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From the 9/17/2021 release of VAERS data:

Found 711,579 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 315 out of 7,116

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VAERS ID: 1625111 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Headache
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101021704

Write-up: Chest pain; Breathlessness; Dizzy spells; Tight chest; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108081847454470-F2ZZA Safety Report Unique Identifier GB-MHRA-ADR 25771749. A 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 at the age of 31 years (Lot number was not reported) as single dose for COVID-19 immunisation. The patient had no medical history. None. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced chest pain on 03Aug2021, breathlessness on 03Aug2021, headache on 01Aug2021, dizzy spells on 02Aug2021, tight chest on 02Aug2021. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Case was reported as serious, other medically important condition. Outcome of events were not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1625126 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Cold sweat, Dizziness, Dizziness postural, Fatigue, Feeling hot, Headache, Illness, Migraine, Myalgia, Nausea, Paraesthesia, Pyrexia, SARS-CoV-2 test, Somnolence, Vaccination site pain, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (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? Yes
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: Mood change
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: temperature; Result Unstructured Data: Test Result:began to rose; Test Date: 20210807; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101021424

Write-up: Migraine headache; Dizziness upon standing; tingling; Vomiting; Fatigue extreme; Muscle pain; Feverish; Drowsiness; Nauseated; the pain in the arm at the injection site became increasingly painful; Temperature began to rose; felt dizzy; headache/ throbbing headache; sickness; feeling hot; sleepy; nauseous; clammy; fatigue, tired , run down; This is a spontaneous report from a contactable healthcare professional. This is a report received from the Regulatory Authority(MHRA). Regulatory authority report number (GB-MHRA-WEBCOVID-202108082100320460-5TSDH). Safety Report Unique Identifier (GB-MHRA-ADR 25772019). A 36-year-old female patient received 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 07Aug2021, at the age of 36 years, (Batch/Lot Number: FF3319) as dose 1, single for COVID-19 immunization. Medical history included mood change and suspected covid-19 from 07Aug2021 to 07Aug2021. The patient is healthy 36-year-old not taking any medications. There were no concomitant medications. On an unspecified date in Aug2021, the patient experienced the pain in the arm at the injection site became increasingly painful, temperature began to rose, felt dizzy, headache/ throbbing headache, sickness, feeling hot, sleepy, nauseous, clammy and fatigue, tired , run down. On 07Aug2021, the patient experienced tingling, vomiting, fatigue extreme, muscle pain, feverish, drowsiness and nauseated. On 08Aug2021, the patient experienced migraine headache and dizziness upon standing. The clinical course was reported as follows: Arm felt tingling within minutes of having the vaccine. After about an hour the pain in the arm at the injection site became increasingly painful. Temperature began to rose, feeling hot and clammy. Fatigue came after a few hours felt very sleepy / drowsy, sickness. Following morning felt dizzy, hot, nauseous, fatigued, tired, run down and terrible throbbing headache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (causing disability). The patient had COVID-19 test (07Aug2021): No - Negative COVID-19 test. The outcome for the events pain in the arm at the injection site became increasingly painful, temperature began to rose, felt dizzy, headache/ throbbing headache, sickness, tingling, feeling hot, sleepy, nauseous, clammy and fatigue, tired , run down was unknown; outcome for vomiting was recovering; outcome for fatigue extreme, muscle pain, feverish, drowsiness, nauseated, migraine headache and dizziness upon standing was not recovered. No follow-up attempts are possible. No further information expected.


VAERS ID: 1625164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature decreased, Fatigue, Headache, Neck pain, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (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: Suspected COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: temperature; Result Unstructured Data: Test Result:under 37; Comments: under 37; Test Name: temperature; Result Unstructured Data: Test Result:37.4; Test Name: temperature; Result Unstructured Data: Test Result:38.5; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101021528

Write-up: neck pain; terrible headaches; tiredness; Feverish; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. Regulatory authority report number is GB-MHRA-WEBCOVID-202108090734440350-XWPNY, Safety Report UniqueIidentifier is GB-MHRA-ADR 25772840. A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation, suspected COVID-19 from 08Jan2021 and ongoing. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications were not reported. Historical vaccine included BNT162B2 (Batch/lot number: Not known, expiry date not reported) on an unspecified date as dose 1, single for COVID-19 immunization. The patient experienced neck pain on an unspecified date with outcome of unknown, terrible headaches on an unspecified date with outcome of unknown, tiredness on an unspecified date with outcome of unknown, and feverish on 01Aug2021 with outcome of not recovered. The patient underwent lab tests and procedures which included SARS-COV-2 test: negative on No - Negative COVID-19 test, body temperature decreased: under 37 on under 37, 37.4 on an unspecified date, and 38.5 on an unspecified date. The events were reported as serious, medically significant by the health authority. Additional Information: Been having temperature from 37.4 to 38.5, normally mine sits well under 37. Terrible headaches, neck pain and tiredness too. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1625213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Headache, Pyrexia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MONTELUKAST; OMEPRAZOLE SODIUM; QVAR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101028624

Write-up: Joint ache; Vomiting; Diarrhea; Headache; Fever chills; This is a spontaneous report from a contactable consumer received from a regulatory authority. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Aug2021 as single dose for COVID-19 immunisation. The patient''s medical history was not reported. She has not had symptoms associated with COVID-19 and not enrolled in clinical trial. Concomitant medications included montelukast, omeprazole sodium, and beclometasone dipropionate (QVAR). The patient experienced vomiting and diarrhea on 07Aug2021; joint ache on 08Aug2021; headache and fever chills on Aug2021. Events were reported as medically significant by health authority. She has not tested positive for COVID-19 since having the vaccine. She underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 07Aug2021. The patient recovered from joint ache, headache, and fever chills on Aug2021, while recovering from other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1625217 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Deafness, Ear discomfort, Hypoacusis, SARS-CoV-2 test, Tinnitus
SMQs:, Hearing impairment (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result: Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101028758

Write-up: Hearing reduced; Sounded like it''s under water, slight sound difference when quite, low hissing noise; blocked ear/No pain except occasionally uncomfortable; hearing loss; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108092207089700-N2QCB. Safety Report Unique Identifier is GB-MHRA-ADR 25777189. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration, administered in left arm on 06Aug2021 (at the age of 33 years old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced hearing loss on Aug2021; and on 06Aug2021, she experienced hearing reduced, blocked ear, and sounded like it''s under water, slight sound difference when quite, low hissing noise. The events were reported as serious per other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The clinical course was reported as follows: Same night (4-5 hours) later developed a blocked ear. Felt like it has pressure behind it. Lack of hearing in that ear. Sounded like it''s under water, slight sound difference when quite, low hissing noise. No pain except occasionally uncomfortable. No change since the vaccine, it hasn''t got any better of any worse. Affected day to day life with hearing loss. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event hearing loss was recovered on Aug2021. The outcome of the remaining events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.


VAERS ID: 1625232 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling of body temperature change, Influenza like illness, Nasopharyngitis, Oropharyngeal pain, Sneezing
SMQs:, Anaphylactic reaction (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (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 INC202101028567

Write-up: Sneezing; Sore throat; cold / flu hit me; Fatigue; Feeling hot and cold; cold; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108100722471520-P9W99, GB-MHRA-ADR 25777724. A 29-year-old female patient received bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: FF3319), via an unspecified route of administration on 07Aug2021 (at the age of 29-years-old) as dose 2, single for COVID-19 immunization. The patient medical history included lactation decreased. The patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient received historical vaccine including bnt162b2 (COVID-19 MRNA VACCINE BIONTECH, Solution for injection, Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. In Aug2021, the patient experienced cold. On 07Aug2021, 12 hours after the vaccination, the patient experienced "feeling hot and cold". On 08Aug2021, the patient experienced "cold / flu hit me", sneezing, sore throat and fatigue. The clinical course was as follows: The patient stated that 12 hours after vaccine, she felt very hot and cold, and then next day felt like she had a cold / flu hit her. The patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event cold was not recovered. The outcome of the events "feeling hot and cold", sneezing, sore throat and fatigue was recovering. The outcome of the event "cold / flu hit me" was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1625533 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Nausea, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: ITPFIZER INC202101016695

Write-up: 10 minutes after administration of the Comirnaty vaccine syncope and tremors resolved spontaneously in a few minutes with subsequent malaise, headache, nausea; 10 minutes after administration of the Comirnaty vaccine syncope and tremors resolved spontaneously in a few minutes with subsequent malaise, headache, nausea; 10 minutes after administration of the Comirnaty vaccine syncope and tremors resolved spontaneously in a few minutes with subsequent malaise, headache, nausea; 10 minutes after administration of the Comirnaty vaccine syncope and tremors resolved spontaneously in a few minutes with subsequent malaise, headache, nausea; 10 minutes after administration of the Comirnaty vaccine syncope and tremors resolved spontaneously in a few minutes with subsequent malaise, headache, nausea; This is a spontaneous report from a contactable physician from the The regulatory authority report number is IT-MINISAL02-765790. A 12-year-old male patient received BNT162B2 (COMIRNATY), via intramuscular route administered in left arm on 01Aug2021 (Batch/Lot Number: FF7481; Expiration Date: 30Nov2021) as dose 1, 0.3 ml single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced 10 minutes after administration of the Comirnaty vaccine, syncope and tremors resolved spontaneously in a few minutes with subsequent malaise, headache, nausea reported as important medical events. Outcome of syncope and tremors was recovered on 01Aug2021, and of remaining events was not recovered. Sender Comment: The severity of the suspected adverse reaction is changed from non-serious to serious - other clinically relevant condition as this is an event included in the IME (Important Medical Events) list. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1625713 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016780

Write-up: had a miscarriage.; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00648178. This is the first out of two reports, for the second dose. A 33-year-old female patient received the second dose of bnt162b2 (COMIRNATY) covid-19 vaccine pfizer injection fluid on 01Aug2021 (lot number: unknown) (at the age of 33-years-old) via unknown route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient was not Previous COVID-19 infection. Patient previously received the first dose of BioNTech/Pfizer vaccin (Comirnaty) on 24Jun2021 via unknown route of administration at single dose for covid-19 immunisation, experienced fever and cramps. Patient experienced Miscarriage on 01Aug2021. The miscarriage occurred at a pregnancy duration of about 4,5 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 4,5 weeks. The first Covid vaccination took place before pregnancy. The outcome of the event was unknown. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (miscariage) was considered as serious by the regulatory authority. Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 24Jun2021. I have previously reported side effects including fever, today I had a miscarriage. Additional information ADR: No idea of course if it has anything to do with the vaccine but Friday I got a fever, Saturday cramps and today a miscarriage. COVID-19 vaccine exposure during pregnancy week: Second time at 4.5 weeks. Previous COVID-19 infection: No. No follow-up attempts possible. No further information expected. Information about lot/batch# cannot be obtain.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 24Jun2021 I have previously reported side effects including fever, today I had a miscarriage Additional information ADR: No idea of course if it has anything to do with the vaccine but Friday I got a fever, Saturday cramps and today a miscarriage confounding factors COVID-19 vaccine exposure during pregnancy week: Second time at 4.5 weeks Previous COVID-19 infection: No; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101061081 same patient; different dose of vaccine


VAERS ID: 1625724 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-08-01
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101017580

Write-up: PERICARDITIS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number NO-NOMAADVRE-FHI-2021-U1q23x. A 46-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Jul2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced pericarditis and was hospitalized on unspecified date in Aug2021. The outcome of the event was unknown. Causality assessment for the event from the regulatory authority was possible. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.


VAERS ID: 1625768 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Decreased appetite, SARS-CoV-2 test, Urine analysis
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Urinalysis; Result Unstructured Data: normal; Test Name: COVID-19 antigen test; Result Unstructured Data: Negative
CDC Split Type: PHJNJFOC20210839265

Write-up: APPETITE LOST; WEAKNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099920] concerned a 74 year old 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: 213C21A, expiry: UNKNOWN) dose was not reported, one total, administered on 30-JUL-2021 at 08:50 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, at 15:00, the patient experienced weakness. On an unspecified date, the patient experienced appetite lost, on and off fever, and astasis. Patient sent to hospital. Laboratory data (dates unspecified) included: Antigen swab (NR: not provided) Negative, and Urinalysis (NR: not provided) normal, but doctor recommended the patient for RT-PCR (polymerase chain reaction) Swab test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and appetite lost. This report was serious ( Disability Or Permanent Damage and Other Medically Important Condition).; Sender''s Comments: V0: 20210839265-Covid-19 vaccine ad26.cov2.s-Appetite lost. 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). 20210839265-Covid-19 vaccine ad26.cov2.s-Weakness. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1625773 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Malaise, Nasopharyngitis, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210806; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210839714

Write-up: DIFFICULTY OF BREATHING; SUSPECTED CLINICAL VACCINATION FAILURE; COUGH; COLD; BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300098387] concerned a 57 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. No follow-up will be requested for this case. No concomitant medications were reported. On 01-AUG-2021, the patient experienced cough, cold and body malaise. On 06-AUG-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 07-AUG-2021, the patient experienced difficulty of breathing, and was hospitalized (date unspecified). On an unspecified date, the patient experienced suspected clinical vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough, cold, body malaise, and difficulty of breathing, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). .; Sender''s Comments: V0: 20210839714-Covid-19 vaccine ad26.cov2.s - Difficulty Of breathing. 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). 20210839714-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1627861 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? 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: Non-smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101038667

Write-up: Headache; Myalgia; Injection site reaction; Fatigue; Feeling unwell; Fever; Nausea; Shivering; very ill; This is a first of two reports and this is a spontaneous report from a contactable consumer or other non HCP downloaded from the Regulatory Authority EudraVigilance-WEB BE-FAMHP-DHH-N2021-103686. This is spontaneous COVID-19 report received by the Belgian authorities on 02Aug2021. A 51-years-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FE7053 and expiry date was not reported), via an unspecified route of administration, on 30Jul2021, as single dose for COVID-19 immunisation. The patient''s medical history included non-smoker. The patient was previously in excellent condition. Concomitant medications were not reported. On 01Aug2021, the patient experienced headache, myalgia, injection site reaction, fatigue, feeling unwell, fever, nausea, shivering, and very ill. The patient did not receive treatment for the events. Outcome of the events was recovering. Reporter''s Comments: Situations - Other: My expertise does not extend that far to assess the possibilities you described above. Time relationship - ADR description - I experienced a few problems with the first vaccination. On the 2nd dose I was very sick and I still don''t feel well. Of course I cannot estimate the end date of the side effects on this day. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - No Evolution of the ADR - Recovering Situations - Other: My expertise does not extend that far to assess the possibilities you described above. Time relationship - ADR description - I experienced few problems with the first vaccination. On the 2nd dose I was very sick and I still don''t feel well. Of course I cannot estimate the end date of the side effects on this day; Sender''s Comments: Linked Report(s) : BE-PFIZER INC-202101082433 1st/2nd dose of the vaccine - same patient


VAERS ID: 1627910 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-08-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7206 / 2 LA / -

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101064917

Write-up: abdominal pain and pain in thigh/ deep vein thrombosis was diagnosed; This is a spontaneous report from a contactable consumer (Patient''s father). A 13-years-old not pregnant female patient received bnt162b2 (PFIZERBIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left at age of 13 years on 24Jul2021 11:00 (Lot Number: FD7206) as dose 2, single for covid-19 immunisation. Medical history was none. No known allergies. There were no concomitant medications. No other vaccine in four weeks, no other medications in two weeks. The patient was administered the second Pfizer-BioNTech Vaccine on 24Jul2021 and started with the side effects on 01Aug2021 09:00 with abdominal pain and pain in thigh. The deep vein thrombosis was diagnosed on 06Aug2021 at PRIVACY Hospital. No other factor or event can explain these blood clots except the administration of the vaccine 8 days before the onset of the symptoms. Adverse event (ae) resulted in physician office visit, emergency room visit, hospitalization, life-threatening disease (as reported). The patient hospitalized for 2 days and received treatment of Enoxaparin. No Covid prior vaccination. No Covid test post vaccination. The outcome of the event was recovering.


