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

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



Case Details (Reverse Sorted by Onset Date)

This is page 413 out of 8,010

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VAERS ID: 1687459 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Erythema, Lymph node pain, Lymphadenopathy, Maternal exposure during breast feeding, Off label use, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site inflammation, Vaccination site pruritus, Vaccination site swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Neonatal exposures via breast milk (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUTICASONE; PARACETAMOL.
Current Illness: Breast feeding.
Preexisting Conditions: Medical History/Concurrent Conditions: Headaches cluster; Sinusitis.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101126890

Write-up: bruise; swelling in arm; injection site raised, red and itchy; injection site raised, red and itchy; injection site raised, red and itchy; swelling at injection site; Maternal exposure during breast feeding; off label use; Swollen arm; Itchy; Lymph node pain; lymph nodes in arm pit of injection arm swollen and painful; Painful arm; Redness; Bruising; This is a spontaneous report from a contactable consumer received from the Regulatory Authority (UK-MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108262019126220-QGPQY and Safety Report Unique Identifier is GB-MHRA-ADR 25856332. A 23-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown) via an unspecified route of administration on 24Aug2021 (23-year-old at the time of vaccination) as dose 2, single for COVID-19 immunization. Medical history included ongoing breast feeding, sinusitis and cluster headache. Concomitant medication(s) included fluticasone (FLUTICASONE) taken for sinusitis from 20Aug2021 to 23Aug2021; paracetamol (PARACETAMOL) taken for cluster headache from 16Aug2021 to 22Aug2021. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced bruise, swelling in arm was low and appeared after swelling at injection site, injection site was raised, red and itchy, maternal exposure during breast feeding and off label use. On 24Aug2021, the patient experienced redness, painful arm, bruising. On 25Aug2021, the patient experienced swollen arm, itchy, lymph node pain, lymph nodes in arm pit of injection arm swollen and painful. It was reported that swelling in arm was low and appeared after swelling at injection site. Injection site was raised, red and itchy. Redness was still spreading and was starting to bruise. Lymph nodes in arm pit of injection arm swollen and painful. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of the event bruise, swelling in arm was recovering; swollen arm, redness, itchy, lymph node pain, painful arm, bruising was not recovered while for the other events 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-202101117846 split due to Maternal exposure during breast feeding


VAERS ID: 1687469 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101117581

Write-up: Lymph node pain; Fever; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108262140432780-NBQPP and Safety Report Unique Identifier GB-MHRA-ADR 25856756. A 39-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 2 via an unspecified route of administration on 24Aug2021 (at the age of 39 years) as dose 2, single for COVID-19 immunisation. The patient took the historical vaccine BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On 24Aug2021, the patient experienced lymph node pain and fever. The clinical outcome of the events was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687476 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Eye pain, Fatigue, Headache, Magnetic resonance imaging, SARS-CoV-2 test, Ultrasound scan
SMQs:, Glaucoma (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain (At the end of 2020/start of 2021 I suffered severe abdominal pain); Implant removal; Lactation decreased; Oral contraception
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: ultrasound scans; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101117716

Write-up: Headache; Menstrual cramps; Sore eyes; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108262255055960-3ZGJO, Safety Report Unique Identifier GB-MHRA-ADR 25857080. A 25-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on 24Aug2021 (at the age of 25-year-old), as single dose, for COVID-19 immunization. Medical history included oral contraception, abdominal pain (at the end of 2020/start of 2021, suffered severe abdominal pain), lactation decreased, patient attended private gynecology and private urology appointments, but the cause of pain was never found. For around 2 months patient took a variety of tablets such as metronidazole, codeine, naproxen and others anti-inflammatory and pain relief pills patient could not recall the name of. The pain finally lessened when patient had implant removed and changed to oral contraception. Patient still suffer with slight pain but no longer take any medication. Patient was not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Patient was not pregnant at the time of vaccination. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. The patient experienced menstrual cramps, sore eyes and tiredness 24Aug2021. The patient experienced headache on 25Aug2021. On the evening after patient''s vaccine, patient had very bad menstrual cramps and the following morning patient woke up to the darkest period patient has ever seen. Patient took a daily contraceptive pill and usually have no periods whatsoever so was very shocked. The patient underwent lab tests and procedures which included COVID-19 virus test result was negative, MRI (magnetic resonance imaging) and ultrasound scan with unknown results, on an unspecified date. Outcome of the events menstrual cramps and tiredness was not recovered. Outcome of the rest other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-08
Onset:2021-08-24
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Diarrhoea, Illness, Pyrexia, SARS-CoV-2 test
SMQs:, 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:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117800

Write-up: Diarrhoea; Sickness; Fever; Joint pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108270525447230-UOWPU, Safety Report Unique Identifier GB-MHRA-ADR 25857332. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration on 08Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On 24Aug2021, the patient experienced diarrhoea, sickness, fever, joint pain. All the events were considered as serious- medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date (No - Negative COVID-19 test). The outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1687500 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Decreased appetite, Lymphadenopathy, Mouth ulceration, Oropharyngeal pain, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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: LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]; OCTASA; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Crohn''s; Inflammatory bowel disease (Taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis)); Lactation decreased; Pain; Sore throat
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118789

Write-up: aching joints; restless night; Mouth ulcer; Stomach cramps; Swollen lymph nodes; Ache; Vomiting; Sore throat; This is a spontaneous report from a contactable consumer (patient). This is a report received from the regulatory authority report number GB-MHRA-WEBCOVID-202108270903057720-NGSPV, Safety Report Unique Identifier GB-MHRA-ADR 25858489. A 28-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: Fe3380), via an unspecified route of administration on 24Aug2021 (at the age of 28-year-old) as single dose for COVID-19 immunisation. Medical history included lactation decreased, sore throat, inflammatory bowel disease, taking medicines for inflammatory bowel disease (Crohn''s disease, ulcerative colitis), crohn''s disease and pain; all from an unknown date and unknown if ongoing. Concomitant medications included ethinylestradiol, levonorgestrel (LEVEST [ETHINYLESTRADIOL;LEVONORGESTREL]) taken for contraception, start and stop date were not reported; mesalazine (OCTASA) taken for crohn''s disease, start and stop date were not reported; paracetamol (MANUFACTURER UNKNOWN) taken for pain, start and stop date were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. On an unspecified date, the patient experienced aching joints and restless night. On 24Aug2021, the patient experienced vomiting, sore throat, ache. On 25Aug2021, the patient experienced stomach cramps and swollen lymph nodes. On 26Aug2021, the patient experienced mouth ulcer. The patient had aching joints and head from the evening of the vaccine. By that night, the patient had stomach cramps and started vomiting and had a very restless night with a sore throat and took paracetamol. The following day the patient was no better and still had all of the symptoms. The reporting day was the third day after the vaccine. The patient right armpit is very swollen and tender and still have a very sore throat and lots of mouth ulcers. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test. The outcome of the events arthralgia, restless night, vomiting, stomach cramps, pain was resolving and the outcome of the events sore throat, mouth ulceration and swollen lymph nodes was not resolved. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687511 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE3380 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118633

Write-up: Nausea; Headache; This is a spontaneous report from a contactable consumer or other non hcp received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108271012038650-FHVXL, Safety Report GB-MHRA-ADR 25858647. A 16-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE3380), dose 1 via an unspecified route of administration on 24Aug2021, as dose 1, single for COVID-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient experienced nausea and headache on 24Aug2021. The events were reported as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on No - Negative COVID-19 test. The events were recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687563 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 EW0217 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Paraesthesia oral, SARS-CoV-2 test, Vertigo
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Result Unstructured Data: Test Result:Has not tested positive for COVID-19; Comments: Patient has not tested positive for COVID-19 since having the vaccine
CDC Split Type: GBPFIZER INC202101118892

Write-up: Lightheaded; On and off moments of feeling; Vertigo; Tingling lips; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority report number is GB-MHRA-WEBCOVID-202108271642117400-EZRPI, Safety Report Unique Identifier GB-MHRA-ADR 25862842. A 33-year-old female patient received the first dose of first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ew0217), via an unspecified route of administration, on 24Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history included lactation decreased from an unspecified date. Unsure if patient has had symptoms associated with COVID-19. Patient is not pregnant and is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications were unknown. The patient experienced lightheaded (medically significant) on an unspecified date with outcome of unknown, vertigo (medically significant) on 24Aug2021 with outcome of recovering, tingling lips (medically significant) on 24Aug2021 with outcome of recovering, had on and off moments of feeling (medically significant) on 25Aug2021 with outcome of recovered on 27Aug2021. The adverse events were described as "Vaccine was administered, waited at site sitting as Instructed for 15 mins. Then left her equilibrium felt off and she felt very lightheaded. Wednesday, Thursday and Friday she have had on and off moments of feeling as though she was spinning when she was not moving, and bouts of feeling very light headed. Tingling lips also as she left the location where shot was administered and on and off since". Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687651 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Heart rate, Nausea, Oxygen saturation, Presyncope, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood Pressure; Result Unstructured Data: Test Result:112/71; Test Name: Blood Pressure; Result Unstructured Data: Test Result:117/80; Test Name: Blood Pressure; Result Unstructured Data: Test Result:114/75; Test Name: Pulse; Result Unstructured Data: Test Result:82; Test Name: Pulse; Result Unstructured Data: Test Result:84; Test Name: Sats; Test Result: 100 %; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118620

Write-up: faint; Felt queasy; Vasovagal attack; This is a spontaneous report from a contactable other health care professional. This is a report received from the regulatory authority). Regulatory authority report number is GB-MHRA-WEBCOVID-202108281601174990-ZOZKV, Safety Report Unique Identifier GB-MHRA-ADR 25864849. A 19-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration on 24Aug2021 (at the age of 19-Year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Unsure if patient has had symptoms associated with COVID-19. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient experienced vasovagal attack on 24Aug2021, faint and felt queasy on an unspecified date. Legs was elevated with quick recovery. No report was related to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included blood pressure measurement: 112/71, 117/80 and 114/75, heart rate: 82 and 84, oxygen saturation: 100% and sars-cov-2 test: No - Negative COVID-19 test on an unspecified date. The adverse event faint was considered as serious with seriousness criteria of medically significant and felt queasy and vasovagal attack was non-serious. The outcome of the events faint and felt queasy was unknown and event vasovagal attach was resolved on an unspecified date in 2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1687668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Fatigue, Headache, Pain, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Glaucoma (broad), Hypersensitivity (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101118850

Write-up: head aches; stinging; sneezing; exhausted; Sneezing excessive; Eyes stinging; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Authority (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108282203476890-1ZRQ5, Safety Report GB-MHRA-ADR 25865220. A 23-year-old female (not pregnant) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Aug2021 as single dose for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. The patient experienced on an unspecified date with outcome of unknown, stinging on an unspecified date with outcome of unknown, sneezing on an unspecified date with outcome of unknown, sneezing excessive on 25Aug2021 with outcome of not recovered, eyes stinging on 24Aug2021 with outcome of not recovered, exhausted on an unspecified date with outcome of unknown. The events were assessed as medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. It was also informed that patient has not tested positive for COVID-19 since having the vaccine, was not enrolled in clinical trial, has not had symptoms associated with COVID-19 Patient and was not currently breastfeeding. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1687719 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE338D / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Pregnancy (Estimated due date: 26Jan2022)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210822; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:Normal; Comments: Normal after first scan.
CDC Split Type: GBPFIZER INC202101117717

Write-up: Headache; Maternal exposure during pregnancy; Pain in arm; This is a solicited report from the regulatory authority program from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-YCVM-202108261449070190-UFHEA, Safety Report Unique Identifier GB-MHRA-ADR 25854173. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 24Aug2021 (Lot Number: FE338d) as second dose, single, at the age of 29 years old, for COVID-19 vaccination. Medical history included ongoing pregnancy (estimated due date: 26Jan2022). Patient has not had symptoms associated with COVID-19. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced maternal exposure during pregnancy on 24Aug2021. On 24Aug2021, the patient experienced pain in arm. On 25Aug2021, the patient experienced headache. The patient underwent lab tests and procedures which included COVID-19 virus test: No-negative covid-19 test on 22Aug2021, and scan: normal after first scan on an unspecified date. Outcome of the event pain in arm was recovering. Outcome of the event headache was recovered on 26Aug2021. 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 possible. No further information is expected.; Sender''s Comments: Based on the temporal relation, the association between the events of pain in extremity, headache and maternal exposure during pregnancy and the suspect product of BNT162B2 cannot be completely ruled out. 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: 1687728 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia oral, Inappropriate schedule of product administration, Pain in extremity, Throat irritation, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSTAIR; NAPROXEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef...); Joint pain; Lactation decreased; Myalgic encephalomyelitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101115455

Write-up: Numb lips; Itchy throat; Hives; Pain in limb; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108242055483160-VBZ3H, Safety Report Unique Identifier GB-MHRA-ADR 25843383. This is the second of 2 reports. A 29-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FE3380), dose 2 via an unspecified route of administration on 24Aug2021 (age at vaccination:29-year-old) as single dose for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing, asthma from an unknown date and unknown if ongoing, immunodeficiency from an unknown date and unknown if ongoing (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef), M.E (Myalgic encephalomyelitis) from an unknown date and unknown if ongoing, joint pain from an unknown date and unknown if ongoing. Concomitant medications included beclometasone dipropionate, formoterol fumarate (FOSTAIR) taken for an unspecified indication, start and stop date were not reported; naproxen (NAPROXEN) taken for joint pain, start and stop date were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW3143 and expiration dates were not reported), dose 1 via an unspecified route of administration on 08Jun2021 for COVID-19 immunization and experienced pain in limb, itchy throat and numb mouth. Patient is not pregnant at the time of vaccination and was not currently breastfeeding. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19, Patient has not tested positive for COVID-19 since having the vaccine. On 24Aug2021, 5 minutes after the vaccination, the patient experienced numb lips, itchy throat. The patient also experienced hives and pain in limbs on 24Aug2021.The patient was disabled due to these events. The patient also had an inappropriate schedule of vaccine administered on 24Aug2021. The patient reported that vaccine had caused a large flare up of symptoms of the disability M.E. The outcome of numb lips, itchy throat, hives, was recovering, pain in limb not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101105342 Same drug/patient; different dose/event


VAERS ID: 1687737 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FE338D / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Body temperature, Body temperature increased, Fatigue, Inappropriate schedule of product administration, Malaise, Monoplegia, Oropharyngeal pain, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (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: SERTRALINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Temperature; Result Unstructured Data: Test Result:feeling ill with a temperature; Test Date: 20210826; Test Name: Rapid flow test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab; Test Date: 20210827; Test Name: Rapid flow test; Result Unstructured Data: Test Result:Negative; Comments: Nasal Swab
CDC Split Type: GBPFIZER INC202101117142

Write-up: first dose on 28Jun2021 and second dose on 23Aug2021; Lost my voice; At the time of the second dose I felt my arm go "dead" straight after the jab; Sore throat; Felt run down; Feeling ill; Temperature; This is a spontaneous report from a contactable consumer (patient) or other non HCP. A 21-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FE338D, Expiration date was not reported) dose 2 via an unspecified route of administration, administered in Arm Left on 23Aug2021 at 17:30 (at the age of 21-years-old) as Dose 2, Single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: FC9001, Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 28Jun2021 at 11:30 AM, as Dose 1, Single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. On 24Aug2021 at 15:00, 21 hrs 30 min after second dose the patient experienced At the time of the second dose she felt my arm go dead straight after the jab, Sore throat, Felt run down, Feeling ill, Temperature, unwell, Lost my voice. patient did not received any treatment for event. it was reported that, At the time of the second dose she felt my arm go dead straight after the jab. The following day she had a really sore throat and felt run down. she woke up the next day feeling ill with a temperature, it''s now been 4 days since her jab and she still unwell and lost her voice. Have tested negative for Covid. The patient underwent lab tests and procedures which included Rapid flow test (sars-cov-2 test) nasal Swab negative on 26Aug2021, sars-cov-2 test negative nasal Swab on 27Aug2021 and Body temperature feeling ill with a temperature on unspecified date. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1687962 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-24
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214003 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood fibrinogen, Deep vein thrombosis, Fibrin D dimer, Oedema peripheral, Platelet count
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood fibrinogen; Test Result: 539 mg; Result Unstructured Data: 539 milligram; Test Date: 20210825; Test Name: Fibrin D dimer; Test Result: 2167 ng; Result Unstructured Data: 2167 nanogram; Test Date: 20210825; Test Name: Platelet count; Test Result: Inconclusive 127000 [iU]; Result Unstructured Data: 127000 INTERNATIONAL UNIT(S)-(UNDER 1000) 400000/150000
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-776404) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEEP VEIN THROMBOSIS and OEDEMA PERIPHERAL in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214003) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 31-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, the patient experienced DEEP VEIN THROMBOSIS (seriousness criteria hospitalization and medically significant) and OEDEMA PERIPHERAL (seriousness criterion hospitalization). At the time of the report, DEEP VEIN THROMBOSIS and OEDEMA PERIPHERAL outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Aug-2021, Blood fibrinogen (150-450 milligram): 539 milligram 539 milligram. On 25-Aug-2021, Fibrin D dimer (0-250 nanogram): 2167 nanogram 2167 nanogram. On 25-Aug-2021, Platelet count: 127000 international unit 127000 INTERNATIONAL UNIT(S)-(UNDER 1000) 400000/150000. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment - Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related. Other possible confounder is patient''s history of hypertension. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Translation received on 07-Sep-2021 contains significant information such as the description of the event.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related. Other possible confounder is patient''s history of hypertension.


