: left calf, heel, and foot swelled; seizure; This is a spontaneous report from a contactable consumer (patient''s mother). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: SA8721), via an unspecified route of administration in left deltoid on 25Jun2021 12:07 (at the age of 25-years-old) as dose 2, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not have any known allergies and had no recent surgeries. There were no concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: SA8721), via an unspecified route of administration in left deltoid on 21May2021 15.22 (at the age of 25-years-old) as dose 1, single for COVID-19 immunization. The patient experienced seizure on 07Sep2021. The second seizure occurred on 16Sep21. The patient also experienced left calf, heel, and foot swelled on an unspecified date. The events resulted in emergency room visit. Patient was prescribed with antibiotics for left calf, heel, and foot swelled; it helped the swelling. It was reported that patient had no history of epilepsy and was generally a healthy man. Outcome of event seizure was unknown. Event left calf, heel, and foot swelled was resolving.


VAERS ID: 1754468 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-09-07
   Days after vaccination:49
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: Cerebral infarction, Myocarditis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Middle cerebral artery infarct; Acute myocarditis; This case was received via regulatory authority (Reference number: DE-PEI-202100191358) 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 CEREBRAL INFARCTION (Middle cerebral artery infarct) and MYOCARDITIS (Acute myocarditis) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214007) for Prophylactic vaccination. The patient''s past medical history included Obesity. On 20-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced CEREBRAL INFARCTION (Middle cerebral artery infarct) (seriousness criteria hospitalization and medically significant) and MYOCARDITIS (Acute myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBRAL INFARCTION (Middle cerebral artery infarct) and MYOCARDITIS (Acute myocarditis) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. company comment: This case concerns a 36-year-old, male patient with relevant medical history of obesity, who experienced the unexpected event of Cerebral infarction and the expected event of Myocarditis. The events cerebral infarction and myocarditis both occurred approximately 8 days after the second dose of Spikevax. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 36-year-old, male patient with relevant medical history of obesity, who experienced the unexpected event of Cerebral infarction and the expected event of Myocarditis. The events cerebral infarction and myocarditis both occurred approximately 8 days after the second dose of Spikevax. The rechallenge was not applicable as events occurred after second dose. The benefit-risk relationship of Spikevax is not affected by this report.


VAERS ID: 1754678 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 FG4686 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: ESPFIZER INC202101229381

Write-up: Syncope; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Agency (RA)-WEB, regulatory authority number ES-AEMPS-1003876. A 13-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 07Sep2021 (Batch/Lot Number: FG4686; Expiration Date: 30Nov2021) (at the age of 13 years old) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced syncope on 07Sep2021, 25 minutes after administration of the vaccine. The outcome of the event was recovered on 07Sep2021. No follow-up attempts are possible. No further information expected.


VAERS ID: 1755061 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye movement disorder, Fall, Muscle rigidity, SARS-CoV-2 test, Seizure, Tonic convulsion, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No, Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101233799

Write-up: Seizures; tonic post seizure; eyes rolled to back of head; fell forward; arms and legs became rigid; began to shake; This is a spontaneous report from a contactable consumer or other non healthcare professional received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109191427029100-XO2ZI. Safety Report Unique Identifier GB-MHRA-ADR 25966080. A 17-year-old female patient received first dose bnt162b2 (BNT162B2, solution for injection, Lot Number was unknown) via an unspecified route of administration on 07Sep2021 (at the age of 17 years) as a single dose for covid-19 immunisation. Medical history included none. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 07Sep2021, 20 minutes post vaccine the patient (my daughter) had a seizure in the car, eyes rolled to back of head, head went backwards then fell forward as arms and legs became ridgid and began to shake, lasted around 2 minutes. The patient also had tonic post seizure (07Sep2021) for several hours. The patient underwent lab tests and procedures which included sars-cov-2 test: negative (no, negative COVID-19 test). The events tonic post seizure recovered on an unknown date in 2021, and the other events recovered on 07Sep2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755105 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-07
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Migraine, Nausea, Paralysis, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210906; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101233709