VAERS ID: 1629677 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7051 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101022737

Write-up: miscarriage; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female pregnant patient received bnt162b2 (COMIRNATY, solution for injection), via unspecified route of administration on 07Aug2021 (batch/lot number FE7051 and expiry date unknown) at 34 years of age as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received her first injection on Saturday 07Aug2021, but on Friday (in Aug2021) she discovered that she was 3 to 4 weeks pregnant but did not tell her partner. The patient informed that when filling in the questionnaire, she did not mention it. The patient informed that during the night she had blood loss, so she went to the emergency room and later learned that she had a miscarriage. The patient experienced miscarriage in Aug2021, maternal exposure during pregnancy, first trimester (week 1 through 13 (months 1 to 3)). The mother reported she became pregnant while taking bnt162b2. The outcome of the event was unknown.


VAERS ID: 1629684 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-07
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Cardiac flutter, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), Other ischaemic heart disease (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 INC202101028577

Write-up: Palpitations; Cardiac pain; Heart fluttering; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number and Safety Report Unique Identifier is GB-MHRA-ADR 25774975. A 16-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 07Aug2021, at the age of 16 years, (Batch/Lot Number: FF3319) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Usually in good health. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. On 07Aug2021, the patient experienced palpitations. On an unspecified date in Aug2021, the patient experienced cardiac pain and heart fluttering. Palpitations began approximately 90 mins after vaccine. Heart pain when learning forwards. Fluttering in chest. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The case is serious (medically significant). The outcome for the events palpitation, cardiac pain and heart fluttering was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1630284 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Headache, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Nil medical history
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEJNJFOC20210844277

Write-up: VENOUS SINUS THROMBOSIS; SEIZURE; HEADACHE THAT WAS REFRACTORY TO ANALGESIA 10 DAYS AFTER GETTING VACCINE; This spontaneous report received from a pharmacist via a Regulatory Authority (IE-HPRA-2021-082228) concerned a 21 year old male. The patient''s weight was 74.65 kilograms, and height was not reported. The patient''s pre-existing medical conditions included: Nil medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE393 expiry: unknown) dose was not reported, 1 total, administered on 22-JUL-2021 for covid-19 immunisation. Drug start period was 10 days. No concomitant medications were reported. On 01-AUG-2021, the patient experienced headache that was refractory to analgesia 10 days after getting vaccine. On 08-AUG-2021, the patient experienced seizure. On an unspecified date, the patient experienced venous sinus thrombosis, and was hospitalized (date unspecified). Number of hospitalization days were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache that was refractory to analgesia 10 days after getting vaccine, seizure, and venous sinus thrombosis. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening).; Sender''s Comments: V0:This spontaneous report received from a pharmacist (IE-HPRA-2021-082228) and concerns a 21 year old male who experienced venous sinus thrombosis unspecified time after vaccination and was hospitalized. The patient experienced analgesia refractory headache and seizure 10 days and 21 days post vaccination respectively. The Patient''s past medical history , concomitant medications and concurrent medications were not reported. Platelet count was no reported. No other pertinent details were reported. The patient had not recovered from the events. Information is limited in this case, and the occurrence of venous sinus thrombosis could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.


VAERS ID: 1630359 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Ecchymosis, Heart rate, Heart rate increased, Seizure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: heart rate; Result Unstructured Data: Test Result:280; Comments: bpm
CDC Split Type: ITPFIZER INC202101032009

Write-up: rapid heart rate (280 bpm); Ecchymosis; severe pain in the chest; Convulsions; This is a spontaneous report received from a contactable consumer downloaded from the WEB, regulatory authority number IT-MINISAL02-768342. An 18-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FF7481) intramuscular, administered in Arm Right on 01Aug2021 (at the age of 18-year-old) as dose 1 single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Aug2021, the patient experienced rapid heart rate (280 bpm), ecchymosis, severe pain in the chest and convulsions. Seriousness for all events was reported as disability. Reporter reported complete resolution of symptoms. He went to visit the cardiologist. Heart massage to try to control heart rate. Impact on quality of life (8/10). The patient underwent lab tests and procedures which included heart rate: 280 bpm on 01Aug2021. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: none


VAERS ID: 1630819 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN XE389 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Apathy, Arthralgia, Asthenia, Inadequate diet, Myalgia, Pain in extremity, Parosmia, Productive cough, Pyrexia, Seizure, Somnolence, Suspected COVID-19, Taste disorder, Tremor, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ABSENOR [VALPROIC ACID]
Current Illness: Bipolar disorder (Takes Absenor.); Cigarette smoker (changed taste (which made him smoke less cigarettes). Patient smoked a lot but now he did not like the taste of cigarettes)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (COVID-19 infection 8 months ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210840362

Write-up: FEVER; WEAKNESS; STRANGE CONVULSIONS; SOMNOLENCE/SLEEPY; APATHY; MIGHT HAVE CAUGHT COVID AGAIN LESS THAN 28 DAYS AFTER VACCINATION; VIBRATIONS; CHANGED TASTE WHICH MADE HIM SMOKE LESS CIGARETTES; WORSE EYESIGHT/EYESIGHT WAS IMPAIRED FOR SOME TIME; LOST TASTE; LOST SMELL; SHARPENED SMELL/HIS SENSE OF SMELL BETTER THAN BEFORE VACCINATION; EATS LESS; COUGH THAT LASTED ONE DAY WITH WHITE DISCHARGE; PAIN IN THE CALVES; PAIN IN SHOULDERS; MUSCLE ACHES; This spontaneous report received from a patient concerned a 50 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included: covid-19 infection (8 months ago), and concurrent conditions included: bipolar disease, and cigarette smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE389, and expiry: UNKNOWN) dose was not reported, 1 total, administered to left arm on 01-AUG-2021 for prophylactic vaccination. Concomitant medications included valproic acid for bipolar disease. On an unspecified date in AUG-2021, the patient experienced his sense of smell was better than before vaccination. On 01-AUG-2021, the patient experienced changed taste which made him smoke less cigarettes and worse eyesight. On 16-AUG-2021, the patient experienced vibrations, strange convulsions and weakness, apathy and somnolence/sleepy. For some time, patient''s eyesight was impaired, he had no precision in his eyes. The patient thought he might had COVID due to his symptoms/might have caught Covid again less than 28 days after vaccination. It was reported that the patient would probably make a test (unspecified) next week (as reported). Patient thought it might be Delta Covid strain. The patient also reported to have a sharpened smell now (at the time of reporting). It was reported that this week the patient had similar feeling as covid-19 infection, 8 months ago. Patient also had muscle aches, pain in the calves and now pain in shoulders. On an unspecified date in AUG-2021, the patient experienced lost taste, lost smell, eats less, cough that lasted one day with white discharge, pain in the calves that was ascending, pain in shoulders, and muscle aches. On 20-AUG-2021, the patient experienced fever. It was reported that the patient was very positive about COVID vaccine saying that he had a lot of antibodies. Patient reported that he smoked a lot but now he did not like the taste of cigarettes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from worse eyesight/eyesight was impaired for some time on 08-AUG-2021, somnolence/sleepy, apathy, and weakness on 19-AUG-2021, and cough that lasted one day with white discharge on AUG-2021, was recovering from might have caught covid again less than 28 days after vaccination, had not recovered from changed taste which made him smoke less cigarettes, and the outcome of vibrations, strange convulsions, muscle aches, lost taste, pain in the calves, lost smell, sharpened smell/his sense of smell better than before vaccination, pain in shoulders, eats less and fever was not reported. This report was serious (Other Medically Important Condition). Additional information was received from patient on 20-AUG-2021. The following information was updated and incorporated into the case narrative: Added events (convulsions, fever, muscle aches, lost taste, lost smell, pain in the calves, pain in shoulders, eats less, and cough that lasted one day with white discharge). Reported term eyesight was impaired for some time was subsumed with event visual impairment, sharpened smell subsumed with event sense of smell better than before vaccination, sleepy subsumed with event somnolence.; Sender''s Comments: V1: This version is created to update the information regarding events added (convulsions, fever, muscle aches, lost taste, lost smell, pain in the calves, pain in shoulders, eats less, and cough that lasted one day with white discharge. Case updates to serious. 20210840362-covid-19 vaccine ad26.cov2.s -strange convulsions. Follow-up received regarding Clinical Details. 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: 1631519 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-08-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Headache, Joint swelling, Pain
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Intense Joint pain, headache, swollen vein on one wrist which also caused pain, which I had never had before.


VAERS ID: 1631856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20210844651

Write-up: SUSPECTED COVID-19 INFECTION; SUPER UNCOMFORTABLE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 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, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered, on 06-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, patient was super uncomfortable. On 22-AUG-2021, He had no taste, really tired, cough and fever for eight days (coded as suspected covid-19 infection). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and super uncomfortable, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210844651-Covid-19 vaccine ad26.cov2.-Suspected Clinical Vaccine Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.


VAERS ID: 1631865 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Hypokinesia, Nausea, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: EGJNJFOC20210835309

Write-up: FAINTED; UNABLE TO MOVE ALL DAY LONG; HEADACHE; TIRED; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 25 year old female of an unspecified race and ethnic origin The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, frequency time 1 total was administered on 15-AUG-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 16-AUG-2021, the patient fainted once. On an unspecified date of AUG-2021, (about 12 hours after getting the vaccine) the patient experienced unable to move all day long, headache, tired, nausea, fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fainted, headache, tiredness, nausea, fever and unable to move all day long was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210835309-covid-19 vaccine ad26.cov2.s-fainted. 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: 1634018 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Feeling cold, Headache, Migraine, Paraesthesia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101034453

Write-up: Migraine; Vomiting; Pins and needles; Dizziness; Coldness; headache; Spaced out; Rash; This is a spontaneous report from a contactable consumer (patient) report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108101724229230-5LDLE. Safety Report Unique Identifier is GB-MHRA-ADR 25781237. A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FD8813) via an unknown route of administration (age at vaccination: 17 years) on 09Aug2021 as dose 1, single for COVID-19 immunisation. Medical history included pregnancy. The patients concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced headache, spaced out, rash. On 09Aug2021, the patient experienced migraine, vomiting, pins and needles, dizziness, coldness. It was reported that the events occurred within 30 minutes of vaccination. The patient had vomiting every half hour and bed bound. The patient had severe headache and aversion to light. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of events headache, spaced out; rash was reported as unknown. The outcome of the events migraine, vomiting, pins and needles, dizziness, coldness was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1636069 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / UNK - / OT

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

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

Write-up: "Moderna"; This case was received (Reference number: 769945) on 18-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY in an 18-year-old female patient who received mRNA-1273 (batch no. 3003605) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Intramuscular) .5 ml in total. On 01-Aug-2021, the patient experienced HYPERSENSITIVITY (seriousness criterion hospitalization). At the time of the report, HYPERSENSITIVITY had resolved with sequelae. The action taken with mRNA-1273 (Intramuscular) was unknown. Concomitant product use was not 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 event, a causal relationship cannot be excluded. No further information is expected at this time. Translation of the source document has been requested.; Reporter''s Comments: 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. No further information is expected at this time. Translation of the source document has been requested.


VAERS ID: 1638380 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE338D / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Inappropriate schedule of product administration, Maternal exposure during pregnancy, Scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: FOLIC ACID
Current Illness: Anaemia (severe anaemia); Pregnancy (Estimated due date: 05Nov2021)
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: scan; Result Unstructured Data: Test Result:Generally healthy pregnancy; Comments: now with severe anaemia. Baby healthy.
CDC Split Type: GBPFIZER INC202101040615

Write-up: Tiredness; Breathlessness; Inappropriate schedule of vaccination administered; Maternal exposure during pregnancy; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number is GB-MHRA-YCVM-202106011022130600-TVCFR, Safety Report Unique Identifier GB-MHRA-ADR 25783293. A 32-year-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Aug2021 at 32-year-old (Lot Number: FE338D) as dose 2, single for COVID-19 vaccination. Medical history included ongoing pregnancy Estimated due date: 05Nov2021, suspected covid-19 from an unknown date, Unsure when symptoms started, Unsure when symptoms stopped, severe anaemia. Patient not had a COVID-19 test. Patient is not currently breastfeeding. Patient last menstrual period date was 31Jan2021. Concomitant medication(s) included folic acid (FOLIC ACID) taken for Folic acid supplementation, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Jun2021 for COVID-19 vaccination. The patient experienced maternal exposure during pregnancy on 01Aug2021 with outcome of unknown, tiredness on 02Aug2021 with outcome of recovered on 03Aug2021, breathlessness on 02Aug2021 with outcome of recovered on 04Aug2021. The case was reported as serious for medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Patient does not think vaccination had an adverse effect on any aspect of the pregnancy. Details of previous pregnancies: Taking prescribed iron supplements. Patient was exposed to the vaccine Second-trimester (13-28 weeks). Details of scans or investigations: Generally healthy pregnancy, now with severe anaemia. Baby healthy. The mother reported she became pregnant while taking bnt162b2. The mother was 26 Weeks pregnant at the onset of the event. The mother was due to deliver on 05Nov2021.The patient underwent lab tests and procedures which included scan on unspecified date: Generally healthy pregnancy, now with severe anaemia. Baby healthy. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the 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: 1638708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101038910

Write-up: miscarriage occurred at a pregnancy duration of about 11 weeks/at 11 weeks of pregnancy, the heart stopped beating, exactly around the date of vaccination.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, Regulatory authority report number NL-LRB-00660593. This is a maternal report. A pregnant 36-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 31Jul2021 (Lot Number: FE8405, unknown expiration) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. The patient previously received first dose of COMIRNATY on 20Jun2021 for COVID-19 immunisation and experienced maternal vaccine exposure (first COVID vaccination took place at a pregnancy duration of about 5 weeks; no adverse event). The second COVID vaccination took place at a pregnancy duration of about 11 weeks. The patient experienced miscarriage following administration of COVID-19 vaccine Pfizer injection on 01Aug2021 (1 day after start). The miscarriage occurred at a pregnancy duration of about 11 weeks. At 11 weeks of pregnancy, the heart stopped beating, exactly around the date of vaccination. Outcome of the event was unknown. The event was assessed as serious (medically significant). Sender''s comment: HA death altered in HA other medically important condition. No follow-up attempts are possible; information about batch number was already obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101082710 baby case


VAERS ID: 1642385 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Headache, Pericarditis, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: COVID-19 virus test; Test Result: Negative; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: chest pain; fever; headache; Pericarditis; This case was received via RA (Reference number: GB-MHRA-ADR 25823794) on 20-Aug-2021 and was forwarded to Moderna on 20-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CHEST PAIN (chest pain), PYREXIA (fever), HEADACHE (headache) and PERICARDITIS (Pericarditis) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. In August 2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization) and HEADACHE (headache) (seriousness criterion hospitalization). The patient was hospitalized on 18-Aug-2021 due to CHEST PAIN, HEADACHE, PERICARDITIS and PYREXIA. At the time of the report, CHEST PAIN (chest pain), PYREXIA (fever) and HEADACHE (headache) outcome was unknown and PERICARDITIS (Pericarditis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Reportedly, the patient''s chest pain was coming and going for episodes of 20 minutes and was on a cardiac care unit. No treatment information was provided. Patient has not had symptoms associated with COVID-19. Patient is neither pregnant, nor is currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. Company comment Very limited information regarding the events onset and vaccination dates has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding the events onset and vaccination dates has been provided at this time and insufficient to assess the temporal association. No follow up is possible. A causal relationship cannot be excluded.


