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

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



Case Details (Reverse Sorted by Onset Date)

This is page 371 out of 6,867

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VAERS ID: 1504536 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003654 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dizziness, Feeling cold, Oxygen saturation, Skin discolouration
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: Normal; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: BT 37.3 degrees Celsius; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: At 15:55, body temperature was 37.4 degrees Celsius; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: At 16:00, body temperature was 37.3 degrees; Test Date: 20210714; Test Name: SPO2; Result Unstructured Data: SPO2 99%
CDC Split Type: JPTAKEDA2021TJP061584

Write-up: Peripheral dark reddening of both upper extremities; Feeling cold; Giddiness; This regulatory authority case was reported by a physician and describes the occurrence of DIZZINESS (Giddiness), SKIN DISCOLOURATION (Peripheral dark reddening of both upper extremities) and FEELING COLD (Feeling cold) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003654) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021 at 3:40 PM, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DIZZINESS (Giddiness) (seriousness criterion hospitalization). On 14-Jul-2021 at 4:15 PM, the patient experienced SKIN DISCOLOURATION (Peripheral dark reddening of both upper extremities) (seriousness criterion hospitalization) and FEELING COLD (Feeling cold) (seriousness criterion hospitalization). The patient was hospitalized on 14-Jul-2021 due to DIZZINESS, FEELING COLD and SKIN DISCOLOURATION. At the time of the report, DIZZINESS (Giddiness), SKIN DISCOLOURATION (Peripheral dark reddening of both upper extremities) and FEELING COLD (Feeling cold) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Blood pressure measurement: 123/75 (normal) Normal. On 14-Jul-2021, Body temperature: 37.3 (normal) BT 37.3 degrees Celsius, 37.4 (normal) At 15:55, body temperature was 37.4 degrees Celsius and 37.3 (normal) At 16:00, body temperature was 37.3 degrees. On 14-Jul-2021, Oxygen saturation: 99 (normal) SPO2 99%. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered DIZZINESS (Giddiness), SKIN DISCOLOURATION (Peripheral dark reddening of both upper extremities) and FEELING COLD (Feeling cold) to be possibly related. On an unknown date, body temperature before vaccination was unknown. The patient had P (unspecified lab test) performed and result obtained was P 90. On 14-Jul-21, at 15:30, the patient received the first dose of COVID-19 Vaccine Moderna. On 14-Jul-21, at 16:22, the patient was transported to hospital by an ambulance. No concomitant medication information was provided by the reporter. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1504652 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-14
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperpyrexia, Injection site inflammation, Injection site pain, Injection site swelling, Injection site warmth, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: ; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA in a 38-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced INJECTION SITE INFLAMMATION, INJECTION SITE WARMTH, INJECTION SITE SWELLING, INJECTION SITE PAIN, and HEADACHE. On 15-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant), MALAISE, ARTHRALGIA, MYALGIA, CHILLS and FATIGUE. At the time of the report, HYPERPYREXIA and CHILLS was resolving and INJECTION SITE INFLAMMATION, INJECTION SITE WARMTH, MALAISE, ARTHRALGIA, INJECTION SITE SWELLING, MYALGIA, FATIGUE, INJECTION SITE PAIN and HEADACHE had not resolved. No concomitant medications were reported. No treatment information was provided. This case concerns a 38-year-old female with a serious unexpected event of hyperpyrexia, and nonserious malaise, injection site inflammation, injection site warmth, injection site swelling, injection site pain, chills, arthralgia, myalgia, fatigue, and headache. Event latency within 24 hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 38-year-old female with a serious unexpected event of hyperpyrexia, and nonserious malaise, injection site inflammation, injection site warmth, injection site swelling, injection site pain, chills, arthralgia, myalgia, fatigue, and headache. Event latency within 24 hours after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1504986 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypotension, Pyrexia, Syncope
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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: PTJNJFOC20210746837

Write-up: FAINTING/ LOW PRESSURE; FAINTING/ LOW PRESSURE; FEVER; This spontaneous report received from a consumer via a Regulatory Authority (EMEA EVHUMAN NLP, PT-INFARMED-G202107-3017) concerned a 29 year old male of unspecified race and ethnic origin. The patient''s weight was 75 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: Unknown) 0.5 ml, with frequency 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced fainting/ low pressure, fainting/ low pressure and fever were reported. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting/ low pressure, and fainting/ low pressure on 14-JUL-2021, and fever on 15-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210746837-Covid-19 vaccine ad26.cov2.s-fainting, low pressure. 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). 20210746837-Covid-19 vaccine ad26.cov2.s-fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1507110 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202100926934

Write-up: Arm discomfort; Joint ache; Muscle ache; This is a spontaneous report from two contactable consumers downloaded from the Agency WEB, regulatory authority number GB-MHRA-WEBCOVID-202107151255350040-LTBGP, Safety Report Unique Identifier GB-MHRA-ADR 25656320. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021, as single dose (Lot/Batch number was not reported) for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included unclassified medication. The patient experienced arm discomfort, joint ache and muscle ache at the same day as vaccine was administered later in the evening on 14Jul2021. The patient had gotten slightly worse overnight into the next day(on 15Jul2021). The patient underwent lab test included COVID-19 virus test: negative on an unspecified date. The outcome of events "arm discomfort", "joint ache" and "muscle ache" was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1507114 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100909163

Write-up: Vaginal bleeding; SARS-CoV-2 infection; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107162203194100-ZWJBW. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25667330. A 24-years-old non-pregnant female patient received bnt162b2 (Pfizer BioNTech covid-19 vaccine, solution for injection), via an unspecified route of administration on 06Jul2021 (Batch/lot number was not reported) as first dose, single for COVID-19 immunization. Medical history included suppressed lactation, suspected COVID-19 from 13Jul2021 and ongoing. The patient''s concomitant medications were not reported. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. On 14Jul2021, patient experienced sars-cov-2 infection and on 15Jul2021, vaginal bleeding. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Jul2021 yes - positive COVID-19 test. Outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1507456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Headache, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP060715

Write-up: Haemorrhage; Headache; Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Haemorrhage) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Jul-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (Pyrexia). On 15-Jul-2021, the patient experienced HEADACHE (Headache). On 16-Jul-2021, the patient experienced HAEMORRHAGE (Haemorrhage) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Haemorrhage) and HEADACHE (Headache) outcome was unknown and PYREXIA (Pyrexia) was resolving. No concomitant medications were provided. Treatment for the events were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1507474 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003190 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: At 15:51; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: after 5 minutes.; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: At 16:16; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Low; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Low; Test Date: 20210714; Test Name: Pulse rate; Result Unstructured Data: Low
CDC Split Type: JPTAKEDA2021TJP061905

Write-up: Loss of consciousness; Vasovagal reaction; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 19-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003190) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant) and PRESYNCOPE (Vasovagal reaction). On 14-Jul-2021, LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reaction) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Blood pressure measurement: 104/81 (Low) At 15:51, 95/42 (Low) after 5 minutes. and 124/59 (Low) At 16:16. On 14-Jul-2021, Heart rate: 49 (Low) Low, 57 (Low) Low and 38 (Low) Low. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Loss of consciousness) and PRESYNCOPE (Vasovagal reaction) to be possibly related. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter''s Comments: Vasovagal reaction with transient loss of consciousness (about 1 min).; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1507478 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002337 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Heart rate, Respiratory arrest, Tonic convulsion
SMQs:, Anaphylactic reaction (narrow), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Convulsions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: pulse; Result Unstructured Data: weak pulse; pulse pressure decreased
CDC Split Type: JPTAKEDA2021TJP061915

Write-up: Anaphylaxis; Tonic convulsion; Respiratory arrest; This regulatory authority case was reported by a physician and describes the occurrence of TONIC CONVULSION (Tonic convulsion), RESPIRATORY ARREST (Respiratory arrest) and ANAPHYLACTIC REACTION (Anaphylaxis) in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002337) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced TONIC CONVULSION (Tonic convulsion) (seriousness criterion medically significant), RESPIRATORY ARREST (Respiratory arrest) (seriousness criterion medically significant) and ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criteria hospitalization and medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] (intramuscular) for Adverse event, at a dose of 0.3 mg and HYDROCORTISONE SODIUM PHOSPHATE (intravenous) for Adverse event, at a dose of 200 mg. At the time of the report, TONIC CONVULSION (Tonic convulsion), RESPIRATORY ARREST (Respiratory arrest) and ANAPHYLACTIC REACTION (Anaphylaxis) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Heart rate: low (Low) weak pulse; pulse pressure decreased. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis) to be possibly related. No further causality assessments were provided for TONIC CONVULSION (Tonic convulsion) and RESPIRATORY ARREST (Respiratory arrest). Concomitant products were not provided. On 14-Jul-2021, at 15:41, the patient received the 1st dose of this vaccine. At 16:00, during follow-up, the patient suddenly fell forward and had tonic convulsion, respiratory arrest, and weak pulse. Symptoms of anaphylaxis was observed. Blood vessel was secured, and intramuscular (M) administration of adrenaline 0.3 mg and intravenous (V) administration of hydrocortisone sodium phosphate 200 mg were given. Pulse became palpable, and consciousness was restored. The patient was raced to a hospital. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter''s Comments: Not reported.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1507511 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Cyanosis, Dizziness, Loss of consciousness, Nausea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021895593

Write-up: collapse and then unconscious; collapse and then unconscious; nausea; dizzy; purple lip; This is a spontaneous report from a non contactable consumer (patient) via a Pfizer sales representative, based on information received by Pfizer from local distributor for COMIRNATY. A 20-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Jul2021 13:15 (Batch/Lot number was not reported) at the age of 20 years, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was not pregnant. Around 15 minutes later on 14Jun2021 the patient experienced collapse and then unconscious, nausea, dizzy, cyanosis of lip. The outcome of the events was recovering. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.