VAERS ID: 1687965 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004235 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastrointestinal pain, Headache, Hypotension, Injection site pain, Insomnia, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

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

Write-up: This case was received via Regulatory Authority (Reference number: IT-MINISAL02-777222) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE, DIARRHOEA, HYPOTENSION, INJECTION SITE PAIN, INSOMNIA, PYREXIA, GASTROINTESTINAL PAIN and HEADACHE in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004235) for COVID-19 immunisation. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 24-Aug-2021, the patient experienced SYNCOPE, DIARRHOEA, HYPOTENSION, INJECTION SITE PAIN, INSOMNIA, PYREXIA, GASTROINTESTINAL PAIN and HEADACHE. At the time of the report, SYNCOPE, DIARRHOEA, HYPOTENSION, INJECTION SITE PAIN, INSOMNIA, PYREXIA, GASTROINTESTINAL PAIN and HEADACHE was resolving. No concomitant medication information were provided. No treatment information were provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected upon translation of SD. Case was considered serious as per Regulatory Report assessment. Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Follow-up was received on 06 September 2021 and seriousness criteria was updated from caused/prolonged hospitalization to other medically important condition.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected upon translation of SD. Case was considered serious as per Regulatory Report assessment.


VAERS ID: 1687966 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   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 FG4586 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101135848

Write-up: urticaria; facial swelling; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-777396. A 26-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), intramuscular administered in left arm on 23Aug2021 (Batch/Lot Number: FG4586) as dose number unknown, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced urticaria and swelling face. The patient received treatment of antihistamine and cortisone for 7 days at home- emergency room discharge. The clinical outcome of the events were recovered on an unspecified date 2021. Health authority comment: the vaccination was carried out at 19.00 and the reaction was released at 16.00 on 24Jul. Access to an emergency room with intramuscular administration of cortisone and antihistamine therefore a reaction considered serious by the local pv responsible. Reaction in clear improvement. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1688025 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF9944 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Computerised tomogram head, Feeling abnormal, Grip strength, Heart rate, Hypoaesthesia, Oxygen saturation, Vital signs measurement
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: BP; Result Unstructured Data: Test Result:119/75; Comments: 15:00; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before the vaccination; Test Date: 20210824; Test Name: Head CT; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210824; Test Name: Grip strength; Result Unstructured Data: Test Result:right 34 kg, left 34 kg; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:96; Comments: 15:00; Test Date: 20210824; Test Name: SpO2; Test Result: 98 %; Comments: 15:00; Test Date: 20210824; Test Name: vital signs; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101105664

Write-up: Feeling strange from vaccination site to left shoulder/Feeling strange of left face; Numbness of the left clavicle/Numbness of the left half of the body and left arm; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21124705. The patient was a 49-year-old (age at first vaccination) female. On 24Aug2021 at about 10:50 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, solution for injection, lot number FF9944, expiration date 30Nov2021) via an unspecified route of administration as dose 1, single for covid-19 immunisation. Medical history included asthma (unknown if ongoing). The patient''s history, according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status), included that the patient had received an unspecified treatment for asthma. The patient had no family history. Concomitant medications were not reported. Body temperature before the vaccination was 36.5 degrees Centigrade on 24Aug2021. Events'' onset date was reported as on "24Aug2021 at about 14:00 (3 hrs 10 minutes after the vaccination)". The course of the events was as follows: When vaccinated, there was feeling strange from vaccination site to left shoulder. From about 14:00, feeling strange of left face, numbness of the left clavicle, numbness of the left half of the body and left arm appeared. At 15:00, the patient visited a hospital (physician office visit). On 24Aug2021 BP 119/75 (at 15:00), P 96 (at 15:00), there was no paralysis, SpO2 98% (at 15:00), there was no abnormality in vital signs. Lactec G 250 and Solu-Cortef 100 mg DIV was administered and the patient took Calonal 2T orally. After the DIV, symptoms were mostly recovering, but did not disappear completely. To be on the safe side, head CT was performed on 24Aug2021 and showed no abnormality. Grip strength on 24Aug2021: right 34 kg, left 34 kg. The reporting physician classified the events as non-serious and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: After vaccination, there was numbness of the left half of the body (vaccination side), so it was judged that it was an adverse reaction of the vaccination. On 24Aug2021 (the same day of vaccination), the outcome of the events was recovering.


VAERS ID: 1688026 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF3622 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Contusion, Heart rate, Presyncope
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:102/54; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20210824; Test Name: Pulse rate; Result Unstructured Data: Test Result:60
CDC Split Type: JPPFIZER INC202101105670

Write-up: a state close to Syncope; Forehead and lips bruised on the wall; Blood pressure 102/54; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21124717. A 20-year and 2-month-old (age at first vaccination) female patient received bnt162b2 (COMIRNATY; Lot Number: FF3622; Expiration Date: 30Nov2021), intramuscularly on 24Aug2021 16:00 (the day of vaccination) (at the age of 20-years-old) at dose 1, single for COVID-19 immunization. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.2 degrees Centigrade. The patient''s concomitant medications were not reported. After vaccination, it was reported that patient suddenly became a state close to Syncope and forehead and lips were bruised on the wall. Patient''s blood pressure was 102/54. Event onset dates were reported as on 24Aug2021 at 16:00 (the same day of vaccination). The course of the event was as follows: After vaccination, when under observation, the patient suddenly became a state close to Syncope. Forehead and lips bruised on the wall. Blood pressure 102/54, Pulse rate 60. With only lying rest, after 1 hour, the symptoms disappeared and the patient returned home. The reporting physician classified the events as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. On 24Aug2021 (the same day of vaccination), the outcome of the events was recovered. The reporting physician commented as follows: No special comments. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1688099 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Bradycardia, Fall
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Accidents and injuries (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101112162

Write-up: Atrioventricular block third degree; Bradycardia; Fall; This is a spontaneous report from a contactable physician received from a Regulatory Authority. Regulatory authority report number is v21124884. An 89-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date in 2021 (lot number and expiry date were not reported; at the age of 89 years old; as reported) as dose 1, single and via an unspecified route of administration on an unspecified date in 2021 (lot number and expiry date were not reported) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced atrioventricular block third degree, bradycardia and fall on 24Aug2021 10:30. The patient was hospitalized for all events from 24Aug2021 to an unknown date. All events required physician office visit. The clinical course was as follows: On 24Aug2021, the patient was taken by emergency transport to the hospital due to bradycardia and fall. And the patient was hospitalized for observation with atrioventricular block third degree. The reporter classified the events as serious (hospitalized) and assessed the causality between the event and bnt162b2 as unassessable. The outcome of the events was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.


VAERS ID: 1688112 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF3622 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Feeling abnormal, Heart rate, Nausea, Oxygen saturation, Pain in extremity, Presyncope
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THYRADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:150/; Comments: after vaccination; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:120s; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:156/94; Comments: at 11:00; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:153/92; Comments: at 11:05; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:149/84; Comments: after vaccination at 11:12; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:162/95; Comments: after vaccination at 11:18; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:166/97; Comments: at 11:25; Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:74; Comments: after vaccination at 11:00; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:71; Comments: after vaccination at 11:05; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:67; Comments: after vaccination at 11:12; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:71; Comments: after vaccination at 11:18; Test Date: 20210824; Test Name: P; Result Unstructured Data: Test Result:67; Comments: at 11:25; Test Date: 20210824; Test Name: SPO2; Test Result: 99 %; Comments: after vaccination at 11:00; Test Date: 20210824; Test Name: SPO2; Test Result: 99 %; Comments: after vaccination at 11:12
CDC Split Type: JPPFIZER INC202101112452

Write-up: BP162/95/BP 166/97; At 11:05 Feeling strange on left thumb; Vasovagal reflex; Gastrointestinal symptom(Feeling queasy); Feels poorly; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21124922. The patient was a 59-years and 4-month-old female. Body temperature before vaccination was 36.0 degrees Centigrade. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) Hypertension (rvastatin)(as reported) and hypothyroidism (THYRADIN). On 24Aug2021 at 10:45 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3622, Expiration date 30Nov2021) at the age of 59-years-old, via an unspecified route of administration as a dose 1, single for COVID-19 immunization. Medical history includes hypertension and hypothyroidism. The patient''s concomitant medication includes thyroid (THYRADIN) for thyroid function decreased. On 24Aug2021 at 11:00 (15minutes after vaccination) the patient experienced vasovagal reflex. On 24Aug2021 (the day of the vaccination), the outcome of the events was recovering. The course of the event was as follows: After vaccination, the patient experienced feels poorly and noticed Gastrointestinal symptom (Feeling queasy). The patient took a rest in the dorsal position and received examination, Vital was BP 150/, then took usual medication and BP decreased to 120s, there were no generalized abnormal, blood pressure became stable and feeling queasy was recovering, the patient went back home. It was judged as Vasovagal reflex. The symptom was equal to level 5. Response Record: On 24Aug2021, 15 minutes after vaccination. At 11:00 the patient felt poorly BP156/94, P74, SPO2 99%; At 11:05 she was feeling strange on left thumb, BP 153/92, P71; At 11:12 BP149/84, P67, SPO2 99%; At 11:18 (In a sitting position) BP162/95, P71; At 11:25 BP166/97, P67 the patient was feeling better and able to walk by herself, went back home. Corresponding physician was PRIVACY (the reporter). The reporting physician classified the event as non-serious, but causality was not provided.


VAERS ID: 1688113 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-24
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Chest discomfort, Computerised tomogram, Dyspnoea, Pleural effusion
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210825; Test Name: CT; Result Unstructured Data: Test Result:bilateral pleural effusion
CDC Split Type: JPPFIZER INC202101112482

Write-up: Cardiac failure acute; Dyspnoea; Bilateral pleural effusion; Chest distress; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21124881. A 67-years-old (also reported as age at vaccination) male patient received bnt162b2 (COMIRNATY, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 04Aug2021 as dose 2, single for covid-19 immunisation. There were no medical history and concomitant medications. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 14Jul2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number and Expiration date was unknown) for COVID-19 immunisation. On 25Aug2021 at 05:00 (21 days after vaccination (but reported as 11 days after the vaccination)), the patient experienced cardiac failure acute. On 25Aug2021, the patient was admitted to hospital. The events course was reported as follows: On 24Aug2021 (20 days after vaccination (but also reported as 10 days after the vaccination)), the patient experienced chest distress and the symptom became recovering spontaneously. On 25Aug2021, the patient noticed dyspnoea. It required emergency room visit. CT showed bilateral pleural effusion (25Aug2021). The patient was admitted to hospital started receiving inpatient treatment due to cardiac failure acute. Therapeutic measures were taken as a result of the events reported. The outcome of the events was unknown. The reporter classified the events as serious (hospitalized on 25Aug2021) and the causality between the event and bn162b2 as unassessable. Other possible cause of the events such as any other diseases was cardiac failure acute. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1688137 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FF3622 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chest discomfort, Decreased appetite, Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory, Pyrexia, Tachycardia, X-ray
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:37.4 Centigrade; Test Date: 20210826; Test Name: ECG; Result Unstructured Data: Test Result:no abnormality; Test Date: 20210826; Test Name: 24 hours ECG; Result Unstructured Data: Test Result:just because tachycardia, no special result was ob; Test Date: 20210826; Test Name: x ray; Result Unstructured Data: Test Result:no abnormality
CDC Split Type: JPPFIZER INC202101115363

Write-up: Loss of appetite; dyspnoea; pyrexia to 37.8 degree; tight feeling in the chest.; tachycardia; This is a spontaneous report from a non-contactable physician via medical information team. A 16-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Aug2021 (Lot Number: FF3622; Expiration Date: 30Nov2021) at the age of 16 years old as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Detail of the reaction was as follows: On 24Aug2021(Tuesday),16-year-old male, less than five minutes after COMIRNATY 1st, lay down because of tight feeling in the chest. Laying down for 1 to 2 hours, tachycardia occurred, the patient went home after resting for two hours. On 25Aug2021, the patient went to hospital. Pyrexia to 37.8 degrees at the night of 24Aug2021, went to hospital for antipyretic. It was said that dyspnoea also existed on 25Aug2021.On 26Aug2021, yesterday, tight feeling in the chest, went to hospital for Loss of appetite. Dyspnoea even when speaking. Seeing ECG roughly, but there was no findings, and X-ray also had no abnormality. Body temperature was about 37.4 degrees centigrade, terrible. 24 hours ECG was performed on 26Aug2021, visited our hospital on 27Aug. It was found that the patient was hard just because tachycardia, no special result was observed. The patient had never had tachycardia or palpitations. Although examined various things, the abnormality could not be discovered. However, the symptoms of the patient did not disappear. The outcome of the events was not resolved.; Sender''s Comments: Based on the temporal relation, the association between the events of tachycardia and dyspnoea and the suspect product of BNT162B2 cannot be completely ruled out. 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: 1688143 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210827; Test Name: PCR; Test Result: Positive
CDC Split Type: JPPFIZER INC202101117951

Write-up: This is a spontaneous report from a contactable consumer via medical information team. The patient was a 20-year-old male. The patient received BNT162B2 (COMIRNATY; Solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 05Aug2021 as dose 1, single for COVID-19 immunization. The detail of the reaction was reported as follow: On 05Aug2021, the patient received the first dose of COMIRNATY, after which he was infected with corona. On 20Aug2021 (15 days after the vaccination), the patient was in contact with a positive infected person. On 24Aug2021 (19 days after the vaccination), the patient developed a pyrexia. On 27Aug2021 (22 days after the vaccination), the PCR test was positive. Home convalescence for 10 days, that was all. Symptoms were just low-grade fever and nasal discharge. Outcome of events was unknown. Considering for the second dose vaccination. Seriousness criteria, event outcome, the causality between the event and the vaccine was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1688202 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FG0978 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Fall, Presyncope, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Accidents and injuries (narrow), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:186/159 mmHg; Comments: After the fall; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:166/55 mmHg; Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:95/45 mmHg; Comments: stable
CDC Split Type: JPPFIZER INC202101122237

Write-up: syncope; blood pressure 186/159mmHg, it was high. Measured again 166/55mmHg; Vasovagal reflex; fell from chair; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21125036. A 16-year-old (also reported as 16-year and 10-month-old) male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 24Aug2021 12:00 (at the age of 16-year-old)(Batch/Lot Number: FG0978; Expiration Date: 30Nov2021) as dose 1, single for covid-19 immunisation. The patient had no medical history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant medications were not reported. On 24Aug2021, 12:09 (9 minutes after the vaccination), the patient experienced vasovagal reflex. On 24Aug2021 (the day of vaccination), the outcome of the event was recovered. The course of the events was reported as follows: the patient had syncope, 9 minutes after the vaccination, and fell from the chair. The reporter thought it should be vasovagal reflex. After the fall, blood pressure 186/159mmHg, it was high. Measured again 166/55mmHg. Several minutes later, blood pressure 95/45mmHg, stable. Patient recovered 10 minutes later and went home on foot. No more contact with patient. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Outcome of events was recovered on 24Aug2021.