Write-up: migraine; headache; moving/ paralysis; nausea; Dizziness when moving, led down, sat down and standing; This is a spontaneous report from a contactable consumer received from the regulatory authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202109200007309900-5GX3S. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: not reported), via an unspecified route of administration on 07Sep2021 (at the age of 22-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient had no symptoms associated with COVID-19. The patient''s concomitant medications were not reported. On 07Sep2021, patient experienced dizziness when moving, led down, sat down and standing. On an unknown date, she had migraine, headache, moving/ paralysis and nausea. The case was assessed as serious (medically significant). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 06Sep2021. Outcome of the event was resolved on 09Sep2021 and rest of the events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1755360 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-09-07
   Days after vaccination:102
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2229 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal wall haematoma, Cardiac failure, Fluid imbalance, Myocarditis
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101228731

Write-up: Myocarditis; Cardiac failure; Rectus abdominis muscle haematoma; Fluid imbalance; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from Regulatory Authority via report number IT-MINISAL02-787034 with Safety Report Unique Identifier IT-MINISAL02-787034. A 71-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC2229; Expiration Date: 30Sep2021), dose 2 intramuscular, administered in Deltoid Left (left shoulder) on 28May2021 as dose 2, 0.3 mL single (Booster dose number (2)) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY on 07May2021 (Batch/Lot Number: FA5831; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunisation. On 07Sep2021, the patient experienced Rectus abdominis muscle haematoma, Myocarditis, Fluid imbalance and Cardiac failure. Seriousness criteria was reported as hospitalization for all the events. The outcome of events was recovering. Health Authority comment: THE PATIENT HAS CARRIED OUT THE FIRST DOSE ON 07May2021 OF PFIZER VACCINE, BATCH: FA5831 expiry: 31Aug2021: No follow-up attempts are possible. No further information expected.


VAERS ID: 1755375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive.
CDC Split Type: ITPFIZER INC202101232805

Write-up: vaccination failure; PRIVSCY cluster. Positive molecular swab in vaccine. Paucisymptomatic; This is a spontaneous report from a contactable other HCP from the Regulatory Authority IT-MINISAL02-787170. A 60-years-old male patient received first dose of BNT162B2 (COMIRNATY, formulation for injection) via intramuscular route of administration, administered in left arm on 13Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) as dose 1, 0.3mL, single and received second dose of BNT162B2 (COMIRNATY; formulation for injection) via intramuscular route of administration, administered in left arm on 03Feb2021 (Batch/Lot Number: EK9788; Expiration Date: 31May2021) as dose 2, 0.3 mL, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. It was reported that the patient received both the doses of vaccine and on 07Sep2021, the patient experienced positive molecular swab in vaccine. Paucisymptomatic. The patient underwent lab tests and procedures which included COVID-19 PCR test (SARS-CoV-2 test) which was positive on 07Sep2021. The outcome of the events was not recovered. New information received from Product Complaint Team which included investigation summary for lot EK9788 and lot EL1484 which provided Conclusion, the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 and 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 no 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: 1755376 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232822

Write-up: Positive molecular swab in vaccinated person, Paucisymptomatic; Positive molecular swab in vaccinated person, Paucisymptomatic; This is a spontaneous report from a contactable other health professional downloaded from the Regulatory Authority-WEB IT-MINISAL02-787172 and also Product Complaint Team from division Site. An 89-years-old female patient received bnt162b2 (COMIRNATY, formulation: solution for injection, quantity: 0.3 ml; Lot Number: EK9788, expiration date: 31May2021), via intramuscular route administered in Arm left on 3Feb2021 as dose 2, 0.3 mL single and bnt162b2 (COMIRNATY, formulation: solution for injection, quantity: 0.3 ml; Lot Number: EL1484, expiration date: 30Apr2021), via intramuscular route administered in Arm left on 13Jan2021 as dose 1, 0.3 mL single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 07Sep2021, the patient experienced positive molecular swab in vaccinated person, paucisymptomatic. Batch and lot tested and found within specifications checked, Expiration dates added lot EL1484, expiration date: 30Apr2021 and lot EK9788 expiration date: 31May2021. 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 and 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. Site 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 cause or CAPA were identified as the complaint was not confirmed. The patient underwent lab tests and procedures which included Covid-19 virus test 9 (sars-cov-2 test): positive on 07Sep2021. The outcome of events was not recovered.