VAERS ID: 1507644 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Thalassemia minor carrier. Occasionally he suffer from tension breakdowns.
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210749217

Write-up: HEADACHE; SYNCOPE, MORE NAUSEA, NAUSEA AND VOMITING; SYNCOPE, MORE NAUSEA, NAUSEA AND VOMITING; SYNCOPE, MORE NAUSEA, NAUSEA AND VOMITING; SYNCOPE, MORE NAUSEA, NAUSEA AND VOMITING; This spontaneous report received from a consumer via a Regulatory Authority, concerned a 25 year old male of an unspecified race, and ethnic origin. The patient''s weight was 70 kilograms, and height was 170 centimeters. The patient''s pre-existing medical conditions included thalassemia minor carrier. occasionally he suffer from tension breakdowns. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous (not otherwise specified), batch number: XE393, expiry: unknown) 0.5 ml, frequency 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope, woozy, nausea and vomiting. On 15-JUL-2021, the patient experienced headache. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope and vomiting on 14-JUL-2021, and woozy, nausea on 15-JUL-2021, and was recovering from headache. This report was serious (Other Medically Important Condition).; Reporter''s Comments: Other information-Thalassemia Minor Carrier Since the card indicating the batch is handwritten, I am not sure if the batch indicator is XE343 or XE393.; Sender''s Comments: V0: 20210749217-COVID-19 VACCINE AD26.COV2.S-syncope, Vomiting, woozy. 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). 20210749217-COVID-19 VACCINE AD26.COV2.S-Nausea, Headache. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1507645 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dizziness postural, Pyrexia, Thirst
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210752218

Write-up: FEELING DIZZY WHEN GETTING UP; FEELING DIZZY WHEN GETTING UP; EXTREME THIRST; JOINT PAIN; FEVER (39?C); This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-J202107-2925] concerned a 31 year old male of unspecified race and ethnic origin. The patient''s weight was 75 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced feeling dizzy when getting up (felt faint), extreme thirst, joint pain and fever (39 degree celsius). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling dizzy when getting up, extreme thirst, joint pain, and fever (39 degree celsius) on 15-JUL-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210752218-covid-19 vaccine ad26.cov2.s- feeling dizzy when getting up (felt faint), extreme thirst. These events are considered unassessable. The events 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 events. 20210752218-COVID-19 VACCINE AD26.COV2.S- Joint pain and fever (39 degree celsius). This event(s) is labeled per Regulatory Authority and is therefore considered potentially related


VAERS ID: 1507646 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210748886

Write-up: FAINT; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-J202107-2967] concerned a 34-year-old male of unspecified race and ethnicity. The patient''s weight was 90 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, intravenous (not otherwise specified), batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 14-JUL-2021, the patient experienced faint. The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from faint on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210748886- covid-19 vaccine ad26.cov2. s- faint. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507664 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752320

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3602] concerned an adult male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: EX393 and expiry: Unknown) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had more than 20 male users, young with syncopes; Sender''s Comments: V0: 20210752320- Covid-19 vaccine ad26.cov2.s-Syncope. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752321

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3611] concerned an adult male of unknown 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: XE393 and expiry: UNKNOWN) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male users, young men with syncopes; Sender''s Comments: V0: 20210752321-COVID-19 VACCINE AD26.COV2.S-syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507666 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752198

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority (EMEA EVHUMAN NLP, PT-INFARMED-T202107-3614) concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: EX393, expiry: UNKNOWN) .5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had more than 20 male users, young with syncopes; Sender''s Comments: V0: 20210752198-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752324

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3616] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had more than 20 male patients, young with syncope''s.; Sender''s Comments: V0: 20210752324-covid-19 vaccine ad26.cov2.s-syncope with severe hypotension . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507668 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210753099

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3648] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) of 0.5 ml, 1 dosage forms,1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension for duration of 3 minutes . The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male users, young men with syncopes.; Sender''s Comments: V0: 20210753099-covid-19 vaccine ad26.cov2.s-syncope with severe hypotension . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507669 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210753191

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3652] concerned an adult male of unknown 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: XE393 expiry: Unknown) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male users, young men with syncopes; Sender''s Comments: V0: 20210753191-Covid-19 vaccine ad26.cov2.s -Syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1507670 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752744

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3655] concerned an adult male of unknown 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: XE393 expiry: UNKNOWN) .5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: So far we have had more than 20 male users, young people with syncope.; Sender''s Comments: 20210752744-COVID-19 VACCINE Ad26.COV2.S-Syncope with Severe Hypotension. This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1507675 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210749246

Write-up: SEVERE PAIN, ESPECIALLY IN THE ARM; BAD PAINS, HEAD; FEVER; WEAKNESS; This spontaneous report received from a consumer via a Regulatory Authority concerned a 26 year old male, unspecified race and ethnicity. The patient''s weight was 64 kilograms, and height was 176 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 01 total, administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 14-JUL-2021, the patient experienced severe pain, especially in the arm, bad pains, head, fever and weakness. The dose of covid-19 vaccine ad26.cov2.s was not changed. The patient was recovering from severe pain, especially in the arm, bad pains, head, fever, and weakness. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210749246-covid-19 vaccine ad26.cov2.s-severe pain especially in the arm, bad pains head, fever, weakness. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1509164 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752327

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml,1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: "By this time we have had over 20 male users, young men with syncopes"; Sender''s Comments: V0: 20210752327-covid-19 vaccine ad26.cov2.s-syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1509165 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752910

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3641] concerned an adult male of unspecified age, 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: XE393 expiry: unknown) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male users, young men with syncopes; Sender''s Comments: V0:20210752910-Covid-19 Vaccine Ad26.Cov2.S -Syncope with Severe Hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1509166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752780

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3646] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male, young users with syncopes; Sender''s Comments: 20210752780-covid-19 vaccine ad26.cov2.s-Syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1509167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752896

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [PT-INFARMED-T202107-3651] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: XE393) 0.5 ml, 1 total, dose administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male users, young men with syncopes; Sender''s Comments: V0: 20210752896- Covid-19 vaccine Syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1509168 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752714

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3654] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: UNKNOWN) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: "By this time we have had over 20 male users, young men with syncopes"; Sender''s Comments: V0: 20210752714- covid-19 vaccine ad26.cov2.s-Syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1509352 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bruxism, Dyskinesia, Muscle spasms, Muscle tightness, Muscle twitching, Myalgia, Opisthotonus, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Dyskinesia (narrow), Dystonia (narrow), Noninfectious encephalopathy/delirium (broad), Eosinophilic pneumonia (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: LINESSA; CIPROLEX; RABEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to nuts; Asthma; Birch pollen allergy; Gluten sensitivity; Hypermobility syndrome; Irritable bowel syndrome; Lactose intolerance; Pollen allergy; Raynauds
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021893313

Write-up: back arching; body muscle aches; extreme muscle spasms; involuntary movements over her whole body, including leg jerks, hand movements and foot movements; jaw clenching/grinding; jawclenching/grinding; In extreme pain and couldn''t get her body to relax / whole body was extremely sore; muscle twitch; This is a spontaneous report from a contactable consumer (patient). A 25-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 13Jul2021 10:00 (Batch/Lot Number: Unknown) (at the age of 25 years old) as single dose for covid-19 immunisation. Medical history included asthma, irritable bowel syndrome (IBS), Raynaud''s, hypermobility, gluten, lactose intolerance, pollen allergy, birch allergy, and tree nuts allergy. Patient was not pregnant at the time of vaccination. Concomitant medications included linezolid (LINESSA) taken for an unspecified indication, start and stop date were not reported; ciprofloxacin hydrochloride (CIPROLEX) taken for an unspecified indication, start and stop date were not reported; rabeprazole (RABEPRAZOLE) taken for an unspecified indication, start and stop date were not reported and an antihistamine. The patient experienced body muscle aches, extreme muscle spasms, involuntary movements over her whole body, including leg jerks, hand movements and foot movements, jaw clenching/grinding, back arching, in extreme pain and couldn''t get her body to relax/whole body was extremely sore, muscle twitch, all on 14Jul2021. The clinical course was reported as follows: About 12 hours after her vaccine, which was her second shot, she began experiencing full body muscle aches. About 14 hours after her vaccine this turned into extreme muscle spasms and involuntary movements over her whole body, including leg jerks, hand movements and foot movements, jaw clenching/grinding, and back arching. Patient was in extreme pain and she couldn''t get her body to relax. This lasted for over an hour before she ended up taking 10 mg of cyclobenzaprine. After about half an hour the jerking movements lessened and after an hour her muscles finally relaxed with only the occasional muscle twitch. The next day her whole body was extremely sore, and assumed it was from the muscle spasms. Therapeutic measures were taken as result of all the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.


VAERS ID: 1510312 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-07-14
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100912730

Write-up: Covid-19 with mild symptoms; Drug ineffective; This is a spontaneous report from a contactable consumer (patients relative) received via a Pfizer company representative. A female patient of an unspecified age received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Feb2021 as dose number unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer reported that her sister was vaccinated with Comirnaty vaccine since February 2021, and she experienced Covid-19 with mild symptoms since Wednesday on 14Jul2021. The outcome of events was unknown.


VAERS ID: 1510520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100925466

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 587389). A 78-year-old male patient received BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction, bradycardia, hyperhidrosis and loss of consciousness on Jul 14, 2021; with outcome of recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1510660 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Discomfort, Feeling abnormal, Insomnia, Pain in extremity, Pyrexia, Renal pain, Restless legs syndrome, SARS-CoV-2 test, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021893957

Write-up: pain in the arm around injection site; pain in the arm around injection site; discomfort; pain the knees; Legs are restless and achy; Legs are restless and achy; Elbows also began to ache; High temperature; shooting pains in the back/kidney region; shooting pains in the back/kidney region; Foggy feeling in head; Struggled to sleep that night, extremely restless unable to drift off to sleep; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number [GB-RA-WEBCOVID-202107140251263760-LLHYA], Safety Report Unique Identifier [GB-RA-ADR 25645581]. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the arm on 13Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Concomitant medications included citalopram taken for an unspecified indication from 09Jan2016 to an unspecified stop date. The patient experienced pain in the arm around injection site, discomfort on an unspecified date; pain the knees, legs are restless and achy, legs are restless and achy, elbows also began to ache, high temperature, shooting pains in the back/kidney region, shooting pains in the back/kidney region, foggy feeling in head, struggled to sleep that night, extremely restless unable to drift off to sleep on 14Jul2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 13Jul2021. Therapeutic measures were taken as a result of pain in extremity, injection site pain, discomfort, pain the knees, legs are restless and achy, elbows also began to ache, high temperature, shooting pains in the back/kidney region, foggy feeling in head, struggled to sleep that night, extremely restless unable to drift off to sleep. The outcome of the events ''pain in the arm around injection site'' and ''discomfort'' was unknown; outcome of the other events was not recovered. The clinical course was reported as follows: Began with pain in the arm around injection site on day 1. As day 2 progressed experienced discomfort and pain the knees, struggling to weight bare. This worsened throughout day 2. Legs are restless and achy. Elbows also began to ache by afternoon of day 2. Followed by high temperature, shooting pains in the back/kidney region, foggy feeling in head. Struggled to sleep that night, extremely restless unable to drift off to sleep. Paracetamol was taken however did little to ease discomfort. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional Information: Patient has not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1510662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IRON; LAXIDO; LEVOTHYROXINE; VITAMIN D3
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021893903

Write-up: Faint; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107140511325470-QK71H, Safety Report Unique Identifier GB-MHRA-ADR 25645946. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Jul2021 (Lot number: FE1510) as second dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included iron; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO); levothyroxine; vitamin d3. Patient has not had symptoms associated with COVID-19 and 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 faint on 14Jul2021 with outcome of recovered on 14Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1510747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Fatigue, Hypopnoea
SMQs:, Retroperitoneal fibrosis (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900546

Write-up: Backache; Fatigue; Breathing abnormally shallow; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107141037216430-J2THB. Safety Report Unique Identifier GB-MHRA-ADR 25648007. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 13Jul2021 (Lot Number: FA1027) as single dose for COVID-19 immunisation. Medical history included suppressed lactation. Unsure if patient had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced breathing abnormally shallow on 14Jul2021 with outcome of not recovered, backache and fatigue, both on an unspecified date with outcome of not recovered. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. This case was reported as serious with seriousness criteria-other medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1510763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Pain, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decreased lactation.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC2021900501

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107141319345850-NL2SI; safety report unique identifier: GB-MHRA-ADR 25649142). A 25-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# not reported), via an unspecified route of administration, on Jun 24, 2021, single dose, for COVID-19 immunisation. Medical history included decreased lactation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, nor currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date, faint on an unspecified date and painful periods on Jul 14, 2021. The events reported serious (medically significant). The clinical course as follows: Began period. Woke up with pain so bad, had to call (emergency helpline number) for the first time in her life. She was sick multiple times. She thought she was going to faint. Patient was not enrolled in a clinical trial. The patient underwent lab tests and procedures, which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of painful periods: not resolved. The outcome of other events unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1510769 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, SARS-CoV-2 test
SMQs:, Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021900563