VAERS ID: 1688703 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: This case was received via Regulatory Authority (Reference number: -FAMHP-DHH-N2021-105782) on 03-Sep-2021 and was forwarded to Moderna on 03-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ARTHRALGIA , HEADACHE , MYALGIA , PYREXIA , PAIN IN EXTREMITY , FATIGUE , SLEEP DISORDER , NAUSEA , INJECTION SITE REACTION , CHILLS and MALAISE in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Concurrent medical conditions included Eczema. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ARTHRALGIA (seriousness criterion disability), HEADACHE (seriousness criterion disability), MYALGIA (seriousness criterion disability), PYREXIA (seriousness criterion disability), PAIN IN EXTREMITY (seriousness criterion disability), FATIGUE (seriousness criterion disability), SLEEP DISORDER (seriousness criterion disability), NAUSEA (seriousness criterion disability), INJECTION SITE REACTION (seriousness criterion disability), CHILLS (seriousness criterion disability) and MALAISE (seriousness criterion disability). On 25-Aug-2021, ARTHRALGIA , HEADACHE , MYALGIA , PYREXIA , PAIN IN EXTREMITY , FATIGUE , SLEEP DISORDER , NAUSEA , INJECTION SITE REACTION , CHILLS and MALAISE had not resolved. Concomitant information was not provided by reporter. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events doesn?t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report. Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Translation document received on 07Sep2021 contains no new information.; Reporter''s Comments: Treatment - Evolution of the ADR - Situations - ADR description - Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events doesn''t seem to be serious by medical judgement and from a clinical or regulatory standpoint, but they were assessed as serious as per regulatory authority report.


VAERS ID: 1690054 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-08-24
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Base excess, C-reactive protein, Chest discomfort, Computerised tomogram thorax, Dyspnoea, Echocardiogram, Fibrin D dimer, Radioisotope scan
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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: 202108; Test Name: Base excess; Result Unstructured Data: -4.2 (a-puncture); Test Date: 202108; Test Name: Computerised tomogram thorax; Result Unstructured Data: No sign of thrombosis; Test Date: 202108; Test Name: C-reactive protein; Result Unstructured Data: 135 Unit not specified; Test Date: 202108; Test Name: Echocardiography; Result Unstructured Data: No sign of thrombosis; Test Date: 202108; Test Name: Fibrin D dimer; Result Unstructured Data: $g20 Unit not specified; Test Date: 202108; Test Name: Scintigraphy; Result Unstructured Data: Of lungs: No sign of thrombosis
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Difficulty breathing; Chest pressure; This case was received via Regulatory Authority (Reference number: DK-DKMA-ADR 25846746) on 02-Sep-2021 and was forwarded to Moderna on 02-Sep-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DYSPNOEA (Difficulty breathing) and CHEST DISCOMFORT (Chest pressure) in a 23-year-old female patient who received mRNA-1273 (batch nos. 3004730 and 3004493) for COVID-19 immunisation. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hosp) and CHEST DISCOMFORT (Chest pressure) (seriousness criterion hosp). At the time of the report, DYSPNOEA (Difficulty breathing) and CHEST DISCOMFORT (Chest pressure) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Base excess: abnormal (abnormal) -4.2 (a-puncture). In August 2021, C-reactive protein: high (High) 135 Unit not specified. In August 2021, Computerised tomogram thorax: normal (normal) No sign of thrombosis. In August 2021, Echocardiogram: normal (normal) No sign of thrombosis. In August 2021, Fibrin D dimer: normal (normal) $g20 Unit not specified. In August 2021, Radioisotope scan: normal (normal) Of lungs: No sign of thrombosis. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications reported. No treatment information was provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1690284 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dysarthria, Facial paralysis, Headache, Hyperhidrosis, Inappropriate schedule of product administration, Nausea, Paraesthesia
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Vestibular disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101105555

Write-up: sweating; Facial droop; Pins and needles; Slurred speech; Headache; Nausea; felt as though I was going to pass out; The patient received BNT1262B2 dose 1 on 26Jun2021 and dose 2 on 24Aug2021; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108241828185040-OHADB, Safety Report Unique Identifier GB-MHRA-ADR 25842550. A 20-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Aug2021, (batch/lot number not reported), at the age of 20-year-old, as DOSE 2, SINGLE for Covid-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. Patient is not enrolled in clinical trial.The patient''s concomitant medications were not reported. The patient received BNT162B2 dose 1 on 26Jun2021 (batch/lot number not reported) for Covid-19 immunisation. The patient experienced sweating on 24Aug2021 with outcome of unknown, facial droop on 24Aug2021 with outcome of recovered on 24Aug2021, pins and needles on 24Aug2021 with outcome of recovered on 24Aug2021, slurred speech on 24Aug2021 with outcome of recovered on 24Aug2021, headache on 24Aug2021 with outcome of recovering, nausea on 24Aug2021 with outcome of recovering and felt as though I was going to pass out on 24Aug2021 with outcome of recovering. Patient has not tested positive for COVID-19 since having the vaccine. The events were assessed as serious and medically significant by regulatory authority. The clinical course was reported as follows: Straight after the vaccine I felt as though I was going to pass out and started excessively sweating. This then passed after 15 mins however an hour after the arm opposite to the one I had the injection started to get pins and needles and I could not hold it up. I then could talk properly and my face started dropping at one side. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690295 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-15
Onset:2021-08-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Hypersensitivity, Myalgia, Pain, Pruritus, Rash macular, Rash maculo-papular
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FEMODETTE; FEXOFENADINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118713

Write-up: Erythema; Rash macular; Hypersensitivity; Pain; sore; itchy; Rash; This is a spontaneous report from a contactable consumer received from a regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108260945260600-R3UPY, Safety Report Unique Identifier GB-MHRA-ADR 25852737. A 27-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration on 15Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing. Concomitant medication(s) included ethinylestradiol, gestodene (FEMODETTE) taken for contraception, start and stop date were not reported; fexofenadine hydrochloride (FEXOFENADINE HYDROCHLORIDE) taken for food allergy, start and stop date were not reported. The patient never had an allergic reaction to medicine before, patient had no symptoms associated with COVID-19, not had a COVID-19 test. patient was not pregnant; patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The reactions started as a rash on her elbow on 24Aug2021 had spread all over his body later. It was red, itchy and sore. Its still spreading. The rash was both sore lumps and small spots (rash macular). Patient also experienced hypersensitivity and pain. Patient had seen a doctor who thinks this may be a reaction to vaccine for COVID on unspecified date. The outcome of events hypersensitivity and sore was unknown, and outcome of all 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: 1690297 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Fatigue, Headache, Myalgia, SARS-CoV-2 test, Swelling of eyelid, Swollen tear duct
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (narrow), Glaucoma (broad), Eosinophilic pneumonia (broad), Lacrimal disorders (narrow), Periorbital and eyelid disorders (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No-Negative COVID-19 test; Comments: No-Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117672

Write-up: Swollen tear duct; Swollen eyelid; Sore eyes; Headache; Fatigue; Muscle ache; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108261057247900-G7QCO. Safety Report Unique Identifier is GB-MHRA-ADR 25853027. A 27-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 24Aug2021 (age at vaccination was 27-year-old) as single dose for COVID-19 immunisation. Patient was not breastfeeding. Medical history included lactation decreased from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Patient was not enrolled in clinical trial. Since the vaccination, the patient was not tested positive for COVID-19. On 24Aug2021, the patient experienced headache, fatigue and muscle ache. On 25Aug2021, the patient experienced swollen tear duct, swollen eyelid and sore eyes. The patient lab test included COVID-19 virus test (sars-cov-2 test) was no-negative covid-19 test. The outcome of the events swollen tear duct and sore eyes was not resolved. The outcome of the event swollen eyelid, muscle ache and fatigue were resolving. The outcome of the event headache was resolved on 26Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1690298 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Fatigue, Influenza, Maternal exposure during pregnancy, Migraine, SARS-CoV-2 test
SMQs:, Severe cutaneous adverse reactions (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID; PARACETAMOL
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pelvic girdle pain; Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101117844

Write-up: Flu; Blister; Exhaustion; Maternal exposure during pregnancy, third trimester; Migraine; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108261105598120-5YFWF, Safety Report Unique Identifier (GB-MHRA-ADR 25853045). A 34-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FE8087), dose 1 via an unspecified route of administration on 24Aug2021 as dose 1, single (at the age of 34 years) for COVID-19 immunization. Medical history included lactation decreased from an unknown date and unknown if ongoing, vitamin supplementation from an unknown date and unknown if ongoing, ongoing pregnancy, pelvic girdle pain from an unknown date and unknown if ongoing. Concomitant medications included folic acid at 400 ug taken for vitamin supplementation, start and stop date were not reported; paracetamol taken for pelvic girdle pain, start and stop date were not reported. The patient experienced maternal exposure during pregnancy, third trimester, migraine, blister and exhaustion on an 24Aug2021 and flu on 25Aug2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jul2021 No - Negative COVID-19 test. Patient has not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was exposed to the medicine Third trimester (29-40 weeks). The events were reported as medically significant. The outcome of the events migraine, blister, exhaustion and flu was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1690309 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   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 FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Fatigue, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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 INC202101118583

Write-up: Pain in arm; Swelling arm; Redness; Tiredness; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108270911157840-LR552. Safety Report Unique Identifier GB-MHRA-ADR 25858602. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: FE8087), via an unspecified route of administration on 24Aug2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. The patient experienced pain in arm, swelling arm, redness, tiredness on 24Aug2021. The outcome of all the events was not recovered. No follow up attempts are possible. No further information is expected.


VAERS ID: 1690394 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Asthenopia, Chills, Fatigue, Headache, Nausea, Neck pain, Paraesthesia, Pyrexia, SARS-CoV-2 test, Temperature intolerance
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Corneal disorders (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No-Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Fatigue; High temperature; Deep heat; Chills; Fever; Headache; Pins and needles; Stomach pain; Neck pain; Nausea; Eye strain; This case was received via Regulatory Authority(Reference number: GB-MHRA-ADR 25864956) on 29-Aug-2021 and was forwarded to Moderna on 29-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), FATIGUE (Fatigue), PYREXIA (High temperature), TEMPERATURE INTOLERANCE (Deep heat), CHILLS (Chills), ASTHENOPIA (Eye strain), PYREXIA (Fever), HEADACHE (Headache), PARAESTHESIA (Pins and needles), ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea) in a 33-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced ASTHENOPIA (Eye strain) (seriousness criterion medically significant) and NAUSEA (Nausea) (seriousness criterion medically significant). On 25-Aug-2021, the patient experienced NECK PAIN (Neck pain) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PARAESTHESIA (Pins and needles) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (Stomach pain) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (Fatigue) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), TEMPERATURE INTOLERANCE (Deep heat) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). The patient was treated with PARACETAMOL for Adverse reaction, at an unspecified dose and frequency. On 27-Aug-2021, PARAESTHESIA (Pins and needles) and NAUSEA (Nausea) had resolved. On 28-Aug-2021, ABDOMINAL PAIN UPPER (Stomach pain) had resolved. At the time of the report, NECK PAIN (Neck pain) had not resolved, FATIGUE (Fatigue), PYREXIA (High temperature), TEMPERATURE INTOLERANCE (Deep heat) and CHILLS (Chills) outcome was unknown and ASTHENOPIA (Eye strain), PYREXIA (Fever) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No-Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The patient was not enrolled in clinical trial and had no symptoms associated with COVID-19. The patient was not pregnant nor was breast feeding. Concomitant medication use information was not provided by reporter. Treatment use information was provided by reporter that include Deep heat and Rest. After dose1, the patient were experienced Itchy arm (side of injection) and brain fog. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1690591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pain
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101137799

Write-up: Inappropriate schedule of vaccine administered; Pain; This is a non-interventional study report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-YCVM-202106121448200240-TAL7Q, Safety Report Unique Identifier GB-MHRA-ADR 25521817. A 26-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection; Lot Number and Expiry date was not reported), via an unspecified route of administration on 24Aug2021 as single dose for COVID-19 immunization. Medical history included depression from an unknown date and unknown if ongoing. Concomitant medication(s) included citalopram (CITALOPRAM) taken for depression from 01Feb2021 to an unspecified stop date. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: FA1027, Expiration date was not reported), dose 1 via an unspecified route of administration on 22Jun2021 as single dose for COVID-19 immunization and experienced pain. The patient experienced pain on 24Aug2021 and inappropriate schedule of vaccine administered on an unspecified date. The events caused medically significant. Patient was not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. Patient had no symptoms associated with COVID-19. The outcome of the vents was pain was not recovered; inappropriate schedule of vaccine administered was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Considering the close temporal association, the reasonable possibility that pain is related to BNT162B2 vaccine cannot be excluded.. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2021766042 for same patient and different dose/event


VAERS ID: 1690611 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: GRPFIZER INC202101133262

Write-up: COVID-19 with mild symptoms; COVID-19 with mild symptoms; This is a spontaneous report from a contactable physician (patient) via a Pfizer sales representative. This physician reported 2 reports for different patients. This is the first of 2 reports. A female patient of an unspecified age received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE both for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced covid-19 with mild symptoms (medically significant) on 24Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 24Aug2021. The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and vaccination failure. There is limited information provided in this report. This case will be reassessed once additional 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.,Linked Report(s) : GR-PFIZER INC-202101133263 Same reporter, different patient


VAERS ID: 1690716 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Axillary pain, Extra dose administered, Headache, Hypoaesthesia, Nausea, Off label use, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Medication errors (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? 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: ILPFIZER INC202101118447

Write-up: sharp pain in the armpit; fever elevated to 38.6 with headaches, weakness for 24 hours; fever elevated to 38.6 with headaches, weakness for 24 hours; fever elevated to 38.6 with headaches, weakness for 24 hours; third vaccine administration; third vaccine administration; vomiting lasted for two hours; nausea; Numbness in half of the face; This is a spontaneous report from a contactable consumer (the patient) received via Pfizer colleague. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 3 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Dose 1 and 2, dates not provided) for COVID-19 immunisation. On 24Aug2021 developed a sharp pain in the armpit of the injected arm for 32 hours. On 23Aug201 at 19:30, the following day her fever elevated to 38.7 and resolved after 24 hours, including weakness. On 24Aug2021, after 20 hours (to confirm if after vaccination) fever elevated to 38.6 with headaches, weakness for 24 hours. On 24Aug2021, about an hour after vaccination severe nausea, immediately followed with vomiting, vomiting lasted for two hours, nausea for 24 hours. Numbness in half of the face for 15 minutes. The outcome of the events was recovered; Weakness, nausea was recovered on 25aug2021, armpit pain recovered on Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained


VAERS ID: 1690820 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Brain stem haemorrhage, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hemodialysis
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hypertension; Renal failure chronic (in hemodialysis)
Allergies:
Diagnostic Lab Data: Test Date: 20210825; Test Name: Blood pressure; Result Unstructured Data: Test Result:140-170 mmHg; Test Date: 20210826; Test Name: Blood pressure; Result Unstructured Data: Test Result:220 mmHg; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at night; Test Date: 20210825; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0-38.0 Centigrade; Comments: in dialysis
CDC Split Type: JPPFIZER INC202101130495

Write-up: Brain stem haemorrhage; Blood pressure increased(140-170/220); pyrexia of 38.5/37.0-38.0 degrees Centigrade; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21125245_20210831. A 44-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Aug2021 11:00 (Batch/Lot Number: FF3620; Expiration Date: 30Nov2021) at 44-years-old as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history included renal failure chronic from an unknown date and unknown if ongoing (in hemodialysis), hypertension from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, ongoing haemodialysis from an unknown date. Concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 for COVID-19 immunisation and experienced queasy on 03Aug2021 (1st single dose, Lot Number: FE8206, Expiration date:31Oct2021, Route of administration: unknown, Administration time: unknown). On 24Aug2021, the patient experienced pyrexia of 38.5/37.0-38.0 degrees centigrade (hospitalization). On 25Aug2021, the patient experienced blood pressure increased (140-170/220) (hospitalization, medically significant). On 26Aug2021, the patient experienced brain stem haemorrhage (hospitalization, medically significant, life threatening). The events required an emergency room visit. The patient was hospitalized for brain stem haemorrhage, pyrexia of 38.5/37.0-38.0 degrees centigrade, and blood pressure increased (140-170/220) from 26Aug2021 to an unknown date. The clinical course was reported as follows: The patient was a 44-year and 6-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade on 24Aug2021. Family history was not reported. Patient''s history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included renal failure chronic and the patient was undergoing hemodialysis, hypertension and diabetes mellitus. On 03Aug2021, the patient previously received the first dose of BNT162B2 (COMIRNATY, Lot number FE8206, Expiration date 31Oct2021). On 24Aug2021 at 11:00 (the day of vaccination), the patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FF3620, Expiration date 30Nov2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25Aug2021 or 26Aug2021 (1 or 2 days after the vaccination) (as reported), the patient experienced pyrexia and brain stem haemorrhage. On 26Aug2021 (2 days after the vaccination), the patient was admitted to the hospital. The outcome of the event was unknown. The course of the event was as follows: On 03Aug2021, the patient received the first dose of BNT162B2. Side effect was mild queasy and there were no symptoms such as pyrexia. On 24Aug2021 (as reported), the patient received the second dose of BNT162B2. At that night, the patient experienced pyrexia of 38.5 degrees Centigrade. On 25Aug2021, the patient experienced pyrexia of 37.0 to 38.0 degrees Centigrade during dialysis and blood pressure was 140 to 170 mmHg and it was slightly high. (Average blood pressure during dialysis was 140 mmHg). The patient took paracetamol (CALONAL) during dialysis. The patient did not experience headache and other symptoms and went home after dialysis. On 26Aug2021, the patient was supposed to come to her family''s house in the evening, but when her family visited her home because she did not come, the patient collapsed and was transported by emergency. At that time, the patient''s blood pressure reached an abnormally high value of 220 mmHg. The diagnosis result was brain stem haemorrhage. "Now the patient admission awareness had not improved and was in a very serious condition." The reporting physician classified the events as serious (Hospitalized from 26Aug2021) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Originally, the patient lived daily life without any problems while on dialysis. The reporter thought that the patient''s pyrexia was accompanied by stress that caused a rapid rise in blood pressure, and sudden brain stem haemorrhage. The reporter considered that if the patient did not receive the vaccination, this result may not appeared. The reporter also considered that the events were still serious side effects caused by the vaccine. The clinical outcome of the event, brain stem haemorrhage, was not recovered on an unspecified date. The clinical outcome of the event, pyrexia and Blood pressure increased, was unknown. ; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101136551 Same reporter/patient/drug, different dose/AE;JP-PFIZER INC-202101136551 Same reporter/patient/drug, different dose/AE