VAERS ID: 1654234 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration bone marrow, Asthenia, Cardio-respiratory arrest, Dysuria, Full blood count, Gait inability, Oxygen saturation, Pigmentation disorder, Platelet count decreased, Pyrexia, Renal disorder, Respiratory disorder, SARS-CoV-2 test, Skin swelling, Spinal myelogram, Visceral leishmaniasis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Angioedema (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Opportunistic infections (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had ''PD'' (unspecified medical condition) in childhood but was otherwise a healthy woman.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Aspiration bone marrow; Result Unstructured Data: Suspected kala-azar, Tuberculosis or Leukemia; Test Date: 20210809; Test Name: Myelogram; Result Unstructured Data: unknown; Comments: Reporter (consumer) was unable to read the result.; Test Date: 20210817; Test Name: Hemogram; Result Unstructured Data: Low level of platelets; Test Date: 20210817; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 20210824; Test Name: Oxygen saturation; Result Unstructured Data: Drop in saturation; Comments: Saturation was low at night.
CDC Split Type: BRJNJFOC20210852666

Write-up: CARDIOPULMONARY ARREST; RESPIRATORY CONDITION WORSENED; LOW LEVEL OF PLATELETS; SPOTS ON THE SKIN; SPOTS ON THE SKIN, WITHOUT INJURY AND WITH SWELLING; WEAKNESS; FEVER; KIDNEYS WERE COMMITTED; DIFFICULTY TO URINATE; KALA-AZAR; COULD NOT WALK; This spontaneous report received from a consumer concerned a 43 year old female patient of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient had ''PD'' (unspecified medical condition) in childhood but was otherwise a healthy woman. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on 07-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-AUG-2021, the patient''s myelogram was done but the reporter was unable to read the result. It was reported that on 13-AUG-2021, RK29: non-reagent was used for the patient. The patient had no flu symptoms. However, on 17-AUG-2021, the patient felt weak and had spots on the skin, without injury and with swelling. The stains increased, and the patient sought medical help at the hospital. On 17-AUG-2021, the patient''s coronavirus disease (COVID-19) test was negative, hemogram showed low level of platelets, and she was hospitalized. On the same day, RK39: non-reagent was used for the patient. On an unspecified date, in AUG-2021, the patient had fever, received transfusion of two blood bags but still there was no improvement in the number of platelets. The medical team had a suspicion of leukemia, and then referred the patient to another hospital where a worse clinical framework was presented. The medical team made a bone marrow monitoring and suspected kala-azar, tuberculosis or leukemia. As per the medical staff, the patient''s kidneys were also committed. The patient could not walk. Treatment (unspecified) for kala-azar was started and there was a big worsening of the swollen areas. The patient also faced difficulty in urination. She was on hemodialysis, and chemotherapeutic regime. On 24-AUG-2021, during the night, the patient''s respiratory condition worsened, with tachypnea and saturation drop. It was an orotracheal intubation (IOT) at the risk of imminent cardiopulmonary arrest (reported as ''pcr''). During the procedure, the patient experienced cardiopulmonary arrest, reverse in two cycles and mechanical fan. At the time of reporting, the patient was on hemodialysis, chemotherapeutic regime and had a drainage procedure scheduled soon. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weakness, spots on the skin, low level of platelets, fever, spots on the skin, without injury and with swelling, kidneys were committed, could not walk, difficulty to urinate, cardiopulmonary arrest, respiratory condition worsened and kala-azar was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0-20210852666-Covid-19 vaccine ad26.cov2.S-Cardiopulmonary arrest, Kala-Azar, Low level of platelet, Kidneys were committed, Difficulty to urinate, Respiratory condition worsened, could not walk, Spots on the skin, Spots on the skin without injury and with swelling, Weakness, Fever. 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: 1654502 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Allergy to vaccine, Blood pressure measurement, Heart rate, Heart rate increased, Hypoaesthesia, Maternal exposure during pregnancy, Paraesthesia, Physical examination, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (narrow), Dehydration (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:unknown result; Test Name: heart rate; Result Unstructured Data: Test Result:increased; Test Name: test on her limbs and face; Result Unstructured Data: Test Result:unknown result; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101049534

Write-up: heart rate increased; maternal exposure during pregnancy/ exposed to the medicine second-trimester (13-28 weeks); feeling pin and needles; Numbness; allergic reaction to the vaccination; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108131710255200-DEBZN, and Safety Report Unique Identifier is GB-MHRA-ADR 25795774. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 12Aug2021 (lot number: FE3380) as dose 1, single for COVID-19 immunisation. Medical history included lactation decreased, ongoing pregnancy, folic acid supplementation. Healthy individual with no previous serious medical conditions. Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation. The patient experienced heart rate increased on an unspecified date with outcome of recovering, allergic reaction to the vaccination in Aug2021 with outcome of recovering, feeling pin and needles on 12Aug2021 with outcome of recovering, numbness on 12Aug2021 with outcome of not recovered, and maternal exposure during pregnancy/ exposed to the medicine second-trimester (13-28 weeks) on an unspecified date with outcome of unknown. The events ''heart rate increased, allergic reaction to the vaccination, feeling pin and needles and numbness'' were considered serious as other medically important condition. Additional Information: Around 8 hours after the jab, patient have started feeling pin and needles in her jabbed left arm. This then traveled to her left leg and left part of her face giving her also sense of numbness. Attended Accident and Emergency (AE) day after as it seemed to be spreading to the other parts of her body. Blood pressure taken, feel test on her limbs and face carried out. Also, her babies heartbeat checked. She was told this is most likely allergic reaction to the vaccination. Patient has not tested positive for COVID-19 since having the vaccine. Patient was exposed to the medicine second-trimester (13-28 weeks). The patient underwent lab test which included COVID-19 virus test: No-Negative COVID-19 test, blood pressure: unknown result, test on her limbs and face: unknown result, heart rate: increased; all on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1655425 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210858000

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042326) was received on 27-AUG-2021 and concerned a 22 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD955 expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced SARS-CoV-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the SARS-CoV-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1655426 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210857871

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042329) was received on 27-AUG-2021 and concerned a 29 year old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 and expiry: unknown) dose was not reported, with frequency time 1 total administered on 11-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced SARS-COV-2 (severe acute respiratory syndrome coronavirus) infection, and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1656864 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-08-01
   Days after vaccination:74
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Echocardiogram, SARS-CoV-2 test
SMQs:, Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Factor V Leiden carrier; Renal agenesis; Spontaneous abortion (at 6 weeks of pregnancy)
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: echo; Result Unstructured Data: Test Result:pregnancy; Test Date: 20210801; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101055710

Write-up: Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-BR20213093. A 29-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 19May2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included Factor V Leiden carrier, renal agenesis, and spontaneous abortion from 05Dec2020 (at 6 weeks of pregnancy). The patient''s concomitant medications were not reported. The patient experienced miscarriage (hospitalization) on 01Aug2021 with outcome of recovered with sequelae. The report was about the 29-year-old patient who started a pregnancy dated by echo on 19May2021 (LMP: 04May2021). Received a 1st injection of COMIRNATY, batch unknown, on 19May2021. Occurrence of a miscarriage on 01Aug2021 during the first trimester of pregnancy. The mother was 12 Weeks pregnant at the onset of the event. The mother was due to deliver on 08Feb2022. The mother delivered the pregnancy on 01Aug2021. The pregnancy resulted in spontaneous abortion. The patient underwent lab tests and procedures which included echocardiogram: pregnancy on 19May2021 and sars-cov-2 test: negative on 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1657152 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Insomnia, Maternal exposure during pregnancy, Myalgia, Oropharyngeal pain, SARS-CoV-2 test, Tinnitus, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (broad), Lens disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; FOLIC ACID
Current Illness: Breast feeding; Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; Ear infection; Folic acid supplementation; Nasal polyps
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101056924

Write-up: Insomnia/Sleeping become almost impossible, hardly sleep; Tinnitus/ear has a non stop ringing; Sore throat/throat is painful and dry; Muscle ache/muscles pain; Maternal exposure during pregnancy/exposed to the medicine second-trimester 13-28 weeks; Blurred vision; dizzy; This is a spontaneous report from a contactable consumer (patient). This report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108160322422290-JPMBY. Safety Report Unique Identifier GB-MHRA-ADR 25802719. A 42-year-old female patient (age at vaccination: 42-year-old, pregnant and exposed to the medicine second-trimester 13-28 weeks) received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, lot unknown), via an unspecified route of administration on 10Aug2021 as dose 1, single for Covid-19 immunisation. Medical history included nasal polyps, ongoing breast feeding, ongoing pregnancy, folic acid supplementation, asthmatic and had ear infection. Concomitant medications included amoxicillin for ear infection from 01Aug2021 to an unspecified stop date; folic acid for vitamin supplementation, start and stop date were not reported. She experienced blurred vision on 10Aug2021. On 11Aug2021, her left ear had a non-stop ringing sound since after injection, sleeping has become almost impossible/hardly sleep for 2 hours each day, her throat was painful and dry (sore throat), had muscles pain/muscle pain. Sometimes, she felt dizzy when standing up (Aug2021). The events were serious disability. The patient underwent laboratory test which included SARS-CoV-2 test: no negative covid-19 test on unspecified date. The outcome of dizzy was recovered; for other 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: 1658428 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Heart rate
SMQs:, Arrhythmia related investigations, signs and symptoms (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had no history of heart problem.
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: 35
CDC Split Type: BRJNJFOC20210859595

Write-up: HEARTBEAT OF 35; This spontaneous report received from a consumer concerned an elderly male (79 or 80 years old) of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included: The patient had no history of heart problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total administered on 22-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Since an unspecified date on AUG-2021 (reported as last week), the patient had heartbeat of 35. The doctor had no idea it was related to vaccine or not and patient has an appointment with another specialist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heartbeat of 35 was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210860526, 20210860780.; Sender''s Comments: V0: 20210859595-COVID-19 VACCINE AD26.COV2.S- heartbeat of 35. 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: 1661909 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: 202108; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: The result is negative (5.71 RU/ml)
CDC Split Type: BEJNJFOC20210860721

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex and an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, with 1 total administered on 12-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On AUG-2021, the patient had a viral serology Coronavirus SARS-Cov-2 dried blood spot test. The result was negative (5.71 RU/ml) (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). This report was associated with product quality complaint:90000191526.; Sender''s Comments: V0: 20210860721 -Covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1662865 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210857481

Write-up: SARS-CoV-2 infection; Vaccination failure; This spontaneous report received from a physician via Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042348) was received on 27-AUG-2021 and concerned a 28 year old male of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD985, expiry: unknown) dose was not reported, 1 total administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition).


VAERS ID: 1663147 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210844351

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician by a Regulatory Authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-39043) was received on 20-AUG-2021 and concerned a 21 years old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 and expiry: unknown) dose was not reported, frequency time 1 total administered on 16-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient developed Sars-cov-2 infection (vaccination failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and Sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190556.; Sender''s Comments: V0: 20210844351-Covid-19 vaccine ad26.cov2.s-Vaccination 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 20210844351-Covid-19 vaccine ad26.cov2.S- SARS-CoV-2 infection. 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: 1663621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: IBUPROFENO ALTER
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19 PCR test; Result Unstructured Data: Negative
CDC Split Type: ESJNJFOC20210853430

Write-up: Facial droop; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, ES-AEMPS-971409) concerned a 45 year old female. The patient''s weight was 74 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: 21C14-04) 0.5 ml, 1 total, administered on 24-JUN-2021 for covid-19 vaccination on left arm. Duration of drug administration was 1 day. The drug start period and last period was 39 Days. Concomitant medications included ibuprofen pain menstrual and drug start period was 5 days. On 13-JUL-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) Negative. On 01-AUG-2021, the patient experienced facial droop. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from facial droop. This report was serious (Other Medically Important Condition).


VAERS ID: 1664075 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Lymph node pain, Lymphadenopathy, Off label use, Product use issue
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DICLOFENAC; FOLIC ACID
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Endometriosis; Miscarriage; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101034104

Write-up: Miscarriage; Swollen lymph nodes; Painful lymph nodes in armpit; maternal exposure during breast feeding; maternal exposure during breast feeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number {GB-MHRA-WEBCOVID-202108102158130710-JPS7V}, Safety Report Unique Identifier {GB-MHRA-ADR 25782441}. This is the first of three reports. This consumer reported information for both mother and baby. This is the maternal report. Only this case is serious. A 33-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 08Aug2021 (Lot number unknown), dose 2, single for COVID-19 immunisation. Medical history included endometriosis, pregnancy, however patient is no longer pregnant at the time of reporting, breast feeding which is continuing and miscarriage. It was unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. Concomitant medications included diclofenac from an unknown date for endometriosis, folic acid from an unknown date for folic acid supplementation and vitamins (unspecified). The patient previously took dose 1 of BNT162B2 (Lot number was not reported) for COVID-19 immunisation and experienced maternal exposure during pregnancy. The patient did not undergo COVID-19 test. Since the vaccination, the patient had not been tested positive for COVID-19. On 09Aug2021, the patient experienced swollen lymph nodes and painful lymph nodes in armpit. On 11Aug2021, the patient experienced miscarriage. The patient was 3 weeks and 6 days pregnant at the time of vaccination. Pregnancy ended at 4 weeks and 2 days. The events were assessed as serious and medically significant. It was also reported that in Aug2021, the patient experienced maternal exposure during breast feeding. The clinical outcome of the events swollen lymph nodes and painful lymph nodes in armpit were not recovered, miscarriage was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101097903 baby case;GB-PFIZER INC-202101097904 same patient, different dose/event


VAERS ID: 1664583 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Blood test, Lip oedema, Palmar erythema, Rash, Rash erythematous, Rash pruritic, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210811; Test Name: Blood test; Result Unstructured Data: Test Result: within the limits
CDC Split Type: ITPFIZER INC202101056344

Write-up: From 11Aug the appearance of lower left lip edema and erythema of the palm of the hands bilaterally. From 11Aug the appearance of lower left lip edema and erythema of the palm of the hands bilaterally. Appearance of itchy erythematous rash in the lower limbs; Appearance of itchy erythematous rash in the lower limbs. From 11Aug the appearance of lower left lip edema and erythema of the palm of the hands bilaterally. Appearance of itchy erythematous rash in the lower limbs; hives and angioedema (lower lip); hives and angioedema (lower lip); This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) EudraVigilance-WEB. The regulatory authority report number is IT-MINISAL02-770057. A 17-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in arm left (reported as left shoulder) on 09Aug2021 11:49 (Batch/Lot Number: FG4493; Expiration Date: 30Nov2021) as dose 2, single at the age of 17-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced appearance of itchy erythematous rash in the lower limbs on 09Aug2021, from 11Aug2021 the appearance of lower left lip edema and erythema of the palm of the hands bilaterally. Onset of hives and angioedema (lower lip) following 2nd dose of bnt162b2 carried out on 09Aug2021 (Aug2021). The patient underwent lab tests and procedures which included blood tests within the limits on 11Aug2021. Therapeutic measures were taken as a result of events. The event outcome was not recovered. Seriousness reported as hospitalization.; Reporter''s Comments: Onset of hives and angioedema (lower lip) following 2nd dose of anti-Covid19 vaccination (Pfizer) carried out on 09Aug2021.


VAERS ID: 1664700 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blindness transient, Blood pressure decreased, Blood pressure measurement, Heart rate, Nausea, Oxygen saturation, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:95/57 mmHg; Test Date: 20210801; Test Name: Pulse rate; Result Unstructured Data: Test Result:65; Test Date: 20210801; Test Name: Oxygen saturation; Test Result: 96 %; Test Date: 20210801; Test Name: Respiratory rate; Result Unstructured Data: Test Result:16; Comments: /min
CDC Split Type: JPPFIZER INC202101065977

Write-up: Blindness transient; Blood pressure decreased/BP 95/57 mmHg; Queasy; This is a spontaneous report from a contactable healthcare professional received from the Devices Agency (DA). Regulatory authority report number is v21123635. An 18-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 01Aug2021 at 11:10 (Lot Number: FA5829; Expiration Date: 31Aug2021) as dose 1, single (at the age of 18 years old) for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Aug2021 at 11:15 (5 minutes after the vaccination), the patient experienced events. The course of the event was as follows: Queasy and blindness transient occurred. Respiratory rate 16/min, respiratory with chest and abdominal. Blood pressure (BP) 95/57 mmHg, oxygen saturation (SPO2) 96%, pulse rate (P) 65. At 11:15, supine position in bed steadily, at 11:30 symptoms recovering. On 01Aug2021 (the day of vaccination), the outcome of the events was recovered. The reporting Other Health Professional classified the event as non-serious and assessed that the causality between the event and BNT162B2 as unassessable.


