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

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



Case Details (Reverse Sorted by Onset Date)

This is page 323 out of 7,116

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VAERS ID: 1588705 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210832135

Write-up: SUSPECTED GRADE II ANAPHYLAXIS; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines] concerned a 35 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XE395) 1 dosage forms, 1 total, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced suspected grade ii anaphylaxis. The patient was hospitalized (date unspecified). Number of days of hospitalization was not reported. It was unknown if patient was discharged. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected grade ii anaphylaxis. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0:20210832135-covid-19 vaccine ad26.cov2.s-suspected grade ii anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1589134 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2245 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Investigation, Mastitis, Off label use, Product use issue, SARS-CoV-2 test
SMQs:, Functional lactation disorders (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: examination; Result Unstructured Data: Test Result:unknown results; Test Date: 20210730; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998485

Write-up: Mastitis; took bnt162b2 on 14May2021 as first dose/on 31Jul2021 as second dose; currently breastfeeding; currently breastfeeding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority report number is GB-MHRA-APPCOVID-20210803204348, Safety Report Unique Identifier GB-MHRA-ADR 25749984. This consumer reported information for both mother and baby. This is a maternal report. A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW2245), via an unspecified route of administration on 31Jul2021 (at the age of 23 years old) as second dose, single for COVID-19 immunization. Medical history included ongoing breast feeding. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 on 14May2021 (Lot number: EW4109) as first dose, single for COVID-19 immunization. The patient was reported as currently breastfeeding on 31Jul2021. The patient experienced mastitis on 02Aug2021 with outcome of not recovered. The event mastitis required physician office visit; the patient had examination at doctors on unspecified date (examination: unknown result). The patient underwent lab tests and procedures which included COVID-19 virus test: No-negative covid-19 test on 30Jul2021. Patient is not enrolled in clinical trial. Therapeutic measure was taken as a result of the event mastitis which included antibiotics. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202101005385 Baby case


VAERS ID: 1589177 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Insomnia, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998507

Write-up: This is a spontaneous report from a contactable consumer or other non-HCP, received via the regulatory authority (report number: GB-MHRA-WEBCOVID-202108030937348990-7GYSZ; safety report unique identifier: GB-MHRA-ADR 25745420). A 35-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine; batch/lot# FD8813; expiration date: not provided), at the age of 35, via an unspecified route of administration, on Jul 31, 2021, single dose, for COVID-19 immunisation. Patient''s medical history and concomitant medications not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient not enrolled in a clinical trial. Reportedly, patient couldn''t sleep for two days (insomnia), felt fatigue/fatigued (Jul 31, 2021) and had whole body aches (unspecified date). The events assessed serious (medically significant). The outcome of whole body aches: unknown; insomnia/couldn''t sleep for two days recovered on Aug 2, 2021; and fatigue/felt fatigued: recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1589178 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Chills, Dizziness, Fatigue, Lymphadenopathy, Menstruation irregular, Myalgia, Nausea, Neck pain, Pain, Pain in extremity, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Fertility disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CERELLE; CETIRIZINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Pregnancy
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998681

Write-up: upper body aches; pain in arm and back still not recovered; pain in arm and back still not recovered; Nausea; Irregular periods; Swollen lymph nodes/Swollen glands; Neck pain; Injection site pain; Muscle ache; Chills; Joint pain; Dizziness; Tiredness; Shoulder pain; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108030938393810-OAUN1, Safety Report Unique Identifier: GB-MHRA-ADR 25745500. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot# FF3319) dose 2 via an unspecified route of administration on 31Jul2021 (33-year-old at vaccination) at single dose for COVID-19 immunization. The patient''s medical history included pregnancy, hay fever. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial. Concomitant medications included desogestrel (CERELLE) taken for oral contraception from May2009; cetirizine hydrochloride taken for hay fever from 08May2021. The patient experienced swollen lymph nodes, swollen glands, neck pain, injection site pain, muscle ache, chills, joint pain, nausea, irregular periods on 01Aug2021, dizziness, tiredness, shoulder pain on 31Jul2021, upper body aches, pain in arm and back on an unspecified date. Most symptoms started 12 hours after vaccination, was bed/sofa bound for a day. Most resolved 24hrs after. However upper body aches and pain in neck, shoulder, arm and back still not recovered. The patient had taken paracetamol 4 times a day. Adverse reaction did not occur as a result of an exposure during pregnancy. The outcome of events swollen lymph nodes, swollen glands, neck pain, injection site pain, irregular periods, shoulder pain, upper body aches, pain in arm and back was not recovered, outcome of events muscle ache, tiredness was recovering, outcome of rest events was recovered on 02Aug2021. Case is serious as medically significant. No follow-up attempts are possible; No information is expected.


VAERS ID: 1589190 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Inappropriate schedule of product administration, Myalgia, Nausea, Pain, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998674

Write-up: michele aches; Nausea; Muscle ache; Joint pain; Headache dull; First dose on 05Jun2021/ Second dose on 31Jul2021; sore arm; This is a spontaneous report from a contactable consumer (patient) received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031052437660-7XGWB and Safety Report Unique Identifier GB-MHRA-ADR 25745842. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FD8813), dose 2 via an unspecified route of administration on 31Jul2021 (at the age of 28-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Otherwise healthy adult male no long term conditions or known allergies. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 Vaccine) dose 1 on 05Jun2021 (Lot number: EY5456) for COVID-19 Immunisation. In the first 12 hours (on 31Jul2021) following his second dose he suffered with a sore arm after 24 hours (on 01Aug2021) he started to suffer with very dull on and off headaches and continuous nausea, joint pain and Michele aches. Also experienced muscle ache on 01Aug2021. The events were reported as serious due to Other medically important condition by the regulatory authority. The patient underwent lab tests and procedures which included COVID-19 virus test on 02Aug2021: negative (No - Negative COVID- 19 test). The outcome of the events was recovering. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589230 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (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 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998278

Write-up: Very heavy, extremely painful period; Period pains; This is a spontaneous report from a contactable consumer received from the Regulatory authority report number is GB-MHRA-WEBCOVID-202108031529052810-9KX4O, Safety Report Unique Identifier is GB-MHRA-ADR 25747781. A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jul2021 (Lot number and expiry date not reported) as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation (lactation decreased). Patient had not had symptoms associated with COVID-19. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications were not reported. The patient experienced period pains on 31Jul2021 with outcome of recovered with sequelae on 03Aug2021, and very heavy, extremely painful period on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included SARS-COV-2 test: no - negative COVID-19 test. The event period pains was assessed as serious, medically significant by the health authority, while very heavy, extremely painful period was non-serious. Narrative case summary and further information: Case narrative: Very heavy, extremely painful period 5 days after vaccine. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589231 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling cold, Headache, Middle insomnia, Nasopharyngitis, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19.
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998564

Write-up: cold like symptoms; sore arm; waking up at night struggling to get warm; Nauseous; Coldness, struggling to get warm; Dizziness, lightheaded; Headache; Tiredness; This is a spontaneous report from a contactable consumer. This is a report received from Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108031538107410-Z10CU, Safety Report Unique Identifier GB-MHRA-ADR 25747832. A 24-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number FD8813), via an unspecified route of administration as single dose on 31Jul2021 for COVID-19 immunization. Medical history included suspected COVID-19 from 08Jan2021 and ongoing. He was not enrolled in clinical trial and not had a COVID-19 test. The patient''s concomitant medications were not reported. The patient experienced headache and tiredness on 31Jul2021; nauseous, coldness, and dizziness on 01Aug2021; cold like symptoms and sore arm on an unspecified date. Case narrative: Sore arm, then feeling tired, waking up at night struggling to get warm, as the day goes on lightheaded and cold like symptoms. She has not tested positive for COVID-19 since having the vaccine. The outcome of nauseous was recovering; for headache, tiredness, coldness, and dizziness was not recovered; while outcome of other events was unknown. Case reported as medically significant by health authority. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3340 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
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 INC202100998690