VAERS ID: 1690873 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3005235 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypertensive emergency
SMQs:, Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: ADHD (Under outpatient treatment with ADHD); Hypertension (Hypertension (cessation of treatment))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Hypertensive emergency; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP085141) on 24-Aug-2021 and was forwarded to Moderna on 03-Sep-2021. This case, reported by a physician, was received by Takeda via Moderna''s adverse reaction reporting site (TASK0021163), and reported to the Pharmaceuticals and Medical Devices Agency (PMDA) by a physician, was received via the PMDA (Ref, v21124658). On an unknown date, body temperature before the vaccination: 36.7 degrees Celsius. On 24-Aug-2021, at 14:11, the patient received the 1st dose of this vaccine. At 14:40, after the vaccination, increased blood pressure and headache developed. Symptoms were not resolving with bed rest, and the patient was raced to an emergency hospital. Hypertensive emergency was considered. The outcome of hypertensive emergency was unknown. Follow-up investigation will be made. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Although the patient had a history of hypertension, the causal relationship could not be ruled out because of the hypertensive emergency that developed immediately after the vaccination. The progress after the transportation to the hospital is unknown.; 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. However, the patients medical history of hypertension is a confounder.


VAERS ID: 1690892 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004956 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Peripheral neuropathy; This case was received (Reference number: JP-TAKEDA-2021TJP087639) on 27-Aug-2021 and was forwarded to Moderna on 09-Sep-2021. This case, reported by a vaccine recipient except physician, was received by Takeda via Moderna''s adverse reaction reporting site (TASK0021279). Peripheral neuropathy was assessed as serious by the MAH. On 24-Aug-2021, at 12:55, the patient received the 1st dose of this vaccine. At 13:20, numbness in the limbs and feeling of discomfort was noted. These were considered to be symptoms of peripheral neuropathy. At 13:36, numbness in the limbs was alleviated. Thereafter, the recovery from the symptoms was confirmed. The outcome of peripheral neuropathy was reported as recovered. No follow-up investigation will be possible due to the reporter''s non-cooperation. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: Not reported.; Sender''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. A causal relationship cannot be excluded based on the currently available information.


VAERS ID: 1690894 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004956 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Neuropathy peripheral, Sensory disturbance
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Peripheral nerve disorder; Restlessness and tingling in the right upper limb; This case was received via Takeda Pharmaceuticals (Reference number: JP-TAKEDA-2021TJP087694) on 27-Aug-2021 and was forwarded to Moderna on 09-Sep-2021. This case, reported by a non-physician vaccine recipient, was received by Takeda via Moderna''s adverse reaction reporting site (TASK0021280). Peripheral nerve disorder was assessed as serious by the RA. On 24-Aug-2021, at 13:20, the patient received the 1st dose of this vaccine. There was a tingling sensation at the injection site and a feeling of tingling and restlessness in the right upper limb on the side of the inoculation. Peripheral nerve disorder was suspected. The patient took one tablet of betamethasone/d-chlorpheniramine maleate and one tablet of loxoprofen sodium Hydra, which the patient had brought personally. With follow-up, the patient''s symptoms became mild, and the patient recovered. The outcome of peripheral nerve disorder, restlessness and tingling in the right upper limb was reported as recovered. Follow-up investigation will be not possible due to lack of cooperation in the reporter. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship; Sender''s Comments: This case concerns a 20-year-old male with a serious unexpected event of neuropathy peripheral, and non-serious sensory disturbance. Event onset within 24 hours after first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1697102 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139367

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 610189. A 28-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 24Aug2021 with outcome of recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1697335 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0810 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Dyspnoea, Fatigue
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC202101133061

Write-up: severe asthma attack; Fatigue; difficulty breathing; This is a spontaneous report from a contactable consumer (the patient). A 53-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Deltoid Left on 24Aug2021 14:00 (Batch/Lot Number: FD0810) as single dose for covid-19 immunisation (age at vaccination 53 years) . The patient medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 25Jul2021 (lot number FD7206) The patient experienced severe asthma attack (medically significant) on 27Aug2021 with outcome of recovered , fatigue (non-serious) on 24Aug2021 19:00 with outcome of recovering , difficulty breathing (non-serious) on 24Aug2021 19:00 with outcome of recovering. Therapeutic measures were taken as a result of severe asthma attack including aspirin. Course of the event. A few hours after receiving the second dose he started experiencing fatigue and difficulty breathing. He is a very active person, does a lot of hiking (8000 steps per day). 27Aug2021 he went for a walk in the woods and on his way back he had a severe asthma attack (I could not breathe). The attack lasted 45min. He took an aspirin when he got home. He has no allergies and no history of asthma. He is recovering. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1697669 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

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

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

Write-up: Myocarditis; This case was received via the regulatory authority (Reference number: DE-PEI-202100176582) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myocarditis) in a 32-year-old male patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, MYOCARDITIS (Myocarditis) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1698016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive
CDC Split Type: EEJNJFOC20210922356

Write-up: Vaccination failure; COVID-19; This spontaneous report received from a physician via Regulatory Authority (EVHUMAN Vaccines, EE-SAM-49322108268) on 13-SEP-2021 and concerned a 39 year old female 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 (suspension for injection, intramuscular, batch number: 21C17-05 expiry: Unknown) 0.5 ml, 1 total administered on 31-JUL-2021 for active immunization. No concomitant medications were reported. On 24-AUG-2021, the patient experienced vaccination failure and covid-19. On 26-AUG-2021, Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from vaccination failure, and covid-19. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1698671 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Maternal exposure during pregnancy, Myalgia, Pain, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Arthritis (broad), Tendinopathies and ligament disorders (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: FOLIC ACID
Current Illness: Pregnancy
Preexisting Conditions: Medical History/Concurrent Conditions: Folic acid supplementation; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101118862

Write-up: Maternal exposure during pregnancy; sleepy; muscle ache; joint ache; Ache; Fatigue; This is a spontaneous report received from a contactable consumer, downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108270822526930-5OLUR, Safety Report Unique Identifier GB-MHRA-ADR 25858251. This is the first of 2 reports. A 34-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 23Aug2021 as dose 2, single for COVID-19 immunisation. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation and experienced low blood pressure for 4 days following vaccine and was tested positive for COVID-19 on 17Jul2021- (cough, loss taste, smell, fatigue+, brain fog). The events fatigue and brain fog lasted 2-3 weeks while currently sense of smell was not returned. Medical history included lactation decreased, folic acid supplementation, and ongoing pregnancy. Concomitant medication included folic acid (MANUFACTURER UNKNOWN) taken for folic acid supplementation. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patient had a maternal exposure during pregnancy, second trimester (13-28 weeks). The patient received second dose of the vaccine after waiting for 28 days. On 24Aug2021 (next day of second vaccination), patient experienced ache and fatigue, and on an unspecified date, the patient experienced sleepy, muscle ache, and joint ache. The events were reported to be existed for 24-hours. The events were reported as serious (medically significant). Patient was not tested positive for COVID-19 since having the vaccine. The outcome of event pain and fatigue was recovered on 25Aug2021, while somnolence, joint ache and muscle ache recovered on an unspecified date. 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-202101127325 (Same patient, different dose/ AE)


VAERS ID: 1698810 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-22
Onset:2021-08-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Costochondritis, Gastritis, Inflammation, Muscle twitching, Pain in extremity, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific inflammation (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Gastritis; Inflammation; Lactation decreased; Suspected COVID-19; Ulcerative proctitis (long term illness)
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101133132

Write-up: muscle twitching; gastritis; chest inflammation; sharp pain in feet, legs, hands and arms; Costal chondritis; Paresthesia; This is a spontaneous report from a contactable consumer received from the Agency.A 37-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Aug2021 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included inflammation, gastritis, long term illness ulcerative proctitis, lactation decreased from an unknown date and unknown if ongoing, suspected covid-19 from 21Jul2021 to 26Jul2021, and tested positive for Covid on 23Jul2021. Patient is not pregnant at time of vaccination. Patient is not currently breastfeeding. Patient was not currently taking any medication. The patient experienced muscle twitching, gastritis, and chest inflammation on an unspecified date, paresthesia on 24Aug2021, costal chondritis on 26Aug2021, has constant tingling/muscle twitching/sharp pain in feet, legs, hands and arms on an unspecified date. Patient tested positive for Covid 30 days prior to vaccine. She has constant tingling/muscle twitching/sharp pain in feet, legs, hands and arms. Concerning enough that she has been to a doctor, and then also was advised that she had the vaccine too early after covid, despite information online saying 28 days is sufficient after a positive test. She has chest inflammation as well, which she also suspect is gastritis. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included covid-19 virus test: positive on 23Jul2021 Yes - Positive COVID-19 test. The events were reported as medically significant. The outcome of paresthesia and costal chondritis was not recovered while the rest of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-10
Onset:2021-08-24
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Menstruation irregular, SARS-CoV-2 test
SMQs:, Fertility disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101133030

Write-up: Irregular menstrual cycle; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202108302031507000-4IE8D; Safety Report Unique Identifier: GB-MHRA-ADR 25871308. A 29-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 10Aug2021 as single dose for COVID-19 immunisation. Medical history included suppressed lactation. The patient''s concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration on unspecified date (Lot Number and expiry date was not reported) as single dose for COVID-19 immunization. The patient experienced irregular menstrual cycle on 24Aug2021. Missed period. The event was assessed as medically significant. The patient underwent lab tests which included sars-cov-2 test: no - negative COVID-19 test on unknown date. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient had not had symptoms associated with COVID-19. Patient was not pregnant; Patient was not currently breastfeeding. Patient had not recovered from Irregular menstrual cycle. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1698976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
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: Fibrin D dimer, Platelet count, Retinal vein occlusion, Sight disability
SMQs:, Embolic and thrombotic events, venous (narrow), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Comments: Unknown; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown; Comments: Unknown
CDC Split Type: GBPFIZER INC202101138297

Write-up: Retinal vein occlusion; Sudden unilateral sight loss 3 days after vaccine; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108311132172760-QWEOS. Safety Report Unique Identifier GB-MHRA-ADR 25873392. A 40-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FE3380), via an unspecified route of administration, on 21Aug2021, as single dose, for COVID-19 immunization. Medical history included non-tobacco user. The patient previously took heparin. The patient''s concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced retinal vein occlusion and sudden unilateral sight loss 3 days after vaccine on 24Aug2021. Clinical information included sudden unilateral sight loss 3 days after vaccine and diagnosed retinal vein occlusion in the eye clinic 3 days (27Aug2021) after waking with blurred vision. The patient underwent lab tests and procedures which included platelet count and fibrin d dimer results were unknown. Anti-PF4 antibodies identified was unknown. Outcome of the event retinal vein occlusion was not recovered and outcome of the other event was unknown. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1699172 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-08-24
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Haemorrhage, Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Bladder infection (Most recent medication was anti biotics for bladder infection on 25-Jul-2021.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Bleeding; Prolonged heavy periods; This case was received (Reference number: GB-MHRA-ADR 25897014) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3002332 and 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Bladder infection (Most recent medication was anti biotics for bladder infection on 25-Jul-2021.). On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods). On an unknown date, the patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant). At the time of the report, HAEMORRHAGE (Bleeding) had not resolved and HEAVY MENSTRUAL BLEEDING (Prolonged heavy periods) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported . Treatment information was not provided. Patient reported that normal period length 7 days now on day 12 and still bleeding although is a lot lighter since day 7. Patient was not enrolled in clinical trial. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1699242 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest discomfort, Dizziness, Dyspnoea, Heavy menstrual bleeding, Inappropriate schedule of product administration, Menstruation delayed, Nasal congestion, Oropharyngeal pain, Pharyngeal swelling, Pyrexia, Tachycardia, Throat tightness
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Fertility disorders (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Blood test abnormal; Lactation decreased; Lethargy; Miscarriage (9 weeks in Nov 2018 - Temporarily prescribed 10 mg propanalol for anxiety attacks shortly after.); Shoulder pain; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 201811; Test Name: Blood tests; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: GBPFIZER INC202101144867

Write-up: Inappropriate schedule of vaccine administered; Inability to draw enough air in through nose; Low Grade Fever; Tachycardia; Sore Throat; Tight throat & Chest; Breathlessness; sinus & throat tissue severely inflamed; Tight throat & Chest; light headed; Late period; Heavy periods; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-APPCOVID-202109010120411490-MSWKG. Safety Report Unique Identifier GB-MHRA-ADR 25877582. A 35-year-old female patient received BNT162B2 (Formulation: Solution for injection) via an unspecified route of administration on 05Aug2021 as dose 2, single for COVID-19 immunization. Medical history included arthralgia, Miscarriage (at 9 weeks in Nov 2018 - Temporarily prescribed 10 mg propanalol for anxiety attacks shortly after. Pills left over & take intermittently), lactation decreased, blood test abnormal, lethargy, anxiety, suspected covid-19 from 17Mar2020 to 20Apr2020 and Temporary change in reproductive cycle (extended to 31/32 days for 3 months) late summer 2020 and Cycle normal throughout 2021 until vaccinations and Past drug included propranolol and no previous history of allergies and no appetite, no cough. The patient concomitant medications was not reported. The patient previously received bnt162b2 on 10Jun2021 for COVID-19 immunisation and experienced adverse event (Dose 1). Post Covid information included take over the counter antihistamine Cetirizine every couple of days to relieve symptoms of undiagnosed allergies that affect breathing & hearing (head & ear ache / brain fog/ tight chest). Patient has not tested positive for COVID-19 since having the vaccine and Patient is not enrolled in clinical trial and Not had a COVID-19 test and Patient is not pregnant, Patient is not currently breastfeeding. On an unspecified date, the patient experienced late period, low grade fever, tachycardia, sore throat, breathlessness and Inability to draw enough air in through nose and sinus & throat tissue severely inflamed no previous history of allergies) - unable to speak or lie on back, tight throat and chest waves of worsening symptoms every 3-4 hours where gasping for air and becoming light headed and reported both periods after Pfizer vaccinations were late, shorter in duration with unusually heavy clotting reported inappropriate schedule of vaccine administered and on 24Aug2021, heavy periods that varied by one or two days only by more than one week when pregnant. The patient underwent lab tests and procedures which included on unspecified date in Nov2018 Blood tests conducted showed no abnormalities. The outcome of the events heavy periods was not resolved and other events were unknown. Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "Too anxious to go to a medical practice due to COVID-19 risks. 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-202101138073 Same patient/product, different dose/event.


VAERS ID: 1699519 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Hypotension, Presyncope
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101121566

Write-up: Vagal crisis with hypotension and bradycardia; Vagal crisis with hypotension and bradycardia; Vagal crisis with hypotension and bradycardia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-775623. A 43-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in right deltoid on 24Aug2021 15:15 at the age of 43-year-old (Batch/Lot Number: FG4493; Expiration Date: 30Nov2021) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vagal crisis with hypotension and bradycardia on 24Aug2021 with outcome of recovering. Actions taken: atropine i.v. + 0.9% NaCl 500 ml.