VAERS ID: 1664762 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0843 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperthermia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210815; Test Name: body temperature; Result Unstructured Data: Test Result: 36.2 degrees Centigrade; Comments: before vaccination; Test Date: 20210815; Test Name: body temperature; Result Unstructured Data: Test Result: increased to 41 degrees Centigrade; Comments: after vaccination
CDC Split Type: JPPFIZER INC202101072188

Write-up: Pyrexia/ body temperature increased to 41 degrees Centigrade; hyperthermia; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). The regulatory authority report number is v21123725. A 17-years and 5-month-old male patient received the second dose of BNT162B2 (COMIRNATY Solution for injection, Lot number FF0843, Expiration date 31Oct2021), via an unspecified route of administration on 15Aug2021 at 10:30 (the day of vaccination, at the age of 17-years and 5-months-old) at dose 2, single for COVID-19 immunization. The patient''s family history was unknown. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s medical history and concomitant medications were reported as none. The patient''s body temperature before vaccination on 15Aug2021 was 36.2 degrees Centigrade. On 15Aug2021 (the day of vaccination), the patient experienced pyrexia. On 17Aug2021 (2 days after the vaccination), outcome of the event was not recovered. The course of event was as follows: On 15Aug2021, the patient received vaccination and then experienced pyrexia with body temperature increased to 41 degrees Centigrade (after vaccination) and took LOXONIN (60) orally. The reporting physician classified the event as non-serious and assessed that the event was related to BNT162B2. There were no other possible causes of the event such as any other diseases. The reporting physician commented as follows: The physician reported pyrexia as an adverse reaction, especially hyperthermia on Aug2021. Outcome of the event pyrexia was not recovered and for the event hyperthermia was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1665815 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210902171

Write-up: SARS-COV-2 INFECTION; VACCINATION FAILURE; This spontaneous report received from a physician via Regulatory authority (EVHUMAN Vaccines, AT-BASGAGES-2021-042601) on 31-AUG-2021 concerned a 44 year old female. 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: 21C10-03 expiry: UNKNOWN) dose was not reported, 1 total administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced sars-cov-2 infection and vaccination failure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sars-cov-2 infection and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.


VAERS ID: 1667038 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG3716 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Expired product administered, Facial paresis, Glaucoma, Nervous system disorder, Peripheral nerve paresis
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Glaucoma (narrow), Medication errors (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC202101094703

Write-up: Peripheral facial paresis; Neurological problem; Peripheral facial paresis; Administration of an expired vaccine; peripheral glaucoma; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105445. A 17-year-old female patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Aug2021, at 17-year-old, as single dose (Lot Number: FG3716) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unknown date, as single dose(Lot number was not reported) for COVID-19 immunisation. On 18Aug2021, the patient had administration of an expired vaccine. On 19Aug2021, the patient experienced peripheral facial paresis and neurological problem. On Aug2021, the patient had peripheral glaucoma. Therapeutic measures were taken as a result of peripheral facial paresis, neurological problem and peripheral glaucoma which included eye drops (molecules not specified). The outcome of peripheral facial paresis, neurological problem, peripheral glaucoma was recovering. Reporter comment: Treatment: Yes, eye drops provided. Evolution of the ADR: Recovering. Situations: Administration of an expired vaccine. ADR description: peripheral glaucoma. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: Treatment: Yes, eye drops provided. Evolution of the ADR: Recovering. Situations: Administration of an expired vaccine. ADR description: peripheral glaucoma.


VAERS ID: 1674301 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fatigue, Mass, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

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

Write-up: - swelling/fluid feeling in feet when laying down - headaches - sudden mass in vagina area of labia doubled in size over 22 hours came on suddenly -fatigued All symptoms started after day 3 currently at day 5


VAERS ID: 1680001 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Crying, Mood swings
SMQs:, Dementia (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Autistic behavior; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101101924

Write-up: Mood swings; crying; anxiety; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-202108231040246820-VBNQD. Safety Report Unique Identifier GB-MHRA-ADR 25835378. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 22Aug2021 (at the age of 16 years old) (Lot Number: 3380) as single dose for COVID-19 immunisation. Medical history included anxiety, Lactation decreased, Autism spectrum disorder. Patient has 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 previously took fluoxetine 20mg for Autistic/ meltdowns. Additional information: Autistic, used to have severe meltdowns, but put on Fluoxetine 20mg which resolved the issue, had been emotionally very good since then, and improving all the time. The patient experienced anxiety (medically significant) in Aug2021, mood swings (medically significant) on 22Aug2021, crying (medically significant) in Aug2021. It was reported that: Pt on fluoxetine, which had prevented this in the past, but a few hours after the vaccine was given, started to experience serious mood swings from anxiety to sadness to happiness. Would be crying one second then laughing the next. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1680017 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMOXICILLIN; CHLORPHENAMINE; CYCLIZINE; SODIUM CROMOGLICATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101111753

Write-up: facial numbness; facial swelling; This is a spontaneous report from a contactable physician received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-TPP5251969C4207054YC1629216380245 and Safety Report Unique Identifier GB-MHRA-ADR 25848799. A 17-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration on 17Aug2021 as dose number unknown, single (at the age of 17 years), for COVID-19 immunization. There was no medical history (relevant medical history and concurrent conditions: nil). Concomitant medications included amoxicillin (take one 3 times/day) from 04Jun2021 to 09Jun2021; chlorphenamine (take one tablet every 4-6 hrs. when required) from 17Aug2021 to an unspecified stop date; cyclizine (take one up to three times a day as required) from 16Jul2021 to 13Aug2021 and sodium cromoglicate (one drop 4 times/day), from 16Jun2021 to 14Jul2021, all taken for ill-defined disorder. It was stated that, on 17Aug2021, the patient experienced facial numbness and on an unknown date in Aug2021, experienced facial swelling. There was a bilateral lower facial swelling and numbness after Pfizer vaccine. The events were reported as serious with seriousness criteria as other medically important condition. The outcome for the events was unknown, at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: bilateral lower facial swelling and numbness after pfizer vaccine.


VAERS ID: 1680320 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Full blood count, Lymph node abscess, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: full blood count; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC202101101526

Write-up: Maternal exposure during pregnancy/Patient was exposed to the medicine Third-trimester (29-40 weeks); Lymph node abscess; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108230935596550-NQZEB and Safety Report Unique Identifier GB-MHRA-ADR 25835041. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single and via an unspecified route of administration on 24Jul2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included folic acid taken for folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on an unspecified date and lymph node abscess on 01Aug2021. The events were reported as non-serious. Patient was exposed to the medicine Third-trimester (29-40 weeks). Patient has not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test and full blood count: unknown results. The outcome of maternal exposure during pregnancy was unknown while not recovered for the lymph node abscess. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687982 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Bradycardia, Heart rate, Hypotension, Nausea, Presyncope, Vaccination site irritation, Vaccination site pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Medical History/Concurrent Conditions: Vasovagal symptoms
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: Blood pressure; Result Unstructured Data: Test Result:94/61 mmHg; Comments: Hypotension; Test Date: 20210801; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210801; Test Name: Heart rate; Result Unstructured Data: Test Result:49; Comments: /min Bradycardia
CDC Split Type: JPPFIZER INC202100986968

Write-up: Vasovagal reflex caused by painful irritation associated with injection; Vasovagal reflex caused by painful irritation associated with injection; Bradycardia 49/min; vasovagal reflex; hypotension 94/61 mmHg; Queasy; This is a spontaneous report from a contactable physician received through the regulatory authority: Regulatory authority report number is v21122064. A 15-year-old adolescent female received the first dose of intramuscular BNT162B2 (COMIRNATY, solution for injection; Lot FD0348 expiry 31Oct2021) as a single dose on 01Aug2021 at 18:41 (at 15-years-old; the day of vaccination) for COVID-19 immunisation. Relevant medical history (according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included vasovagal reflex. There were no concomitant medications reported. Body temperature on 01Aug2021 before vaccination was 36.8 degrees Centigrade. On 01Aug2021 at 18:45 (four minutes after the vaccination), the patient experienced vasovagal reflex. The reporter described the clinical course as follows: Bradycardia 49/min, hypotension 94/61 mmHg. Queasy. The reporter commented: Vasovagal reflex caused by painful irritation associated with injection. The outcome of the events bradycardia 49/min, vasovagal reflex, hypotension 94/61 mmHg, and queasy was recovered on 01Aug2021 (the day of the vaccination). The outcome of the events painful irritation associated with injection was unknown. The reporting physician assessed the events Bradycardia, Vasovagal symptoms, Hypotension, and Queasy were unrelated to BNT162B2. Other possible cause(s) of the event such as any other diseases was vasovagal reflex.; Sender''s Comments: There is no reasonable possibility that the events vasovagal reflex, bradycardia, and hypotension were related to COMIRNATY use. These are more likely associated with the past medical history of vasovagal reflex that was triggered by the vaccine administration process. 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: 1688585 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-11
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4442 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Insomnia, Mobility decreased, Pain, Vaccination site pain
SMQs:, Parkinson-like events (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101108078

Write-up: Pain in the shoulder and arm (in the vaccination arm); Limited mobility in the arm and shoulder (in the vaccination arm); very difficulty sleeping; The pain also radiated behind the shoulder and the upper part of the shoulder blade; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the . The regulatory authority report number is [SE-MPA-2021-076272]. A 16-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FG4442, Expiry Date: not reported), via an unspecified route of administration on 11Aug2021 (at the age of 16 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pain in the shoulder and arm (in the vaccination arm) and limited mobility in her arm and shoulder (in the arm of the vaccination) on 11Aug2021. The patient described that she had severe pain in her arm to the forearm immediately after the injection of the first dose of vaccine. Increased pain four to five days with very difficulty sleeping and limited mobility in her arm and shoulder. The pain also radiated behind the shoulder and the upper part of the shoulder blade. The events "limited mobility in the arm and shoulder (in the vaccination arm)'' and "pain in the shoulder and arm (in the vaccination arm)" was assessed as a serious, permanent physical impairment. The outcome of events was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1688658 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2595 / 2 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Neck pain
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Zithromax leviquin biaxin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe muscle pain in neck and headache for 2 weeks since second injection. Husband has same reaction.


VAERS ID: 1689609 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 291258A / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia
SMQs:, Arthritis (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: sinuvul, pregabalin, bupropion
Current Illness: uterine fibroids
Preexisting Conditions: uterine fibroids
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: constant astralgia and very strong on shoulders, knees, getting treatment with naproxen to reduce pain, does not eliminate all.


VAERS ID: 1689913 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210915341

Write-up: JOINT ACHE; MYALGIA; HEAD PAIN; EAR ACHE; INFLUENZA LIKE ILLNESS; LIGHT HEADEDNESS; PYREXIA; CHILLS; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021154906) on 08-SEP-2021 concerned a 53 year old female of unspecified race and ethnic origin. The patient''s weight was 95 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: unknown and expiry: unknown) dose was not reported, 1 total administered on 01-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 01-AUG-2021, the patient experienced joint ache, myalgia, had head pain, ear ache, influenza like illness, light headedness, pyrexia, chills and was hospitalized (on date unspecified) for unspecified days. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from joint ache, myalgia, head pain, ear ache, influenza like illness, light headedness, pyrexia, and chills. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1697449 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 2915BA / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Discouragement, Dyspnoea, Ear discomfort, Hypersensitivity, Investigation, Laryngopharyngitis, Pain, Pharyngotonsillitis, Pruritus, Pyrexia, Rash, Suspected COVID-19, Urticaria
SMQs:, Anaphylactic reaction (narrow), Agranulocytosis (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer (Paternal grandparents); Food allergy; Hypothyroidism (mother); Migraine (father); Thalassemia (mother); Thalassemia
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: Body temperature; Result Unstructured Data: Test Result:fever; Test Date: 202108; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: fever; Test Date: 20210823; Test Name: Body temperature; Result Unstructured Data: Test Result:39 Centigrade; Comments: fever/ fever of 39 degrees at 1 am; Test Date: 20210829; Test Name: pharyngotonsillitis Streptoa test; Test Result: Positive ; Comments: pharyngotonsillitis Streptoa test Positive (+); Test Date: 20210828; Test Name: test; Result Unstructured Data: Test Result:acute pharyngolaryngitis
CDC Split Type: COPFIZER INC202101089605

Write-up: pharyngotonsillitis Streptoa test Positive (+); acute pharyngolaryngitis; started to affect the ear; V072 suspected SARS COV-2 infection; rash all over the body slight at first and then large/big rash all over the body; general pain; weakness/ loss of motor forces; discouragement; L500 Allergic urticaria; severe allergy; shortness of breath; fever of 37.9/fever/fever of 39 degrees; very itchy; This is a spontaneous report from a contactable consumer (reporting for herself as patient) and a contactable consumer (patient''s mother), from the portal. A 16-year-old female patient (not pregnant) received bnt162b2, dose 1 via intramuscular, administered in left arm on 22Aug2021 19:00 (Lot Number: 2915ba) as single dose, at the age of 16-year-old for COVID-19 immunisation. Medical history included thalassemia from 02Feb2020, allergy to apple cider vinegar. Family history included cancer (Paternal grandparents), severe migraines (father), hypothyroid (mother), "thalassemic" (mother). Concomitant medications were not reported. The patient did not receive any vaccine four weeks prior to vaccination. The patient experienced pharyngotonsillitis streptoa test positive (+) on 29Aug2021 with outcome of unknown, severe allergy on 22Aug2021 with outcome of unknown, shortness of breath on 22Aug2021 with outcome of unknown, fever of 37.9/fever/fever of 39 degrees from 22Aug2021 with outcome of recovering , rash all over the body slight at first and then large/big rash all over the body on 23Aug2021 01:00 with outcome of recovering, L500 allergic urticaria on 23Aug2021 with outcome of unknown, very itchy in Aug2021 with outcome of not recovered, general pain on 23Aug2021 01:00 with outcome of recovering, weakness/ loss of motor forces on 23Aug2021 01:00 with outcome of recovering, discouragement on 23Aug2021 01:00 with outcome of recovering , V072 suspected SARS cov-2 infection on 26Aug2021 with outcome of unknown, acute pharyngolaryngitis on 28Aug2021 with outcome of recovering, started to affect the ear on 28Aug2021 with outcome of recovering. Clinical course: The reporter informed that the patient received attention twice in a clinic, and also informed that the patient received the vaccine on 22Aug2021 and the reaction started at 1 am on 23Aug2021 with symptoms of fever, big rash all over the body, general pain, weakness, discouragement, loss of motor forces, was with fever of 39 degrees, without improvement until 28Aug2021 when a test was performed to the patient and the result was acute pharyngolaryngitis because it started to affect the ear, patient was prescribed antibiotic and until 31Aug2021 the signs started to normalize. The reporter informed that the patient received adrenalin intramuscular from 22Aug2021 to 23Aug2021 due to severe allergy, shortness of breath and fever, hydroxyzine intramuscular from 22Aug2021 to 23Aug2021 due to severe allergy, shortness of breath and fever, dipyrone intramuscular from 22Aug2021 to 23Aug2021 due to severe allergy, shortness of breath and fever, amoxicillin from 29Aug2021 and ongoing due to pharyngolaryngitis. The reporter also attached medical records of the patient: 23Aug2021: Diagnosis: L500 Allergic urticaria, medical leave from 23Aug2021 to 25Aug2021; 26Aug2021: medical leave from 26Aug2021 to 28Aug2021, number of days: 3 days, diagnosis: V072 suspected SARS COV-2 infection; 29Aug2021: Diagnosis: Y590 Adverse effects of viral vaccines, medical leave: from 29Aug2021 to 02Sep2021, Clinical data: pharyngotonsillitis Streptoa test Positive (+). The reporter wanted to know if it was convenient that the patient receives the second dose, and if it was safe. Second dose scheduled on 19Nov2021. The patient underwent lab tests and procedures which included body temperature: fever on 22Aug2021, body temperature: 37.9 centigrade (fever) in Aug2021, body temperature: fever/ fever of 39 degrees on 23Aug2021 at 1 am, pharyngotonsillitis Streptoa test: pharyngotonsillitis Streptoa test Positive (+) on 29Aug2021, test on 28Aug2021: acute pharyngolaryngitis. Treatment received for the events (pharyngotonsillitis streptoa test positive (+), severe allergy, shortness of breath, fever, rash, allergic urticaria, very itchy, Suspected SARS cov-2 infection, acute pharyngolaryngitis, started to affect the ear). Follow-up (31Aug2021): New information was received from a contactable consumer (patient''s mother) included: reporter information, route of administration, medical history, additional events, lab test and clinical course, case upgrade to serious.