Write-up: Myocarditis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-RA-WEBCOVID-202107141431101110-PROEV, Safety Report Unique Identifier is GB-RA-ADR 25649611. A 28-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC9001) via an unspecified route of administration at single dose on 29Jun2021 for COVID-19 immunization. Medical history included suspected COVID-19, it was unsure when symptoms started and when symptoms stopped. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. COVID-19 virus test was no-negative. Concomitant medications were not reported. The patient experienced myocarditis (medically significant) on 14Jul2021 with outcome of not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1510774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021900100

Write-up: Period pains; 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-202107141636195800-GNUIB} Safety Report Unique Identifier {GB-MHRA-ADR 25650376}. A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1, via an unspecified route of administration on 04Jul2021 (lot number: Not known, Expiration Date: not reported), as dose 1, single for COVID-19 immunization. Medical history included lactation decreased. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not pregnant, not currently breastfeeding. On 14Jul2021, the patient experienced period pains. The event was considered serious as other medically important condition. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on an unknown date. The outcome of the event was not recovered. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1510796 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Maternal exposure during pregnancy, SARS-CoV-2 test, Scan
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: FOLIC ACID; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Muscle pain
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210712; Test Name: Scan; Result Unstructured Data: Test Result:Pregnancy progressing normally
CDC Split Type: GBPFIZER INC2021900618

Write-up: Maternal exposure during pregnancy; severe diarrhea; stomach pain; Diarrhea; Stomachache; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107142127011840-NOICC. Safety Report Unique Identifier GB-MHRA-ADR 25652237. A 28-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Jul2021 (Lot Number: Ew3143) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing pregnancy, folic acid supplementation, muscle pain. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication(s) included folic acid (FOLIC ACID) taken for Folic acid supplementation; paracetamol (PARACETAMOL) taken for Muscle pain. The patient experienced maternal exposure during pregnancy, severe diarrhea, stomach pain, diarrhea on 14Jul2021, stomachache on 14Jul2021. Moderate stomach pain and severe diarrhea started abruptly roughly 48 hours after the vaccine. The mother reported she became pregnant while taking bnt162b2. The mother was 2 trimester pregnant (22 weeks) at the onset of the event. The patient underwent lab tests and procedures which included COVID-19 virus test negative 12Jul2021, scan: Pregnancy progressing normally on 12Jul2021. No treatment required. The outcome of events was recovering. Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1510802 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Pain in extremity, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021900379

Write-up: Fever; Joint pain; Painful arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number GB-MHRA-WEBCOVID-202107142226217390-E1Y7W, Safety Report Unique Identifier GB-MHRA-ADR 25652560. A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 14Jul2021 (at the age of 23-years-old) as dose 2, single for COVID-19 immunization. Patient had not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. Patient was not enrolled in clinical trial. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient experienced fever, joint pain and painful arm on 14Jul2021. The events were reported as serious as important medical events. The patient underwent lab tests and procedures which included COVID-19 virus test: negative. Patient had not tested positive for COVID-19 since having the vaccine. The patient had not recovered from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1510808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Myalgia, Oropharyngeal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms started)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900481

Write-up: Headache; Joint pain; Muscle pain; Sore throat; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107142259165290-BW7AC Safety Report Unique Identifier GB-MHRA-ADR 25652918. A 22-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suppressed lactation, suspected covid-19 Unsure when symptoms started. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced headache, joint pain, muscle pain and sore throat on 14Jul2021. Patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The outcome of all events was not resolved. All events were serious with medically significant. No follow-up attempts are possible. Information about batch no cannot be obtained. No further information is expected.


VAERS ID: 1510815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUTIFORM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900522

Write-up: Swollen lymph nodes; painful lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107150736215680-LTHWQ. Safety Report Unique Identifier: GB-MHRA-ADR 25653966 A 24-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: FA1027) as single dose for COVID-19 immunisation. Medical history included Lactation decreased, suspected COVID-19 from 13Mar2020 (Unsure when symptoms stopped), asthma. Not had a COVID-19 test. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included fluticasone propionate, formoterol fumarate (FLUTIFORM) taken for asthma, start and stop date were not reported. The patient previously took first dose BNT162B2 for COVID-19 immunization. The patient experienced swollen lymph nodes (medically significant) on 14Jul2021, painful lymph nodes (medically significant) on 14Jul2021. The outcome of event swollen lymph nodes was not recovered. The outcome of event painful lymph nodes was unknown. The clinical course was reported as follows: Very swollen and painful lymph nodes under patient''s armpit and in neck only on the left side of patient''s body where patient had the vaccine, Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1510832 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-07-14
   Days after vaccination:118
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: PCR test/lateral flow; Test Result: Positive ; Comments: Nasal Swab; Test Date: 20210722; Test Name: PCR test/lateral flow; Test Result: Negative ; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202100949563

Write-up: COVID-19 infection which occurred 4 months after receiving the second dose of the vaccine; COVID-19 infection which occurred 4 months after receiving the second dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 25-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Feb2021 (at the age of 25 years) (Batch/Lot number: Unknown) as a single dose and dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 25 years) (Batch/Lot number: Unknown) as a single dose for COVID-19 immunisation. Patient had no medical history. The patient''s concomitant medications were not reported. The patient experienced COVID-19 infection which occurred 4 months after receiving the second dose of the vaccine, on 14Jul2021. No treatment was received. Outcome of the events was recovering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient has been tested for COVID-19 (nasal swab: positive on 21Jul2021, nasal swab: negative on 22Jul2021). The lot numbers for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1510941 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210752125

Write-up: ANAPHYLACTIC SHOCK AFTER JANSSEN VACCINE; This spontaneous report received from a physician via a Regulatory Authority concerned a 31 year old male with unspecified race and ethnicity. The patient''s weight was 85 kilograms, and height was 175 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: 21c18-03 expiry: Unknown) 0.5 ml, 1 total, administered on 14-JUL-2021 for Covid-19 vaccination. No concomitant medications were reported. On 14-JUL-2021, after a few minutes from the vaccination the patient experienced anaphylactic shock, lost consciousness, had cold sweating and at the detection of vital parameters neither the pulse nor the arterial pressure were detectable, in addition to a major desaturation. after appropriate therapy the parameters have slightly improved and was sent to the ER (emergency room). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anaphylactic shock after vaccine. This report was serious (Life Threatening).; Reporter''s Comments: After a few minutes from the vaccination the subject lost consciousness, had cold sweating and at the detection of vital parameters neither the pulse nor the arterial pressure were detectable, in addition to a major desaturation. after appropriate therapy the parameters have slightly improved and was sent to the ER with 118.; Sender''s Comments:Covid-19 Vaccine Ad26.Cov2.S-Anaphylactic Shock. This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1510942 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose, Dysphagia, Laryngeal oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypersensitivity (narrow), Medication errors (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: ITMODERNATX, INC.MOD20212

Write-up: Patient administered 0.3 milliliter of Moderna vaccine; This regulatory authority case was reported by a physician and describes the occurrence of LARYNGEAL OEDEMA in a 71-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003655) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .3 milliliter. On 14-Jul-2021, the patient experienced LARYNGEAL OEDEMA (seriousness criterion medically significant), DYSPHAGIA and ACCIDENTAL UNDERDOSE (Patient administered 0.3 milliliter of Moderna vaccine). On 14-Jul-2021, LARYNGEAL OEDEMA, DYSPHAGIA and ACCIDENTAL UNDERDOSE (Patient administered 0.3 milliliter of Moderna vaccine) had resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not reported. Treatment medication was not reported. Company Comment: This report refers to a case of accidental under dose for mRNA-1273, lot # 3003655. with associated AEs of laryngeal oedema and dysphagia. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 3003655. with associated AEs of laryngeal oedema and dysphagia. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1510943 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Obstructive airways disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad)

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of DYSPNOEA, OBSTRUCTIVE AIRWAYS DISORDER and MALAISE in a 28-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003605) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced DYSPNOEA (seriousness criterion hospitalization), OBSTRUCTIVE AIRWAYS DISORDER (seriousness criterion hospitalization) and MALAISE (seriousness criterion hospitalization). At the time of the report, DYSPNOEA, OBSTRUCTIVE AIRWAYS DISORDER and MALAISE had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (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. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded


VAERS ID: 1511008 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hyperlipidaemia; Hypertension; Hyperuricaemia; Late effects of cerebral infarction; Nausea (before vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021889467

Write-up: Vomiting; nausea; nausea; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 77-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination (detail unknown). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included Late effects of cerebral infarction, Hypertension, Diabetes mellitus, Hyperlipidaemia and Hyperuricaemia. On 14Jul2021 at 11:00 (the day of vaccination), the patient received of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) intramuscular in the left arm as dose 1, single for COVID-19 immunization. On 14Jul2021 at 11:00 (same time after vaccination), the patient experienced adverse events. The course of the event was as follows: Before vaccination, the patient complained of nausea when the patient went out, but the patient was vaccinated because he answered in the questionnaire that "there was no problem with her health". After vaccination, nausea and vomiting occurred, but no other symptoms were found. Infusion was performed after judging as gastrointestinal symptoms due to side reactions. The reporter stated the events results in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered with treatment including intravenous injection of saline and antiemetics. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on currently known drug safety profile, a causal association between the reported events and BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.


VAERS ID: 1511018 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Depressed level of consciousness, Dyspnoea, Feeling abnormal, Flushing, Presyncope, Respiratory depression, Seizure, Tremor
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result: 36.0 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC2021890213

Write-up: Consciousness clouding/consciousness level I-1; vasovagal reflex; Feels poorly; Difficulty in breathing; generalized convulsion; Tremor; flushed face; Anaphylaxis; Respiratory depression; This is a spontaneous report from a contactable nurse via a Pfizer sales representative and from the Regulatory Authority. Regulatory authority report number is v21119938. The patient was a 58-year-old female adult. The patient had no medical history. On an unspecified date, the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) for COVID-19 immunization and experienced pyrexia at level of 38 degrees centigrade, feelings of weakness and malaise. After the first dose of vaccination, the patient experienced pyrexia at level of 38 degrees centigrade, malaise and feelings of weakness and needed observation. Body temperature of the patient before vaccination was 36.0 degrees Centigrade (14Jul2021). On 14Jul2021 at 10:13 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021, Dosage was 0.3 mL) via intramuscular for COVID-19 immunization. On 14Jul2021 (after the vaccination), the patient experienced anaphylaxis which was assessed as serious (medically significant) by reporting nurse. Outcome of anaphylaxis was unknown (as initially reported) and reporting nurse assessed it was definitely related to the vaccine. Respiratory depression. Emergency transportation by inhaling oxygen and continuing infusion. The course of the events was as follows: On 14Jul2021, the patient was emergency transported after the second dose. 1 minute after the vaccination, it was found that the condition was abnormal, the patient experienced Tremor, generalized convulsion, flushed face. The level of consciousness did not decline. The patient was taken EPIPEN 1 was added. Oxygen 5 liters, saline 500, Solu-Cortef administration. On 14Jul2021 at 10:15 (2 minutes after the vaccination), the patient experienced convulsion and vasovagal reflex. The course of the event was as follows: 2 minutes after the second dose of vaccination, the patient complained about feels poorly and difficulty in breathing. The patient experienced flushed face and consciousness clouding. O2 5L, EPIPEN 1A were started at the area of right thigh. Route secured with saline (500) and performed with MAX. Saline (20)+ Solu-Cortef Injection received, the patient had mild generalised convulsion and consciousness level I-1. The patient was emergently transported to hospital. The patient was examined and treated at the hospital and returned home on the same day. On 14Jul2021 (the day of the vaccination), the final outcome of the events was recovering. The reporting nurse classified the events as serious (caused 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. Follow up attempts are completed. No further information is expected.