Write-up: worst symptoms; Stomach ache; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108031745351660-OYVNO, Safety Report GB-MHRA-ADR 25748754. A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 30Jul2021 (Lot Number: FE3340) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced stomach ache getting progressively worse on 31Jul2021. And Worst symptoms (diarrhoea) early morning on an unknown date. Seriousness criteria was provided as other medically important condition. The patient underwent lab tests and procedures which included No - Negative COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. The outcome of stomach ache was not recovered. The outcome of worst symptoms (diarrhoea) was unknown. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1589249 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Asthenia, Headache, Lethargy, Malaise, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Taste and smell disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998484

Write-up: Headache; Taste loss/loss of taste; Malaise; Lethargy; Muscle ache/muscle aches all over; lack of energy; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108031814309480-SNVIS, Safety Report Unique Identifier: GB-MHRA-ADR 25748989. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 31Jul2021 (Lot number was not known) as dose 2, single for COVID-19 immunisation. Medical history included depression. Patient has not had symptoms associated with COVID-19. Concomitant medication included citalopram taken for depression from 01Jan2016. The patient experienced lack of energy, loss of taste on an unspecified date; muscle ache on 31Jul2021; malaise, lethargy, and taste loss on 01Aug2021; and headache on 02Aug2021. Clinical course reported: malaise, muscle aches all over, headache, lack of energy, loss of taste. Symptoms lasted approx. 3 days. Patient unable to work during this time. 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: no - negative COVID-19 test on 21Jul2021. The outcome of the events lack of energy was recovered on an unspecified date; muscle ache/muscle aches all over was recovered on 03Aug2021; malaise and taste loss/loss of taste was recovered on 04Aug2021; headache was recovered on 05Aug2021; and lethargy was recovering. Regulatory authority assessed the events as serious: medically significant. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589278 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, Dizziness, Fatigue, Headache, Lymphadenopathy, Nausea, Pain in extremity, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: Dermoid cyst; Endometriosis; Lactation decreased; Migraine; Miscarriage (One miscarriage); Polycystic ovarian syndrome
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 degree Centigrade; Comments: I had a slight raised temperature of 37.5; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 degree Centigrade; Comments: I''m usually 36.4?c.; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998645

Write-up: raised temperature; Arm pain; Headaches; light headedness; vomiting; extreme fatigue; Glands swollen; nausea; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108032013450430-5XNII, Safety Report Unique Identifier is GB-MHRA-ADR 25749807. A 29-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at the arm on 31Jul2021 at 09: 45 at the age of 29 years old as single dose for COVID-19 immunization. Medical history included lactation decreased from an unknown date, miscarriage (one miscarriage) from Apr2021, polycystic ovaries (PCOS) from Apr2021, endometriosis from Apr2021, migraine from Apr2021, dermoid cyst from Apr2021. The patient''s concomitant medications were not reported. The patient experienced raised temperature on an unspecified date; nausea, and extreme fatigue, glands swollen all on 31Jul2021. The events were reported as serious (disability, medically significant). Clinical course was reported as follows: Had my 2nd dose on Saturday 31Jul2021 at 9.45am, an hour later my whole right arm was in pain (administered arm) I then proceeded to have headaches, light headedness, pain in glands, swelling under arms and next to breasts, extreme fatigue, nausea and vomiting in the first 24hrs - the vomiting ended after 24hrs. I had a slight raised temperature of 37.5 when I''m usually 36.4?c. I''m three days after the 2nd dose and I''m still experiencing these symptoms but they are reduced slightly, have no vomiting. 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 SARS-COV-2 test with no - negative COVID-19 test result on an unknown date. The patient recovered from vomiting on 01Aug2021 while patient had not recovered from glands swollen. The patient was recovering from the other events. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589282 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100998287

Write-up: pain; Period is a week early; Heavy bleeding; Period pains; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines and Healthcare products Regulatory Agency (UK-MHRA). Regulatory authority report number [GB-MHRA-WEBCOVID-202108032114136490-UJBMF], Safety Report Unique Identifier [GB-MHRA-ADR 25750173]. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, on 24Jul2021 (Lot/batch number not known) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced pain, period is a week early and heavy bleeding on an unspecified date; and period pains on 31Jul2021. The events were assessed as serious (medically significant). The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on an unknown date. The outcome of the event ''pain'' was recovered on an unspecified date; event ''period is a week early'' was unknown; events ''period pains'' and ''heavy bleeding'' was recovering. The clinical course was reported as follows: Her period was a week early, very painful on the same side she got the vaccine (left). It''s heavy bleeding like last time but the pain was uncomfortable. Last time lasted 5 days, she was on day 4 and its only easing a bit this time after 2nd shot so may be longer. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Additional information: Patient has not had symptoms associated with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1589285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-31
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202100998521

Write-up: breathless; Palpitations; This is a spontaneous report from a contactable consumer (patient). This is a report received from the United Kingdom''s Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202108032136075950-O1ZMC, Safety Report Unique Identifier GB-MHRA-ADR 25750264. A 26-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 21Jul2021 at single dose for COVID-19 immunisation. Medical history included lactation decreased and suspected COVID-19 from 15Mar2020 and unknown if ongoing (reported as unsure when symptoms stopped). Patient is not enrolled in clinical trial. Patient is not pregnant at the time of the vaccination. Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on unspecified date for COVID-19 immunisation. The patient experienced strong palpitations that came on and off since 31Jul2021. Breathing exercises etc. do not seem to help. She has continued with training for a triathlon whilst the palpitations have been ongoing. Exercise does not seem to worsen the issue at all (although she has found herself to get slightly more breathless when exercising, and this is most obvious when swimming as she has had to change how often she breathe). The patient had negative COVID-19 virus test on unspecified date. The outcome of the events was not recovered. The events were considered serious, medically significant. No follow-up attempts are possible; information about lot number cannot be obtained.


VAERS ID: 1589287 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Discomfort, Fatigue, Headache, Lymphadenopathy, Pain, 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? 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 INC202100998603

Write-up: headache; fatigue; chills; discomfort; Swelling of the underarm; Aches and pains; Fever; Swelling; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108032205109170-DLVVE, Safety Report Unique Identifier is GB-MHRA-ADR 25750374. A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: FF3319, Expiry date not reported), via an unspecified route of administration on 30Jul2021 as dose 2, single for COVID-19 immunization. Medical history included suppressed lactation (lactation decreased). Patient had not had symptoms associated with COVID-19, not had a COVID-19 test. Patient was not pregnant. Patient was not currently breastfeeding. Concomitant medications were not reported. The patient experienced headache on an unspecified date with outcome of not recovered, fatigue on an unspecified date with outcome of not recovered, chills on an unspecified date with outcome of not recovered, discomfort on an unspecified date with outcome of not recovered, fever on 31Jul2021 with outcome of recovered on 01Aug2021, swelling on 31Jul2021 with outcome of recovering, swelling of the underarm on an unspecified date with outcome of unknown, and aches and pains on an unspecified date with outcome of unknown. The events were reported as serious, medically significant by the health authority. Case narrative: Swelling of the underarm on the side the jab was given. Discomfort. Fever and chills. Headache. Aches and pains. Fatigue ongoing. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Maternal exposure during pregnancy, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100998282

Write-up: Vomiting; Pregnant 22 weeks; 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-202108040647419560-QRL55. Safety Report Unique Identifier GB-MHRA-ADR 25750996. This is a maternal report. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (Batch/Lot number was not reported) as DOSE 2, 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 is not enrolled in clinical trial. The patient experienced vomiting on 03Aug2021. The event was assessed as serious (medically significant). The patient became pregnant while taking BNT162B2. The patient was 22 Weeks pregnant at the onset of the event. The outcome of the event vomiting was recovering. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1589329 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH F61510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Feeling abnormal, Inappropriate schedule of product administration, Lymph node pain, Lymphadenopathy, Myalgia, Pain, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data: Test Date: 20201219; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Date: 20210731; Test Name: High temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: GBPFIZER INC202101005955