VAERS ID: 1699530 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Fatigue, Oxygen saturation, Presyncope, Streptococcus test, Streptococcus test positive, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (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: SUSTENIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood pressure; Result Unstructured Data: Test Result:105/60; Test Date: 20210824; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210824; Test Name: Antistreptolysin titre; Result Unstructured Data: Test Result:positive DOSAGE FORM
CDC Split Type: ITPFIZER INC202101125619

Write-up: Lipothymic crisis/Pre-syncope; hyper arrhythmia; fatigue crisis; Antistreptolysin titre: positive; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority-WEB IT-MINISAL02-775706. A 21-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 24Aug2021 (Batch/Lot Number: FG4686; Expiration Date: 30Nov2021) (at the age of 21 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included aceglutamide, cyanocobalamin, fosfocreatinine disodium, pyridoxine hydrochloride (SUSTENIUM) taken for an unspecified indication from 24Aug2021 to 24Aug2021. The patient experienced lipothymic crisis/ pre-syncope with hyper arrhythmia/tachycardia, fatigue crisis all on 24Aug2021 with outcome of recovered on 24Aug2021; Antistreptolysin titre: positive dosage form on 24Aug2021 with outcome of unknown. The events lipothymic crisis/ pre-syncope with hyper arrhythmia/tachycardia, fatigue crisis resulted in emergency room visit. The patient underwent lab tests and procedures which included blood pressure measurement: 105/60 on 24Aug2021, oxygen saturation: 98 % on 24Aug2021, Antistreptolysin titre: positive dosage form on 24Aug2021. Sender comment: RLFV 27Aug2021 As per the requested follow-up, updated instrumental examination fields, description of the case, outcome, severity and date of vaccine inoculation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1699579 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure increased, Burning sensation, Loss of consciousness, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (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), Hypertension (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: IT-MINISAL02-776127) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS in a 51-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214019) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form in total. On 24-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion medically significant), BURNING SENSATION, BLOOD PRESSURE INCREASED and TACHYCARDIA. At the time of the report, LOSS OF CONSCIOUSNESS, BURNING SENSATION, BLOOD PRESSURE INCREASED and TACHYCARDIA had not resolved. Concomitant product use was not provided by the reporter. A few minutes after administration of the second Moderna vaccine, the patient felt a strong sensation of widespread burning, collapse, tachycardia and very high blood pressure. The patient was kept under observation for an hour and then went home. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Translation received on 03 Sep 2021 contains dose number was added and narrative updated.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1699627 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7387 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram, Headache, Pericarditis, Pyrexia, Troponin I
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (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)

Life 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: 20210824; Test Name: C-reactive protein; Result Unstructured Data: Test Result:unknown results; Test Date: 20210825; Test Name: Echocardiography; Result Unstructured Data: Test Result:unknown resuts; Test Date: 20210824; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:unknown results; Test Date: 20210824; Test Name: Troponin I; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC202101129240

Write-up: chest pain; pericarditis; back pain; low-grade fever; headache; This is a spontaneous report from a contactable physician downloaded from the Agency. A 16-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FG7387), intramuscular on 23Aug2021 as dose number unknown, single for COVID-19 immunization. Medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced chest and back pain, pericarditis, low-grade fever and headache on 24Aug2021. The patient underwent lab tests and procedures which included c-reactive protein: unknown results on 24Aug2021, echocardiogram: unknown results on 25Aug2021, electrocardiogram: unknown results on 24Aug2021, troponin i: unknown results on 24Aug2021. The outcome of all events was recovering. Reporter''s comments The patient is currently in clinical and instrumental follow-up. Viral serologies are in progress aimed at excluding an infectious form of pericarditis. No follow-up attempts possible. No further information expected; Reporter''s Comments: The patient is currently in clinical and instrumental follow-up. Viral serologies are in progress aimed at excluding an infectious form of pericarditis.


VAERS ID: 1699670 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-24
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: This case was received via regulatory authority(Reference number: IT-MINISAL02-777787) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of PERICARDIAL EFFUSION in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3003605) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 24-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced PERICARDIAL EFFUSION (seriousness criterion medically significant). At the time of the report, PERICARDIAL EFFUSION had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 03-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication details were reported. No treatment medication details was reported. 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.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1699675 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004492 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blepharospasm, Diplopia, Muscular weakness, Nystagmus, Somnolence, Vision blurred
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), Hypoglycaemia (broad)

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

Write-up: This case was received via Medicines Agency (Reference number: IT-MINISAL02-777865) on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SOMNOLENCE, BLEPHAROSPASM, DIPLOPIA, MUSCULAR WEAKNESS, NYSTAGMUS, VISION BLURRED and ASTHENIA in a 17-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004492) for COVID-19 vaccination. Concurrent medical conditions included Food allergy. On 24-Aug-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter in total. On 24-Aug-2021, the patient experienced SOMNOLENCE (seriousness criterion medically significant), BLEPHAROSPASM (seriousness criterion medically significant), DIPLOPIA (seriousness criterion medically significant), MUSCULAR WEAKNESS (seriousness criterion medically significant), NYSTAGMUS, VISION BLURRE (seriousness criterion medically significant) and ASTHENIA (seriousness criterion medically significant). At the time of the report, SOMNOLENCE, BLEPHAROSPASM had resolved with sequelae. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products were not provided. Treatment medication were not reported. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1699698 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF7481 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Cold sweat, Hypothermia, Lethargy, Loss of consciousness, Pain in extremity, Pyrexia, SARS-CoV-2 test, Serology test, Vaccination site reaction
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), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 to 39 Centigrade; Test Date: 20210825; Test Name: body temperature; Result Unstructured Data: Test Result:35.5-35.6 Centigrade; Comments: for another two days, by low body temperature (35.5-35.6); Test Date: 20210826; Test Name: body temperature; Result Unstructured Data: Test Result:35.5-35.6 Centigrade; Comments: for another two days, by low body temperature (35.5-35.6); Test Name: Sars-CoV-2 test; Test Result: Negative ; Test Date: 202101; Test Name: serological test; Result Unstructured Data: Test Result:igG and igM of Covid 19
CDC Split Type: ITPFIZER INC202101174854

Write-up: This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority IT-MINISAL02-779944. A 59 year old female had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: FF7481 was reported) via an unspecified route of administration into in the right deltoid on 23Aug2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was Suspected COVID-19 and concomitant medications were not reported. It was reported that during the adverse events the patient was on vacation with his 21 year old daughter but with out his husband. On 24& 25 Aug2021 the patient had experienced serious state of semi unconsciousness and lethargy, complete asthenia with fever from 38.5 to 39 for a whole day and the following night. The high fever was followed, for another two days, by low body temperature (35.5-35.6) with episodes of cold sweat and assume low blood pressure (which, however, she could not detect, staying at rest and not going out). On the fourth day following the administration, she was able to resume basic activities to a minimum and only after the sixth day after the administration of the first dose of the vaccine was I able to enjoy regular well-being. The right arm, interested in the inoculation, was sore, heavy and burning throughout the period. The patient underwent lab test and procedures, which included body temperature on Jan 2021 and diagnosed as having 38 degrees centigrade fever. On 24Aug2021 the patient was diagnosed as having 38.5 to 39 degrees centigrade fever. on 25 Aug2021 and 26Aug2021 patient underwent lab test again and was diagnosed as having 35.5-35.6 degrees centigrade fever and concluded for another two days, by low body temperature (35.5-35.6). and also on an unspecified date underwent serological test which included igG and igM of Covid 19. Clinical course: Patient Stated that, starting from mid-January 2021 I had a maximum of 38 flu-like intermittent fever. I was in isolation at home as a precaution, working in smart working. After the presumed flu, (early February) I carried out a serological test for my scruple and safety which detected igG and igM of Covid 19. The ASL (Local Health Authority), put me in quarantine at the end of which, the swab performed by the ASL (Local Health Authority) was negative at Covid. The recovery from Covid was spontaneous, without taking any drugs and her last menstruation: 2006. The outcome of the events were recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s): IT-PFIZER INC-202101185213 Different patient, same product and reporter.


VAERS ID: 1699709 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Mechanical ventilation, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Name: Mechanical ventilation; Result Unstructured Data: Test Result:needed; Test Date: 20210824; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive; Comments: First swab positive (gene cycle):18-18-18
CDC Split Type: ITPFIZER INC202101175524

Write-up: vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable physician who reported similar events for six patients. This is the fifth of six reports. A 91-year-old unspecified gender patient received BNT162B2 (solution for injection, Lot Number: not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history includes systemic arterial hypertension and non-smoker and BMI$g30 was no. Concomitant medications were not reported. The patient don''t not have chronic ischemic heart disease, diabetes mellitus, chronic renal failure and autoimmune disease. The reporter sending the file the data relating to 6 patients hospitalized for COVID-19 on 24Aug2021, all after a complete course of Pfizer vaccination. As you can see, for 4 of these the anti-S BAU (Diasorin) titre is high (column X). In any case, it was a Delta variant. The patient underwent lab tests and procedures which included SARS-CoV-2 test, resulted positive on 24Aug2021 (First swab positive (gene cycle):18 -18 -18) and need mechanical ventilation. Outcome of the events was unknown.; Sender''s Comments: Based on the limited information provided the lack of efficacy of the vaccine BNT162B2 cannot be excluded. The case will be reassessed once detailed information regarding vaccination schedule is provided.


VAERS ID: 1699735 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-08-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF9942 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101119537

Write-up: One of them received the first vaccination on 19Aug2021 and became positive for the novel coronavirus on 24Aug2021.; This is a spontaneous report from a contactable consumer. An 18-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Aug2021 (Batch/Lot Number: FF9942; Expiration Date: 30Nov2021) as a single dose, for covid-19 immunization. Medical history and concomitant medications were not reported. The patient received the first vaccination on 19Aug2021 and became positive for the novel coronavirus on 24Aug2021. The outcome of the event was not reported. No follow up attempts are possible. No further information is expected. .


VAERS ID: 1699775 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Internal haemorrhage, Neuralgia, Pain, Vaccination site haemorrhage
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (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: IBUPROFEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glaucoma
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: Blood test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: JPPFIZER INC202101128736

Write-up: internal haemorrhage; pain; neuralgia; injection site haemorrhage subcutaneous; This is a spontaneous report from a contactable pharmacist via a sales representative. A 56-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Aug2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunisation. Medical history included glaucoma. Concomitant medication included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient experienced injection site haemorrhage subcutaneous on 24Aug2021, neuralgia on 25Aug2021, internal haemorrhage on 27Aug2021 and pain on 27Aug2021. The clinical course was as follows: This was a patient for the second inoculation of CMT with initial unknown. On 24Aug2021 (after vaccination), the patient experienced injection site haemorrhage subcutaneous. The patient had haemorrhage subcutaneous after injection. The area of bleeding was a circle with a diameter of about 3cm. On 25Aug2021 (1 day after vaccination), the patient experienced neuralgia. The next day after vaccination (25Aug2021), neuralgia developed near the right pinna on the opposite side of the vaccination and then gradually spread to the back. The patient took OTC Ibuprofen orally on her own decision, which didn''t lead the pain to hinder her life. The patient visited the hospital on 27Aug2021, but the symptoms had not disappeared even now. On 27Aug2021 (3 days after vaccination), the patient experienced internal haemorrhage with pain. On 27Aug2021, bleeding was observed inside the right axilla and gradually spread to the peripheral of arm, along with neuralgia at the same time. On 30Aug2021, as an outpatient, a blood test was conducted. The patient visited the hospital today (30Aug2021) and confirmed it, but it has not recovered even now. Together with other previously reported side reactions (haemorrhage subcutaneous at the vaccination site and neuralgia from the right pinna to the back), the situation was still unrecovered. The putcome of events was not recovered. The reporter classified the event (injection site haemorrhage subcutaneous) as non-serious and the causality between the suspect drug and event was probably related. The reporter classified the event (neuralgia) as non-serious and the causality between the suspect drug and event was probably related. The action taken was permanently withdrawn. The reporter classified the event (internal haemorrhage with pain) as non-serious and the causality between the suspect drug and event was probably related. The action taken was permanently withdrawn. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Internal haemorrhage cannot be totally excluded. The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1699812 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Investigation, Oxygen saturation, Petit mal epilepsy, Vital signs measurement
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (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: Asthma bronchial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: Before vaccination; Test Date: 20210824; Test Name: examination; Result Unstructured Data: Test Result:Wheeze was heard in the upper chest region, diagno; Comments: Wheeze was heard in the upper chest region, diagnosed as asthmatic attack (petit mal); Test Date: 20210824; Test Name: Sat; Result Unstructured Data: Test Result:99; Comments: not low; Test Date: 20210824; Test Name: other vital signs; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101131429

Write-up: asthmatic attack (petit mal); asthmatic attack (petit mal); This is a spontaneous report from a contactable physician received from the Regulatory authority, report number is v21125255. A 43-year-old female patient received bnt162b2 (COMIRNATY; Solution for injection), dose 1 at vaccination age of 43-year-old via an unspecified route of administration on 24Aug2021 (the day of vaccination) at 16:15 (Lot Number: EY5423; Expiration Date: 31Aug2021) as single dose (dose 1, single) for covid-19 immunisation. Medical history included ongoing asthma bronchial. Body temperature before vaccination was 35.9 degrees Centigrade. The patient''s concomitant medications were not reported. On 24Aug2021 at 16:20 (5 minutes after the vaccination), the patient experienced asthmatic attack. On 24Aug2021 (the day of the vaccination), the outcome of the event was recovering. The course of the event was as follows: After the first dose of vaccine, before leaving the hospital after the follow-up observation, the patient experienced cough, pharynx strange sensation of and Dyspnoea. Sat (Saturation) was 99 and not low, and other vitals were also normal. Wheeze was heard in the upper chest region during examination and was diagnosed as asthmatic attack (petit mal). Inhalation of beta stimulator and IV drip of mpSL (methylprednisolone) 80mg were performed as medical treatments. After that, symptoms were recovering, and the patient went home. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. Other possible cause of the event such as any other diseases was Asthma bronchial. The reporting physician commented as follows: It was thought that the asthmatic attack was caused by the vaccination.


VAERS ID: 1699942 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Anaphylactic reaction, Photophobia
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139340

Write-up: Anaphylactic reaction; Photophobia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 609620. A 38-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction and photophobia on 24Aug2021. The patient is recovering from the events. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1699944 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Concomitant disease aggravated, Facial paralysis, Somnolence, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hearing impairment (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139347

Write-up: This is a spontaneous report from a contactable other healthcare professional, via the regulatory authority (report number: 609775). A 55-year-old female patient received BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications not reported. The patient experienced facial paralysis (medically significant), aggravated concomitant disease, somnolence and tremor all on Aug 24, 2021; with outcome of not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.


VAERS ID: 1699955 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Confusional state, Syncope, Tonic clonic movements
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139439

Write-up: This is a spontaneous report from a contactable healthcare professional, via the regulatory authority (report number: 610372). A 31-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient''s medical history and concomitant medications not reported. On Aug 24, 2021, patient experienced tonic clonic movements, syncope and state of confusion; with outcome of not recovered. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.


VAERS ID: 1699988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139699

Write-up: Pericarditis; This is a spontaneous report from a contactable health professional via the Regulatory Authority. Regulatory authority report number is 611942. A 23-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 24Aug2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1699995 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Cardiac flutter
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Tachyarrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101139770

Write-up: Cardiac flutter; This is a spontaneous report from a contactable other healthcare professional (HCP), received from the Regulatory Authority. The regulatory authority report number is 612069. A 37-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as dose number unknown, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced cardiac flutter. The patient was not recovered from cardiac flutter at the time of the report. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.