VAERS ID: 1697828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210918049

Write-up: HEADACHE; TACHYCARDIA; MALAISE; This spontaneous report received from a consumer via a Regulatory Authority (EVHUMAN Vaccines, DE-PEI-CADR2021155190) on 08-SEP-2021 concerned a 32 year old male. The patient''s weight was 65 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, route of admin not reported, batch number: 21C18-01 expiry UNKNOWN) dose was not reported, 1 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, the patient experienced tachycardia, malaise. On 02-AUG-2021, the patient experienced headache. On an unspecified date, patient was hospitalized (days not reported) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tachycardia, malaise, and headache. This report was serious (Hospitalization Caused / Prolonged).


VAERS ID: 1698035 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-02
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Anxiety, Basophil count, Chest pain, Dizziness, Dyspnoea, Electrocardiogram, Eosinophil count, Eructation, Fibrin D dimer, Haematocrit, Haemoglobin, Headache, Incorrect route of product administration, International normalised ratio, Mean cell volume, Monocyte count, Platelet count, Prothrombin level, Respiratory distress, SARS-CoV-2 test, Sensation of foreign body, Sleep disorder, Tachycardia, Vomiting, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210807; Test Name: CT angiography; Result Unstructured Data: Test Result:Without modifications; Test Date: 20210809; Test Name: Basophils; Test Result: 0.20 %; Test Date: 20210811; Test Name: ECG; Result Unstructured Data: Test Result:110 bpm; Comments: Sinus tachycardia. No delta wave; Test Date: 20210809; Test Name: Eosinophils; Test Result: 1.20 %; Test Date: 20210806; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:977 ng/ml; Comments: normal pulmonary ANGIOTC; Test Date: 20210809; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:926 ng/ml; Test Date: 20210809; Test Name: Hto; Test Result: 38.80 %; Test Date: 20210809; Test Name: Hb; Result Unstructured Data: Test Result:12.90 g/dl; Test Date: 20210809; Test Name: INR; Result Unstructured Data: Test Result:1.35; Test Date: 20210809; Test Name: MCV; Result Unstructured Data: Test Result:84.10; Comments: fL; Test Date: 20210809; Test Name: Monocytes; Result Unstructured Data: Test Result:0.80 X10^3 uL; Test Date: 20210809; Test Name: Platelet count; Result Unstructured Data: Test Result:147.00 x10^3 uL; Test Date: 20210811; Test Name: Platelet count; Result Unstructured Data: Test Result:211.00 x10^3 uL; Test Date: 20210809; Test Name: Prothrombin activity; Test Result: 74 %; Test Date: 20210806; Test Name: Covid PCR; Test Result: Negative ; Test Date: 20210809; Test Name: Leukocytes; Result Unstructured Data: Test Result:8.10 x10^3 uL; Comments: N: 71.50 %, L: 17.30 %
CDC Split Type: ESPFIZER INC202101125404

Write-up: Chest aching; Dizzy spells; Anxiety attack; Head pain; Vomited/several episodes of vomiting; Pharyngolarynx foreign body feeling; Distress respiratory; Tachycardia; received BNT162B2 (COMIRNATY), subcutaneously; feeling of shortness of breath; difficulty falling asleep and sleeps during the day; eructs of night predominance; This is a spontaneous report from a contactable consumer reporting for a family member downloaded from the regulatory authority-WEB, regulatory authority number ES-AEMPS-971167. A 15-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: FF2752), subcutaneously on 02Aug2021 (at the age of 15-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dizzy spells, anxiety attack, distress respiratory, head pain, vomited, chest aching, pharyngolarynx foreign body feeling on 05Aug2021, tachycardia and feeling of shortness of breath on 02Aug2021, difficulty falling asleep and sleeps during the day and eructs of night predominance on an unspecified date in Aug2021. The events distress respiratory, tachycardia and chest aching were assessed as medically significant. The details of the events were reported as follows: A 15-year-old female reported a feeling of shortness of breath that made it difficult to breathe and was accompanied by tachycardica. Apparently the clinical symptoms started 02Aug2021 after the first dose of COVID 19 vaccine. She had presented several episodes of vomiting without pathological products. No fever, no diarrhea, assessed on 06Aug21 with negative Covid PCR and normal pulmonary ANGIOTC after dimer D 977 was evidenced. The patient reported a foreign body sensation in the oropharynx that conditioned the need to burp without achieving it. On 09Aug2021, she went to the emergency room since for a few days she had presented an episode of ''''feeling of shortness of breath'''', mechanical chest pain and eructs of night predominance (during the day it is fine). During the night she had difficulty falling asleep and sleeps during the day. The patient was still at doctors. The patient underwent lab tests and procedures which included angiogram: without modifications on 07Aug2021; Blood count: Hb: 12.90 g/dL, Hematocrit: 38.80 %, MCV: 84.10 fL, Platelets: 147.00 x10^3/uL, Leukocytes: 8.10 x10^3 /uL, (N: 71.50 %, L: 17.30 %), Eosinophils: 1.20 %, Basophils: 0.20 %, Monocytes: 0.80 X10^3/uL, Coagulation: Prothrombin activity: 74 %, INR: 1.35, DIMER D: 926.00 ng/mL, all on 09Aug2021 and platelets: 211.00 x10^3/uL, ECG: Sinus tachycardia at 110 bpm. PR 0,20. Q III, T III. No delta wave on 11Aug2021. Therapeutic measures were taken as a result of dizzy spells, anxiety attack, head pain, vomited, chest aching included paracetamol, diacepan and primperan. The patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: FG4592), via an unspecified route of administration on 23Aug2021 at single dose for COVID-19 immunisation. The outcome of the events "difficulty falling asleep and sleeps during the day" and "eructs of night predominance" was unknown, of the other events was recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1698081 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-13
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE472 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Alanine aminotransferase increased, Anti-thyroid antibody, Aspartate aminotransferase, Auscultation, Basophil count, Blood alkaline phosphatase, Blood bilirubin, Blood chloride, Blood cholesterol, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood creatinine, Blood fibrinogen, Blood fibrinogen increased, Blood glucose, Blood potassium, Blood pressure increased, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood triglycerides, Blood urea, Blood uric acid, C-reactive protein, C-reactive protein increased, Cardiac monitoring, Chest X-ray, Chest pain, Cytology, Cytomegalovirus test, Decubitus ulcer, Dyspnoea, Echocardiogram, Electrocardiogram, Eosinophil count, Gamma-glutamyltransferase, Glomerular filtration rate, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Heart rate, Herpes simplex test, High density lipoprotein, Human herpes virus 6 serology, Hypothyroidism, International normalised ratio, Investigation, Low density lipoprotein, Lymphocyte count, Magnetic resonance imaging heart, Mean cell haemoglobin, Mean cell volume, Mean platelet volume, Measles antibody, Mononucleosis heterophile test, Mumps antibody test, Mycoplasma test, Myocarditis, Neutrophil count, Neutrophil/lymphocyte ratio, Non-high-density lipoprotein cholesterol, Oxygen saturation, Parvovirus B19 test, Physical examination, Platelet count, Protein total, Prothrombin time, Pyrexia, Red blood cell count, Rubella antibody test, SARS-CoV-2 test, Thyroglobulin, Thyroxine, Toxoplasma serology, Troponin I, Troponin I increased, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypothyroidism (narrow), Hyperthyroidism (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210818; Test Name: aPTT; Result Unstructured Data: Test Result:27.8; Comments: s / ratio 1.03; Test Date: 20210819; Test Name: aPTT; Result Unstructured Data: Test Result:27.9; Comments: s /ratio 1.04; Test Date: 20210817; Test Name: ALAT/Glutamic pyruvic transaminase; Result Unstructured Data: Test Result:117 IU/l; Test Date: 20210818; Test Name: ALAT/Glutamic pyruvic transaminase; Result Unstructured Data: Test Result:102 IU/l; Test Date: 20210818; Test Name: Antiperoxidase antibodies; Result Unstructured Data: Test Result:1300 IU/ml; Test Date: 20210819; Test Name: Antiperoxidase antibodies; Result Unstructured Data: Test Result:1300 IU/ml; Test Date: 20210819; Test Name: Antithyroglobulin antibodies II; Result Unstructured Data: Test Result:2.1 IU/ml; Test Date: 20210818; Test Name: ASAT; Result Unstructured Data: Test Result:67 IU/l; Test Date: 202108; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:Murmur vesicular conserved: without overadded nois; Comments: Murmur vesicular conserved: without overadded noises; Test Date: 20210818; Test Name: Basophiles; Result Unstructured Data: Test Result:60; Test Date: 20210819; Test Name: Basophiles; Result Unstructured Data: Test Result:40; Test Date: 20210818; Test Name: ALP; Result Unstructured Data: Test Result:107 IU/l; Test Date: 20210818; Test Name: Total bilirubin; Test Result: 0.41 mg/dl; Test Date: 20210818; Test Name: Cl; Result Unstructured Data: Test Result:106 mmol/L; Test Date: 20210819; Test Name: Cl; Result Unstructured Data: Test Result:109 mmol/L; Test Date: 20210820; Test Name: Cl; Result Unstructured Data: Test Result:111 mmol/L; Test Date: 20210818; Test Name: Cholesterol total; Test Result: 170 mg/dl; Test Date: 20210817; Test Name: CPK; Result Unstructured Data: Test Result:624 IU/l; Test Date: 20210818; Test Name: CPK; Result Unstructured Data: Test Result:348 IU/l; Test Date: 20210817; Test Name: Serum creatinine; Test Result: 0.72 mg/dl; Test Date: 20210818; Test Name: Serum creatinine; Test Result: 0.75 mg/dl; Test Date: 20210819; Test Name: Serum creatinine; Test Result: 0.79 mg/dl; Test Date: 20210820; Test Name: Serum creatinine; Result Unstructured Data: Test Result:Unknown results mg/dl; Test Date: 20210817; Test Name: Fibrinogen; Test Result: 638 mg/dl; Test Date: 20210818; Test Name: Fibrinogen; Test Result: 545 mg/dl; Test Date: 20210819; Test Name: Fibrinogen; Test Result: 543 mg/dl; Test Date: 20210818; Test Name: Glycemia; Test Result: 79 mg/dl; Test Date: 20210819; Test Name: Glycemia; Test Result: 76 mg/dl; Test Date: 20210820; Test Name: Glycemia; Test Result: 115 mg/dl; Test Date: 20210817; Test Name: Serum potassium; Result Unstructured Data: Test Result:Unknown results mmol/L; Test Date: 20210818; Test Name: Serum potassium; Result Unstructured Data: Test Result:4.4 mmol/L; Test Date: 20210819; Test Name: Serum potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Date: 20210820; Test Name: Serum potassium; Result Unstructured Data: Test Result:Unknown results mmol/L; Test Date: 202108; Test Name: Blood pressure; Result Unstructured Data: Test Result:134/85 mmHg; Comments: upon entry; Test Date: 20210817; Test Name: Serum sodium; Result Unstructured Data: Test Result:138 mmol/L; Test Date: 20210818; Test Name: Serum sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210819; Test Name: Serum sodium; Result Unstructured Data: Test Result:137 mmol/L; Test Date: 20210820; Test Name: Serum sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210818; Test Name: TSH; Result Unstructured Data: Test Result:14.53 MiU/L; Test Date: 20210818; Test Name: TG; Test Result: 85 mg/dl; Test Date: 20210819; Test Name: Urea; Test Result: 35 mg/dl; Test Date: 20210820; Test Name: Urea; Test Result: 30 mg/dl; Test Date: 20210818; Test Name: Urate; Test Result: 6.3 mg/dl; Test Date: 202108; Test Name: Cardiac auscultation; Result Unstructured Data: Test Result:rhythmic, no murmurs; Test Date: 202108; Test Name: Chest X-Ray; Result Unstructured Data: Test Result:Cardiothoracic index (ICT) within normal, pulmona; Comments: Cardiothoracic index (ICT) within normal, pulmonary parenchyma without significant alterations.; Test Date: 20210817; Test Name: C-reactive protein; Result Unstructured Data: Test Result:41.5 mg/l; Test Date: 20210818; Test Name: C-reactive protein; Result Unstructured Data: Test Result:22 mg/l; Test Date: 20210819; Test Name: C-reactive protein; Result Unstructured Data: Test Result:11.7 mg/l; Test Date: 20210820; Test Name: C-reactive protein; Result Unstructured Data: Test Result:5.9 mg/l; Test Date: 20210818; Test Name: Large unstained cells; Result Unstructured Data: Test Result:320; Test Date: 20210819; Test Name: Large unstained cells; Result Unstructured Data: Test Result:220; Test Date: 20210819; Test Name: CYTOMEGALOVIRUS; Test Result: Negative ; Comments: ANALYSIS: CYTOMEGALOVIRUS (CMV) DEFINITIVE RESULT: RESULT DATE: 19Aug2021 CMV IgG (EIA) NEGATIVE; Test Date: 202108; Test Name: Regulated transthoracic echocardiogram; Result Unstructured Data: Test Result:Echocardiogram performed in sinus rhythm with an a; Comments: Echocardiogram performed in sinus rhythm with an average heart rate of 70 bpm. Limited by subtopic acoustic window. Left ventricle not dilated or hypertrophic with normal global systolic function. No clear alterations of segmental contraction. Right ventricle of normal size and function. Both atria are normal in size. Mild tricuspid insufficiency that does not allow estimating systolic pressure of the pulmonary artery. No indirect signs of pulmonary hypertension. No pericardial effusion. Undilated inferior vena cava with normal respirophasic variations. Aorta displayed of normal size.; Test Date: 202108; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:at discharge: sinus rhythm at 73 bpm, normal PR, n; Comments: at discharge: sinus rhythm at 73 bpm, normal PR, narrow QRS, normal axis, negative T in III and flattened in aVF and lateral face.; Test Date: 202108; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:on admission: Sinus rhythm at 90 bpm, normal PR, n; Comments: on admission: Sinus rhythm at 90 bpm, normal PR, narrow QRS with normal axis, diffuse concave elevation of the ST segment without other significant alterations of repolarization.; Test Date: 20210818; Test Name: Eosinophils; Result Unstructured Data: Test Result:200; Test Date: 20210819; Test Name: Eosinophils; Result Unstructured Data: Test Result:240; Test Date: 20210818; Test Name: GGT; Result Unstructured Data: Test Result:50 IU/l; Test Date: 20210817; Test Name: Glomerular filtration (CKD-EPI); Result Unstructured Data: Test Result:90; Comments: mL/min/1.73m2; Test Date: 20210818; Test Name: Glomerular filtration (CKD-EPI); Result Unstructured Data: Test Result:90; Comments: mL/min; Test Date: 20210819; Test Name: Glomerular filtration (CKD-EPI); Result Unstructured Data: Test Result:90; Comments: mL/min; Test Date: 20210818; Test Name: HbA1C; Test Result: 5.6 %; Test Date: 20210818; Test Name: Hematocrit; Test Result: 44.5 %; Test Date: 20210819; Test Name: Hematocrit; Test Result: 44.5 %; Test Date: 20210817; Test Name: Hb; Result Unstructured Data: Test Result:15.9 g/dl; Test Date: 20210818; Test Name: Hb; Result Unstructured Data: Test Result:14.7 g/dl; Test Date: 20210819; Test Name: Hb; Result Unstructured Data: Test Result:14.8 g/dl; Test Date: 202108; Test Name: Heart rate; Result Unstructured Data: Test Result:80; Comments: bpm; Test Date: 20210820; Test Name: HERPES SIMPLEX; Test Result: Negative ; Comments: ANALYSIS: HERPES SIMPLEX (1/2) DEFINITIVE RESULT: RESULT DATE: 20Aug2021 VHS IgG (EIA) NEGATIVE VHS IgM (EIA) NEGATIVE; Test Date: 20210818; Test Name: HDL; Test Result: 48 mg/dl; Test Date: 20210820; Test Name: HERPES-6; Result Unstructured Data: Test Result:Doubtful; Comments: ANALYSIS: HERPES-6 DEFINITIVE RESULT: RESULT DATE: 20Aug2021 HERPES 6 (IFI) DOUBTFUL 1/80; Test Date: 20210817; Test Name: INR; Result Unstructured Data: Test Result:1.00; Test Date: 20210818; Test Name: INR; Result Unstructured Data: Test Result:1; Test Date: 20210819; Test Name: INR; Result Unstructured Data: Test Result:1; Test Date: 20210818; Test Name: Mastocytes; Result Unstructured Data: Test Result:440; Test Date: 20210819; Test Name: Mastocytes; Result Unstructured Data: Test Result:390; Test Date: 20210819; Test Name: R. CONORI; Test Result: Negative ; Comments: R. CONORI (ELISA) NEGATIVE; Test Date: 202108; Test Name: Ventricular function study; Result Unstructured Data: Test Result:(calculated in short axis) Post-processing perform; Comments: (calculated in short axis) Post-processing performed including papillary muscles in the ventricular volume. Normality values taken from Kawel-Boehm. Journal of Cardiovascular Magnetic Resonance (JCMR) 2020; 22(1):87. Left ventricle: Telediastolic volume: 148 ml (71 ml/m2) Telesistolic volume: 52ml (25 ml/m2) Sistolic Volume: 96 ml Cardiac output: 8.3 l/min Ejection fraction (EF %): 68 % Mass: 149 g (72 g/m2) Right ventricle: Telediastolic volume: 164 ml (78 ml/m?) Telesistolic volume: 67 ml (32 ml/m2) Volumen sist?lico: 97 ml Cardiac output: 8.4 l/min Ejection fraction (EF %): 59 % Extracardiac findings: No alterations are observed. Conclusion Left ventricle with normal segmental and global contractility (LVEF: 68%). Right ventricle of normal size and morphology with preserved function. Sub-optimal quality in late enhancement sequences with gadolinium, which shows no significant pathological enhancements.; Test Date: 20210818; Test Name: LDLc; Test Result: 105 mg/dl; Test Date: 20210818; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2550; Test Date: 20210819; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2650; Test Date: 202108; Test Name: Cardiac nuclear magnetic resonance imaging; Result Unstructured Data: Test Result:Study quality: suboptimal by respiratory movements; Comments: Cardiac magnetic resonance imaging is performed in Avanto 1.5T equipment, with "black blood" sequences in the axial plane, CINE in short axis, four chambers, three chambers and long axis, STIR sequences in short axis and 4C and sequences of late enhancement after the administration of Intravenous contrast (iv) (Dotarem 30ml). Study quality: suboptimal by respiratory movements. Finds: Morphological study. The left ventricle is not dilated or hypertrophic. Interventricular septum 10 mm, Telediastolic diameter 49 mm, posterior wall 10 mm, Telesystolic diameter 33 mm. It presents a normal segmental and global contractility (Left ventricular ejection fraction. (LVEF) 68%). The edema sequence shows no data of myocardial inflammation (signal hyperintensity in STIR). After the administration of intravenous contrast, we did not observe pathological late enhancements, although the quality of the images is suboptimal by respiratory artifacts. The right ventricle is of normal size with preserved function (LVEF 59 %). It does not present alterations in its morphology or enhancement after the administration of contrast. Normal-sized atria (left atrium 18 cm2, right atrium 20 cm2, measurements in 4 chambers). Normal-sized aortic root. No valvular insufficiencies or stenosis are observed. No pleural or pericardial effusion is observed, nor is the presence of late enhancement with gadolinium.; Test Date: 20210818; Test Name: MCH; Test Result: 30.1 pg; Test Date: 20210819; Test Name: MCH; Test Result: 30.3 pg; Test Date: 20210818; Test Name: MCV; Result Unstructured Data: Test Result:91.2; Comments: fL; Test Date: 20210819; Test Name: MCV; Result Unstructured Data: Test Result:90.9; Comments: fL; Test Date: 20210818; Test Name: MPV; Result Unstructured Data: Test Result:10; Comments: fL; Test Date: 20210820; Test Name: MEASLES; Test Result: Positive ; Comments: ANALYSIS: MEASLES DEFINITIVE RESULT: RESULT DATE: 20Aug2021 MEASLES IgG (EIA) POSITIVE; Test Date: 20210819; Test Name: INFECTIOUS MONONUCLEOSIS; Result Unstructured Data: Test Result:VCA IgM: NEGATIVE; Comments: ANALYSIS: INFECTIOUS MONONUCLEOSIS DEFINITIVE RESULT: RESULT DATE: 19Aug2021 VCA IgM (CLIA) NEGATIVE EBNA IgG (CLIA) POSITIVE; Test Date: 20210819; Test Name: INFECTIOUS MONONUCLEOSIS; Result Unstructured Data: Test Result:EBNA IgG POSITIVE; Comments: ANALYSIS: INFECTIOUS MONONUCLEOSIS DEFINITIVE RESULT: RESULT DATE: 19Aug2021 VCA IgM (CLIA) NEGATIVE EBNA IgG (CLIA) POSITIVE; Test Date: 20210820; Test Name: MUMPS; Test Result: Positive ; Comments: ANALYSIS: MUMPS DEFINITIVE RESULT: RESULT DATE: 20Aug2021 MUMPS IgG (EIA) POSITIVE; Test Date: 20210820; Test Name: MYCOPLASMA PNEUMONIAE; Result Unstructured Data: Test Result:1.37; Comments: ANALYSIS: MYCOPLASMA PNEUMONIAE. DEFINITIVE RESULT: RESULT DATE: 20Aug2021 M. PNEUMONIAE IgG (Electroimmunoassay (EIA) POSITIVE 1.37 M. PNEUMONIAE IgM (EIA NEGATIVE 0.15; Test Date: 20210820; Test Name: MYCOPLASMA PNEUMONIAE; Result Unstructured Data: Test Result:0.15; Comments: ANALYSIS: MYCOPLASMA PNEUMONIAE. DEFINITIVE RESULT: RESULT DATE: 20Aug2021 M. PNEUMONIAE IgG (Electroimmunoassay (EIA) POSITIVE 1.37 M. PNEUMONIAE IgM (EIA NEGATIVE 0.15; Test Date: 20210818; Test Name: Neutrophiles; Result Unstructured Data: Test Result:2880; Test Date: 20210819; Test Name: Neutrophiles; Result Unstructured Data: Test Result:3460; Test Date: 20210818; Test Name: N/L; Result Unstructured Data: Test Result:1.13; Test Date: 20210819; Test Name: N/L; Result Unstructured Data: Test Result:1.31; Test Date: 20210818; Test Name: non-HDL; Test Result: 122 mg/dl; Test Date: 202108; Test Name: Sat02; Test Result: 98 %; Comments: basal; Test Date: 20210820; Test Name: PARVOVIRUS; Test Result: Negative ; Comments: ANALYSIS: PARVOVIRUS DEFINITIVE RESULT: RESULT DATE: 20Aug2021 PARVOVIRUS IgG (EIA) NEGATIVE PARVOVIRUS IGM (EIA) NEGATIVE; Test Date: 202108; Test Name: Physical examination; Result Unstructured Data: Test Result:Good general condition. Conscious and oriented. Eu; Comments: Good general condition. Conscious and oriented. Eupneic at rest. No Jugular venous ingurgitation. Lower limbs: no edema.; Test Date: 20210817; Test Name: Platelets; Result Unstructured Data: Test Result:177 x10 9/l; Test Date: 20210818; Test Name: Platelets; Result Unstructured Data: Test Result:202 x10 9/l; Test Date: 20210819; Test Name: Platelets; Result Unstructured Data: Test Result:200.000 x10 9/l; Test Date: 20210817; Test Name: Total proteins in serum; Result Unstructured Data: Test Result:8.4 g/dl; Test Date: 20210818; Test Name: Total proteins in serum; Result Unstructured Data: Test Result:7.2 g/dl; Test Date: 20210818; Test Name: PT; Result Unstructured Data: Test Result:10.9; Comments: s / 100%; Test Date: 20210819; Test Name: PT; Result Unstructured Data: Test Result:11; Comments: s / 97%; Test Date: 20210818; Test Name: Erythrocytes; Result Unstructured Data: Test Result:4.880.000; Comments: /uL; Test Date: 20210819; Test Name: Erythrocytes; Result Unstructured Data: Test Result:4.900.000; Comments: /uL; Test Date: 20210819; Test Name: RUBELLA; Test Result: Positive ; Comments: ANALYSIS: RUBELLA DEFINITIVE RESULT: RESULT DATE: 19Aug2021 RUBELLA IgG (EIA) POSITIVE; Test Date: 202108; Test Name: PCR SARS-CoV-2; Test Result: Negative ; Test Date: 20210819; Test Name: PCR SARS-CoV-2; Test Result: Negative ; Test Date: 20210819; Test Name: THYROGLOBULIN; Result Unstructured Data: Test Result:3.96 ng/ml; Test Date: 20210818; Test Name: Free T4; Result Unstructured Data: Test Result:1.08 ng/dL; Test Date: 20210819; Test Name: TOXOPLASMA IgG; Test Result: Negative ; Comments: ANALYSIS: TOXOPLASMOSIS DEFINITIVE RESULT: DATE OF RESULT: 19Aug2021 TOXOPLASMA IgG (EIA) NEGATIVE; Test Date: 20210817; Test Name: Troponin I; Result Unstructured Data: Test Result:7954.9 - 9203.5 ng/L; Test Date: 20210818; Test Name: Troponin I; Result Unstructured Data: Test Result:7485 - 9203 ng/L; Test Date: 20210819; Test Name: Troponin I; Result Unstructured Data: Test Result:13.862.5 ng/L; Test Date: 20210820; Test Name: Troponin I; Result Unstructured Data: Test Result:2507.1 ng/L; Test Date: 20210817; Test Name: Leukocytes; Result Unstructured Data: Test Result:8.91 x10 9/l; Test Date: 20210818; Test Name: Leukocytes; Result Unstructured Data: Test Result:6.450 x10 9/l; Test Date: 20210819; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.000 x10 9/l
CDC Split Type: ESPFIZER INC202101124988