Write-up: Swollen painful lymph nodes in armpit; Swollen painful lymph nodes in armpit; Fatigue; Chills; 2nd dose is outside of the 19-42 day vaccination window; body pain; High temperature; Muscle pain; hours; This is a spontaneous report from a contactable consumer or other non-health care professional received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108040933097800-8Y8DS, Safety Report Unique Identifier GB-MHRA-ADR 25751990. A 37-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: F61510), via an unspecified route of administration on 31Jul2021 (at the age of 37-years) as dose 2, single for COVID-19 immunization. Medical history included lactation decreased and suspected covid-19 from 14Dec2020 to an unknown date (unsure when symptoms stopped). Patient is not currently breastfeeding. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (lot number: ET8885) via an unspecified route of administration on 25May2021 as dose 1, single for COVID-19 immunization. On an unspecified date in 2021, the patient experienced hours (feeling abnormal). On 31Jul2021, the patient experienced body pain, high temperature, muscle pain and chills. On 01Aug2021, the patient experienced fatigue, swollen painful lymph nodes in armpit. It was reported that, a few hours after vaccine, the patient had chills followed by whole body pain which lasted about 48hours. High temperature of 38 centigrade about 15-20hours after vaccine. Swollen painful lymph nodes in armpit, same side as injection, 2-4days after vaccine. 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 high temperature: 38 centigrade on 31Jul2021 and COVID-19 virus test: negative on 19Dec2020. The outcome of events hours, body pain was recovered on an unspecified date in 2021, high temperature was recovered on 01Aug2021, muscle pain, fatigue was recovered on 02Aug2021, lymph node pain and axillary lymph nodes enlarged was recovered on 03Aug2021 and chills was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589343 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9001 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005865

Write-up: Pins and needles / tingling sensation in arm, hand, leg and toes on the opposite side to vaccine; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202108041026092680-J4J3T) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25752241). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: FF3319) as SINGLE DOSE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: FC9001) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Never had any illnesses or diseases. Patient has not had symptoms associated with COVID-19. The patient experienced pins and needles / tingling sensation in arm, hand, leg and toes on the opposite side to vaccine (medically significant) on 31Jul2021. The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative covid-19 test on an unknown date. The outcome of the event was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1589349 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal, Hypoaesthesia, Lymphadenopathy, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Dementia (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBIMAZOLE; FEXOFENADINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atopic eczema; Chronic urticaria; Hyperthyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101006161

Write-up: extremely docile; sore/dead arm; sore/dead arm; Swollen lymph nodes; armpit swelling; This is a spontaneous report from a contactable consumer, This report is received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041052057980-PILUO and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25752507. A 30-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FF3319, expiration date: unknown), via an unspecified route of administration on 31Jul2021 (at the age of 30 years) as dose 2, single for covid-19 immunisation. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunisation. Medical history included urticaria chronic, hyperthyroidism and dermatitis atopic. Concomitant medications included Carbimazole taken for hyperthyroidism from 03Jun2021, and Fexofenadine taken for urticaria from 11Jun2019. It was reported that patient had not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. On 31Jul2021, patient experienced armpit swelling. On 01Aug2021, patient had Swollen lymph nodes and on an unknown date, patient had extremely docile. The events were considered serious as medically significant events. It was reported that after receiving the vaccine, the lymph node in the armpit was swollen and was very tender. Very notable compared to the other armpit. The armpit which reacted was the same side as the injection site. The common sore/dead arm side effect also present and extremely docile. The armpit swelling is going down now (4/8/21 - 4 days later) but still not fully resolved yet and was worse side effects out of the 2 vaccines. At the time of report, patient was recovering from the events armpit swelling and Swollen lymph nodes while outcome of event extremely docile was reported as unknown. No follow-up attempts were possible. No further information was expected.


VAERS ID: 1589398 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Body temperature, Diarrhoea, Fatigue, Inappropriate schedule of product administration, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202101006042

Write-up: High temperature; Diarrhoea; Abdominal pain; Fatigue; first dose on 25May2021, second dose on 31Jul2021; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202108041632057360-1GLWP. Safety Report Unique Identifier GB-MHRA-ADR 25754969. A 38-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 (at the age of 38-year-old) (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on 25May2021 (Lot number was not reported) for covid-19 immunization. The patient experienced high temperature, diarrhoea on 03Aug2021; abdominal pain, fatigue on 01Aug2021; all medically significant. The patient experienced first dose on 25May2021, second dose on 31Jul2021. All of the above side effects occurred with second vaccine. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the events high temperature and abdominal pain was recovering, events diarrhoea and fatigue was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589444 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Body temperature, Cold sweat, Fatigue, Feeling hot, Headache, Hyperhidrosis, Influenza, Influenza like illness, Pyrexia, SARS-CoV-2 test, Tremor, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: temperature; Result Unstructured Data: Test Result:high; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005712

Write-up: flu; cold sweats; Shaking; Flu-like aching; High temperature; Vomiting; Heavy sweating; Tiredness; Vivid dreams; Headache dull; so much hot; This is a spontaneous report from a contactable consumer received from the regulatory authority report number is GB-MHRA-WEBCOVID-202108042309078700-EMXFO. Safety Report Unique Identifier GB-MHRA-ADR 25756930. A 40-year-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Not known), via an unspecified route of administration at the age of 40-year-old on 31Jul2021 at single dose (dose number unknown) for COVID-19 immunisation. Medical history included lactation decreased. The patient''s concomitant medications were not reported. The patient experienced flu, cold sweats, shaking, flu-like aching, high temperature, vomiting, heavy sweating, tiredness, vivid dreams and headache dull on 31Jul2021. All symptoms started exactly 12 hours after jab. Subsided by 30 hours after jab administration. Felt like the worst flu she had ever had in her life, couldn''t even get out of bed to vomit, body was shaking so much hot and cold sweats. Paracetamol had no effect on the symptoms. Her husband thought they may have to see a doctor he had never seen someone so unwell. The events were serious for being medical significant. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests included COVID-19 virus test: negative on unspecified date (reported as No - Negative COVID-19 test). The outcome of event flu was recovering and other events was recovered on 01Aug2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1589931 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood test, Body temperature, Chest discomfort, Dyspnoea
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; PITAVASTATIN; EZETIMIBE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood test; Result Unstructured Data: Test Result:almost no problem; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101010464

Write-up: Anaphylaxis; dyspnoea; a sick feeling in the chest; This is a spontaneous report from a contactable physician received from the Regulatory authority. A 60-year and 1-month-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 31Jul2021 15:34 (the day of vaccination) (at the age of 60-year and 1-month-old) (Batch/Lot Number: EY0572; Expiration Date: 31Oct2021) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Patient''s medical history according to the Vaccine Screening Questionnaire (including underlying diseases, allergies, vaccinations received or diseases developed within the last month, medications used, past adverse drug reaction history, and growth status) included angina pectoris. The patient concomitant medications included clopidogrel 75 mg was orally taking ongoing, pitavastatin, ezetimibe tablet. On 31Jul2021 at 15:50 (the day of the vaccination), the patient experienced anaphylaxis. On 31Jul2021 (the day of the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 31Jul2021 at around 15:45, approximately 11 minutes after receiving the first vaccination with the novel coronavirus vaccine, the patient experienced dyspnoea and a sick feeling in the chest. At 15:58, adrenaline 0.3 mg was intramuscularly injected by a physician in the vaccination venue. (The information including the vital signs at that time was unknown.) When the patient arrived at the hospital, the patient had no blood pressure decreased or worsening of respiratory status, but mild chest symptoms persisted. The patient received treatment including steroid administration in order to prevent biphasic reactions and was admitted to the hospital for observation. Blood test showed almost no problem. The patient underwent lab tests and procedures which included on 31Jul2021 blood test: almost no problem and body temperature: 36.7 centigrade before vaccination. Therapeutic measures were taken as a result of events. The patient was hospitalized for the events from 31Jul2021 to 02Aug2021. The reporting physician classified the events as serious (caused hospitalization from 31Jul2021 to 02Aug2021) and assessed that the event was related to bnt162b2. There were other possible causative factors (such as other diseases). On 02Aug2021 (2 days after the vaccination), the outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1590027 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004496 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 2021; Test Name: blood pressure; Result Unstructured Data: Decreased blood pressure (less than 90 mmHg) and multiple vomiting (gastrointestinal symptoms) led to the diagnosis of anaphylaxis. Thereafter, blood pressure resolved with follow-up, and queasy persisted.; Test Date: 20210731; Test Name: blood pressure; Result Unstructured Data: blood pressure decreased to 70s
CDC Split Type: JPTAKEDA2021TJP071852