VAERS ID: 1755377 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-09-07
   Days after vaccination:237
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 20210907; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232831

Write-up: vaccination failure; covid-19; Cellini cluster. Positive molecular swab in vaccine. Paucisymptomatic; This is a spontaneous report from a contactable other health care professional downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-787174. A 95-Year-old Female patient received bnt162b2 (Comirnaty, Formulation: Solution for injection, Lot number: EK9788, Expiration Date :31May2021) dose 2, 0.3 ml Via an Intramuscular route of administration administered in left deltoid on 03Feb2021 as a single dose for COVID-19 immunisation and received bnt162b2 (Comirnaty, Formulation: Solution for injection ,Lot number : EL1484, Expiration Date :30Apr2021) dose 1, 0.3 ml Via an Intramuscular route of administration administered in left deltoid on 13Jan2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced Cellini cluster. Positive molecular swab in vaccine. Paucisymptomatic , vaccination failure, and Covid-19 on 07Sep2021. Patient underwent lab test COVID-19 PCR test positive: positive on 07Sep2021. Outcome of the event was not recovered for Positive molecular swab in vaccine, Paucisymptomatic and unknown for covid-19. Investigation summary received for the lot EK9788: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, analysis of the complaint history for the reported lot and product type. 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. Regulatory authority 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. Investigation summary received for the lot EL1484 : The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, analysis of the complaint history for the reported lot and product type. 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. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected


VAERS ID: 1755378 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-09-07
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-10-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 2 LA / 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: Medical History/Concurrent Conditions: Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232841

Write-up: COVID-19 confirmed by positive COVID-19 test; PRIVACY cluster. Molecular swab in vaccine. Asymptomatic; This is a spontaneous report from a contactable other health care professional downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-787176. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET7205, Expiration Date: 31Jul2021), via intramuscular route, administered in left arm on 08Apr2021 at 0.3mL as single dose and received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX3599, Expiration Date: 31Aug2021), via intramuscular route, administered in left arm on 29Apr2021 at 0.3mL as single dose for COVID-19 immunisation. Medical history included neoplasm from 14Oct2011 to an unknown date. The patient''s concomitant medications were not reported. On 07Sep2021, the patient presented asymptomatic Covid-19 with positive COVID-19 PCR test reported as privacy cluster, molecular swab in vaccine, asymptomatic. Vaccine failure with an interval of at least 21 days between each dose. Vaccine failure was identified about 4 months 9 days after the second dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Sep2021. Report received from a Product Quality Complaint Group on 22Sep2021 included complaint record received with summary investigation from the site regulatory authority. Information obtained: 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 EX3599 and ET7205. 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. Regulatory authority 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. The outcome of asymptomatic Covid-19 was not resolved. No follow-up attempts possible. No further information expected.


VAERS ID: 1755379 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: 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: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232857