VAERS ID: 1511139 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CONIEL; MYSLEE; TAKEPRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hyperthyroidism; Reflux oesophagitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021895377

Write-up: cardiac failure; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. A 72-years-old (non-pregnant) female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FC3661; Expiration Date: 30Sep2021), intramuscular, administered in left arm on 07Jul2021 10:45 (at the age of 72 years old) as dose 1, single for covid-19 immunisation. Medical history included hypertension, hyperthyroidism and reflux oesophagitis, all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included benidipine hydrochloride (CONIEL), zolpidem tartrate (MYSLEE), and lansoprazole (TAKEPRON), all taken for an unspecified indication, start and stop date were not reported and reported as taken within 2 weeks of vaccination. On 14Jul2021 at 09:00 (6 days 22 hrs 15 min after the vaccination), the patient experienced cardiac failure which caused hospitalization on unknown dates. The reporter stated the event results in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was unknown without treatment.; Sender''s Comments: Based on current information available, the event cardiac failure mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authority, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1511163 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypertension (narrow), Vestibular 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: VALSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:185/85; Comments: mg/mg
CDC Split Type: JPPFIZER INC2021897962

Write-up: Blood pressure increased (185mg/85mg); giddiness; This is a spontaneous report received from a contactable physician via a Pfizer sales representative. The patient was a 79-year-old female. Medical history included hypertension. Concomitant medication included oral valsartan, daily dose 80mg and ongoing. On 14Jul2021, the patient received dose 1 of BNT162b2 (COMIRNATY, INTRAMUSCULAR, Lot number unknown) via an unspecified route of administration, single, for COVID-19 immunization. On 14Jul2021, the patient experienced blood pressure increased (185mg/85mg) and giddiness. The patient recovered after 15 minutes of rest and returned home. The reporter refused further investigation. The reporter classified the seriousness of the events as non-serious, and the causality between the suspect drug and events was probably related. On 14Jul2021, The outcome of events was recovered. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162b2 and the events blood pressure increased and dizziness cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 1511170 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Chest discomfort, Heart rate, Hyperhidrosis, Oxygen saturation
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:100/73; Comments: at 15:10; Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:124/71; Comments: at 15:15; Test Date: 20210714; Test Name: blood pressure; Result Unstructured Data: Test Result:108/64; Comments: at 16:07; Test Date: 20210714; Test Name: Palse rate; Result Unstructured Data: Test Result:78; Comments: at 15:10; Test Date: 20210714; Test Name: Palse rate; Result Unstructured Data: Test Result:76; Comments: at 16:07; Test Date: 20210714; Test Name: SpO2; Test Result: 98 %; Comments: at 15:10; Test Date: 20210714; Test Name: SpO2; Test Result: 98 %; Comments: at 16:07
CDC Split Type: JPPFIZER INC2021901492

Write-up: Sweaty; Chest distressed feeling; Anaphylaxis; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21119782. A 23-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on 14Jul2021 15:00, at 23 years of age, (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as single dose for COVID-19 immunization. The patient had no relevant medical history. The patient''s concomitant medications were not reported. On 14Jul2021 15:00 the patient experienced anaphylaxis; on 14Jul2021 at 15:05 (as reported), 5 minutes after the vaccination, the patient was sweaty and experienced a chest distressed feeling. On 14Jul2021 at 15:10 (10 minutes after the vaccination), 0.3 mg EPIPEN was administrated via IM route. Blood pressure was 100/73, pulse rate 78, SpO2 98%. On 14Jul2021 at 15:15 (15 minutes after the vaccination), the blood pressure was 124/71. On 14Jul2021 at 16:07 (67 minutes after the vaccination), blood pressure was 108/64, pulse rate 76, SpO2 98%. On 14Jul2021 at 16:30 (90 minutes after the vaccination), the patient went to home as the situation became stable. On 14Jul2021 (the day of vaccination) the outcome of the events was reported as recovering. The reporting physician classified the event as non-serious and assessed that the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: It was suspected to be anaphylaxis. The Company assessed the event "Anaphylaxis" as medically significant.


VAERS ID: 1511198 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Dyspnoea, Heart rate, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:154/93 mmHg; Comments: 15: 03; Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:159/97 mmHg; Comments: 15:10; Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:164/95 mmHg; Comments: 15:16; Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:178/108 mmHg; Comments: 15:32; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: before vaccination; Test Date: 20210714; Test Name: P; Result Unstructured Data: Test Result:78; Comments: 15: 03; Test Date: 20210714; Test Name: P; Result Unstructured Data: Test Result:84; Comments: 15:10; Test Date: 20210714; Test Name: P; Result Unstructured Data: Test Result:84; Comments: 15:13; Test Date: 20210714; Test Name: SpO2; Test Result: 97 %; Comments: 15: 03; Test Date: 20210714; Test Name: SpO2; Result Unstructured Data: Test Result:95-97 %; Comments: 15:16; Test Date: 20210714; Test Name: SpO2; Test Result: 97 %; Comments: 15:32
CDC Split Type: JPPFIZER INC2021902712

Write-up: BP 154/93 mmHg/BP 178/108; Dyspnoea; This is a spontaneous report from a contactable other health professional received from the Regulatory authority report number is v21119740. A 52-year and 11-month-old female patient received BNT162B2 (COMIRNATY), 1st dose via an unspecified route of administration on 14Jul2021 14:30 (Lot Number: FC5947; Expiration Date: 30Sep2021) at age of 52 years old as a single dose for covid-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included Sleep apnea syndrome, urticaria caused by allergic to loxonin, Solantal, Macrolide antibiotics, New Quinolone and Flomox. The patient''s concomitant medications were not reported. The patient previously took solantal, flomox, loxonin and experienced urticaria. The patient experienced dyspnoea, BP 154/93 mmhg/BP 178/108, both on 14Jul2021 15:03. The outcome of the events was unknown. Clinical course: After 30-minute observation, the patient complained Dyspnoea, BP 154/93 mmHg, P78, SpO2 97 and no Arrhythmia. At 15:10, BP 159/97 mmHg, P84, doctor examination. At 15:13, P84, according to the instruction of the doctor, called the emergency ambulance. At 15:16, BP 164/95, still experiencing Dyspnoea, SpO2 95-97%. At 15:32, BP 178/108, SpO2 97%. At 15:37, the patient was sent by emergency ambulance. The reporting other-HCP classified the event as non-serious and assessed that did not provide the causality between the event and bnt162b2. No follow-up attempts possible. No further information expected.


VAERS ID: 1511205 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cough, Feeling abnormal, Heart rate, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:92/54 mmHg; Comments: before vaccination; Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:106/62 mmHg; Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: heart rate; Result Unstructured Data: Test Result:69; Comments: bpm before vaccination; Test Date: 20210714; Test Name: heart rate; Result Unstructured Data: Test Result:62; Comments: bpm
CDC Split Type: JPPFIZER INC2021903329

Write-up: Feels poorly; queasy; cough; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119733. A 46-year and 10-month-old female patient received the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) at the age of 46-years, via an unspecified route of administration on 14Jul2021 at 11:00 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Family history was unknown. The patient had history of schizophrenia, no vaccine received and no disease within two weeks. Concomitant medications were not reported. The patient received olanzapine 2.5mg 2T1X, venlafaxine hydrochloride (EFFEXOR OR) 5mg 3T1X, brotizolam 0.25mg 1T1X, flunitrazepam 2mg 1T1X, aripiprazole (ABILIFY) 6mg 1T1X, aripiprazole (ABILIFY) tablet 12mg, mirtazapine (REMERON) 15mg 3T1X, magnesium oxide (MAGMITT) 500mg 4T1X. The patient experienced feels poorly on 14Jul2021 at 11:10 with outcome of recovering; queasy on 14Jul2021 at 11:10 with outcome of recovering; cough on 14Jul2021 with outcome of recovering. Clinical course detail provided as follows: before vaccination, BP 92/54 mmHg, heart rate 69 bpm; 10 minutes after the vaccination, sudden feels poorly and queasy occurred. Immediately, asked the patient took a shock position on bed. At this time, rash and erythema could not be conformed. At 11:12, epinephrine (BOSMIN) 0.3mg was injected intramuscularly, line secured by 5% glucose injection. After that, BP 106/62, heart rate 62 bpm. As queasy disappeared, line removed. At 12:05, the patient was able to walk by herself and went back home. At 16:40, there was a call that cough, queasy continued. Observation performed, (illegible writing), no dyspnoea. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Possible cause of the event such as any other diseases was unknown. The reporting physician commented as follows: it was considered that the events were related to the vaccination. No follow-up attempts possible. No further information expected.


VAERS ID: 1511211 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Nausea
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result: 36.5 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC2021903833

Write-up: Anaphylaxis; queasy; This is a spontaneous report from a contactable other hcp received from the Regulatory Authority. The Regulatory authority report number is v21119884. A 40-year and 11-month-old female patient received the first dose of bnt162b2 (COMIRNATY, Lot number FD1945, Expiration date 31Oct2021) via an unspecified route of administration on 14Jul2021 at 13:50 (the day of vaccination) (at age of 40-year-old), as dose 1, single for COVID-19 immunization and body temperature before vaccination was 36.5 degrees Centigrade. The patient''s medical history and concomitant medications were not reported. The patient''s historical drugs included Aleviatin and pill, on an unspecified date. On 14Jul2021 at 13:55 (5 minutes after the vaccination), the patient experienced anaphylaxis. The course of the event was as follows: 5 minutes after vaccination, when the patient awaiting, complained of queasy. On 14Jul2021 (the day of vaccination), the outcome of the event was resolved. The reporting other hcp classified the event as non-serious and assessed that the causality between the event and bnt162b2 as un-assessable. There was no other possible cause of the event such as any other diseases. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1511407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752319

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority concerned an adult male, race and ethnicity unspecified. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 expiry: unknown) 0.5 ml, 1 total, administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1511408 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752917

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3642] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: XE393 and expiry: unknown) 0.5 ml,1 total, administered on 14-Jul-2021 for Covid-19 immunisation. No concomitant medications were reported. On 14-Jul-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine was not applicable. The patient recovered from syncope with severe hypotension on 14-Jul-2021. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210752319, 20210752198, 20210752317, 20210752320, 20210752321, 20210752324, 20210752327, 20210752714, 20210752744, 20210752780, 20210752802, 20210752805, 20210752825, 20210752896, 20210752910 and 20210753034.; Reporter''s Comments: By now we have had more than 20 male, young users with syncopes. Sender''s Comments: V0:20210752917-syncope with severe hypotension. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1511409 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210753034

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3645] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393) 0.5 ml,1 total, dose administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By now we have had more than 20 male users, young men with syncopies; Sender''s Comments: V0:20210753034-covid-19 vaccine ad26.cov2.s- syncope with severe hypotension.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1511410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752805