Write-up: Loss of consciousness; Anaphylaxis (decreased blood pressure, vomiting); This case was received via the RA (Reference number: 2021TJP071852) on 04-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case, initially reported to the RA by a (physician), was received via the PMDA (Ref, v21122420). Anaphylaxis and loss of consciousness were assessed as serious by the RA. On 31-Jul-2021, at 16:30, the patient received the 1st dose of this vaccine. At 16:40, loss of consciousness developed during follow-up. The patient recovered consciousness immediately in a supine position, but blood pressure decreased to 70s, and vomiting developed. No other respiratory or skin symptoms were noted. Decreased blood pressure (less than 90 mmHg) and multiple vomiting (gastrointestinal symptoms) led to the diagnosis of anaphylaxis. Thereafter, blood pressure resolved with follow-up, and queasy persisted. Vasovagal reflex may be another factor. The outcome of anaphylaxis (decreased blood pressure and vomiting) and loss of consciousness was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; 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: 1590053 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002540 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chest pain, Electrocardiogram, Myocarditis
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: 36.9 degrees Celsius; Test Date: 20210801; Test Name: Electrocardiogram; Result Unstructured Data: Electrocardiogram showed ST elevation
CDC Split Type: JPTAKEDA2021TJP072230

Write-up: Acute myocarditis; Chest pain; This case was received via Agency Regulatory Authority (Reference number: v21122524) on 06-Aug-2021 and was forwarded to Moderna on 14-Aug-2021. This case, initially reported to the Regulatory Authority by a (physician), was received via Regulatory Authority (Ref, v21122524). On an unknown date, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.9 degrees Celsius. On 29-Jul-2021, the patient received the 2nd dose of this vaccine. On 31-Jul-2021, at around 04:00, the patient was aware of chest pain. Thereafter, the symptom was once improved, then exacerbated, and improved again. On 01-Aug-2021, around 03:00-04:00, the symptom was exacerbated again, and emergency call was made. Electrocardiogram showed ST elevation. The patient was admitted to a cardiovascular department for acute myocarditis. Other factors may include other viral infections and collagen diseases. The outcome of chest pain and acute myocarditis was reported as resolving. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 20-year-old male hospitalized with a serious unexpected event of chest pain and myocarditis. Event latency 3 days after second dose mRNA-1273. Event resolving. 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: 1590082 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-31
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002618 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactoid reaction, Heart rate
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: heart rate; Result Unstructured Data: tachycardia (90-100 beats/min)
CDC Split Type: JPTAKEDA2021TJP072280

Write-up: Anaphylactoid symptoms (palpitations, feels poorly, muzziness, tachycardia); This case was received via Regulatory Authority (Reference number: 2021TJP072280) on 04-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This spontaneous case was reported by a physician and describes the occurrence of ANAPHYLACTOID REACTION (Anaphylactoid symptoms (palpitations, feels poorly, muzziness, tachycardia)) in a 42-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3004229 and 3002618) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Jul-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced ANAPHYLACTOID REACTION (Anaphylactoid symptoms (palpitations, feels poorly, muzziness, tachycardia)) (seriousness criteria hospitalization and medically significant). The patient was treated with EPINEPHRINE (EPIPEN) for Anaphylactoid reaction, at an unspecified dose and frequency; ADRENALINE [EPINEPHRINE] (intramuscular) for Anaphylactoid reaction, at an unspecified dose and frequency and ADRENALINE [EPINEPHRINE] (intramuscular) for Anaphylactoid reaction, at a dose of 0.3 milligram. On 04-Aug-2021, ANAPHYLACTOID REACTION (Anaphylactoid symptoms (palpitations, feels poorly, muzziness, tachycardia)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Heart rate: 90-100 (High) .tachycardia (90-100 beats/min). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTOID REACTION (Anaphylactoid symptoms (palpitations, feels poorly, muzziness, tachycardia)) to be possibly related. No concomitant medications were reported. This case concerns a 42-year-old male hospitalized with a serious unexpected event of anaphylactoid reaction. Event latency 20 minutes after second dose mRNA-1273. Event 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. Reporter did not allow further contact; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 42-year-old male hospitalized with a serious unexpected event of anaphylactoid reaction. Event latency 20 minutes after second dose mRNA-1273. Event 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: 1590094 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004228 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP072325

Write-up: Anaphylaxis (Precordial urticaria, Itching, Pharynx strange sensation); This case was received via regulatory authority on 11-Aug-2021 and was forwarded to Moderna on 18-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis (Precordial urticaria, Itching, Pharynx strange sensation)) in a 52-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3004228) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis (Precordial urticaria, Itching, Pharynx strange sensation)) (seriousness criterion medically significant). On 31-Jul-2021, ANAPHYLACTIC REACTION (Anaphylaxis (Precordial urticaria, Itching, Pharynx strange sensation)) had resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered ANAPHYLACTIC REACTION (Anaphylaxis (Precordial urticaria, Itching, Pharynx strange sensation)) to be possibly related. 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. Mild anaphylaxis (partial urticaria and pharynx strange sensation).; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1590133 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Heart rate, Hyperhidrosis, Pallor, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Heart rate; Result Unstructured Data: bpm 64 with a tendency to bradycardia (40-50)
CDC Split Type: MDJNJFOC20210831175

Write-up: BRADYCARDIA; FAINT; PALE; SWEATING; This spontaneous report received from a physician via a regulatory authority concerned a 34 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 206C21A expiry: UNKNOWN) dose was not reported,1 total, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at 11:10 AM, the patient experienced faint, pale, sweating and bradycardia. Laboratory data included: Heart rate (NR: not provided) bpm 64 with a tendency to bradycardia (40-50) and patient was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from faint, pale, sweating, and bradycardia. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210831175-COVID-19 VACCINE AD26.COV2.S-Faint, Pale, Sweating, Bradycardia- This event(s) is considered un-assessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590334 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101002447

Write-up: for the first time in my life suddenly passed out, with my head fallen on the street; Convulsion; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB: NL-LRB-00647330. A 32-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC5089) via an unspecified route of administration on 31Jul2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (COMIRNATY, Solution for injection) on 23Jun2021 as dose 1, single for COVID-19 immunisation and had no adverse event. Previous the patient had no COVID-19 infection. About half an hour after the vaccination the patient was on the ferry in the city center and spontaneously passed out, he went to the ground with my bike and all he experienced syncope on 31Jul2021. According to people who helped him up, he had convulsions on 31Jul2021, 30 minutes after vaccination, he fell hard with eye socket on the floor and now he had a black eye. It came very abruptly, within about 10 seconds, he had no problems when leaving the puncture location, and when waiting for and boarding the ferry, he ate well beforehand and slept well. The patient was athletic, physically strong and healthy, and have never had any physical problem in life, and have never fainted before. The events were considered as serious (Medically Significant) by health authority. The outcome of the events was resolved on 31Jul2021. Sender comments: Since the nature of the reported reaction does not imply seriousness according to one of the critera, the report was considered as non-serious by the PRIVACY. Reporters comments: -BioNTech/Pfizer vaccine (Comirnaty) -Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No Date: 23Jun2021. - for the first time in my life suddenly passed out, with my head fallen on the street. convulsion -Additional information ADR: About half an hour after the injection I was on the ferry in the city center and I spontaneously passed out. I went to the ground with my bike and all. According to people who helped me up, I had convulsions. I fell hard with my eye socket on the floor and now I have a black eye. It came very abruptly, within about 10 seconds. I had no problems when leaving the puncture location, and when waiting for and boarding the ferry. I ate well beforehand and slept well. I am 32, athletic, physically strong and healthy, and have never had any physical problem in my life, and have never fainted before. - COVID-19 - Previous COVID-19 infection: No Comirnaty LOT/Batch number was reported as: FC5089.