Write-up: Vaccination failure; Cellini cluster. Positive molecular swab in the vaccinated subject. Pauci-symptomatic; COVID-19; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority WEB - [IT-MINISAL02-787178]. A 100-year-old female patient received second dose of BNT162B2 (COMIRNATY; Solution for injection, Batch/Lot Number: EK9788; Expiration Date: 31May2021), via intramuscularly in arm left on 08Jan2021 at a dose of 0.3 ml as single dose and first dose via intramuscularly in arm left on 29Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021) at a dose of 0.3ml as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient had Cellini cluster. Positive molecular swab in the vaccinated subject. Pauci-symptomatic and covid-19 on 07Sep2021 and exhibited vaccination failure on unknown date. The patient underwent lab tests and procedures which included COVID-19 PCR test (Sars-cov-2 test): Positive on 07Sep2021. Conclusion: 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 EL1484 and EK9788 of the reported lot EL1484 and 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 cause or were identified as the complaint was not confirmed. The outcome of the event Cellini cluster. Positive molecular swab in the vaccinated subject. Pauci-symptomatic and covid-19 was not recovered and vaccination failure was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1755380 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: 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: 20210907; Test Name: Molecular swab; Test Result: Positive; Comments: molecular swab positive in vaccinated person.
CDC Split Type: ITPFIZER INC202101232871

Write-up: vaccination failure; Paucisymptomatic; This is a spontaneous report from a contactable other hcp from the Regulatory Authority. The regulatory authority number IT-MINISAL02-787179. A 64-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection) as dose 2, 0.3 ml single on 03Feb2021 (Lot number: EK9788, Expiration date: 31May2021) and as dose 1, 0.3 ml single on 13Jan2021 (Batch/Lot Number: EL1484; Expiration Date: 30Apr2021), both administered in Arm left via intramuscular for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Sep2021 the patient underwent molecular swab positive in vaccinated person. Paucisymptomatic and vaccination failure. The outcome of the events was not recovered. The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference sample, 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 and lot EL1484 respectively. 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 for lot EK9788. The process determined that a regulatory notification was required for lot EL1484. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed.


VAERS ID: 1755381 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: 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: Blindness; Neoplasm NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232907

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-787181. A 70-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EK9788, Expiry date: 31May2021) via intramuscularly, administered in Arm Left on 03Feb2021 as dose 2, 0.3ml single and dose 1 intramuscularly, administered in Arm Left on 13Jan2021 (Lot Number: EL1484, Expiration Date: 30Apr2021) as dose 1, 0.3ml single for COVID-19 immunisation. Medical history included blindness from 22Mar1994 to an unknown date and neoplasm from 24Apr2017 to an unknown date. The patient concomitant medications were not reported. On 07Sep2021 the patient experienced covid-19 confirmed by positive covid-19 test. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Sep2021. The outcome of the event was unknown. 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 and 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. Regulatory authority 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. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1755382 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-09-07
   Days after vaccination:216
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: COVID-19, Conjunctivitis, SARS-CoV-2 test, Vaccination failure
SMQs:, Severe cutaneous adverse reactions (broad), Lack of efficacy/effect (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertensive end-organ damage
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210907; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC202101232916

Write-up: vaccination failure; Cellini cluster. Positive molecular and antigenic buffer in vaccine; Cellini cluster. Positive molecular and antigenic buffer in vaccine. Paucisymptomatic (conjunctivitis); This is a spontaneous report from a contactable other-healthcare professional downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-787182. A 85-years-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EK9788; Expiration Date: 31May2021), via intramuscularly, administered in Left Arm on 03Feb2021 as dose 2, 0.3ml single, and received first dose of bnt162b2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EL1484; Expiration Date: 30Apr2021), via intramuscularly, administered in Left Arm on 13Jan2021 as dose 1, 0.3ml single both doses for covid-19 immunisation. The patient medical history included hypertensive end-organ damage and diabetes mellitus from 18Nov2004 to an unknown date. The patient''s concomitant medications were not reported. On 07Sep2021, the patient experienced cellini cluster. positive molecular and antigenic buffer in vaccine, COVID-19, vaccination failure and conjunctivitis. The patient underwent lab tests and procedures which included sars-cov-2 antigen test with positive and sars-cov-2 PCR test with positive on 07Sep2021. The outcome of the events was not recovered. Conclusion: The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5579153 (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, 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. Regulatory authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5648370 (see File attachment in this investigation record) The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(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. Regulatory authority 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.


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