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3650] concerned an adult male of unspecified age, 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 (suspension for injection, intramuscular, batch number: XE393 expiry: Unknown) 0.5 ml, 01 total, administered on 14-JUL-2021 for covid-19 immunization. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition). Reporter''s Comments: By this time we have had over 20 male users, young men with syncopes. Sender''s Comments: V0: 20210752805-COVID-19 VACCINE Syncope with severe hypotension. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1511411 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752825

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3653] concerned an adult male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine (suspension for injection, intramuscular, batch number: XE393, and expiry: unknown) 0.5 ml, with frequency time 1 total administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: By this time we have had over 20 male, young users with syncopes; Sender''s Comments: V0: 20210752825-Covid-19 vaccine - syncope with severe hypotension. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1512134 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003189 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Malaise, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Headache (Headache before the vaccination)
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (Hypertension (oral medication until 2 months ago)); Malaise (Due to influenza vaccine); Pyrexia (Due to influenza vaccine)
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: at 10:40; Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: at 11:10; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Low; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: at 10.40; Test Date: 20210714; Test Name: Pulse; Test Result: Inconclusive ; Result Unstructured Data: 72; Test Date: 20210714; Test Name: Pulse; Test Result: Inconclusive ; Result Unstructured Data: 90
CDC Split Type: JPTAKEDA2021TJP062964

Write-up: Malaise; Queasy; Pyrexia; Increased blood pressure; This regulatory authority case was reported by a physician and describes the occurrence of MALAISE (Malaise), NAUSEA (Queasy), PYREXIA (Pyrexia) and BLOOD PRESSURE INCREASED (Increased blood pressure) in a 40-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003189) for COVID-19 vaccination. The patient''s past medical history included Hypertension (Hypertension (oral medication until 2 months ago)), Pyrexia (Due to influenza vaccine) and Malaise (Due to influenza vaccine). Concurrent medical conditions included Headache (Headache before the vaccination). On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MALAISE (Malaise) (seriousness criterion hospitalization), NAUSEA (Queasy) (seriousness criterion hospitalization), PYREXIA (Pyrexia) (seriousness criterion hospitalization) and BLOOD PRESSURE INCREASED (Increased blood pressure) (seriousness criterion hospitalization). At the time of the report, MALAISE (Malaise), NAUSEA (Queasy), PYREXIA (Pyrexia) and BLOOD PRESSURE INCREASED (Increased blood pressure) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Blood pressure measurement: 205/130 (High) at 10:40 and 180/117 (High) at 11:10. On 14-Jul-2021, Body temperature: 36.8 degree celsius (Low) Low and 37,4 degree celsius (High) at 10.40. On 14-Jul-2021, Heart rate: 72 (Inconclusive) 72 and 90 (Inconclusive) 90. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MALAISE (Malaise), NAUSEA (Queasy), PYREXIA (Pyrexia) and BLOOD PRESSURE INCREASED (Increased blood pressure) to be possibly related. Concomitant product was not provided by the reporter. The patient''s symptoms did not improve, and the patient was raced to a hospital. It was reported that hypertension may be another factor. Treatment product was not provided by the reporter. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1512144 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210752802

Write-up: SYNCOPE WITH SEVERE HYPOTENSION; This spontaneous report received from a health care professional via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-T202107-3643] concerned an adult male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: XE393) 0.5 ml, 1 total, dose administered on 14-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 14-JUL-2021, the patient experienced syncope with severe hypotension. The action taken with covid-19 vaccine was not applicable. The patient recovered from syncope with severe hypotension on 14-JUL-2021. This report was serious (Other Medically Important Condition).; Reporter''s Comments: "By this time we have had over 20 male users, young men with syncopes"; Sender''s Comments: V0:20210752802-covid-19 vaccine -Syncope with hypotension. This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1512303 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XD985 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
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: 20210714; Test Name: COVID-19 antibody test; Result Unstructured Data: Negative (0.2)
CDC Split Type: DEJNJFOC20210758602

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a 6 decade old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985, expiry: UNKNOWN) dose was not reported, 1 total, administered on 10-JUN-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the patient had COVID-19 antibody test for which result showed as negative (0.2) (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210758602-Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1513215 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-07-14
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100926769

Write-up: Vaccination failure symptomatic COVID-19 disease after complete immunization; Vaccination failure symptomatic COVID-19 disease after complete immunization; Respiratory symptom; This is a serious spontaneous report from a contactable Consumer or other non HCP from the Regulatory Authority AT-BASGAGES-2021-37129. A 20-years-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route on 29Jan2021 as dose 2, single, and received first dose of COMIRNATY (Batch/Lot Number: Unknown), via an unspecified route on 08Jan2021 as dose 1, single; both for covid-19 immunization. Medical history, concurrent conditions and concomitant medications were not reported. On 14Jul2021, after complete immunization, the patient experienced vaccination failure, symptomatic COVID-19 disease, other, and respiratory symptom. The patient underwent lab tests and procedures which included CT value was 26.54 and shows no sequencing of the virus variant available. The outcome of events was unknown. Reporters comments: CT value: 26.54. no sequencing of the virus variant available. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.


VAERS ID: 1513374 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Burning sensation, Chills, Erythema of eyelid, Fatigue, Headache, Illness, Lymphadenopathy, Myalgia, Peripheral swelling, Presyncope, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Periorbital and eyelid disorders (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIGRALEVE [BUCLIZINE HYDROCHLORIDE;CODEINE PHOSPHATE;PARACETAMOL]; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Functional neurological symptom disorder; Migraine
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Fever; Result Unstructured Data: Test Result: Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906825

Write-up: Swollen lymph nodes; Burning sensation; Sickness; Near fainting; Headache; Swollen arm; Fever; Chills; Muscle ache; Fatigue; swollen arms/redness of eyelid; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is -MHRA-APPCOVID-202107152137101850-GYWVZ, Sender''s (Case) Safety Report Unique Identifier -MHRA-ADR 25659983. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FF3319), dose 2 via an un-specified route of administration on 14Jul2021 as dose 2, single for covid-19 immunisation. Medical his-tory included functional neurological symptom disorder, migraine and anxiety. Concomitant medications included buclizine hydrochloride, codeine phosphate, paracetamol (MIGRALEVE [BUCLIZINE HY-DROCHLORIDE; CODEINE PHOSPHATE; PARACETAMOL]) taken for migraine from 15Apr2021 to an un-specified stop date and sertraline taken for anxiety from 27Feb2020 to an unspecified stop date. Patient has not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on unspecified date for covid-19 immunisation. On 14Jul2021, the patient experienced swollen lymph nodes, burning sensation, sickness, near fainting, headache, swollen arm, fever, chills, muscle ache and fatigue. On unspecified date in 2021, the patient experienced redness of eyelid. It was stated that most symptoms were similar to those expected, however unusual symptoms were swollen arms and hands and a burning sensation on the skin in various areas of the body. Since the vaccination, the patient had not been tested positive for covid-19. The events were serious (medically significant). The patient underwent lab tests and procedures which included fever unknown results on 14Jul2021 and covid-19 virus test negative on unspecified date. Outcome of the event burning sensation was recovered on 15Jul2021. Outcome of the events near fainting and swollen arm was recovering. Outcome of the event redness of eyelid was unknown. Outcome of the other events was not re-covered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513390 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: YASMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907297

Write-up: Swollen armpit; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-EYC 00256207, Safety Report Unique Identifier GB-MHRA-ADR 25649883. A 21-year-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: Fd8813), via parenteral route of administration at single dose on 12Jul2021 for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included drospirenone, ethinylestradiol (YASMIN). The patient experienced swollen armpit on 14Jul2021 with outcome of not recovered. Event was reported as serious as medically significant. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-14
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAP1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pregnancy on contraceptive
SMQs:, Normal pregnancy conditions and outcomes (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: Contraceptive implant
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900192

Write-up: Pregnancy on contraceptive; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107141213466370-HAOCM , Safety Report Unique Identifier is GB-MHRA-ADR 25648659. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Jun2021 (lot number: PAP1027) as single dose for COVID-19 immunisation. The patient''s medical history included ongoing implant. Concomitant medications were not reported. She has not had symptoms associated with COVID-19 and not had a COVID-19 test. Unsure if she was enrolled in clinical trial. The patient experienced pregnancy on contraceptive on 14Jul2021 with outcome of unknown. Case narrative: Had the jab on Friday 18th and fell pregnant after even though she was on the implant, she believed the vaccine interfered with the effectiveness of her implant. She has not tested positive for COVID-19 since having the vaccine. Case was reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513524 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cystitis, Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed, Micturition urgency, Premenstrual pain, SARS-CoV-2 test, Urethral pain, Urethral spasm, Urinary tract inflammation
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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021900393

Write-up: cramps for several days before period started; period slightly delayed; bleeding with lots of clots; inflammation of urinary tract; spasms in urethra; pains in urethra; feeling need to pass water; Painful periods; Heavy periods; Cystitis; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107141314454400-VIT6Q, Safety Report Unique Identifier GB-MHRA-ADR 25649186. A 30-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administraion on 07Jul2021 (Batch/Lot Number: FD5613) as dose 1, single for COVID-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. On 14Jul2021, the patient had painful periods, heavy periods and cystitis. On an unspecified date, period slightly delayed, cramps for several days before period started, bleeding with lots of clots, inflammation of urinary tract, spasms in urethra, pains in urethra, feeling need to pass water. The clinical course was reported as follows: Period slightly delayed but cramps for several days before it started which is atypical for the patient. Once period started, lots of pain - cramps and heavy bleeding with lots of clots. Suspected inflammation of urinary tract, spasms/pains in urethra and feeling need to pass water. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient had COVID-19 Virus test (13Jul2021): No - Negative COVID-19 test. The outcome for the events painful periods, heavy periods and cystitis was not recovered; outcome for cramps for several days before period started was recovering; outcome for period slightly delayed, bleeding with lots of clots, inflammation of urinary tract, spasms in urethra, pains in urethra and feeling need to pass water was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513541 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall, Hyperhidrosis, Physical examination, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Visible evaluation of any rashes or swelilng; Result Unstructured Data: Test Result:No rashes anywhere on the body or at the injection
CDC Split Type: GBPFIZER INC2021900291

Write-up: Fainting; sweating; fell on the floor; This is a spontaneous report from a contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107141603091120-EOHSJ. Safety Report Unique Identifier GB-MHRA-ADR 25650225. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (batch/ Lot# FD5613) (at the age of 34-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Nil regular medicines, NKDA (as per patient). Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced fainting and sweating on 14Jul2021. The events were reported as non-serious. The clinical course was reported as follows: patient fainted roughly 2/3 minutes after receiving vaccine. He fell on the floor while seated and hit the back of his head on the shelf. Recovered within 30-45 seconds. No visible injuries/bump on head. No rashes anywhere on the body or at the injection site. No signs of Anaphylaxis. Sweating. Gave some water to drink and let him rest while seating on the floor. Provided reassurance. Stayed in Pharmacy for another 30 minutes and said feeling perfectly fine now. Happy to walk home (2-3 minutes walk away) although reporter offered to send someone to accompany him. This report was not related to possible blood clots or low platelet counts. The patient under visible evaluation of any rashes or swelling on 14Jul2021: No rashes anywhere on the body or at the injection site. The patient recovered from the events on 14Jul2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513561 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900544