VAERS ID: 1590340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-07-31
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chest X-ray, Echocardiogram, Electrocardiogram, Fatigue, Headache, Malaise, Myalgia, Myocarditis, Pericarditis, Pyrexia, Troponin
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Nickel sensitivity (allergy: Nikkel)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: 38 tot 40.5; Test Name: Thorax X-ray; Result Unstructured Data: No abnormalities; Test Name: Echocardiography; Result Unstructured Data: No abnormalities; Test Name: Electrocardiogram; Result Unstructured Data: No abnormalities; Test Name: Troponin; Result Unstructured Data: 20
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: ) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDITIS and PERICARDITIS in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3004224) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Nickel sensitivity (allergy: Nikkel) since an unknown date. Concomitant products included PARACETAMOL for an unknown indication. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced MYOCARDITIS (seriousness criteria hospitalization and medically significant) and PERICARDITIS (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MALAISE , PYREXIA (Pyrexia), FATIGUE , MYALGIA and HEADACHE . At the time of the report, MYOCARDITIS , PERICARDITIS and FATIGUE had not resolved, MALAISE and MYALGIA was resolving and PYREXIA (Pyrexia) and HEADACHE had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 38 to 40.5 (High) 38 tot 40.5. On an unknown date, Chest X-ray: no abnormalities (normal) No abnormalities. On an unknown date, Echocardiogram: no abnormalities (normal) No abnormalities. On an unknown date, Electrocardiogram: no abnormalities (normal) No abnormalities. On an unknown date, Troponin: 20 (High) 20. ECG, Echocardiography, Thorax xray and Troponine test were performed and the result were no abnormalities for ECG, Echicardiography and Thorax x ray. On an unknown date, the patient had blood test and result was not reported. Treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow up received contains No new information.; Sender''s Comments: This is a RA report of Myocarditis/Pericarditis within 24-48 hs after receiving the second dose of the product in a 31-years-old man, whose medical history was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Translation pending for completing assessment.


VAERS ID: 1590346 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Suicidal ideation
SMQs:, Suicide/self-injury (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLJNJFOC20210830980

Write-up: URGE TO JUMP OFF A BALCONY OR WHEN I WAS DRIVING IN THE CAR TO STEER THE CAR INTO THE WALL; ANXIETY ATTACKS; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, NL-LRB-00654237] concerned a 24 year old male of unknown race and ethnicity. The patient''s weight was 76 kilograms, and height was 189 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: XD974 expiry: unknown) 0.5 ml, 1 dosage forms administered on 30-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. On 31-JUL-2021, the patient experienced anxiety attacks and urge to jump off from a balcony or when he was driving in the car to steer the car into the wall (suicidal ideation). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety attacks, and urge to jump off from a balcony or when he was driving in the car to steer the car into the wall (suicidal ideation). This report was serious (Life Threatening).; Sender''s Comments: V0:20210830980- covid-19 vaccine ad26.cov2.s-URGE TO JUMP OFF A BALCONY OR WHEN I WAS DRIVING IN THE CAR TO STEER THE CAR INTO THE WALL, ANXIETY ATTACKS. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590583 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210824602

Write-up: SWELLING OF LEFT EYE; ITCHING ON BOTH HANDS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095857] concerned a 29 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, and expiry: UNKNOWN) dose was not reported, administered 1 total on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, 17:41 the patient experienced itching on both hands, swelling of left eye and visited emergency room. On the same day at 18:35, the patient was treated with Diphenhydramine intravenously and at 19:35 and sent home with other prescribed medications (unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching on both hands, and swelling of left eye. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210824602 -covid-19 vaccine ad26.cov2.s- itching on both hands, and swelling of left eye.. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590587 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test
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: Test Date: 20210803; Test Name: SARS-CoV-2 test; Result Unstructured Data: positive
CDC Split Type: PHJNJFOC20210826410

Write-up: COVID 19 POSITIVE; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA,PH-PHFDA-30009787] concerned a 45 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 30-JUL-2021 at 14:45 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at 01:00 the patient complained of Cough, Diarrhea, Fever, Loss of Appetite, Headache, Shortness of Breath and Loss of Sense of Smell. The patient underwent Swab Test at 03-AUG-2021 and on 04-AUG-2021 SARS-CoV-2 test (NR: not provided) (swab test) result was released and it was Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid 19 positive. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0-20210826410-covid-19 vaccine ad26.cov2.s-COVID-19 positive. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1590680 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210832338

Write-up: MILD FEVER; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-R202108-29] concerned a 36 year old male of unspecified race and ethnic origin. The patient''s weight was 77 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C13-01 expiry: unknown) 0.5 ml, frequency time 1 total administered on 31-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 31-JUL-2021, the patient developed mild fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild fever on 01-AUG-2021. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210832338- Covid-19 vaccine ad26.cov2.s- Mild fever. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1590789 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214012 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: This case received via the regulatory authority (reference number: 157513) on Aug 12, 2021 and forwarded to Moderna. This regulatory authority case reported by a consumer, describes the occurrence of myocarditis (thoracic pain myocarditis, radiological (MRI) secured, 6 days inpatient stay) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 214012) for prophylactic immunization. No medical history reported. On Jul 30, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 31, 2021, patient experienced myocarditis/thoracic pain myocarditis, radiological (MRI) secured, 6 days inpatient stay (hospitalization and medically significant). At the time of the report, myocarditis (thoracic pain myocarditis, radiological (MRI) secured, 6 days inpatient stay) not resolved. No concomitant medications or treatment information reported. Sender''s comments: Very limited information regarding the events provided at this time. No further information expected.


VAERS ID: 1590803 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Cough, Drug ineffective
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Infective pneumonia (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210832252

Write-up: COVID PNEUMONIA; DRUG INEFFECTIVE; COUGH; This spontaneous report received from a physician via a Regulatory Authority [EVHUMAN Vaccines, ES-AEMPS-970957] concerned a 69year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-APR-2021 for covid-19 vaccination. The drug start period and drug last period was 93 days. No concomitant medications were reported. On 31-JUL-2021, the patient experienced cough. On 07-AUG-2021, the patient experienced covid pneumonia and drug ineffective. On an unknown date, the patient was hospitalized. Duration of hospitalization was not reported. Treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 30-APR-2021. The patient had not recovered from covid pneumonia, cough, and drug ineffective. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210832252-COVID-19 VACCINE AD26.COV2.S.- Covid pneumonia, Cough. This events is considered unassessable. The events has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210832252-COVID-19 VACCINE AD26.COV2.S.- Drug ineffective. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1590877 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-31
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: PTPFIZER INC202101011122

Write-up: Bilateral pneumonia; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES). A 47-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm left on 13Jul2021 at 16:00 (lot number and expiry date: unknown) at the age of 47-year-old, as dose number unknown single, for Covid-19 immunization. Medical history included diabetes and hypertension. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced bilateral pneumonia on 31Jul2021 19:00. The patient was hospitalized on unspecified date due bilateral pneumonia, for 12 days. The patient underwent lab tests and procedures which included COVID-19 test: negative on 31Jul2021. Therapeutic measures were taken as a result of bilateral pneumonia which included antibiotic. The outcome of the event was recovering. No follow-up attempts possible. Information on lot/batch number cannot be obtained. No further Information is expected.