Write-up: Myopericarditis; chest pain/centrothoracic pain, oppressive, radiated to both hemithorax; Subclinical hypothyroidism with positive autoimmunity + possible effect of diseased euthyroid; Fibrinogen; Alanine aminotransferase; TROPONIN I; C-REACTIVE PROTEIN; Blood creatine phosphokinase (CPK) 624 UI/L; a slight sensation of dyspnea; decubitus; Fever; Blood pressure 134/85 mmHg; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB, regulatory authority number ES-AEMPS-983429. A 16-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number FE472), at the age of 16 years old, via intramuscular on 13Aug2021 at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. It was unknown that the patient had COVID-19 history. The patient had no previous diseases of interest. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, lot number FD9309), via intramuscular on 23Jul2021 at single dose for COVID-19 immunisation. The patient with no medical history of interest who went to the emergency room for an episode of centrothoracic pain, oppressive, radiated to both hemithorax, starting at rest and approximately one hour long, not associated with vegetative courtship, yes to a slight sensation of dyspnea. The pain worsened slightly with the decubitus, with no clear changes with the breathing movements. He denied previous episodes of chest pain. He received second dose of BNT162B2 on 13Aug2021. The next day (on 14Aug2021) he developed a fever, and 3 days later (on 16Aug2021) he started with chest pain. He denied clinical heart failure. It did not refer infectious clinic to other levels. Reason for admission was reported as chest pain. On 17Aug2021, the patient experienced myopericarditis. Admitted to the Coronary Unit for acute myopericarditis (probably related to SARS-CoV-2 vaccination) of 3 days of evolution, for monitoring and anti-inflammatory treatment. During hospitalization, hemodynamically stable always, without the need for vasoactive support, without having presented arrhythmic events in telemetry. Progressive correction of repolarization disorders in serial electrocardiograms. Transthoracic echocardiogram and cardiac magnetic resonance imaging are performed, which show preserved biventricular function and absence of segmental alterations of contractility or pathological enhancements. An etiological study of myocarditis with multiple serologies and autoantibodies (ANAs and ANCAs) is complete, pending complete results. As an incidental finding, hypothyroidism with positive anti-thyroid peroxidase antibodies (anti-TPO), pending the remainder of the study, so it is valued by Endocrinology (see interconsultation). He is transferred to a conventional plant, where, given his good clinical evolution, he is discharged from the hospital. The patient underwent lab tests and procedures which included Physical examination: Upon entry: Blood pressure 134/85 mmHg. Heart rate 80 bpm. Oxygen saturation (Sat02) 98% basal. Good general condition. Conscious and oriented. Eupneic at rest. No Jugular venous ingurgitation. Cardiac auscultation: rhythmic, no murmurs. Pulmonary auscultation: Murmur vesicular conserved: without overadded noises. Lower limbs: no edema. Summary of complementary tests: Laboratory: Urgent analytics 17Aug2021: Hemoglobin (Hb) 15.9 g/dL (12.5 - 16.6), Leukocytes 8.91 x10 9/l (4.2 - 11.4), Platelets 177 x10 9/l (160 - 400), International normalised ratio (INR) 1.00 (0.8 - 1.2), Fibrinogen 638 mg/dL (150 - 450), Serum creatinine 0.72 mg/dL (0.5 - 1), Glomerular filtration (CKD-EPI) 90 mL/min/1.73m2 (75 - 999999), Serum sodium 138 mmol/L (136 - 145), Serum potassium Unknown results mmol/L (3.5 - 5.1), Alaninoaminetransferase (ALAT)/Glutamic pyruvic transaminase 117 IU/L (0 - 35), Blood creatine phosphokinase (CPK) 624 UI/L, Troponin I (high-sensitivity assay (hs-TnI)) 7954.9 - 9203.5 ng/L (0 - 53.5), Total proteins in serum 8.4 g/dL (6.4 - 8.3), C-reactive protein (CRP) 41.5 mg/L (0 - 5). Deferred analytics 18Aug2021: Erythrocytes 4.880.000/uL, Hb 14.7 g/dL, Hematocrit (Hto) 44.5%, Mean corpuscular volume (MCV) 91.2 fL, Mean cell haemoglobin (MCH) 30.1 pg, Leukocytes 6.450 x10 9/l, Neutrophiles (N) 2880, Lymphocytes (L) 2550, Mastocytes (M) 440, Eosinophils (E) 200, Basophiles (B) 60, Large unstained cells (LUC) 320, Neutrophil-Lymphocyte Ratio (N/L) 1.13, Platelets 202 x10 9/l, Mean platelet volume (MPV) 10 fL, Prothrombin time (PT) 10.9 s / 100%, INR 1, Fibrinogen 545 mg/dL, Activated partial thromboplastin time (aPTT) 27.8 s / ratio 1.03, Glycemia 79 mg/dL, Glycosylated hemoglobin (HbA1C) 5.6%, Cholesterol total 170 mg/dL, High density lipoprotein (HDL) 48 mg/dL, non-HDL 122 mg/dL, Low density lipoprotein cholesterol (LDLc) 105 mg/dL, triglycerides (TG) 85 mg/dL, Creatinine 0.75 mg/dL, Filtering 90 mL/min, Urate 6.3 mg/dL, Sodium (Na+) 140 mmol/L, Potassium (K+) 4.4 mmol/L, chlorine (Cl-) 106 mmol/L, Aspartate aminotransferase (ASAT) 67 IU/L, ALAT 102 IU/L, Alkaline phosphatase (ALP) 107 IU/L, Gamma-glutamyltransferase (GGT) 50 IU/L, Total bilirubin (TB) 0.41 mg/dL, CPK 348 IU/L, Troponina I (hs-TnI) 7485 - 9203 ng/L, Proteins 7.2 g/dL, CRP 22 mg/L, Blood thyroid stimulating hormone (TSH) 14.53 mIU/L, Free thyroxine (T4) 1.08 ng/dL, Antiperoxidase antibodies 1300 IU/mL (0 - 60). Analytic 19Aug2021: Erythrocytes 4.900.000 x10 9/l, Hb 14.8 g/dL, Hto 44.5%, MCV 90.9 fL, MCH 30.3 pg, Leukocytes 7000/uL [N 3460, L 2650, M 390, E 240, B 40, LUC 220, N/L 1.31], Plaquetas 200.000 x10 9/l, PT 11 s / 97%, INR 1, Fibrinogen 543 mg/dL, aPTT 27.9 s /ratio 1.04, Glycemia 76 mg/dL, Creatinine 0.79 mg/dL, Filtering 90 mL/min, Urea 35 mg/dL, Na+ 137 mmol/L, K+ 3.7 mmol/L, Cl- 109 mmol/L, Troponin I (hs-TnI) 13.862.5 ng/L, CRP 11.7 mg/L. THYROGLOBULIN 3.96 ng/mL (1.6 - 59.9), Antithyroglobulin antibodies II 2.1 IU/mL (0 - 4.5), Antiperoxidase antibodies 1300 IU/mL (0 - 60). Deferred analytics 20Aug2021: Glycemia 115 mg/dL, creatine in serum unknown results mg/dL (0.5 - 1), Urea 30 mg/dL, Na+ 134 mmol/L, K+ unknown results mmol/L (3.5 - 5.1), Cl- 111 mmol/L, Indication: 2. Followed chest pain, Troponin I (hs-TnI) 2507.1 ng/L, CRP 5.9 mg/L. Autoimmunity: antinuclear antibodies (ANAs) and anti-neutrophil cytoplasmic antibodies (ANCAs) pending. Imagen: Chest X-ray: Cardiothoracic index within normal, pulmonary parenchyma without significant alterations. Regulated transthoracic echocardiogram: Echocardiogram performed in sinus rhythm with an average heart rate of 70 bpm. Limited by subtopic acoustic window. Left ventricle not dilated or hypertrophic with normal global systolic function. No clear alterations of segmental contraction. Right ventricle of normal size and function. Both atria are normal in size. Mild tricuspid insufficiency that does not allow estimating systolic pressure of the pulmonary artery. No indirect signs of pulmonary hypertension. No pericardial effusion. Undilated inferior vena cava with normal respirophasic variations. Aorta displayed of normal size. Cardiac nuclear magnetic resonance imaging: Cardiac magnetic resonance imaging is performed in Avanto 1.5T equipment, with "black blood" sequences in the axial plane, CINE in short axis, four chambers, three chambers and long axis, STIR sequences in short axis and 4C and sequences of late enhancement after the administration of Intravenous contrast (iv) (Dotarem 30ml). Study quality: suboptimal by respiratory movements. Finds: Morphological study. The left ventricle is not dilated or hypertrophic. Interventricular septum 10 mm, Telediastolic diameter 49 mm, posterior wall 10 mm, Telesystolic diameter 33 mm. It presents a normal segmental and global contractility (Left ventricular ejection fraction. (LVEF) 68%). The edema sequence shows no data of myocardial inflammation (signal hyperintensity in STIR). After the administration of intravenous contrast, we did not observe pathological late enhancements, although the quality of the images is suboptimal by respiratory artifacts. The right ventricle is of normal size with preserved function (LVEF 59 %). It does not present alterations in its morphology or enhancement after the administration of contrast. Normal-sized atria (left atrium 18 cm2, right atrium 20 cm2, measurements in 4 chambers). Normal-sized aortic root. No valvular insufficiencies or stenosis are observed. No pleural or pericardial effusion is observed, nor is the presence of late enhancement with gadolinium. Ventricular function study (calculated in short axis) Post-processing performed including papillary muscles in the ventricular volume. Normality values taken from Kawel-Boehm. Journal of Cardiovascular Magnetic Resonance (JCMR) 2020; 22(1):87. Left ventricle: Telediastolic volume: 148 ml (71 ml/m2) Telesistolic volume: 52ml (25 ml/m2) Sistolic Volume: 96 ml Cardiac output: 8.3 l/min Ejection fraction (EF %): 68 % Mass: 149 g (72 g/m2) Right ventricle: Telediastolic volume: 164 ml (78 ml/m2) Telesistolic volume: 67 ml (32 ml/m2) Systolic volume: 97 ml Cardiac output: 8.4 l/min Ejection fraction (EF %): 59 % Extracardiac findings: No alterations are observed. Conclusion Left ventricle with normal segmental and global contractility (LVEF: 68%). Right ventricle of normal size and morphology with preserved function. Sub-optimal quality in late enhancement sequences with gadolinium, which shows no significant pathological enhancements. Other tests: Electrocardiogram (ECG) on admission: Sinus rhythm at 90 bpm, normal PR, narrow QRS with normal axis, diffuse concave elevation of the ST segment without other significant alterations of repolarization. ECG at discharge: sinus rhythm at 73 bpm, normal PR, narrow QRS, normal axis, negative T in III and flattened in aVF and lateral face. PCR SARS-CoV-2 on admission and 19Aug2021: negative. Other analysis lab data was captured in the field only due to the character limit. Main diagnosis: Acute, undyplicated myopericarditis likely related to SARS-CoV-2 vaccine. Preserved global biventricular systolic function. Other diagnoses: Subclinical hypothyroidism with positive autoimmunity + possible effect of diseased euthyroid. The outcome of event myopericarditis was recovered on 20Aug2021. The outcome of other events was unknown. No follow-up attempts are possible. No further information expected.