Write-up: Faint/fainting; This is a spontaneous report from a contactable pharmacist received from the regulatory authority. The regulatory authority report number is [GB-MHRA-WEBCOVID-202107141837195050-WY2K6], Safety Report Unique Identifier [GB-MHRA-ADR 25651164]. A 23-year-old female patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 23-years, on 14Jul2021 (Lot Number: FC9001) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Unsure if patient had symptoms associated with COVID-19 and not had a COVID-19 test. The patient experienced faint/fainting on 14Jul2021. Treatment received. The event outcome was recovered. The clinical course was reported as follows: Patient was admististered Pfizer vaccine. During 15minute observation she fainted in waiting area. She was given fainting first aid by two immunisation assistants. Patient recovered after 15-30 minutes and left store. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513567 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Inappropriate schedule of product administration, Influenza like illness, SARS-CoV-2 test, Vaccination site pain
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Clinical trial participant (Covid study); Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021900403

Write-up: Flu-like aching; Light-headed; Fatigue; Pain injection site; Patient received PFIZER-BIONTECH COVID-19 VACCINE, first dose on 19May2021 and second dose on 14Jul2021; 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-202107141937282810-NB37D, Safety Report Unique Identifier GB-MHRA-ADR 25651531. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (batch/lot number: FE1510), via an unspecified route of administration at dose 2, single on 14Jul2021 (at the age of 38-years-old) for COVID-19 immunisation. Medical history included lactation and a clinical trial participant in a Covid Study. However, it was also reported that the patient''s relevant medical history was ''none''. Patient has not had symptoms associated with COVID-19. Patient was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 19May2021 (Batch/lot number: EE4109) for Covid-19 immunisation. The patient experienced flu-like aching, light-headed, fatigue and pain injection site on 14Jul2021. The events were reported as serious (medically significant). The clinical course was reported as follows: within a couple of hours of the injection the area around the injection site became very tender and painful to touch. Approximately 10 hours after injection started feeling fatigued and flu like aching in limbs. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test on 14Jul2021: No - Negative COVID-19 test. The outcome of flu-like aching, light-headed, fatigue and pain injection site was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513570 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Blood pressure decreased, Disorientation, Dizziness postural, Dyspnoea, Hot flush, Malaise, Nausea, Swollen tongue, Tongue biting, Tremor, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (broad), Parkinson-like events (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: REBOXETINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900338

Write-up: Drop in blood pressure; Shortness of breath; Swollen tongue; hot flushes; disorientated; shaking; wheezy; Dizziness postural; Anxiety attack; feel very unwell; had teeth imprints in the side of her tongue; fear patient would vomit everywhere.; This is a spontaneous report from a contactable consumer received from the Regulatory Authority). The regulatory authority report number is GB-MHRA-WEBCOVID-202107142011128220-RCV7S; Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25651841. A 21-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FD8813), via an unspecified route of administration on 14Jul2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included suppressed lactation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Concomitant medications included reboxetine (REBOXETINE) taken for attention deficit hyperactivity disorder from 01Apr2021 and sertraline (SERTRALINE) taken for depression from 01Aug2020 (both to an unspecified stop date). Patient attended her appointment today, patient was fine to get the vaccine patient gave absolutely no fear of needles or being vaccinated. After patient got the vaccine, patient sat down in the observation room and felt fine. A few minutes into getting the vaccine, patient started to feel very unwell but was unable to speak in fear patient would vomit everywhere. Patient took off her mask to increase oxygen intake but noticed that her chest had become wheezy and so patient used her inhaler. Patient did go to stand and ask to speak with the nurse to initially raise her issue of possible drop in the blood pressure. As patient went to stand, patient felt like losing her balance and clung onto the seat instead. As her concerns grew, patient grew more anxious and words would not come out of her mouth. Unfortunately, patient did not inform anyone within the vaccination centre that she did not feel well. Patient just kept taking deep breaths as much as her chest would allow. Patient left the room once patient had the go ahead from the steward and walked slowly out of the room focusing on her walking. For the next hour after her vaccine, patient felt like patient was falling asleep at her bus stop and could not keep her eyes open, her body had hot flushes everywhere and felt like she was going to scream patient could not get any relief from the heat her body was feeling. Patient then spent the next few hours after getting home sleeping unable to speak. Patient woke up 4 hours later disorientated feeling like patient could not fit her tongue inside her mouth properly. Upon looking patient had teeth imprints in the side of her tongue. Trying to walk, felt like her legs were shaking and going to collapse underneath her at any point. Patient tried to contact 111 but could not get through due to busy lines and decided patient would contact my GP in the morning instead. Outcome of the events swollen tongue, dizziness postural was not resolved. Outcome of the events drop in blood pressure, hot flushes, disorientated, shaking, wheezy, feel very unwell, had teeth imprints in the side of her tongue, nausea was unknown while anxiety attack was resolving. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Rash erythematous, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Generalised anxiety disorder; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021900427

Write-up: Red rash; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202107142121178480-UGPBM and Safety Report Unique Identifier GB-MHRA-ADR 25652184. A 38-year-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Not known, Expiration Date: not reported), via an unspecified route of administration on 13Jul2021, as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and generalised anxiety disorder. Patient has not had symptoms associated with COVID-19. Patient is not pregnant; Patient is not currently breastfeeding. Concomitant medication included venlafaxine taken for generalised anxiety disorder from 01Jan2009. On 14Jul2021 patient experienced red rash. Patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. The patient had COVID-19 Virus test on 14Jul2021: no - negative covid-19 test. The case is serious (medically significant). The outcome of the event red rash was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amlodipine; Sertraline
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; decreased lactation; suspected COVID-19.
Allergies:
Diagnostic Lab Data: Test Date: 10/23/2020; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Yes - Positive COVID-19 test.
CDC Split Type: GBPFIZER INC2021900123

Write-up: This is a spontaneous report from a contactable consumer (patient), received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202107150246496070-MFQI3; safety report unique identifier: GB-MHRA-ADR 25652987). A 40-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, lot# and expiration date unknown), via an unspecified route of administration, on Jul 13, 2021, single dose, for COVID-19 immunization. Medical history included decreased lactation, suspected COVID-19 from Oct 21, 2020 to Oct 28, 2020 and hypertension. Patient was not currently breastfeeding. The patient underwent a COVID-19 virus test on Oct 23, 2020 with the following result: Yes - Positive COVID-19 test. Concomitant medications included amlodipine taken for hypertension from Jun 18, 2021; and sertraline taken from an unspecified start date to May 24, 2021. The patient experienced numbness in feet and arms, pins and needles on Jul 14, 2021, at 16:30. The events reported serious (other medically important condition). The clinical course reported as follows: Upon waking from sleep, numbness in her feet and arms, followed by pins and needles. This happened at approximately 4:30 pm today (as reported); after napping for 1.5 hours and again during the night; after being asleep for approximately 2.5 hours. Patient has not tested positive for COVID-19 since the vaccination. Patient not enrolled in a clinical trial. The outcome of numbness in feet and arms not recovered; while outcome of the pins and needles unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1513603 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Esophageal reflux
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021900232

Write-up: Pins and needles; This is a spontaneous report from a contactable consumer received from the . The regulatory authority report number is GB-MHRA-WEBCOVID-202107150619285110-VA0C4. Safety Report Unique Identifier is GB-MHRA-ADR 25653678. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunization. Medical history included esophageal reflux. Patient has not had symptoms associated with COVID-19 and has not had a COVID-19 test. Concomitant medication included omeprazole (OMEPRAZOL) taken for esophageal reflux from 07Sep2020. The patient experienced pins and needles on 14Jul2021. The event was reported as serious per other medically important condition. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event was not recovered. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1513607 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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 INC2021906850

Write-up: feeling cold; Body temperature; Muscle pain; Joint ache; Headache; Exhaustion; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202107150804066140-8ATAO. Safety Report Unique Identifier GB-MHRA-ADR 25654155. A 27-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number: not reported), via an unspecified route of administration on 14Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced feeling cold, On 15Jul2021, body temperature, muscle pain, joint ache, headache, On 14Jul2021, exhaustion. Therapeutic measures were taken as a result of feeling cold, body temperature. Unsure if patient has had symptoms associated with COVID-19. Patient had not a COVID-19 test. Taken paracetamol and still hadn''t gone. Couldn''t lift himself up out of bed. Keep feeling cold but really hot to touch. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event feeling cold was recovering and other events were not recovered. No follow-up attempts are possible. Information about Lot/ Batch number cannot be obtained.


VAERS ID: 1513608 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210711; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906779

Write-up: Maternal exposure during pregnancy; Sore throat; Headache; Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107150815203520-0UONZ, Safety Report Unique Identifier GB-MHRA-ADR 25654363. A 36-years-old female patient (patient was pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 14Jul2021 (age at vaccination was 36 years) as dose 2, single for COVID-19 immunization. The patient''s medical history included lactation decreased and ongoing pregnancy. The patient has not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. Concomitant medications included folic acid taken for vitamin supplementation. The patient was exposed to the medicine in third-trimester (29-40 weeks). On 14Jul2021, the patient experienced fatigue and pain in arm. On 15Jul2021, the patient experienced sore throat and headache. The patient underwent lab test which included COVID-19 virus test: negative on 11Jul2021. The outcome of the events was not resolved.


VAERS ID: 1513609 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Myalgia, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907334

Write-up: very painful gland in armpit of arm the vaccine was given (swelling arm); painful gland in armpit; painful muscles; Glands swollen; Joint pain; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202107150817416870-S3JW3. Safety Report Unique Identifier GB-MHRA-ADR 25654257. A 38-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 as single dose for COVID-19 immunisation. Medical history included lactation decreased. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced very painful gland in armpit of arm the vaccine was given (swelling arm) on an unspecified date, glands swollen on 15Jul2021, joint pain on 14Jul2021, painful gland in armpit on an unspecified date. Very painful gland in armpit of arm the vaccine was given; very painful muscles and joints especially. Patient was not enrolled in clinical trial. Case was reported as serious, other medically important condition. Outcome of glands swollen and joint pain were not recovered and the other events were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Fatigue, Migraine, Muscular weakness, Paraesthesia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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: GBPFIZER INC2021907134

Write-up: Muscular weakness; Tingling skin; Shivers; Tired all the time; Dizzy spells; Migraine headache; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202107150934026200-HYWMY, Safety Report Unique Identifier GB-MHRA-ADR 25654935. A 22-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 2021 (Batch/Lot Number: Not known) as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced shivers, tired all the time, dizzy spells, migraine headache on 14Jul2021; muscular weakness, tingling skin on 15Jul2021; all medically significant. Patient is not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1513694 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5613 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021907151

Write-up: Fever; Muscle pain; Fatigue; This is a spontaneous study report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number [GB-MHRA-WEBCOVID-202107151034469320-7L9FO], Safety Report Unique Identifier [GB-MHRA-ADR 25655250]. A 21-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 14Jul2021 (at the age of 21 years old) (Lot Number: FD5613) at single dose for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. The patient experienced fever (medically significant) on 14Jul2021, muscle pain (medically significant) on 14Jul2021, fatigue (medically significant) on 14Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 13Jul2021. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.