VAERS ID: 1592480 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004672 / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Menstrual disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIPOLAC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blepharitis; Keratoconus; Rosacea
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20212

Write-up: Menstruaci?n anormal; This case was received via Medicines Agency (Reference number: 963487) on 06-Aug-2021 and was forwarded to Moderna on 06-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Menstruaci?n anormal) and HEADACHE in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004672) for COVID-19 vaccination. The patient''s past medical history included Keratoconus, Blepharitis and Rosacea. Concomitant products included CARBOMER (LIPOLAC) for an unknown indication. On 30-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 31-Jul-2021, after starting mRNA-1273 (Spikevax), the patient experienced MENSTRUAL DISORDER (Menstruaci?n anormal) (seriousness criterion medically significant). On 01-Aug-2021, the patient experienced HEADACHE (seriousness criterion medically significant). At the time of the report, MENSTRUAL DISORDER (Menstruaci?n anormal) was resolving and HEADACHE had not resolved. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 30-Jul-2021. Concomitant medication included LIPOLASIC 2 mg/g GEL OFTALMICO , 1 tubo de 10 g. Treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Events seriousness captured as per Regulatory Authority assessment in Source Document. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Translation document received and drugs information and concomitant medication were translated. On 09-Aug-2021: follow-up received on 09 Aug 2021 and updated the event Headache aggravated; 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. Events seriousness captured as per Regulatory Authority assessment in Source Document.


VAERS ID: 1592481 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101010333

Write-up: This is a spontaneous report from a contactable consumer, downloaded via the regulatory authority (ES-AEMPS-963540). A 36-year-old female patient (not pregnant) received the second dose of BNT162B2 (Comirnaty, batch/lot# FE8244), intramuscularly, left arm, on Jul 30, 2021, single dose, for COVID-19 immunization. Medical history and concomitant medication not reported. The patient received the first dose of BNT162B2 (Comirnaty, batch/lot# FD7959), intramuscularly, on Jul 9, 2021, single dose, for COVID-19 immunization. On Jul 31, 2021, patient experienced sharp chest pain, with outcome of recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1592694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-07-31
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Atrial fibrillation, Biopsy heart, Blood creatinine increased, Blood pressure increased, Blood pressure measurement, Body temperature, Cardiogenic shock, Chest pain, Computerised tomogram, Cough, Echocardiogram, Ejection fraction, Electrocardiogram, Heart rate, Hepatojugular reflux, Lymphopenia, Magnetic resonance imaging, Myocarditis, Oxygen saturation, Pericarditis, Pleural effusion, Positron emission tomogram, Pyrexia, Rales, Sinus tachycardia, Troponin, Troponin increased, Ultrasound scan, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BACTRIM; UROREC; CERIS; TAMSULOSIN; METEOSPASMYL [ALVERINE CITRATE;SIMETICONE]; ESOMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy (Notion of allergy to Amoxicillin (diffuse erythema).); Digital fracture (Fracture of the 5th finger of the right hand and the elbow, operated.); Epilepsy (Epilepsy in childhood, treatment suspended for more than 20 years.); Renal colic (Right and left renal colic, last in May 2021.)
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:angiographically non-obstructive arteries; Test Date: 20210803; Test Name: Endomyocardial biopsy; Result Unstructured Data: Test Result:without evidence for acute myocarditis; Test Name: Blood pressure; Result Unstructured Data: Test Result:167/88 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:39.3 Centigrade; Test Name: TAP CT; Result Unstructured Data: Test Result:without abnormality; Test Name: transthoracic echocardiogram; Result Unstructured Data: Test Result:Moderate diffuse hypokinesia; Comments: Left ventricle not dilated (DTDVG 54 mm), not hypertrophied, Mass 100 g / m square. Septum 6 mm, posterior wall 11 mm. Left ventricular function LVEF 45-50%. Moderate diffuse hypokinesia. Normal cardiac output calculated 5.2 l / min or 2.9 l / min / m? (CCVG (left ventricular flushing chamber) 2.4 cm, ITVsao (under aortic intraventricular) 16.1 cm, heart rate 74 bpm). Diastolic function E / A 7.1, E / Ea lateral 7.5, E / Ea septal 8.5. Left eye slightly dilated 38 ml / m square. Absence of mitral valve disease. Tricuspid aortic valve without leakage or stenosis. Undilated aorta: ascending tubular 30 mm, valsalva 33 mm. Absence of aortic coarctation. Undilated right ventricle, normal visual right ventricular function. TAPSE (Tricuspid annular plane systolic excursion) 22 mm, PAPS (Systolic pulmonary arterial pressure) estimated via IT at 12 mmHg plus 8 mmHg. Dilated inferior vena cava 24 mm well depressible estimating a central venous pressure at 8 mmHg. No pericardial effusion. No vegetation visualized.; Test Name: LVEF; Test Result: 20 %; Test Name: ECG; Result Unstructured Data: Test Result:regular rhythm; Comments: regular rhythm, sinus, fine normoaxed QRS, under ST in D1, D2, in the anterolateral leads; Test Date: 20210803; Test Name: ECG; Result Unstructured Data: Test Result:sinus tachycardia; Comments: sinus tachycardia 120 / min, fine QRS, aspect of elevation of the concave ST segment in the lower leads. no conduction disturbance, PR160ms; Test Name: Heart rate; Result Unstructured Data: Test Result:75; Comments: Units: min; Test Date: 20210804; Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: Units: min; Test Date: 20210806; Test Name: Heart rate; Result Unstructured Data: Test Result:90; Comments: Units: min; Test Date: 20210803; Test Name: myocardial MRI; Result Unstructured Data: Test Result:overall increase in T1 and T2; Comments: overall increase in T1 and more discreetly in T2 compatible with the presence of myocarditis over the entire myocardium associated with an almost circumferential sub-epicardial contrast enhancement in the basal third and affecting the anterior and lateral walls. in the middle third of the left ventricle. Lowered left ventricular ejection fraction measured at 26% on an undilated left ventricle. Right ventricular ejection fraction lowered to 22% on an undilated right ventricle. Pericardial effusion of low circumferential abundance. Small bilateral pleural effusion. In total, MRI compatible with fulminans myocarditis.; Test Name: Oxygen saturation; Test Result: 98 %; Test Date: 20210804; Test Name: PET scan; Result Unstructured Data: Test Result:unknown results; Comments: requested following the myocardial MRI to support the hypothesis of myocarditis and as part of the etiological assessment; Test Name: Troponins; Result Unstructured Data: Test Result:1400 ng/L; Test Date: 20210803; Test Name: Troponins; Result Unstructured Data: Test Result:3400 ng/L; Test Date: 20210701; Test Name: Abdomino-pelvic ultrasound; Result Unstructured Data: Test Result:caliceal calculus in the right kidney; Comments: Absence of ultrasound abnormality except for a 4 mm inferior caliceal calculus in the right kidney. From 09Jul2021 normal.; Test Date: 20210806; Test Name: Abdomino-pelvic ultrasound; Result Unstructured Data: Test Result:No significant mirtoaortic valve disease; Comments: Left ventricle not dilated (DTDVG: 53mm) Not hypertrophied (SiV: 9mm). LVEF visual 40-45%, Biplane 40%, Cardiac output 5.6L / min; ITVsAo = 16cm. No significant mirtoaortic valve disease, mitral profile type 2, E / E ''8, controlled LV filling pressures. Non-dilated right ventricle, normokinetic (TAPSE: 29mm; SVD wave: 13cm / s). No IT to estimate PAPS. The pericardial effusion described on the CT scan is not visualized. No obvious thrombus, 23mm VCI but well breathable.
CDC Split Type: FRPFIZER INC202101045373