VAERS ID: 1698616 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-16
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG6273 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Migraine, SARS-CoV-2 test, Somatic symptom disorder, Strabismus, Visual analogue scale
SMQs:, Ocular motility disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine headache
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: COVID-19 test: Polymerase chain reaction; Result Unstructured Data: Test Result:Negative; Test Date: 202108; Test Name: Visual Analogue Scale; Result Unstructured Data: Test Result:7/8
CDC Split Type: FRPFIZER INC202101195336

Write-up: Migraine; left eye ''squinting''; somatisation; This is a spontaneous report from a contactable consumer (patient) and healthcare professional. This is the second of two reports, for COMIRNATY vaccine second dose. The first dose case (202101125105) was downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-AN20213426. A 15-year-old female patient received BNT162B2 (COMIRNATY, Lot FG6273, second dose) solution for injection intramuscular in left arm on 16Aug2021 (at the age of 15-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine headache. Concomitant medications were not reported. There was no history of allergy/hypersensitivity. Historical vaccine included BNT162B2 (COMIRNATY, first dose) for Covid-19 immunisation on 26Jul2021 and experienced migraine. The patient did not previously experience Covid-19. On 16Aug2021, the patient experienced migraine, 20min after the injection, which required emergency room (ER) visit and hospitalization on 22Aug2021. On 21Aug2021, the patient experienced left eye ''squinting'' required ER visit. In Aug2021, the patient experienced somatization required ER visit. On 22Aug2021, consultation at the emergency room, hospitalization in pediatrics. Lab tests included COVID-19 test: Polymerase chain reaction on 12Apr2021 was negative. Visual Analogue Scale in Aug2021 was 7/8. No complementary exam was done, diagnosis of somatization. Treatment for the events included Doliprane, ibuprofen, sumatriptan, ketoprofen and Laroxyl during the hospitalization, without improvement according to the mother. The outcome of the event migraine was not recovered. The outcome of the events eye squinting and somatization was unknown. No follow-up attempts are possible, no further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101125105 same patient, different dose


VAERS ID: 1698681 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Inappropriate schedule of product administration, SARS-CoV-2 test, Scan
SMQs:, Termination of pregnancy and risk of abortion (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Folic acid
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: SCAN; Result Unstructured Data: Test Result:8-week scan was fine; Test Name: SCAN; Result Unstructured Data: Test Result:11 weeks baby''s heart stopped; Comments: 12-week scan revealed baby''s heart had stopped at 11 weeks
CDC Split Type: GBPFIZER INC202101118685

Write-up: Dose 1 on 10Jun2021 and Dose 2 on 06Aug2021 (Outside range of 19-42 days); Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108272145226060-SJDYM, Safety Report Unique Identifier GB-MHRA-ADR 25862305. A 40-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number FE3380), via an unspecified route of administration on 06Aug2021 as dose 2, single for COVID-19 immunization. Patient was not currently breast feeding. Medical history included lactation decreased and pregnancy (Patient was no longer pregnant at the time of reporting). Concomitant medications included folic acid (MANUFACTURER UNKNOWN) taken for Folic acid supplementation. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number FC8089) via an unspecified route of administration on 10Jun2021 as dose 1, single for COVID-19 immunization. It was stated that patient was exposed to the medicine first-trimester (1-12 weeks). The patient had an inappropriate schedule of product administration (Dose 1 on 10Jun2021 and Dose 2 on 06Aug2021), which was outside range of 19-42 days. On an unspecified date in Aug2021, the patient experienced miscarriage of pregnancy. The event miscarriage of pregnancy was serious (medically significant and congenital anomaly). It was reported as unsure if the medicine had an adverse effect on any aspect of the pregnancy. The patient underwent lab tests and procedures which included SARS CoV-2 test: Negative (No - Negative COVID-19 test), and Scan: 8-week scan was fine, and 12-week scan revealed baby''s heart had stopped at 11 weeks, on an unspecified date. The details of relevant investigations or tests conducted was reported as ongoing. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was reported as recovered on an unspecified date in Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701623 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion missed
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101144512

Write-up: missed miscarriage discovered at 11 weeks pregnant; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number not provided), via an unspecified route of administration on an unspecified date in 2021 (at the age of 36 years old) as single dose for COVID-19 immunisation. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient''s medical history and concomitant medications were not reported. The patient experienced missed miscarriage discovered at 11 weeks pregnant in Aug2021. The mother reported she became pregnant while taking BNT162B2 in 2021. The mother was 4 Weeks pregnant at the onset of the event. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn''t been tested for COVID-19. The outcome of the event was unknown. The lot number for BNT162B2 was not provided and will be requested during follow up.


VAERS ID: 1702691 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Abortion spontaneous, Back pain, Pyrexia, Ultrasound scan vagina
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cyst
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: TVS; Result Unstructured Data: Test Result:pregnant at that time; Test Date: 20210824; Test Name: TVS; Result Unstructured Data: Test Result:confirm the miscarriage
CDC Split Type: PHPFIZER INC202101143992

Write-up: miscarriage; fever; back ache; abdominal pain; This is a spontaneous report from a contactable nurse. This is the first of two reports for the first dose. A 33-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular on 03Aug2021 (at the age of 33 years old, Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included ovarian cyst. concomitant medications were not reported. The patient experienced miscarriage on 24Aug2021 with outcome of unknown, fever on 03Aug2021 with outcome of unknown, back ache on 03Aug2021 with outcome of unknown, abdominal pain in Aug2021 with outcome of unknown, maternal exposure (1st trimester) on 03Aug2021 with outcome of unknown. The patient experienced fever and back ache started after vaccination (same day), these events were non-serious. No value was given to the reporter for the fever temp. The patient had experienced severe abdominal pain in Aug2021 after the first dose and thought that her ovarian cyst would explode so she seek consult and had a Ultrasound scan vagina (TVS) done in Aug2021 but found out that she was pregnant at that time. Her last menstrual cycle was 23Jun2021. She was 6 Weeks pregnant at the onset of the event. She was due to deliver on 30Mar2022. The pregnancy resulted in spontaneous abortion. She had severe vaginal bleeding on 24Aug2021 which prompted for her to get another TVS after consulting a physician regarding the her unusual vaginal bleeding. She had another TVS done on 24Aug2021 that confirm the miscarriage. The abdominal pain became severe after the first dose was on 24Aug2021 when the miscarriage occurred.The patient complaint about abdominal pain and was inquiring if this was a normal since she experienced on both doses. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the reported information ,a causal relationship between the event Abortion spontaneous and suspected drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate,Linked Report(s) : PH-PFIZER INC-202101143994 same patient, product, similar events and different dose


VAERS ID: 1706171 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Ultrasound scan, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Termination of pregnancy and risk of abortion (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: 2021; Test Name: echo; Result Unstructured Data: Test Result:Unknown result
CDC Split Type: NLPFIZER INC202101143255

Write-up: Miscarriage; Miscarriage due to bleeding; This is a spontaneous report from a contactable consumer (patient) downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00674407 and the safety report unique identifier is NL-LRB-00675615. A 27-year-old female patient received BNT162B2 (COMIRNATY, lot number: FE8235), via an unspecified route of administration on 10Aug2021 at dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. She has no previous COVID-19 infection. The patient previously received BNT162B2 (COMIRNATY, lot number and expiration date were not provided), via an unspecified route of administration on 06Jul2021 at dose 1, 0.3 mL single for COVID-19 immunisation. It was reported that the first COVID vaccination took place before pregnancy. On 18Aug2021, the patient experienced miscarriage due to bleeding which started from Aug2021. It started at a pregnancy duration of about 6 weeks and occurred at a pregnancy duration of about 7 weeks (as reported). These occurred after the second dose of COMIRNATY which took place at a pregnancy duration of about 5 weeks. The patient underwent lab test and procedure which included echo on an unspecified date in 2021 with unknown result. The outcome of the event miscarriage was recovered on 23Aug2021 and unknown for the other event. The event miscarriage was reported as serious, medically significant. Reporter''s Comment: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): Yes. ADRs: No (as reported). Date: 06Jul2021. Miscarriage: Additional information ADR: Miscarriage due to bleeding. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 0 (as reported). COVID-19: Previous COVID-19 infection: No. Other: Diagnostic procedures: Echo. Follow-up: 31Aug2021 Received follow-up: At 7 weeks of pregnancy. I received the second vaccination at 5 weeks of pregnancy. I indicated this and the advice was a vaccination. Miscarriage stop date: 23Aug2021. Sender''s Comment: Since the nature of the reported reaction does imply seriousness according to one of the regulatory authority criteria, the reaction was considered as serious by the lab. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): Yes. ADRs: No. Date: 06Jul2021. Miscarriage: Additional information: Miscarriage due to bleeding. Confounding factors: COVID-19 vaccine exposure during pregnancy week: 0. Previous COVID-19 infection: No. Diagnostic procedures: Echo. Follow-up: 31Aug2021 Received follow-up: At 7 weeks of pregnancy. I received the second vaccination at 5 weeks of pregnancy. I indicated this and the advice was a vaccination. Miscarriage stop date: 23Aug2021.


VAERS ID: 1515692 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: post-administration pt got dizzy, vision blurry, fainted momentarily. paramedics were called, pt was screened and vital were okay.