VAERS ID: 1513697 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Lipoma, Pain
SMQs:, Lipodystrophy (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 INC2021906875

Write-up: pain; areas where his lipomas were generally concentrated became extremely uncomfortable; Lipoma; This is a spontaneous report from a contactable consumer (patient). This is a report received from the Medicines Healthcare products Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202107151110526770-JVVWO, Safety Report Unique Identifier is GB-MHRA-ADR 25655468. A 41-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date and dose 2 on 13Jul2021 (lot number FA1027), via an unspecified route of administration as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. He has not had symptoms associated with COVID-19, not had a COVID-19 test, and not enrolled in clinical trial. The patient experienced pain on an unspecified date and lipoma on 14Jul2021. Case narrative: He suffered with multiple lipomatosis. He had many lipomas over his body. After having his first vaccination, he noticed pain in the lipomas and after the second vaccination he had the same reaction but even more severe. The lipomas were very sore to touch and the areas where his lipomas were generally concentrated became extremely uncomfortable. This was in contrast to the other areas of his body which were not affected. He has not tested positive for COVID-19 since having the vaccine. Case was reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513699 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906767

Write-up: Headache; Armpit pain; 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-202107151117136670-YCKZO. Safety Report Unique Identifier GB-MHRA-ADR 25655480. A 26-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Lactation decreased, suspected covid-19 from 15Jul2021 and ongoing. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced armpit pain on 14Jul2021, headache on 15Jul2021. All the events were assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: negative, No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of events was reported as not recovered. No follow-up attempts are possible. Information about Lot/ Batch number cannot be obtained.


VAERS ID: 1513731 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907098

Write-up: Tenderness in armpit; Swollen lymph nodes/swelling in my left armpit which is around the size of half a tennis ball; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151609077600-LWHFU. Safety Report Unique Identifier GB-MHRA-ADR 25657710. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: FD8813) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Tenderness in armpit on the evening of 14Jul2021. Woke up on 15Jul2021 with swelling in my left armpit which is around the size of half a tennis ball (also reported as "Swollen lymph nodes"). The events were assessed as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event swollen lymph nodes was not recovered; tenderness in armpit was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513748 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Strabismus
SMQs:, Ocular motility disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907337

Write-up: convergent squint, squint; 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-202107151841214940-FBRNQ, Safety Report Unique Identifier GB-MHRA-ADR 25658746. A 37-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FD8813) at the age of 37 years as single dose for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were none. Patient was not taking any medication. Patient received botulinum toxin 19 months before vaccine to affected eye. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient previously took botulinum toxin for strabismus. The patient experienced convergent squint, squint on 14Jul2021. The patient''s hospitalization was caused/prolonged as a result of event. Appearance of convergent squint approximately 4 to 5 hours after vaccine, some minor improvement on the next day. This squint was fixed with botulinum toxin 19 months previously and recent follow up confirmed all still ok. No issues on the morning before having the vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1513749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Pain in extremity, Palpitations
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021907346

Write-up: Dizziness; Palpitations; Leg pain; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151846532650-1WGF1 , Safety Report Unique Identifier GB-MHRA-ADR 25658744. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jul2021 (Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Patient was not enrolled in clinical trial. No other medication or treatment being received. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced dizziness and palpitations on 15Jul2021, leg pain on 14Jul2021. Outcome of dizziness and palpitations was recovered on 15Jul2021, outcome of leg pain was recovered on 15Jul2021. Case was reported as serious medically significant. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible, Information about Batch/Lot Number cannot be obtained. No further information is expected.


VAERS ID: 1513754 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Mental fatigue, Muscle fatigue, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased.
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC2021906795

Write-up: Headache; Muscle fatigue; Mental fatigue; Fever chills; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151920355120-NTDE3, Safety Report Unique Identifier GB-MHRA-ADR 25658950. A 38-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported, Solution for injection), dose 2 via an unspecified route of administration, on 13Jul2021 as single dose for COVID-19 immunization. Medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not pregnant and not currently breastfeeding. Patient is not enrolled in clinical trial. The patient was previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date for COVID-19 immunization. Concomitant medication(s) included Sertraline (Manufacturer unknown) taken for an unspecified indication from 01Apr2018. On 14Jul2021, the patient experienced headache, muscle fatigue, mental fatigue, fever chills. The events accessed as a medically significant. Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: Negative on 30May2021 (No - Negative COVID-19 test). The outcome of headache, mental fatigue is not recovered and for fever chills is recovering. The outcome of muscle fatigue is recovered on 15Jul2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513788 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pain in extremity, Palpitations
SMQs:, Anaphylactic reaction (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), 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: SUMATRIPTAN; ZOLMITRIPTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Migraine
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021906793

Write-up: shortness of breath; Breath shortness; Chest pain; Palpitations; Painful arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107160706162740-DZ9F9, safety report unique identifier is GB-MHRA-ADR 25661243. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 14Jul2021 (age at vaccination 35-years-old) as dose 2, single for covid-19 immunisation. Medical history included suppressed lactation and migraine from an unknown date and unknown if ongoing. Concomitant medications included sumatriptan and zolmitriptan taken for migraine. Patient has not tested positive for COVID-19 since having the vaccine, patient was not pregnant and Patient is not enrolled in clinical trial. On an unspecified date, the patient experienced first episode of shortness of breath, on 14Jul2021, painful arm, on 15Jul2021 second episode of breath shortness, chest pain, palpitations. Clinical course reported that had the vaccine in the morning of the 14th, that even got a painful arm. The next day woke with chest pains, shortness of breath and palpitations. The outcome of the events first episode of shortness of breath, painful arm were resolving and other events were not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1513793 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021906771

Write-up: Painful periods; 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-202107160755103290-0XPDV, Safety Report Unique Identifier GB-MHRA-ADR 25661494. A 23-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: not known) (non-pregnant at the time of vaccination), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history included suppressed lactation. The patient''s concomitant medications were not reported. On 14Jul2021, the patient experienced painful periods. The patient underwent lab tests and procedures which included SARS-COV-2 test: no - negative COVID-19 test on. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. The outcome of event painful periods was not recovered. No follow-up attempts are possible. No further information was expected.


VAERS ID: 1513827 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1021 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea haemorrhagic, Inappropriate schedule of product administration, Nausea, Peripheral coldness, Pyrexia
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100917230

Write-up: Fever; Joint pain; Nauseous; Diarrhea bloody; Cold feet; first dose on 19May2021, second dose on 14Jul2021; This is a spontaneous report from a contactable consumer. The is the second of two reports. The first report was received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107151804199970-UZBKY, Safety Report Unique Identifier GB-MHRA-ADR 25658482. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: fa1021) as dose 2, single for COVID-19 immunisation at age of 37 years old. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not pregnant, Patient was not currently breastfeeding. Patient is not enrolled in clinical trial. The patient previously received the first dose of BNT162B2 on 19May2021 (Batch/Lot Number: Ew4109) for COVID-19 immunisation and experienced bloody diarrhea and heavy flu symptoms. The patient experienced fever, joint pain, nauseous, diarrhea bloody, cold feet on 14Jul2021. The case was serious per medically significant. The outcome of the events fever, joint pain, nauseous, diarrhea bloody, cold feet was not resolved. Patient has not tested positive for COVID-19 since having the vaccine. No follow up attempts are possible. No further information is expected.


VAERS ID: 1513945 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Band sensation, Cough
SMQs:, Anaphylactic reaction (broad), Demyelination (broad)

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

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COUGH and BAND SENSATION in a 29-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003605) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 14-Jul-2021, the patient experienced COUGH (seriousness criterion hospitalization) and BAND SENSATION (seriousness criterion hospitalization). On 14-Jul-2021, COUGH and BAND SENSATION had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided by the reporter. Company comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information (translation) is expected; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information (translation) is expected


VAERS ID: 1514098 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Hypertension, Oxygen saturation, Vital signs measurement
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:160/89 mmHg; Comments: 14:05; Test Date: 20210714; Test Name: BP; Result Unstructured Data: Test Result:122/87 mmHg; Comments: 15:05; Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before the vaccination; Test Date: 20210714; Test Name: P; Result Unstructured Data: Test Result:85; Comments: 14:05; Test Date: 20210714; Test Name: P; Result Unstructured Data: Test Result:80; Comments: 15:05; Test Date: 20210714; Test Name: SpO2; Test Result: 97 %; Comments: 14:05; Test Date: 20210714; Test Name: VS; Result Unstructured Data: Test Result:was measured; Comments: 14:05
CDC Split Type: JPPFIZER INC2021903644

Write-up: Blood pressure increased; Fuzzy head; Hypertension; This is a spontaneous report from a contactable nurse received from the Agency. Regulatory authority report number is v21119870. A 41-year and 2-month-old female patient received the first dose of bnt162b2 (COMIRNATY, solution for injection, lot number: EW0203, expiration date: 30Sep2021) via an unspecified route of administration on 14Jul2021 at 13:56 (the day of vaccination, at the age of 41-years-old), as dose 1, single for COVID-19 immunization. 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. Body temperature before vaccination, on 14Jul2021, was 36.3 degrees Centigrade. On 14Jul2021 at 14:05 (9 minutes after the vaccination), the patient experienced blood pressure (BP) 160/89, hypertension and fuzzy head. The course of the event was as follows: after the vaccination, there was a complaint from the patient that she was fuzzy head, and when vital signs (VS) was measured, BP 160/89 mmHg, pulse (P) 85, SpO2 97%. Confirmed with the patient and requested to take amlodipine 5 mg. After that, rest observation process. 1 hour later, on 14Jul2021 at 15:05, BP 122/87 mmHg, P: 80. Symptoms were improving and subjective symptoms disappeared. On 14Jul2021 (the day of vaccination), the outcome of the event was recovered. The reporting nurse classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1514102 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough
SMQs:, Anaphylactic reaction (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: Contrast media allergy; Stevens-Johnson syndrome (Drug-induced)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021904242

Write-up: Chest discomfort; cough; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This case has been also received by the Regulatory Authority (RA). Regulatory authority report number is v21120080. A 67-year and 5-month-old male patient received the first dose of BNT162b2 (COMIRNATY, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration on 14Jul2021 15:30 (the day of vaccination) (at the age of 67-year-old) at single dose for COVID-19 immunisation. Relevant medical history included drug-induced SJS and contrast media allergy. The family history was 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, etc.). On 14Jul2021 15:18 (15 minutes after the vaccination), the patient experienced chest discomfort and cough. So consulted physician for treatment. The course of event was as follows. Experienced chest discomfort and cough. Performed Solu-Cortef injection (100mg) DIV. Recovered. On 14Jul2021 (the day of vaccination), the outcome of the events was recovered. The reporter commented as follows: In the past, the patient had Stevens-Johnson syndrome related to drugs. And past history of contrast media allergy. The reporter classified the event as non-serious and assessed the causality between the event and the BNT162b2 as related.


VAERS ID: 1514178 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-14
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache, Hyperpyrexia, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data:
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a consumer and describes the occurrence of HYPERPYREXIA ) in a 51-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003604) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Disease risk factor. On 09-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant). 14-Jul-2021, the patient experienced MALAISE, HEADACHE , MYALGIA, ARTHRALGIA and NAUSEA . 14-Jul-2021, the patient experienced CHILLS . On 15-Jul-2021, the patient experienced FATIGUE . On 15-Jul-2021, CHILLS had resolved. At the time of the report, HYPERPYREXIA and NAUSEA was resolving and MALAISE , HEADACHE , MYALGIA , ARTHRALGIA and FATIGUE had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, Body temperature: high (High) . No relevant concomitant medications reported. No treatment medications reported. The action taken with the drug in response to the event was not applicable. The causality with respect to all event was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.