Write-up: Acute myocarditis; cardiogenic shock; chest pain; increased troponin; lymphopenia; creatininemia; sinus tachycardia; Small bilateral pleural effusion; loss of 6 kg; atrial fibrillation; very discreet bilateral crackling; Visible hepatojugular reflux; fever of 39.3 C; non-productive cough; 167/88 mmHg; pericarditis-like pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 43-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 14Jun2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation; alverine citrate, simeticone (METEOSPASMYL [ALVERINE CITRATE;SIMETICONE]), oral from 09Jul2021 (Batch/Lot Number: Unknown) to an unspecified date, at 3 DF, 3x/day for abdominal pain upper; esomeprazole (ESOMEPRAZOLE), oral from 09Jul2021 (Batch/Lot Number: Unknown) to an unspecified date, at 1 DF for 4 weeks for Epigastric pain; serenoa repens extract (PERMIXON), oral from 24Jul2021 (Batch/Lot Number: Unknown) to an unspecified date, at not specified for prostatitis; sulfamethoxazole, trimethoprim (BACTRIM), oral from 24Jul2021 (Batch/Lot Number: Unknown) to an unspecified date, at 2 DF, 2x/day for prostatitis. Medical history included Digital fracture Fracture of the 5th finger of the right hand and the elbow, operated, Epilepsy in childhood, treatment suspended for more than 20 years, renal colic from an unknown date to May2021 Right and left renal colic, last in May 2021, Allergy Notion of allergy to Amoxicillin (diffuse erythema). Concomitant medications included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported; silodosin (UROREC) taken for an unspecified indication, start and stop date were not reported; trospium chloride (CERIS) taken for an unspecified indication from 02Jul2021 to 09Jul2021; tamsulosin (TAMSULOSIN) taken for an unspecified indication from 02Jul2021 to 09Jul2021; alverine citrate, simeticone (METEOSPASMYL [ALVERINE CITRATE;SIMETICONE]) taken for an unspecified indication, start and stop date were not reported; esomeprazole (ESOMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced Drug allergy, and diffuse erythema. Patient presenting a picture of deterioration of the general condition with symptoms suggestive of prostatitis, urinary functional signs (pollakiuria, urination burns, and a few episodes of macroscopic hematuria), treated probabilistically with Bactrim. Associated loss of 6 kg, abdominal CT (computed tomogram) scans and abdominopelvic ultrasounds which returned without particularity. From 31Jul2021, he presented with a fever of 39.3 C as well as a non-productive cough and pericarditis-like pain. He consults in the emergency room. Faced with a picture of myocarditis with an elevation of troponins to 1400 ng / l, he was hospitalized. The clinical examination at the entrance finds: Heart rate at 75 / min; blood pressure: 167/88 mmHg, oxygen saturation: 98%, temperature: 38.8 C. Regular heart sounds with no breath heard. Rather clear and symmetrical vesicular murmurs, very discreet bilateral crackling. No edema of the lower limbs. Visible hepatojugular reflux. No abnormality of the neurological examination. Supple, depressible and painless abdomen. ECG(Echocardiogram) at the entry registered regular rhythm, sinus, fine normoaxed QRS, under ST in D1, D2, in the anterolateral leads. The transthoracic echocardiogram on arrival shows: Left ventricle not dilated (DTDVG 54 mm), not hypertrophied, Mass 100 g / m square. Septum 6 mm, posterior wall 11 mm. Left ventricular function LVEF 45-50%. Moderate diffuse hypokinesia. Normal cardiac output calculated 5.2 l / min or 2.9 l / min / m2 (CCVG (left ventricular flushing chamber) 2.4 cm, ITVsao (under aortic intraventricular) 16.1 cm, heart rate 74 bpm). Diastolic function E / A 7.1, E / Ea lateral 7.5, E / Ea septal 8.5. Left eye slightly dilated 38 ml / m square. Absence of mitral valve disease. Tricuspid aortic valve without leakage or stenosis. Undilated aorta: ascending tubular 30 mm, valsalva 33 mm. Absence of aortic coarctation. Undilated right ventricle, normal visual right ventricular function. TAPSE (Tricuspid annular plane systolic excursion) 22 mm, PAPS (Systolic pulmonary arterial pressure) estimated via IT at 12 mmHg plus 8 mmHg. Dilated inferior vena cava 24 mm well depressible estimating a central venous pressure at 8 mmHg. No pericardial effusion. No vegetation visualized. Faced with this chest pain with increased troponin, performing a coronary angiography which found angiographically non-obstructive arteries. Subsequently, the patient progresses to a picture of fulminant myocarditis with severe alteration of LVEF (left ventricle ejection fraction) up to 20%, inotropic treatment with Dobutamine and Noradrenaline is introduced, hydrosodium depletion by Furosemide administered intravenously is carried out. A broad etiology of myocarditis has started, in particular bacterial and viral infectious, autoimmune, there is no element of orientation at the initial phase for an infectious or systemic cause. Probabilistic antibiotic therapy with Rocephine and Amiklin is introduced. TAP CT imaging is performed without abnormality. Endomyocardial biopsies are performed on 03Aug2021 in order to consider corticosteroid therapy in the absence of viral inclusions. Faced with a pejorative development despite inotropic support without a found etiology, the patient is transferred to consider ECMO-type assistance. Biology: no abnormalities in the lines apart from lymphopenia, creatininemia: 123?mol / L, troponinemia 3400ng / L, Hepatic assessment moderate cytolysis 2.5N on ALT. ECG: sinus tachycardia 120 / min, fine QRS, aspect of elevation of the concave ST segment in the lower leads. no conduction disturbance, PR160ms. Myocarditis biopsies are made negative without evidence for acute myocarditis. A myocardial MRI is performed, finding an overall increase in T1 and more discreetly in T2 compatible with the presence of myocarditis over the entire myocardium associated with an almost circumferential sub-epicardial contrast enhancement in the basal third and affecting the anterior and lateral walls. in the middle third of the left ventricle. Lowered left ventricular ejection fraction measured at 26% on an undilated left ventricle. Right ventricular ejection fraction lowered to 22% on an undilated right ventricle. Pericardial effusion of low circumferential abundance. Small bilateral pleural effusion. In total, MRI compatible with fulminans myocarditis. In view of the slight increase in T2, the possibility of a late enhancement lesion pre-existing to this episode is discussed. After collegial discussion and extended etiological assessment, it was decided to perform Boli of Solumedrol IV (intravenously) in the event of fulminant myocarditis. Cure carried out from 05Aug2021 to 07Aug2021 after treatment with stromectol in prevention of malignant anguillulose. The evolution thereafter is favorable with regression of asthenia and deterioration of the general condition, correction of renal and hepatic failures, and hemodynamic and ultrasound improvement, with progressive recovery of LVEF. Dobutamine is reduced from 05Aug2021, from 10 to 4u, with good tolerance. Note a transition to atrial fibrillation at 130 / min on 04Aug2021 after the first treatment of solumedrol, well tolerated from a haemodynamic point of view, reduced by bolus of cordarone, maintenance-free in the course of the course. Given bolus of Solumedrol intravenously on 06Aug2021, then relayed by an oral cure at 1 mg / Kg, decreasing rapidly over 10 days. A pet scanner was requested following the myocardial MRI(Magnetic resonance image) to support the hypothesis of myocarditis and as part of the etiological assessment. The ultrasound re-evaluation on 06Aug2021 found: (under dobutamine 5?g / Kg / min) Left ventricle not dilated (DTDVG: 53mm) Not hypertrophied (SiV: 9mm). LVEF visual 40-45%, Biplane 40%, Cardiac output 5.6L / min; ITVsAo = 16cm. No significant mirtoaortic valve disease, mitral profile type 2, E / E ''8, controlled LV filling pressures. Non-dilated right ventricle, normokinetic (TAPSE: 29mm; SVD wave: 13cm / s). No IT to estimate PAPS. The pericardial effusion described on the CT scan is not visualized. No obvious thrombus, 23mm VCI but well breathable. At the exit, the rhythm is sinus, regular 90 / min. In total: 43-year-old patient with no notable history hospitalized for fulminant myocarditis complicated by cardiogenic shock, 20% LVEF alteration occurring on a picture of deterioration of general condition for several weeks and suspicion of prostatitis treated probabilistically, without referral infectious, normal abdominal imaging. Hemodynamic degradation under amine and discussion of circulatory assistance. Etiology retained: fulminant myocarditis, on MRI data (unequivocal biopsy). Hemodynamic stabilization after bolus of solumedrol 1g (last treatment on 06Aug) relayed PO in short course of 10 days, decrease expected. Dobutamine during withdrawal, at 4u.Kg.min on transfer, LVEF reassessment at 40%. Onset of myocarditis on Day 49 of a 1st injection of COMIRNATY. Evolution: In recovery. The event Acute myocarditis was assessed as life-threatening. The patient was hospitalized for the event myocarditis. The events were assessed as serious (167/88 mmHg, pericarditis-like pain, atrial fibrillation, cardiogenic shock) (medically significant). The patient underwent lab tests and procedures which included angiocardiogram: angiographically non-obstructive arteries on an unspecified date, biopsy heart: without evidence for acute myocarditis on 03Aug2021, blood pressure measurement: 167/88 mmhg on , body temperature: 38.8 centigrade on an unspecified date, body temperature: 39.3 centigrade on 31Jul2021, computerised tomogram: without abnormality on an unspecified date, echocardiogram: moderate diffuse hypokinesia on an unspecified date Left ventricle not dilated (DTDVG 54 mm), not hypertrophied, Mass 100 g / m square. Septum 6 mm, posterior wall 11 mm. Left ventricular function LVEF 45-50%. Moderate diffuse hypokinesia. Normal cardiac output calculated 5.2 l / min or 2.9 l / min / m? (CCVG (left ventricular flushing chamber) 2.4 cm, ITVsao (under aortic intraventricular) 16.1 cm, heart rate 74 bpm). Diastolic function E / A 7.1, E / Ea lateral 7.5, E / Ea septal 8.5. Left eye slightly dilated 38 ml / m square. Absence of mitral valve disease. Tricuspid aortic valve without leakage or stenosis. Undilated aorta: ascending tubular 30 mm, valsalva 33 mm. Absence of aortic coarctation. Undilated right ventricle, normal visual right ventricular function. TAPSE (Tricuspid annular plane systolic excursion) 22 mm, PAPS (Systolic pulmonary arterial pressure) estimated via IT at 12 mmHg plus 8 mmHg. Dilated inferior vena cava 24 mm well depressible estimating a central venous pressure at 8 mmHg. No pericardial effusion. No vegetation visualized , ejection fraction: 20 % on an unspecified date, electrocardiogram: regular rhythm on an unspecified date regular rhythm, sinus, fine normoaxed QRS, under ST in D1, D2, in the anterolateral leads , electrocardiogram: sinus tachycardia on 03Aug2021 sinus tachycardia 120 / min, fine QRS, aspect of elevation of the concave ST segment in the lower leads. no conduction disturbance, PR160ms , heart rate: 75 on an unspecified date Units: min , heart rate: 130 on 04Aug2021 Units: min , heart rate: 90 on 06Aug2021 Units: min , magnetic resonance imaging: overall increase in t1 and t2 on 03Aug2021 overall increase in T1 and more discreetly in T2 compatible with the presence of myocarditis over the entire myocardium associated with an almost circumferential sub-epicardial contrast enhancement in the basal third and affecting the anterior and lateral walls. in the middle third of the left ventricle. Lowered left ventricular ejection fraction measured at 26% on an undilated left ventricle. Right ventricular ejection fraction lowered to 22% on an undilated right ventricle. Pericardial effusion of low circumferential abundance. Small bilateral pleural effusion. In total, MRI compatible with fulminans myocarditis, oxygen saturation: 98 % on an unspecified date. The action taken in response to the events for alverine citrate, simeticone was unknown, for serenoa repens extract was unknown, for sulfamethoxazole, trimethoprim was unknown. Therapeutic measures were taken as a result of acute myocarditis. The outcome of the event acute myocarditis was recovering, was unknown for the rest of the events. No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.