VAERS ID: 1700016 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101140115

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 613316. A 36-year-old female patient received bnt162b2 [COMIRNATY(mRNA)], via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced pericarditis. The outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1700024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
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: Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101140186

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 613757. A 49-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 24Aug2021. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701458 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Pain in extremity, SARS-CoV-2 test
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210830; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138181

Write-up: Pain in arm; Diarrhea; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory . Regulatory authority report number [GB-MHRA-WEBCOVID-202108312356282100-SEFS5], Safety Report Unique Identifier [GB-MHRA-ADR 25877555]. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 24Aug2021 (at the age of 20-years-old) (Lot Number: FE8087; Expiry date: Not reported) as dose 2, single for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 24Aug2021, the patient experienced pain in arm and diarrhea. The events were assessed as medically significant. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 30Aug2021. Patient had recovered on 26Aug2021 from both events. Additional information: Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1701482 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
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: Diarrhoea, Dizziness, Dyspnoea, Fatigue, Pain, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101145427

Write-up: Dizziness; Diarrhea; Fainted; Fatigue; Ache; Breathlessness; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109011135124130-VRSMR, Sender''s (Case) Safety Report Unique Identifier GB-MHRA-ADR 25879356. A 31-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 24Aug2021 (at the age of 31 years old) (Lot Number: FE3380) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No major health issues. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on unknown date for COVID-19 immunisation. The patient experienced fatigue on 24Aug2021, ache on 24Aug2021, breathlessness on 24Aug2021, diarrhea on 24Aug2021, fainted on 24Aug2021, dizziness on 25Aug2021. Reaction was immediate. Fainted, waited the 15 minutes and made way home where reactions accelerated. All events are medically significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the event fatigue was recovered on 31Aug2021, ache was recovered on 29Aug2021, breathlessness, dizziness was recovered on 26Aug2021, diarrhea was recovered on 24Aug2021 and event fainted was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701538 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Fatigue, Headache, Lymphadenopathy, Nausea, Pain, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUOXETINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145421

Write-up: Nausea; Headache; Fatigue; Glands swollen; Dizzy spells; Ache; Chest tightness; This is a spontaneous report from a contactable consumer or other non-health care professional received from a Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202109012013424730-1SNWH, Safety Report Unique Identifier GB-MHRA-ADR 25882127. A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 24Aug2021 (at the age of 44-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history included fibromyalgia. Unsure if patient has had symptoms associated with COVID-19. Concomitant medication included fluoxetine (FLUOXETINE) taken for fibromyalgia from Jul2006 to an unspecified stop date. On 24Aug2021, the patient experienced headache, fatigue, glands swollen, dizzy spells, ache, chest tightness; nausea on 25Aug2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on an unspecified date, No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The outcome of event chest tightness was recovered on 26Aug2021 and outcome of 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: 1701595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-08-24
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Throat tightness, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANADOL EXTRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hives; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20213

Write-up: Hives; Throat tightness; Inappropriate schedule of vaccine administration; This case was received via regulatory authority. ***(Reference number: GB-MHRA-ADR 25901321) on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of URTICARIA (Hives) and THROAT TIGHTNESS (Throat tightness) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch nos. 3002621 and 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test. The patient''s past medical history included Hives. Concomitant products included CAFFEINE, PARACETAMOL (PANADOL EXTRA) for Migraine aura. On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration). On 29-Aug-2021, the patient experienced URTICARIA (Hives) (seriousness criterion medically significant) and THROAT TIGHTNESS (Throat tightness) (seriousness criterion medically significant). On 24-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administration) had resolved. On 30-Aug-2021, URTICARIA (Hives) and THROAT TIGHTNESS (Throat tightness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment medications were provided. Company Comment: This report refers to a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # 3003651 with associated AEs (Urticaria and Throat tightness). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As this a RA case, reported events seriousness is kept as per RA assessment.; Sender''s Comments: This report refers to a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # 3003651 with associated AEs (Urticaria and Throat tightness). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Seriousness of the events are based on the Regulatory Report received. As this a RA case, reported events seriousness is kept as per RA assessment.


VAERS ID: 1701620 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FT3380 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SALBUTAMOL; SOPROBEC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma exercise induced (asthma); Constipation; Steroid therapy (Taking regular steroid treatment (e.g. orally or rectally))
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101138135

Write-up: Arm discomfort; This is a solicited report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-YCVM-202108231231149690-SBAET, Safety Report Unique Identifier GB-MHRA-ADR 25877520. A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Ft3380), via an unspecified route of administration on 24Aug2021 (at the age of 16-year-old) at single dose for COVID-19 vaccination. Medical history included steroid therapy (Taking regular steroid treatment (e.g. orally or rectally)), asthma exercise induced (also reported as asthma), constipation. Patient last menstrual period date was 01Aug2021. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Patient is not enrolled in clinical trial. Concomitant medications included salbutamol taken for asthma exercise induced from 01May2013; beclometasone dipropionate (SOPROBEC) taken for asthma exercise induced from 01Feb2020. The patient experienced arm discomfort on 24Aug2021. The patient underwent lab test which included COVID-19 virus test: No - Negative COVID-19 test on an unspecified date. The outcome of the event was recovering. This report was reported as serious due to medically significant. The reporter''s assessment of the causal relationship of the event 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: 1701691 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-21
Onset:2021-08-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1E025A / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (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: HKPFIZER INC202101191386

Write-up: BELL''S PALSY (RIGHT); This is a spontaneous report from a non-contactable other health professional via Regulatory Authority (Regulatory authority report number: DH/21/5588), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS003377), license party for bnt162b2(COMIRNATY). A female patient of 57-year-old age received second dose of Tozinameran (COMIRNATY) (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was 1E025A), second dose via an unknown route of administration on 21Aug2021 at unspecified dosing frequency for COVID-19 immunization. She received first dose on unknown date. No medical history reported. No concomitant and past product reported. On 24Aug2021 after three days of vaccination patient experienced Bell''s palsy (Right). Bell''s palsy (Right) met the seriousness criterion of hospitalization. The action taken was not applicable. The outcome of Event was unknown. Initial report was received on 03-Sep-2021. Follow-up closed, no further information is possible.


VAERS ID: 1701843 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
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: Blood test, Fibrin D dimer, Presyncope
SMQs:, Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Blood test; Result Unstructured Data: Test Result:Within normal limits; Test Date: 20210824; Test Name: D-dimer; Result Unstructured Data: Test Result:Within normal limits
CDC Split Type: ITPFIZER INC202101135899

Write-up: Presyncope episode; This is a spontaneous report from a contactable physician downloaded from the Agency. A 38-year-old female patient received BNT162B2 (COMIRNATY; solution for injection; lot number was not reported), intramuscularly on 24Aug2021 10:15 (at the age of 38-years-old) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Aug2021 10:45, the patient experienced presyncope episode that appeared about 30 minutes after the administration of BNT162B2. The patient was accompanied to the emergency room (ER) by a first aid personnel, where a satisfactory clinical condition was restored after intravenous (IV) hydration. Blood tests were performed, and the results were within normal limits including d-dimer. discharged. The outcome of the event was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1701848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-24
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Dysarthria, Ischaemia, Magnetic resonance imaging head abnormal
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: cerebral CT; Test Result: Negative ; Test Date: 20210824; Test Name: brain MRI; Result Unstructured Data: Test Result:signal alteration of the left corona radiata...; Comments: signal alteration of the left corona radiata extended to the posterior arm of the internal capsule compatible with subacute ischemic lesion, concomitant multiple small bilateral areas compatible with soft areas.
CDC Split Type: ITPFIZER INC202101135918

Write-up: Disartria; brain MRI shows signal alteration of the left corona radiata extended to the posterior arm of the internal capsule compatible with subacute ischemic lesion; brain MRI shows signal alteration of the left corona radiata extended to the posterior arm of the internal capsule compatible with subacute ischemic lesion; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number is IT-MINISAL02-777164. A 57-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), dose 1 intramuscular, administered in left arm on 05Aug2021 (Batch/Lot Number: FG4493) as dose 1, 0.3 mL, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Aug2021, the patient experienced appearance of dysarthria, negative cerebral CT, brain MRI shows signal alteration of the left corona radiata extended to the posterior arm of the internal capsule compatible with subacute ischemic lesion, concomitant multiple small bilateral areas compatible with soft areas. The events caused hospitalization. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1701872 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-08-24
   Days after vaccination:40
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cerebral ischaemia, Computerised tomogram head, Neurological examination, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (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: RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Internal carotid aneurysm (aneurysm clipping surgery in left internal carotid bifurcation)
Allergies:
Diagnostic Lab Data: Test Name: Blood test NOS; Result Unstructured Data: Test Result:normal; Test Name: CT brain scan; Result Unstructured Data: Test Result:circumscribed right perirolandic hypodensity; Test Name: Neurological examination; Result Unstructured Data: Test Result:no surgical indications; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: ITPFIZER INC202101149960

Write-up: ischemia cerebrale; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number IT-MINISAL02-777739. A 55-years-old patient of an unspecified gender received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number FF0688; Expiration Date: 31Oct2021)via intramuscular route of administration, administered in Arm Left on 15Jul2021 at 18:39 as dose 2, 0.3 ml, single for COVID-19 immunization. Medical history included hypertension arterial from an unknown date and unknown if ongoing, internal carotid aneurysm from 01Nov2020 to an unknown date aneurysm clipping surgery in left internal carotid bifurcation unknown if ongoing. Concomitant medications included ramipril (RAMIPRIL) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number, Expiration Date were not reported), via an unspecified route of administration on 10Jun2021 as dose 1, single for covid-19 immunisation. On 24Aug2021, the patient had experienced ischemia cerebrale. The patient underwent lab tests and procedures which included blood test: normal, computerised tomogram head: circumscribed right perirolandic hypodensity, neurological examination: no surgical indications, sars-cov-2 test: negative on an unspecified date. The outcome of event was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1701902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-08-24
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2229 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Chest X-ray, Erysipelas, Sepsis, X-ray limb
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INEGY; CARVEDILOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicectomy; Arthroplasty of hip; Chronic venous insufficiency; Diverticulitis; Hypertension arterial; Obesity; Recovered smoker; Spinal canal stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood culture tests; Test Result: Negative; Test Date: 20210824; Test Name: CXR; Result Unstructured Data: Test Result: normal; Test Date: 20210824; Test Name: X-ray of thigh, knee, & lower leg; Result Unstructured Data: Test Result: normal.
CDC Split Type: ITPFIZER INC202101149945

Write-up: sepsis in the course of erysipelas right leg; sepsis in the course of erysipelas right leg; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number IT-MINISAL02-777911. A 76-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: solution for injection) via intramuscularly, administered in left arm (left shoulder) on 28May2021 (Batch/Lot Number: FC2229; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Patient previously received first dose of bnt162b2 (COMIRNATY, formulation: solution for injection) via unspecified route of administration on 07May2021 for covid-19 immunisation. The patient''s medical history included recovered smoker, spinal canal stenosis, appendicectomy, diverticulitis, arthroplasty of hip, obesity, chronic venous insufficiency, and hypertension arterial from an unknown date and unknown if ongoing. The patient''s concomitant medications included INEGY and CARVEDILOL taken for an unspecified indication, start and stop date were not reported. On 24Aug2021, the patient experienced sepsis in the course of erysipelas right leg and hospitalized. The patient underwent lab tests and procedures which included blood culture test on 24Aug2021, and result was negative. The patient also had chest xray, and xray of thigh, knee, and lower leg on 24Aug2021 which results were normal. The outcome of the events were recovering. Update on 08Sep2021 included attached clinical report provided by the reporter. No follow-up attempts possible. No further information expected.


VAERS ID: 1702034 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Orthostatic dysregulation
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101139197

Write-up: Blood pressure decreased; Pallor facial; Queasy; vagal reflex; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21125448. A 15-year and 6-month-old female patient received first dose of bnt162b2 (COMIRNATY, Intramuscular injection, Lot number EY0573, Expiration date 30Sep2021), dose 1 via unspecified route of administration on 24Aug2021 at 14:05 (the day of vaccination) (age at first vaccination: 15-year and 6-month-old) as dose 1, single for covid-19 immunisation. The patient medical history included orthostatic dysregulation. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations, and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination was 36.7 degrees Centigrade. Concomitant medications were not reported. The event onset time for queasy, pallor facial and blood pressure was reported as 24Aug2021, 14:17 (12 minutes after the vaccination). On 24Aug2021 (the same day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: The patient experienced queasy, pallor facial and blood pressure decreased and was laid in bed and treated with drip infusion (therapeutic measure). The symptom showed a tendency of recovering, but it recurred when the patient got up, the patient was hospitalized on that day. On the next day, the symptoms were recovering, and the patient was discharged. On 25Aug2021 (1 day after the vaccination), the outcome of the events was recovering, and patient was discharged from hospital. The patient underwent lab tests and procedures which included blood pressure: decreased on 24Aug2021 and body temperature 36.7 before vaccination on 24Aug2021. The outcome of the event vasovagal reflex was unknown and for rest all the events was recovering. The reporting physician classified the event queasy, pallor facial and blood pressure as serious (hospitalized) and assessed the causality between the events and bnt162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was orthostatic dysregulation. The reporting physician commented as follows: vasovagal reflex occurred at where the patient originally had Orthostatic dysregulation, it probably had prolonged the symptoms.


VAERS ID: 1702037 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Colitis ulcerative, Eczema, Frequent bowel movements, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal ulceration (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMPONI; LIALDA; BIO-THREE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Colitis ulcerative (being administered BIO preparations)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101139268

Write-up: Frequent bowel movements/Number of defecations increased from 8 times to 15 times; Abdominal pain; pyrexia; Eczema; Colitis ulcerative aggravated; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was a 54-year-old female (Age at vaccination 54-years). The patient had a medical history of Colitis ulcerative. On 24Aug2021 (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, 0.3ml, Lot number not provided) for COVID-19 immunization. Concomitant drugs were reported as follows: Simponi Subcutaneous Injection, Daily dose: 100mg/once; Lialda taken orally, Daily dose: 4800mg; BIO-THREE. On 27Aug2021 (3 days after the vaccination), the patient experienced Frequent bowel movements, Abdominal pain, pyrexia and Eczema. The details of the reaction were reported as follow: On 24Aug2021 (the day of vaccination), after the patient received the second dose of vaccination, the patient experienced Colitis ulcerative aggravated. On 01Sep2021 (8 days after the vaccination), the patient visited the hospital. Times of defecations increased from 8 times to 15 times, Abdominal pain, pyrexia and Eczema were found. The outcome of the events was not recovered. The reporter stated the events as non-serious. The causality of the events was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the events Colitis ulcerative aggravated cannot be excluded but consider also patient medical history of . 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: 1702049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-18
Onset:2021-08-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Drug ineffective, Suspected COVID-19
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: Exposure to COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade
CDC Split Type: JPPFIZER INC202101140175

Write-up: insufficient effect after vaccination/pyrexia at 37.2 degrees Centigrade (minor illness); insufficient effect after vaccination/pyrexia at 37.2 degrees Centigrade (minor illness); This is a spontaneous report received from a contactable physician via a Pfizer colleague. A 50-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Aug2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE, and the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included patient''s daughter, new coronavirus infection was positive from 24Aug2021 and ongoing. The patient''s concomitant medications were not reported. On 24Aug2021, the patient experienced insufficient effect after vaccination/ pyrexia at 37.2 degrees Centigrade, and it was minor illness. The clinical course was reported as follows: On 24Aug2021, the patient''s daughter, new coronavirus infection was positive. On the same day, the patient also experienced pyrexia at 37.2 degrees Centigrade, and it was minor illness (as reported). The event was considered medically significant. The patient underwent lab tests and procedures which included body temperature: 37.2 centigrade on 24Aug2021. The outcome of the event was unknown. The reporter classified the events as non-serious and considered that the Causality between the suspect drug and event was definitely related. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1702053 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Decreased appetite, Dizziness, Pain in extremity, Pyrexia, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity (coming to the hospital for a long time and was prescribing the Chinese medicine for obesity.)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: weight; Test Result: 2 kg; Comments: Lost about 2kg in weight
CDC Split Type: JPPFIZER INC202101140506