VAERS ID: 1514226 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cold sweat, Dizziness, Headache, Hypotension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (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: PTJNJFOC20210758016

Write-up: HEADACHES; LACK OF STRENGTH; FAINTING 15 MINUTES AFTER TAKING JANSSEN VACCINE COVID-19; HYPOTENSION; COLD SWEAT; DIZZINESS; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-G202107-3100] concerned a 37 year old male. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: x F393 expiry: UNKNOWN) .5 ml, 1 total, administered on 14-JUL-2021 for covid-19 vaccination. The duration of drug administration was 0 days. No concomitant medications were reported. On 14-JUL-2021, 15 minutes after vaccination the patient experienced fainted. On the same day the patient also experienced cold sweat, dizziness and hypotension. On 15-JUL-2021, the patient experienced headaches, and lack of strength. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, dizziness, fainting 15 minutes after taking Janssen vaccine covid-19, hypotension, headaches, and lack of strength. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210758016-COVID-19 VACCINE AD26.COV2.S - cold sweat, dizziness, fainting 15 minutes after taking Janssen vaccine covid-19, hypotension. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210758016-COVID-19 VACCINE AD26.COV2.S - headaches, and lack of strength. These events are labeled and are therefore considered potentially related.


VAERS ID: 1514316 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Syncope; Headache; Vomiting; This regulatory authority case was reported by a physician and describes the occurrence of SYNCOPE (Syncope) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), HEADACHE (Headache) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncope), HEADACHE (Headache) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1514355 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Headache, Magnetic resonance imaging, Platelet count, Thrombocytopenia
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: NECT of brain; Test Result: Inconclusive ; Result Unstructured Data: No ICH or empty sinus sign; Test Date: 20210713; Test Name: MRI/MRV; Test Result: Inconclusive ; Result Unstructured Data: no evidence of acute stroke or Sino venous thrombosis; Test Date: 20210713; Test Name: Platelet count; Test Result: Inconclusive ; Result Unstructured Data: x10^3/microliter
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Thrombocytopenia; Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOCYTOPENIA (Thrombocytopenia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criterion medically significant) and HEADACHE (Headache). At the time of the report, THROMBOCYTOPENIA (Thrombocytopenia) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, Computerised tomogram head: inconclusive (Inconclusive) No ICH or empty sinus sign. On 13-Jul-2021, Magnetic resonance imaging: inconclusive (Inconclusive) no evidence of acute stroke or Sino venous thrombosis. On 13-Jul-2021, Platelet count: 10^3 (Inconclusive) x10^3/microliter. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of thrombocytopenia is assessed as serious as per IME list. Translation of narrative is still pending.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Event of thrombocytopenia is assessed as serious as per IME list. Translation of narrative is still pending.


VAERS ID: 1514360 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Vaccination site pruritus
SMQs:

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

Write-up: Itchy rash at the injection site; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchy rash at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy rash at the injection site) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PRURITUS (Itchy rash at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Very limited information regarding this event has been provided at this time. No further information is expected at this time


VAERS ID: 1514825 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / 1 - / -

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: ZAPFIZER INC202100919788

Write-up: Faint feeling in her head; This is a spontaneous report from a contactable other HCP. A 55-years-old female patient received first dose of BNT162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FE2090; Expiration Date: 30Jul2021) on 14Jul2021 10:25 (at the age of 56-years-old) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced faint on 14Jul2021. The outcome of event was recovered on an unspecified date. No further information was available at the time of this report.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event syncope and the suspect drug BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1514975 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular disorder
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident (The patient was in excellent condition improvement and had recuperate a 80 percent level of her condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210761043

Write-up: UNSPECIFIED CEREBRAL EVENT; This spontaneous report received from a consumer concerned a 48 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included cerebral stroke. The reporter stated that the patient was in excellent condition improvement and had recuperate a 80 percent level of her condition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, frequency of one total, administered on 09-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the patient experienced unspecified cerebral event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified cerebral event was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210761043- covid-19 vaccine ad26.cov2.s- unspecified cerebral event. 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: MEDICAL HISTORY.


VAERS ID: 1515807 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-07-14
   Days after vaccination:108
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory symptom, 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 Name: ct value; Result Unstructured Data: Test Result: 18.31; Comments: CT value: 18.31 no sequencing of the virus variant available.
CDC Split Type: ATPFIZER INC202100926780

Write-up: Vaccination failure symptomatic COVID-19 disease after complete immunization; Vaccination failure symptomatic COVID-19 disease after complete immunization; Respiratory symptoms; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-37116. A 53-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 28Mar2021 as DOSE 2, SINGLE and received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 07Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included Ct value: 18.31 on unspecified date, no sequencing of the virus variant available. On 14Jul2021, the patient experienced vaccination failure symptomatic covid-19 disease after complete immunization, respiratory symptoms. Event vaccination failure symptomatic covid-19 disease after complete immunization was considered as serious (medically significant). At the time of report, the outcome of events was unknown. Reporter Comment: CT value: 18.31 no sequencing of the virus variant available No follow-up activities possible. No further information expected. Batch/LOT cannot be obtained. Reporter''s Comments: CT value: 18.31 no sequencing of the virus variant available


VAERS ID: 1515808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-07-14
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Respiratory symptom, 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 Name: ct value; Result Unstructured Data: Test Result:33.61; Comments: Ct value: 33.61 no sequencing of the virus variant available
CDC Split Type: ATPFIZER INC202100926843

Write-up: Vaccination failure symptomatic COVID-19 disease after complete immunization; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non hcp from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-37117. A 45-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: Unknown) as dose 1, single, and dose 2 via an unspecified route of administration on 04Jun2021 (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications reported. On 14Jul2021, the patient experienced vaccination failure (Vaccination failure symptomatic COVID-19 disease after complete immunization), respiratory symptom. The patient underwent lab tests and procedures which included sars-cov-2 test: 33.61 on unspecified date, Ct value: 33.61 no sequencing of the virus variant available. The outcome for events was reported as unknown. Health Authority Comment: Ct value: 33.61 no sequencing of the virus variant available. No follow-up activities possible. No further information expected. Batch/LOT numbers cannot be obtained. Reporter''s Comments: Ct value: 33.61 no sequencing of the virus variant available


VAERS ID: 1515819 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-07-14
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory symptom, 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 Name: covid-19 pcr; Result Unstructured Data: Test Result: postive; Comments: CT value: 25.19. S-gene mutations: P681R.
CDC Split Type: ATPFIZER INC202100927071

Write-up: Vaccination failure symptomatic COVID-19 disease after complete immunization; Vaccination failure symptomatic COVID-19 disease after complete immunization; Respiratory symptom; This is a spontaneous report from a contactable consumer or other non-healthcare professional from the Regulatory Authority BASGAGES-2021-37204. A 27-year-old male patient received second dose BNT162B2 (COMIRNATY COVID-19 vaccine, solution for injection, batch/Lot Number: Unknown), via an unspecified route of administration on 29May2021 as single dose and first dose BNT162B2 (COMIRNATY COVID-19 vaccine, solution for injection, batch/Lot Number: unknown), via an unspecified route of administration on 24Apr2021 as single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure symptomatic covid-19 disease after complete immunization and respiratory symptom on 14Jul2021. The patient lab test included sars-cov-2 test was positive (CT value: 25.19. S-gene mutations: P681R) on an unknown date. The outcome of the events was unknown. Reporter comments: CT value: 25.19. S-gene mutations: P681R No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained. Reporter''s Comments: CT value: 25.19 S-gene mutations: P681R


VAERS ID: 1515823 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-07-14
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone decreased, COVID-19, Cough, Fibrin D dimer, Hepatomegaly, Oropharyngeal pain, Oxygen saturation decreased, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test, Vaccination failure
SMQs:, Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (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 Name: TSH; Result Unstructured Data: Test Result:low; Comments: TSH level was too low and the left lobe of the liver was enlarged.; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:elevated; Test Date: 20210715; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: ATPFIZER INC202100927938

Write-up: runny nose; pain in righ calf; TSH level low; needed oxygen; Left lobe of liver enlarged; vaccination failure; Covid-19; cough; extreme sore throat; This is a spontaneous report from a contactable nurse received from medical information team. A 32-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for Injection, Batch/Lot number: EK9788; Expiration Date: 31May2021) via an unspecified route of administration on 09Feb2021 and second dose on 02Mar2021 (Batch/Lot Number: EP2163; Expiration Date: 31May2021) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that patient developed a corona infection despite having been double vaccinated in March. Previous week the patient fell ill with Corona. First symptoms on 14 July was cough, runny nose , extreme sore throat. Patient was on holiday in country and then cut the holiday short. Patient went home on 15 July and was tested on 16 July and then went into quarantine. It got so bad that patient needed oxygen and was then also screened for thrombosis at the hospital because patient had pain in her right calf and the dimers were elevated. The TSH level was too low and the left lobe of the liver was enlarged. On Thursday, the patient found out which variant of the virus it was. The patient was surprised to get sick as 1649 antibodies for spike WHO had been found on 6May2021 and nucleocapsid test was negative. Neutralising AK were present. The outcome of the events was unknown. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID and PR ID 5648370 resulted in the following conclusion: Reference PR ID 5741000 (see File attachment in this investigation record) The complaint for "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EP2163 and 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. Company 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. No further information was reported.; Sender''s Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events


VAERS ID: 1516295 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

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

Write-up: fra; This regulatory authority case was reported by a physician and describes the occurrence of PYREXIA (fra) in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Adrenal insufficiency. On 13-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 14-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced PYREXIA (fra) (seriousness criterion hospitalization prolonged). On 15-Jul-2021, PYREXIA (fra) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications and Treatment medications were not reported. Batch number of the suspect product is unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Not applicable) was Not applicable.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1516320 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure increased, Dizziness, Pain in extremity, Paraesthesia, SARS-CoV-2 test, Vision blurred
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Hypertension (narrow), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (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:
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:140/90; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100908832

Write-up: dizzy; patients blood pressure; Blurred vision; Tingling sensation; Pain in calf; This is a spontaneous report from a contactable Pharmacist. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-APPCOVID-202107162108520060-RXQOZ, Safety Report Unique Identifier GB-MHRA-ADR 25667063. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot Number: FF3319), via an unspecified route of administration on 14Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. On an unspecified date, the patient experienced dizzy, patients blood pressure, On 14Jul2021, blurred vision, tingling sensation, pain in calf. The patient underwent lab tests and procedures which included blood pressure abnormal: 140/90 on, sars-cov-2 test: negative on No - Negative COVID-19 test.Therapeutic measures were taken as a result of dizzy. At the time shortly after the vaccination in the waiting area patient was feeling dizzy/light headed. Patient was then taken to the bed and was asked to lie down. Patient was continually monitored and given water and glucose. Patient started feeling better and went back to the waiting area. Shortly after the patient was feeling dizzy again. And patient went back to the bed. Patients blood pressure was taken reading 140/90. Approx 10.24am. Patient then complained of a pain in the calf. This continued and at this point ambulance services was called. Who advised for the patient to get to a hospital/gp surgery for assessment. The rest of the information will be with staff at the hospital. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Yes report relate to possible blood clots or low platelet counts. Patient was assessed at the local hospital. And diagnosis was not known. " Was the platelet count less than 150 ? -109 per L: "Unknown". Was the D-dimer more than 4000: "Unknown". Were anti-PF4 antibodies identified?: "Unknown". The outcome of events were unknown. No follow-up attempts are possible. No further information is expected.


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