VAERS ID: 1518368 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 054C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Mass, Muscle spasms
SMQs:, Dystonia (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Toes on left foot locked up and very hard ball formed under foot. Happened for several minutes. Tried flexing my toes and massaging the ball-like mass under foot. It went away eventually.


VAERS ID: 1518383 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939893 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abnormal dreams, Condition aggravated, Pain in extremity
SMQs:, 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: Arm soreness, malaise
Other Medications: Prenatal vitamin, fish oil, chewable biotin hair gummies
Current Illness: None
Preexisting Conditions: None
Allergies: Seasonal allergies, oats, flax seed, barley
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extreme arm soreness and vivid dreams to the point of almost being lifelike. I?ve never had such a lifelike vivid realistic dream in my entire life. Did not have this side effect with the first dose. Only the 2nd.


VAERS ID: 1518385 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-22
Onset:2021-07-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Feeling hot, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Low dose Aspirin, Levothyroxine, Omeprazole DR, Pravastatin, Sumatriptan, Metformin, Breztri Inhaler, Tramadol, Tizanidine
Current Illness: None
Preexisting Conditions: C.O.P.D.
Allergies: Morphine, Prednisone
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Arm is swelled, hot and sore again 9 days after the injection


VAERS ID: 1518399 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-23
Onset:2021-07-31
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 2 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8735 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Deafness, Disorientation, Loss of consciousness, Presyncope, Vertigo positional
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), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily adult multivitamin
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: TB skin test Ketorolac CT contrast dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: Sudden onset of positional vertigo. Have never had vertigo before. Multiple short vertigo events throughout the night and morning of 7/31/21, especially when tilting head upward. Additionally, the week prior had one vasovagal episode that lasted about 10-15 seconds. Stopped in hallway, vision blacked out and all sounds felt far away, disoriented after the event.


VAERS ID: 1518421 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (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: vitamins b and d co q 10 vit b 12
Current Illness:
Preexisting Conditions:
Allergies: penicillin, shellfish, compazine , gluten
Diagnostic Lab Data:
CDC Split Type:

Write-up: Dizzy Low blood pressure


VAERS ID: 1518424 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (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: none
Current Illness: none
Preexisting Conditions: no
Allergies: Contrast Dye Rash Gluten: Hives MVI (unsure of brand) anaphylaxis Peanuts- Hives Shellfish
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient stated to - RN who gave the vaccination that she has been extremely nervous and anxious about getting vaccine. Was very nervous about getting vaccine. She stated that she had her own epi pen because she had anaphylaxis reaction to something in her MVI. then stated that he could give vaccine lying down on a cot- but she declined. She was in the observation center (going to watch for 30 minutes) instead of normal 15minutes. She leaned over to her husband at 9:30 and said they she felt like she was going to pass out. Nurses brought over the gurney to patient and she laid down and vital signs were taken 9:33- 50/43 100% with o2 nasal canula 9:34 64/30 100% with o2 nasal canula . Patient also had to defecate- just did so on sheets. 9:35 78/33 and 99/53 100% with o2 nasal canula 9:35 EMT called and arrived at 9:38 9:44 100/64 9:46- BP sitting 100/66 9:50 standing 98/60 Ent spoke with patient and also husband. She states that she was feeling much better. Patient decided that she did not want to go to the ER. Advised patient to call her PCP and if it is decided to get second dose- that she eats and drinks prior to coming to vaccine center and that we give her second shot lying down. Took patient out to the car in wheelchair. She felt good and was very thankful for the care.


VAERS ID: 1518435 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Extravasation events (injections, infusions and implants) (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: Concerta
Current Illness:
Preexisting Conditions: ADHD
Allergies: amoxicillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Redness at injection site Nausea & vomiting


VAERS ID: 1518442 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Headache, Neck pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Back Pain, neck pain, headache, 100 F fever


VAERS ID: 1518448 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0584 / 2 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness
SMQs:, Anticholinergic syndrome (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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient started to feel dizzy at around 4:00 am and went back to sleep. He got up around 9:30 am and felt dizzy. Blood pressure was 156/102. He then rested for about an hour. At around 10:40, he did some light exercise, playing tennis and he felt better at around 11:00 am.


VAERS ID: 1518452 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Patient became light headed while sitting in chair 5 minutes after vaccine was administered. Patient fainted and fell from chair to floor. Patient was unconscious approximately 1 minute and then regained consciousness. When patient came to she was alert and oriented x3. Dr. to see patient. Patient was assisted under her own strength to reclining chair. Vital signs stable. BP 106/70, sat 99% on room air. pulse 61, resp 18, temp 97.4. Patient stated she often does this with blood draws.


VAERS ID: 1518453 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Anxiety, Chills, Dizziness
SMQs:, Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

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

Write-up: The patient was complaining about filling light headed having chills and anxiety. Patient declined to have his vitals checked, the patient was moved to an observation area and monitored by qualified staff. No further actions were taken.


VAERS ID: 1518467 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood glucose, Communication disorder, Dizziness
SMQs:, Anticholinergic syndrome (broad), 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: Ibuprofen
Diagnostic Lab Data: Vitals were taking by EMS: glucose and blood pressure.
CDC Split Type:

Write-up: Patient was given his second dose of moderna covid-19 at 11:44am, around 11:52 am he began feeling dizzy and having trouble communicating his symptoms. I asked what he was experiencing and he kept pointing at his head and eyes and was unable to make complete sentences. His friend requested EMS to come check him out and as I was on the phone with dispatch he began feeling better. He stated he had not eaten or has anything to drink today and EMS checked his vitals and advised him to eat and drink water.


VAERS ID: 1518479 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-23
Onset:2021-07-31
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EQ0182 / 1 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia
SMQs:, Taste and smell disorders (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient has a history of covid-19 infection a few months before the vaccination. After immunization, he now has 2 months of almost complete loss of taste and smell.


VAERS ID: 1518482 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0183 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, No adverse event
SMQs:, Medication errors (broad)

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

Write-up: Patient received Pfizer as a second dose in series, their first dose was Moderna. No adverse conditions noted on the 30 min observation time.


VAERS ID: 1518483 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Balance disorder, Flushing, Hyperhidrosis, Thirst, Vision blurred
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypersensitivity (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: none reported
Preexisting Conditions: non reported
Allergies: non reported
Diagnostic Lab Data: None reported
CDC Split Type:

Write-up: Patient wash flushed reported blurred vision and lost balance and dropped to the floor. Did not lose conciousness. Lay down for less than minute and sat up. Was flushed and sweating. EMS contacted at initial observation of incident. Pulse measure at 78 bpm. EMS arrived. Patient was sitting and thirsty. EMS monitored patient. Patient declined to go to ER or further.


VAERS ID: 1518489 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

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

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

Write-up: fainted


VAERS ID: 1518497 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Paraesthesia, Sensation of foreign body
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Patient c/o tingling in left face and neck and lump in throat 20 minutes after vaccine given. She was given benadryl 50 mg IM and stated symptoms were gone after 15 minutes. O2 sats 100%


VAERS ID: 1518498 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amoxicillin Finished a steroid pack
Current Illness: no
Preexisting Conditions: Sleep Apnea- on Cpap Has lingual thyroid which gets evaluated, denies difficulty swallowing or SOB
Allergies: NKDA
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Patient stated that he felt very diaphoretic once placed in observation area He received vaccine at 11:10 and felt symptoms at 11:23 Had patient lie down on Gurney and vs were monitored 11:23 120/74 77 pulse 100% room air 11:36 138/85 65 pulse 100% Still felt a little warm 11:47 134/83 58 100% Denies any allergies. Medication Augmentin ( he saw ENT) about 10 days ago. Patient states he went because he felt like something in throat. He had dosage series of steroids which finished a couple days ago and then placed on Augmentin. He has a inguinal thyroid. 11:56 139/91 62 100% denies feeling warm/diaphoretic 12:10 142/82 52 100% pulse ox 12:15 142/102 64 100% pulse ox 12:20 148/91 74 100%pulse ox 12:26 139/103 74 12:32 143/95 76 100% pulse ox Wife stated that he take anti anxiety medication but did not take last evening. He was feeling anxious Patient took liquids, some food while being observed Let feeling much better, BP stable. Advised that he let PCP know what happened. Also let him know that for his next dose we will have him on gurney to give shot and monitor. Escorted by wife and daughter.


VAERS ID: 1518502 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event
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: Pfizer covid vaccination
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: NO ADVERSE EVENT OBSERVED AFTER INJECTION .PATIENT WAIT FOR 15 MINUTES .


VAERS ID: 1518503 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Crying, Loss of consciousness
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), Depression (excl suicide and self injury) (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: N/A
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient was nervous prior to receiving vaccine. After receiving vaccine she stood up from chair and within 2 seconds lost consciousness for less than a second. She slowly began to drop down to the floor while leaning against the wall. Her father was present and held her as she slumped down. She regained consciousness before getting to the floor and began to cry, seemingly scared at what had occurred. She remained sitting on the floor for 5 minutes before moving to the chair for another 15 minutes. Patient was given water. She sat in the waiting area with father and had no changes after that. When asked, she declined having any shortness of breath, itchiness, redness, or swelling.


VAERS ID: 1518508 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), 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: NONE, PT WAS GETTING A MODENA VACCINE. PT GOT LIGHT HEADED AND FAINTED
Current Illness: NONE, PT WAS GETTING A MODENA VACCINE. PT GOT LIGHT HEADED AND FAINTED
Preexisting Conditions: NONE, PT WAS GETTING A MODENA VACCINE. PT GOT LIGHT HEADED AND FAINTED
Allergies: NONE, PT WAS GETTING A MODENA VACCINE. PT GOT LIGHT HEADED AND FAINTED
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Pt got a covid vaccine. got light headed/fainted


VAERS ID: 1518513 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 066D21A / 1 LA / IM

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

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

Write-up: Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch Generalized-Mild, Additional Details: hives on inside of both arms, back of knees and up through thigh and lower back lasting from 3am to 6am. No medical attention was seeked by the patient


VAERS ID: 1518524 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: New York  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006D21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Feeling hot, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NKDA
Current Illness: NONE
Preexisting Conditions: HTN
Allergies: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Patient received a first dose of his COVID-19 Moderna vaccine and 10 minutes post administration said he felt very hot and visible perspiration was covering his body. He felt just very anxious right after the vaccine. I gave him water and asked if he wanted to lay down to ensure he was not going to faint. Once he was down on the ground, he said he felt 100% better and realized it was just anxiety.


VAERS ID: 1518530 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-01
Onset:2021-07-31
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: positive COVID antigen test
CDC Split Type:

Write-up: breakthrough COVID positivity


VAERS ID: 1518531 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: Louisiana  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939902 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Panic attack
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: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT HAD A PANIC ATTACK DUE TO PHOBIA OF NEEDLES


VAERS ID: 1518539 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

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

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

Write-up: 33 yo male with a history of severe needle phobia presents with a syncopal episode after receiving the COVID-19 Janssen injection. Injection was given at approximately 1:38. Patient sat in chair for 4 minutes complaining of "dizziness" after injection. Patient was brought back to our in-house ER bed when he started "feeling better" at 1:42 pm so he could lie down. Patient presented with syncopal episode at 1:43 while being assisted to the back. Episode lasted for 30 seconds. Vital signs taken at 1:43 pm were the following: BP 108/61, pulse 48, sp02 96%, temp 97.2. Patient was able to drink orange juice at 1:43. Vitals taken again at 1:54 pm were the following: BP 103/63, pulse 62, sp02 98%. Patient drank another orange juice at 2:08. Vitals taken at time patient left vaccine clinic 2:09 were the following: blood pressure 108/77, pulse 70, and sp02 100%. Patient left vaccine clinic at 2:19 stating he felt "good enough to walk out of building." No further care was needed.


VAERS ID: 1518541 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Puerto Rico  
Vaccinated:2021-03-20
Onset:2021-07-31
   Days after vaccination:133
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039C21A / 1 - / IM

Administered by: Public       Purchased by: ?
Symptoms: Wrong product administered
SMQs:, 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: N/A
Current Illness: UNKNOWN
Preexisting Conditions: Diabetes; Hx Cancer thyroid surgery.
Allergies: UNKNOWN
Diagnostic Lab Data: N.A
CDC Split Type:

Write-up: Patient female 26 years old received a dose Janssen lot-1805018 in the associated medical facilities on March 20, 2021. Patient came in July 17, 2021 in the vaccination center of to receive her first Moderna vaccine lot 039C21A since she said she was worried of the effectness of Janssen and her health conditions of diabetes, hx of cancer thyroid and being a care giver of the elderly, It is for this reason that she agrees to have omitted the information from the previous vaccination of Janssen.


VAERS ID: 1518554 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Cyanosis, Mydriasis, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none known
Preexisting Conditions: none known
Allergies: none known
Diagnostic Lab Data: none known
CDC Split Type:

Write-up: Patient received first dose of the Pfizer COVID vaccine, approximately 5-10 minutes later parent alerted that she had syncopal episode while sitting in a chair. Parent noticed her eyes were dilated. Called 911 while parent and pharmacist watched patient. Patient regained consciousness about 1 minute later. Noticed lips were blue in color and pale skin. EMS came to escort patient to nearest medical facility.


VAERS ID: 1518555 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives on both hands


VAERS ID: 1518560 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 035C21A / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: Pt received Moderna Vaccine for first dose and Pfizer for second dose


VAERS ID: 1518565 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Melatonin 6mg at bedtime
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None as of yet
CDC Split Type:

Write-up: Approx 14 hours post vax was woken up with nausea. Vomited once. Couldn?t sleep. Vomited again approx 18 hours post vax. Started running a fever of 101.5 after second vomit episode.


VAERS ID: 1518576 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site erythema, Injection site swelling, Pruritus
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortly after receiving 2nd Moderna within the 15 min. observation period patient said her arm was itching and upon viewing it was red and little swollen at the injection site. Patient was given an ice pack to place on injection site and around 10:12am she was feeling better and she left the pharmacy.


VAERS ID: 1518577 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-01
Onset:2021-07-31
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Anosmia, COVID-19, Malaise, Oropharyngeal pain, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: COVID PCR and antigen
CDC Split Type:

Write-up: breakthrough COVID infection with symptoms - loss of smell, sore throat and malaise


VAERS ID: 1518578 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Myalgia, Pyrexia
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)

Life 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:

Write-up: fever 101 degrees, arm muscle soreness


VAERS ID: 1518585 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 078C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event
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:

Write-up: No adverse events were reported when I asked the patient if the patient was ok after vaccine administration


VAERS ID: 1518589 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 051C21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fall, Hyperhidrosis, Ocular hyperaemia, Pallor, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Glaucoma (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:

Write-up: PATIENT WAS SWEATING, AND SHIVERING. HE BECAME PALE AND HIS EYE WERE RED. HE DRANK WATER. THEN HE WAS SHAKING AND FALLING. HIS DAUGHTER CALLED 911.AMBULANCE CAME. PARAMEDICS CHECKED HIM. HE WAS FEELING BETTER THAT TIME. THEY DIDN''T TAKE HIM TO HOSPITAL .HE CAME TO PHARMACY AND SAID HE IS NORMAL AND LEFT.


VAERS ID: 1518590 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
SMQs:, 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: autoimmune disease, thrombocytopenia Asthma
Preexisting Conditions:
Allergies: Rabbits & Cats
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received first dose Moderna Vaccine at Pharmacy on 5/16/21. She presented for her second dose on 7/31/21. This is beyond the recommended period between doses and so it is being reported as an adverse event.


VAERS ID: 1518591 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Mydriasis, Oropharyngeal pain, Presyncope
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PATIENT IS TYPE- 1 DIABETIC AND IS ON INSULIN.
Current Illness: N/AP
Preexisting Conditions: TYPE-1 DIABETIC
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: PATIENT HAD A SYNCOPE KIND OF REACTION. PATIENT DID NOT COMPLETELY PASS OUT BUT EYES WERE DILATED AND THROAT WAS HURTING IN THE BEGINNING. 911 WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL.


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