Write-up: Giddiness; Pyrexia; Pain in Thumbs on both hands (around the base of the thumb by Gestures); Inappetence; Lost about 2kg in weight; the prodromal symptoms of cerebral thrombosis; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative and via Regulatory Authority. A 50-year-old female patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown) via an unspecified route of administration on 24Aug2021 (the day of vaccination, at the age of 50-year-old) as Dose 1 single, for COVID-19 immunization. The patient had no other medical history but had obesity tendency (The regular patient had been coming to the hospital for a long time and was prescribing the medicine for obesity). The patient''s concomitant medications included medicine (unspecified) for obesity. On 24Aug2021 (the day of vaccination), the patient experienced Pyrexia and Giddiness. On unspecified date in 2021 (after the vaccination), the patient experienced pain in thumbs on both hands (around the base of the thumb by Gestures) and Inappetence. On unspecified date in 2021, the prodromal symptoms of cerebral thrombosis and lost about 2kg in weight. The clinical course was reported as follows: On 24Aug2021, the patient received the first vaccination of COMIRNATY and on the same day the patient came to the hospital to prescribe a week''s supply of medicine for Giddiness. The patient was scheduled to come back next week. The Giddiness was probably appeared immediately after the vaccination, but the reporter had not confirmed the date. It was the case that severe side reaction caused by COMIRNATY vaccination; Giddiness happened when the first dose of COMIRNATY. The Giddiness seemed to be quite serious, so the reporter prescribed some medicines for the patient. There was a patient who experienced strong Giddiness after the first dose of COMIRNATY, there was fear of the prodromal symptoms of cerebral thrombosis, so worried about how to do the second vaccination. The reporter was wondering if the patient should continue the second vaccination since the prodromal symptoms of thrombosis might also occur. The doctor was told and admitted that it was up to the patient''s hope and the doctor''s judgment to determine. The patient also had pain in thumbs on both hands (around the base of the thumb by Gestures), and the pain continued. The event onset date was unknown. The patient had Inappetence which was continued until now. And the patient Lost about 2kg in weight. On the day of vaccination, the patient experienced Pyrexia. On 08Sep2021, the patient was diagnosed, and her dizziness was completely resolved. The three medicines, Merislon, Adetphos and oleic acid prescribed last time, although did not know whether the medicines are effective, but still continue to prescribe them. After discussing with the patient and plan to receive the second vaccination. Side effects other than dizziness have not been confirmed. On 25Aug2021, the outcome of pyrexia was recovered, the outcome of giddiness was recovered on unspecified date in 2021, outcome of the events ''pain in thumbs on both hands (around the base of the thumb by gestures) and inappetence'' was not recovered, while the outcome of rest all events was unknown. All side effects were non-serious. For the above adverse events, the reporter classified the events as non-serious and assessed that the events were related to BNT162B2 (Causality was small (as reported)). The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of cerebral thrombosis. 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: 1702079 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8162 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Diarrhoea, Feeling hot, Oropharyngeal discomfort, Oxygen saturation
SMQs:, Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Drug hypersensitivity; Vegetable allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood pressure; Result Unstructured Data: Test Result:130/70; Comments: stable; Test Date: 20210824; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210824; Test Name: SAT 99-100; Result Unstructured Data: Test Result:99-100
CDC Split Type: JPPFIZER INC202101141633

Write-up: Pharynx strange sensation; warm feeling; Diarrhoea; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21125499. A 41-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: FE8162; Expiration Date: 30Nov2021), via an unspecified route of administration on 24Aug2021 (at the age of 41-years-old) as dose 1, single for COVID-19 immunisation. Medical history allergy to (illegible characters), vegetable, anesthesia, (illegible characters), and Fexofenadine. Body temperature before vaccination was 36.6 degrees Centigrade. The patient''s concomitant medications were not reported. On 24Aug2021 the patient experienced pharynx strange sensation, warm feeling and diarrhoea. The clinical course was as follows: on 24Aug2021 (the day of vaccination), the patient experienced the following events. 1-2 minutes after vaccination, the patient experienced pharynx strange sensation and warm feeling. Consciousness clear. Blood pressure:130/70, stable, SAT 99-100. Started the intravenous drip, Rinderon (illegible characters). The symptoms alleviated. (illegible characters). After returning home, diarrhoea occurred. On 25Aug2021 (1 day after vaccination), the outcome of the event was recovering. The reporting physician classified the event as non-serious and assessed that the event was related to bnt162b2. The reporting physician commented as follows: The situation of 2nd does was still uncertain. It is uncertain whether it can be vaccinated.


VAERS ID: 1702085 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-20
Onset:2021-08-24
   Days after vaccination:4
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: Axillary pain, Body temperature, Computerised tomogram, Lymphadenitis, Polymerase chain reaction, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (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: THYRADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hashimoto''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210830; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210831; Test Name: CT; Result Unstructured Data: Test Result:Right Axillary lymphadenitis; Test Date: 20210830; Test Name: PCR; Test Result: Negative
CDC Split Type: JPPFIZER INC202101142590

Write-up: Right Axillary lymphadenitis; pyrexia(38.5 degrees centigrade); Right Axillary pain; Swelling in right armpit; This is a spontaneous report from a contactable other HCP via a Pfizer sales representative received from the Regulatory Authority. Regulatory authority report number is v21125865. A 31-year-old female patient received first dose of BNT162B2 (COMIRNATY) Intramuscular on 20Aug2021 10:00 at single dose (at the age of 31-year-old) for COVID-19 immunisation. Body temperature before vaccination was 36.4 degrees Centigrade. Medical history included Hashimoto''s disease. Concomitant medication included ongoing thyroid (THYRADIN). On 20Aug2021, the patient took vaccination. On 24Aug2021 (4 days after the vaccination), Right Axillary pain and swelling in right armpit occurred. On 30Aug2021, pyrexia (38.5 degrees centigrade), Right Axillary pain continued. PCR showed negative. Because of side effects consultation at hospital. On 31Aug2021, went to hospital for diagnosis due to Right Axillary pain worsen. After CT, Right Axillary lymphadenitis was confirmed. Symptoms improved after IV treatment. On 01Sep2021, confirmed condition by telephone, pyrexia relieved after took medicine by oral, but Right Axillary pain continued. The outcome of pyrexia was resolving. The outcome of other events was not resolved. The reporting other HCP classified the event as serious (Medically Significant), and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. The reporting other HCP commented as follows: No symptoms so far, kind of healthy. As symptoms occurred after vaccination, the reporter thought the event was related to bnt162b2. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1702216 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-06
Onset:2021-08-24
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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

Write-up: COVID-19 infection; This case was received via regulatory authority(Reference number: JP-TAKEDA-2021TJP085195) on 02-Sep-2021 and was forwarded to Moderna on 15-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 infection) in a 49-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced COVID-19 (COVID-19 infection) (seriousness criterion medically significant). At the time of the report, COVID-19 (COVID-19 infection) had resolved. This case concerns a 49-year-old male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19. The event occurred approximately19 days after the first dose of COVID-19 vaccine mRNA (mRNA 1273). The event was considered related to the product per the reporter''s assessment. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.; Reporter''s Comments: Not reported.; Sender''s Comments: This case concerns a 49-year-old male patient with no relevant medical history, who experienced the unexpected serious event of COVID-19. The event occurred approximately19 days after the first dose of COVID-19 vaccine mRNA (mRNA 1273). The event was considered related to the product per the reporter''s assessment. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting, however, there was no information in the source document of seriousness from a clinical or regulatory standpoint.


VAERS ID: 1702246 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004232 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALINE HYDROCHLORIDE; LORATADINE; LEMBOREXANT; HANGEKOBOKUTO
Current Illness: Colitis ulcerative; Depression; Panic disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: body temperature before the vaccination 36.1 degrees Celsius
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Blood in stool; Diarrhoea; This case was received via regulatory authority (Reference number: 2021TJP087702) on 02-Sep-2021 and was forwarded to Moderna on 09-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MELAENA (Blood in stool) and DIARRHOEA (Diarrhoea) in a 36-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004232) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: mesalazine (Discontinued due to symptoms of cold). Concurrent medical conditions included Colitis ulcerative, Depression and Panic disorder. Concomitant products included SERTRALINE HYDROCHLORIDE, LORATADINE, LEMBOREXANT, HANGEKOBOKUTO and BYAKKOKANINJINTO for an unknown indication. On 23-Aug-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced MELAENA (Blood in stool) (seriousness criteria hospitalization and medically significant) and DIARRHOEA (Diarrhoea) (seriousness criterion hospitalization). At the time of the report, MELAENA (Blood in stool) and DIARRHOEA (Diarrhoea) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 36.1 (normal) body temperature before the vaccination 36.1 degrees Celsius. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MELAENA (Blood in stool) and DIARRHOEA (Diarrhoea) to be possibly related.; Reporter''s comments: Ulcerative colitis may have been another possible contributing factor. The causality with the vaccine is unclear. Sender''s comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The events occurred as signs of exacerbation of ulcerative colitis.


VAERS ID: 1702628 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Facial paralysis, Fatigue, Headache, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hearing impairment (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: IBUX
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: ansiktslammelse; hjertebank; tr?tthet; hodepine; This case was received via Regulatory Authority on 06-Sep-2021 and was forwarded to Moderna on 06-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (ansiktslammelse) in a 31-year-old female patient who received mRNA-1273 (Spikevax) for Vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included IBUPROFEN (IBUX) from 25-Aug-2021 to an unknown date for Pain. On 24-Aug-2021 at 4:30 PM, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced FATIGUE (tr?tthet) and HEADACHE (hodepine). On 25-Aug-2021, the patient experienced FACIAL PARALYSIS (ansiktslammelse) (seriousness criterion medically significant) and PALPITATIONS (hjertebank). At the time of the report, FACIAL PARALYSIS (ansiktslammelse) and PALPITATIONS (hjertebank) was resolving and FATIGUE (tr?tthet) and HEADACHE (hodepine) had not resolved. No treatment details were reported. The patient reports that it was worst on day 2. Company comment: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.


VAERS ID: 1702694 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3430 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: blood pressure measurement; Result Unstructured Data: Test Result:140/100 mmHg
CDC Split Type: PHPFIZER INC202101146211

Write-up: Elevated BP; dizziness; This is a spontaneous report from a contactable other healthcare professional (hcp). This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300102028. A 62-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: FE3430, expiry date not reported), intramuscular on 24Aug2021 (at the age of 62 years old) as dose number unknown, single covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of the report and of the vaccination. On 24Aug2021 10:10, the patient experienced elevated bp, which was reported as medically significant; and dizziness, which was reported as non-serious. The patient underwent lab tests and procedures which included blood pressure measurement: 140/100 mmhg on 24Aug2021. The events recovered on an unspecified date in 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1702846 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: SARS-CoV-2 RT-PCR test; Result Unstructured Data: Not reported
CDC Split Type: PTJNJFOC20210923118

Write-up: VACCINATION FAILURE; ASYMPTOMATIC COVID-19; This spontaneous report received from a physician via a Regulatory Authority (PT-INFARMED-B202108-3599) on 13-SEP-2021 and concerned a 24 year old male of unknown race and ethnicity. The patient''s weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393, expiry: unknown) 0.5 ml, 1 total, administered on 21-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 24-AUG-2021, the patient experienced asymptomatic covid-19 and vaccination failure. Laboratory data included: SARS-CoV-2 RT-PCR test (NR: not provided) Not reported. The dose of covid-19 vaccine ad26.cov2.s was not changed. The outcome of the asymptomatic covid-19 and vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint.; Reporter''s Comments: Other information: Vaccinated (single dose). PCR SARS-CoV-2 positive on 24-Aug-2021. Asymptomatic, will be discharged on 02-Sep-2021


VAERS ID: 1703166 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Myocardial infarction
SMQs:, Anaphylactic reaction (narrow), Myocardial infarction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, arterial (narrow), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Multiple allergies
Preexisting Conditions: Medical History/Concurrent Conditions: Anaphylaxis (the patient has previously reacted with anaphylaxis on several occasions, unclear when); Stroke (About 15 years ago.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101150121

Write-up: myocardial infarction; Anaphylaxis grade 3; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number SE-MPA-2021-078440. A 76-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 24Aug2021 (76-year-old at time of vaccination) as single dose for COVID-19 immunisation. Medical history included ongoing allergies to multiple substances, unspecified; ongoing hypertension; anaphylaxis (the patient has previously reacted with anaphylaxis on several occasions, unclear when); stroke (about 15 years ago). The patient previously received acetylsalicylic acid and experienced drug allergy (the patient has allergies to multiple medications, including acetylsalicylic acid, not further specified). The patient''s concomitant medications were not reported. The patient experienced anaphylaxis grade 3 (life threatening) on 24Aug2021. Verbatim: Report from a hospital physician. Reported suspected adverse reaction was anaphylaxis grade 3. The report states that the patient received first dose of vaccine and was subsequently assessed to have allergic reaction anaphylaxis grade 3 and as a result suffered a myocardial infarction. Case was assessed as serious, life threatening. The outcome of the events was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.


VAERS ID: 1703760 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chills
SMQs:, Retroperitoneal fibrosis (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: BEPFIZER INC202101149682

Write-up: Low back pain; Shivering; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-105945. A 36-years-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration, on 24Aug2021, at single dose, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On 24Aug2021, the patient experienced low back pain and shivering. The adverse events were assessed as serious (disability). The patient did not recover from the adverse events at time of this report. Reporter comment: Treatment - No Outcome of the adverse drug reaction - No improvement No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1703834 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-24
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Blood test, C-reactive protein, Electrocardiogram, Urine analysis
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiety; Obsessive-compulsive disorder (Patient has OCD/anxiety/intrusive thoughts)
Preexisting Conditions: Comments: The patient is very rarely physically ill
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 202108; Test Name: C-reactive protein; Result Unstructured Data: 28 Unit not specified; Test Date: 202108; Test Name: EKG; Result Unstructured Data: Nothing abnormal; Test Date: 202108; Test Name: Urine strip test; Result Unstructured Data: Nothing abnormal
CDC Split Type: DKMODERNATX, INC.MOD20213

Write-up: Severe abdominal pain between belly button and bottom part of sternum; This case was received via regulatory authority (Reference number: DK-DKMA-ADR 25862049) on 08-Sep-2021 and was forwarded to Moderna on 08-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe abdominal pain between belly button and bottom part of sternum) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004959 and 3004493) for COVID-19 immunisation. The patient is very rarely physically ill. Concurrent medical conditions included Anxiety and Obsessive-compulsive disorder (Patient has OCD/anxiety/intrusive thoughts). On 20-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, after starting mRNA-1273 (Spikevax), the patient experienced ABDOMINAL PAIN UPPER (Severe abdominal pain between belly button and bottom part of sternum) (seriousness criterion hospitalization). On 25-Aug-2021, ABDOMINAL PAIN UPPER (Severe abdominal pain between belly button and bottom part of sternum) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood test: normal (normal) Normal. In August 2021, C-reactive protein: 28 (abnormal) 28 Unit not specified. In August 2021, Electrocardiogram: normal (normal) Nothing abnormal. In August 2021, Urine analysis: normal (normal) Nothing abnormal. No relevant concomitant medications were reported. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1703864 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Angioedema, Arthralgia, Dyspnoea, Haemodynamic test, Headache, Investigation, SARS-CoV-2 test, Skin reaction
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal allergic conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ADENURIC; INEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness: Arthritis gouty; Iodine contrast media allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Clear cell renal cell carcinoma; Gastric ulcer; Nephrectomy (right)
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: Hemodynamics; Result Unstructured Data: Test Result:stable; Test Date: 20210824; Test Name: clinical examination; Result Unstructured Data: Test Result:normal; Comments: normal in the emergency room, apart from the persistence of mild headaches and diffuse arthralgias; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101166538

Write-up: Anaphylaxis/rade II anaphylactic reaction; Headache; Polyarthralgia; the onset of dyspnea; abdominal pain; skin reaction; angioedema of the face; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-BR20213340]. A 43-year-old male patient received 1st dose of BNT162B2 (COMIRNATY) at single dose intramuscular on 24Aug2021 11:00 at 43-year-old for COVID-19 immunisation. Medical history included right nephrectomy for clear cell renal cell carcinoma, ongoing arthritis gouty, gastric ulcer, ongoing allergy to iodine contrast products. Concomitant drugs included usual treatments of febuxostat (ADENURIC) and esomeprazole magnesium (INEXIUM). Adverse events were reported as c, headache, and polyarthralgia with onset date of 24Aug2021. On 24Aug2021, in the minutes following the injection, skin reaction with angioedema of the face, treated with antihistamine and solupred, then return home. A few hours later, help was called due to the onset of dyspnea, abdominal pain and headache. No blood pressure figures available on the emergency report during the initial treatment, but patient treated by the Mobile emergency and resuscitation service, having benefited from 2 injections of adrenaline (0.5 mg intramuscular then 0.02 mg intravenous), antihistamines and 4mg of morphine. Hemodynamics were noted as stable. The clinical examination was normal in the emergency room, apart from the persistence of mild headaches and diffuse arthralgias. No dosage of tryptase transmitted. Given the effectiveness of the treatment initiated in the emergency room, clinicians conclude that there was a probable anaphylaxis following the first injection of COMIRNATY. Allergological monitoring was planned: contraindication to the second injection pending the allergological assessment. SARS-CoV-2 test was negative on an unknown date. It was concluded that patient experienced grade II anaphylactic reaction following the first injection of COMIRNATY. Outcome of headache was resolved on 24Aug2021. Outcome of anaphylaxis and polyarthralgia was resolving. Outcome of the other events was unknown. The event anaphylaxis was assessed as serious with seriousness criteria of hospitalization, medically significant, life-threatening. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705122 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-24
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202101169973

Write-up: Pericarditis; This is a spontaneous report from a contactable other health professional via the Agency Regulatory Authority. Regulatory authority report number is 613757. A 49-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pericarditis on 24Aug2021 with outcome of unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705133 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-17
Onset:2021-08-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Computerised tomogram head, Disturbance in attention, Eye pain, Fatigue, Headache, Malaise, Muscular weakness, Myalgia, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Glaucoma (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 202108; Test Name: Computerized tomography brain scan; Result Unstructured Data: Test Result:unknown
CDC Split Type: BEPFIZER INC202101142607

Write-up: Pain in the left part of the skull; Pain behind the left eye; Sensation of the left cheek falling asleep; Fatigue; Muscle aches; Difficulty concentrating; Headache; Malaise; Muscular weakness; This is a spontaneous report from a contactable consumer downloaded from the WEB, regulatory authority number BE-FAMHP-DHH-N2021-105798. A 31-years-old male patient received the first dose of bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Aug2021 (Batch/Lot Number: FE7053) as single dose for covid-19 immunisation. Medical history included light alcohol consumption (wine or beer during dinner). Patient did not smoke. No known medical condition. No known allergy. No known medical history. The patient''s concomitant medications were not reported. Patient experienced malaise, fatigue, myalgia, headache, mental concentration difficulty, muscular weakness on 24Aug2021. Pain in the left part of the skull (impression of having a spike planted in the brain). Pain behind the left eye. Sensation of the left cheek falling asleep. Difficulty concentrating, The above symptoms were felt when patient was driving and therefore seated. The symptoms below were observed after getting out of the vehicle. Muscle weakness in the left arm, muscle weakness in the left leg. Case was reported as serious, hospitalization. Examinations: Computerized tomography brain scan in Aug2021. Patient had no treatment. Outcome of malaise, fatigue, myalgia, headache, mental concentration difficulty, muscular weakness were recovering and the other events were unknown. Reporter comment: Treatment: No. Evolution of the adverse drug reaction: In the process of improvement. Situations: Other: 7 days after the inoculation. Examinations: Computerized tomography brain scan.; Reporter''s Comments: Treatment: No. Evolution of the adverse drug reaction: In the process of improvement. Situations: Other: 7 days after the inoculation. Examinations: Computerized tomography brain scan.


VAERS ID: 1705139 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Chills, Headache, Hypoaesthesia, Myalgia, Nausea, Pyrexia, Vaccination site reaction
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (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: Dust allergy; Pollen allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: fever; Result Unstructured Data: Test Result:38.1 C; Comments: (as high was 38.1c)
CDC Split Type: BEPFIZER INC202101142592

Write-up: skin numbness in the face, hands, arms, legs and back..; Headache; Injection site reaction; Arthralgia; Nausea; Shivering; Fever; Muscle pain; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority number is BE-FAMHP-DHH-N2021-105895. A 38-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot Number: Unknown) as dose 2, single (at the age of 38 years) for covid-19 immunisation. Medical history included dust allergy and pollen allergy from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced headache, injection site reaction, arthralgia, nausea, shivering, fever and muscle pain on 24Aug2021 18:00. The patient was treated with paracetamol (for now). It was reported that the patient intend to go see the doctor if it continues. It was further reported that the injection took place in the morning. Beginning at 6 p.m., chills and headaches, pain in muscles and joints. Temperature going as high as 38.1 C, taking Paracetamol. Very intense headache despite Paracetamol. She was unable to take care of her children. The next evening 25Aug2021, the fever disappeared but she started to have numbness of the skin in my face, hands, arms, legs and back. The outcome of the event fever was recovered on 25Aug2021, while recovering from all the other events at the time of the report. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Evolution of ADR: in the process of improvement, intend to go see the doctor if it continues. ADR description: Injection in the morning. At 6PM, chills and headaches, pain in muscles and joints. Temp as high as 38.1C. Very intense headache despite Paracetamol. Unable to take care of children. Next evening, ever disappeared but started to have numbness of the skin in my face, hands, arms, legs and back. Still have numbness in face and left arm, back.


VAERS ID: 1705323 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Crying, Echocardiogram, Electroencephalogram, Headache, Loss of consciousness, Magnetic resonance imaging, Memory impairment, Moaning, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Organ failure (at birth); Septic shock (at birth)
Allergies:
Diagnostic Lab Data: Test Name: heart echo; Result Unstructured Data: Test Result:No known organic diseases; Comments: regularly carried out; Test Name: electroencephalogram; Result Unstructured Data: Test Result:No known organic diseases; Comments: regularly carried out; Test Date: 202108; Test Name: electroencephalogram; Result Unstructured Data: Test Result:unknown results; Test Name: magnetic resonance imaging; Result Unstructured Data: Test Result:No known organic diseases; Comments: regularly carried out
CDC Split Type: DEPFIZER INC202101142663

Write-up: Nocturnal seizure with loss of consciousness (approx. 3 a.m.); Nocturnal seizure with loss of consciousness (approx. 3 a.m.)/unconscious state; vomiting; headache; could not remember anything; moaning; wailing; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority number is DE-PEI-CADR2021170532, Safety Report Unique Identifier is DE-PEI-202100177606. A 14-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 23Aug2021 at 18:30 (Batch/Lot Number: Unknown) as dose number unknown, single for COVID-19 immunisation. Medical history included septic shock and complete organ failure at birth. The patient''s concomitant medications were reported as none. The patient previously took methylphenidate. The patient experienced nocturnal seizure with loss of consciousness (approx. 3 a.m. on 24Aug2021) after the vaccination the evening before at 6.30 p.m. Emergency doctor and ambulance transport to the hospital. 2 days inpatient stay with EEG etc. The patient underwent years of examinations and treatments in special care centers and clinics. Patient underwent drug therapy with methylphenidate. Currently the patient is not undergoing any drug therapy, integrative medicine treatment or getting any school support. No known organic diseases (magnetic resonance imaging, electroencephalogram, heart echo regularly carried out). In an unconscious state while moaning and wailing in bed. Not responsive, no reaction. Soaked, no fever. Fire brigade, emergency doctor and ambulance arrived. Transported immediately to the children''s clinic. On 24Aug2021, the patient was vomiting in the emergency room and suffered from a headache. The patient was given saline and paracetamol infusions. Subsequently hospitalised. The next day on 25Aug2021, the patient had a severe headache and could not remember anything from the night before. The patient''s memory only begins to slowly return during the day. Neurological examinations, such as an electroencephalogram, were carried out. The patient was hospitalized due to seizure, loss of consciousness, vomiting and headache from 24Aug2021 to 26Aug2021. Outcome of seizure and loss of consciousness was recovered on 24Aug2021 while remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1705385 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dizziness, Inflammatory bowel disease, Irritable bowel syndrome, Pyrexia, Vaccination site oedema, Vaccination site pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic colitis (broad), Vestibular disorders (broad), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: fever (over 38C); Result Unstructured Data: Test Result:over 38 Centigrade
CDC Split Type: FIPFIZER INC202101149847

Write-up: Possible irritable bowel syndrome/inflammatory bowel disease; Possible irritable bowel syndrome/inflammatory bowel disease; Oedema extremity upper; Pyrexia; Dizziness; Pain in arm; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20214290. A 20-year-old female patient received bnt162b2 (COMIRNATY, Lot number was unknown), dose 2 via an unspecified route of administration, administered in left arm on 24Aug2021 (at the age of 20-year-old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) on unspecified date as dose 1, single for COVID-19 immunization. On 24Aug2021, the patient experienced oedema extremity upper (vaccination site oedema), fever (over 38C)/ pyrexia, dizziness, pain in arm (vaccination site pain). The patient also experienced possible irritable bowel syndrome/inflammatory bowel disease on unspecified date. The outcome of the event possible irritable bowel syndrome/inflammatory bowel disease was unknown, and the outcome of the remaining 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: 1705421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4493 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101143091

Write-up: Edema hands; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is FR-AFSSAPS-BX20217890. A 22-year-old male patient received the first dose of BNt162B2 (COMIRNATY; Lot Number: FG4493), intramuscular on 23Aug2021 as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced edema hands on 24Aug2021. The outcome of the event was not recovered. The regulatory authority assessed the report as serious (medically significant). The clinical course was reported as follows: 12 hours after vaccination, edema of the left hand ( vaccinated side) rendering grip strength nonfunctional 4 days off work. Management: Consultation. Evolution : Not recovered. NB: Imputation made without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable procedures of compensation. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705561 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCEL5 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Chest pain, Chills, Dyspnoea, Echocardiogram, Electrocardiogram, Heart sounds, Hyperthermia, Influenza like illness, Nausea, Pericarditis, Specialist consultation, Troponin, Vertigo, White blood cell count
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (narrow), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210826; Test Name: blood pressure; Result Unstructured Data: Test Result:117/66 mmHg; Test Date: 20210824; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Test Date: 20210824; Test Name: brain natriuretic peptide; Result Unstructured Data: Test Result:< 5 ng/L; Test Date: 20210824; Test Name: C-reactive protein; Result Unstructured Data: Test Result:8.2 mg/l; Test Date: 20210826; Test Name: Echocardiography-doppler; Result Unstructured Data: Test Result:Normal left ventricular function - strain - 22%; Comments: normal left ventricular systolic function (left ventricular ejection fraction 61% SB-STRAIN-22%) with no abnormal segmental kinetics. Left ventricle is non-dilated and non-hypertrophied (parietal thicknesses at 8/8 mm). Normal cardiac output. Non-dilated ascending thoracic aorta 25 mm in its tubular portion. Diastolic function: Normal mitral profile with E/A ratio 1.4. Left fill pressures not increased. Left atrium not dilated. Absence of significant valve disease. Non-dilated and normo-kinetic right ventricle. Systolic Pulmonary Artery Pressure 27 mmHg. No shunt at the atrial and ventricular stages. No hypervolemia. Dry pericarditis.; Test Date: 20210826; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Sinus rhythm at 62 bpm. Normal atrioventricular; Comments: Sinus rhythm at 62 bpm. Normal atrioventricular conduction (PR interval = 116 ms). Physiological QRS axis. Incomplete right block. No repolarisation abnormality.; Test Date: 20210826; Test Name: Heart sounds; Result Unstructured Data: Test Result:Regular without audible murmur. No sign of lef; Comments: Regular without audible murmur. No sign of left or right cardiac insufficiency. Free pulmonary auscultation; Test Date: 20210826; Test Name: cardiologist consultation; Result Unstructured Data: Test Result:general condition is good; Test Date: 20210824; Test Name: troponin HS; Result Unstructured Data: Test Result:< 3 ng/L; Test Date: 20210824; Test Name: white blood cells; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC202101142988

Write-up: Pericarditis sicca/Dry pericarditis; Influenza like illness; Shivers; Hyperthermia at 39.2?C; Vertigo; Nausea; Inspiro-dependent chest pain/anterior medio-thoracic and basi-pulmonary pain - inspiro-dependent pain - oppressive/ pinching; Inspiratory blockpnea; This is a spontaneous report from a contactable consumer and healthcare professional downloaded from the regulatory authority number FR-AFSSAPS-ST20213234. A 14-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: SCEL5), intramuscular on 23Aug2021 as dose 2, 0.3ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient has no medical history of COVID-19. The patient experienced pericarditis sicca/dry pericarditis on 26Aug2021, and influenza like illness on 24Aug2021. At Day 1 on 24Aug2021, shivers, hyperthermia at 39.2?C, vertigo, nausea and inspiro-dependent chest pain, and inspiratory blockpnea were reported. Functionally it was reported as anterior medio-thoracic and basi-pulmonary pain - inspiro-dependent pain - oppressive/ pinching. Treatment with anti-inflammatory Aspegic, iNexium 40 mg for 4 weeks, and Colchimax were reported. Blood test on 24Aug2021 includes: C-reactive protein: 8.2 mg/L; troponin HS: <3 ng/L; brain natriuretic peptide: <5 ng/L; white blood cells: normal. Cardiac consultation on 26Aug2021 indicated: At clinical examination, general condition is good. Blood pressure: 117/66 mmHg, heart sounds are regular without audible murmur. No sign of left or right cardiac insufficiency. Free pulmonary auscultation. Electrocardiography on 26Aug2021 showed: Sinus rhythm at 62 bpm. Normal atrioventricular conduction (PR interval = 116 ms). Physiological QRS axis. Incomplete right block. No repolarisation abnormality. Echocardiography-doppler on 26Aug2021 showed normal left ventricular systolic function (left ventricular ejection fraction 61% SB-STRAIN-22%) with no abnormal segmental kinetics. Left ventricle is non-dilated and non-hypertrophied (parietal thicknesses at 8/8 mm). Normal cardiac output. Non-dilated ascending thoracic aorta 25 mm in its tubular portion. Diastolic function: Normal mitral profile with E/A ratio 1.4. Left fill pressures not increased. Left atrium not dilated. Absence of significant valve disease. Non-dilated and normo-kinetic right ventricle. Systolic Pulmonary Artery Pressure 27 mmHg. No shunt at the atrial and ventricular stages. No hypervolemia. Dry pericarditis. Conclusion: Normal left ventricular function - strain - 22%. Electrocardiography without notable abnormalities. Post-vaccine pericarditis: Based on semiological data without seriousness criteria (left ventricular ejection fraction no abnormality, STRAIN-22%); no effusion. No evidence for myocarditis given a normal troponin assay. The outcome of the event Pericarditis sicca/Dry pericarditis was not recovered, and for influenza like illness was recovered on an unknown date, and for other events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1705614 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8087 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Cough, Headache, Limb discomfort, Off label use, Product use issue, Pyrexia, Rhinorrhoea, SARS-CoV-2 test, Sinus headache
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CODEIN; HEPARIN; OMEPRAZOL
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Gallbladder pain; Gallstones; Pregnancy; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101145549

Write-up: Off label use; Drug use in unapproved population; Loss of taste; Loss of smell; Cough; Runny nose; Fever; Sinus headache; Arm discomfort; Headache; This is a spontaneous report from a contactable consumer received from the Regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202109011901026460-YI2MA. Safety Report Unique Identifier GB-MHRA-ADR 25881754. This consumer reported information for both mother and baby. This is the mother report. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FE8087, Expiry date not reported), via an unspecified route of administration on 24Aug2021 (age at vaccination was 31 years) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing breast feeding, suspected COVID-19 from 27Jun2021, biliary colic (gallbladder pain), pregnancy, and cholelithiasis (gallstones). Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not pregnant. Concomitant medications included codeine phosphate (CODEIN) taken for biliary colic (gallbladder pain) from 30Apr2021 to an unspecified stop date; heparin taken for pregnancy from 18Jul2021 to an unspecified stop date; omeprazole (OMEPRAZOL) taken for cholelithiasis from 30Apr2021 to an unspecified stop date. The patient experienced sinus headache on 28Aug2021 with outcome of not recovered, arm discomfort on 24Aug2021 with outcome of recovered on 27Aug2021, headache on 24Aug2021 with outcome of not recovered, cough on 29Aug2021 with outcome of not recovered, runny nose on 29Aug2021 with outcome of not recovered, fever on 29Aug2021 with outcome of not recovered, loss of taste on 31Aug2021 with outcome of not recovered loss of smell on 30Aug2021 with outcome of not recovered; off label use and drug use in unapproved population on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 30Jun2021 No - Negative COVID-19 test. The events were reported as serious, medically significant by the health authority No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101151273 Baby report


VAERS ID: 1705717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-08-24
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Joint swelling, SARS-CoV-2 test, Vasculitis
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE; VITAMINE D
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:unknown results; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101152261

Write-up: Vasculitis legs; Joint swelling; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number: GB-MHRA-WEBCOVID-202109022104487880-X8LI5; Safety Report Unique Identifier: GB-MHRA-ADR 25889427. A 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FD8813, Expiry date was not reported), via an unspecified route of administration on 13Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included emtricitabine, tenofovir disoproxil fumarate was taken for an unspecified indication from 01Mar2021 to an unspecified stop date; colecalciferol (VITAMINE D) taken for an unspecified indication from 17Aug2021 to an unspecified stop date. On 24Aug2021, patient experienced vasculitis legs and joint swelling. The events assessed as medically significant. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included blood test was unknown results, sars-cov-2 test was negative (No - Negative COVID-19 test) on an unspecified date. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.


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