VAERS ID: 1592835 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Malaise, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: 20210801; Test Name: Body Temperature; Result Unstructured Data: Test Result:High
CDC Split Type: GBPFIZER INC202100992245

Write-up: Fever/ High temperature; Painful arm; Malaise; This is a spontaneous report from a contactable consumer received from the Regulatory Authority; report number is GB-MHRA-WEBCOVID-202108021902225880-EQO5M, Safety Report Unique Identifier is GB-MHRA-ADR 25742947. A 30-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW3143), via an unspecified route of administration on 31Jul2021 (at the age of 30-year-old) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced painful arm and malaise on 31Jul2021; fever and high temperature on 01Aug2021. The events were reported as serious (medically significant). Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient was recovering from fever and high temperature while patient has not recovered from painful arm and malaise. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1592848 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FELODIPINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101012929

Write-up: Muscle pain; Fatigue; Stomach ache; This is a spontaneous report from a contactable consumer. received from The regulatory authority report number is GB-MHRA-WEBCOVID-202108050842342420-WWOGQ. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25757993. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Lot Number: FF3319) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Concomitant medication included felodipine. On 31Jul2021, the patient experienced muscle pain, fatigue, stomach ache. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Outcome of the events was not recovered. The report was serious with seriousness criteria of medically significant. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1592892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE1510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, Pain in extremity, Rash, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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 Date: 20210804; 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 INC202101013013

Write-up: pain; Neck rash; Leg pain; This is a spontaneous report from a contactable consumer. This report received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108051219163960-HJLFQ. Safety Report Unique Identifier GB-MHRA-ADR 25758990. A 24-year-old female patient received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on 29Jul2021 with Lot Number: FE1510 as single dose for covid-19 immunisation. Medical history included Lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant, Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced pain on an unspecified date, neck rash on 04Aug2021, leg pain on 31Jul2021; all medically significant. Lower leg pain in left leg, hurts to straighten leg, bend leg and when weight is put on to the leg the pain makes patient loose balance. 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: no - negative covid-19 test on 04Aug2021. The outcome of the event leg pain was recovered in 2021, neck rash was recovering, pain was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593007 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Headache, Hyperhidrosis, Migraine, SARS-CoV-2 test, Skin discolouration
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012558

Write-up: migraine; sharp sudden pain in my head; shortness of breath; Heavy sweating; turned grey/no color in skin; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202108052102533240-BZL4B, Safety Report Unique Identifier GB-MHRA-ADR 25761945. A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 31Jul2021 (Lot number was not reported), at the age of 24 years old, as second dose, single for COVID-19 immunisation. Medical history included migraine. Unsure if patient has had symptoms associated with COVID-19. Concomitant medications were reported as none; no medicines or allergies. On 31Jul2021, the patient experienced shortness of breath, heavy sweating and turned grey/no color in skin. On 02Aug2021, the patient experienced sharp sudden pain in my head. On unspecified date, the patient experienced migraine. Events shortness of breath, heavy sweating and turned grey/no color in skin required physician office visit. "Within 5 minutes of vaccination (31Jul2021), shortness of breath and extreme sweating occurred. A health professional advised I had turned grey and there was no color in my skin so I should lie down on a mat provided. Here I lay for 15 minutes profusely sweating from my neck and back (the health professional/volunteer was concerned). After 20 minutes the sweating stopped. Over the next two days (02Aug2021), I experienced sharp sudden pains in my head (similar to that of a migraine but short sharp sudden bursts no more than 5 seconds). On day 3, I was back to normal. The staff at the vaccination center advised to contact my GP to conduct tests." 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: No - Negative COVID-19 test on an unspecified date. Outcome of the events shortness of breath, migraine was not recovered. Outcome of the event heavy sweating was recovered on 31Jul2021. Outcome of the other events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593011 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amnesia, Dizziness, Dysstasia, Nausea, Pain, SARS-CoV-2 test, Tinnitus, Vertigo, Vision blurred
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Vestibular disorders (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EVRA; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control; Depression
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101012538

Write-up: Nausea; Blurred vision; Ache; Ear noises; cannot stand up for too long; lightheaded; i have ringing in my ears; memory loss; Vertigo; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202108052134564350-SFH83, Safety Report Unique Identifier is GB-MHRA-ADR 25762122. A 21-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported, Expiry date not reported), via an unspecified route of administration on 31Jul2021 (age at vaccination was 21 years) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included contraception (birth control), and depression. Patient had not had symptoms associated with COVID-19. Historical vaccine included BNT162B2 on unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced nausea. Concomitant medications included ethinylestradiol, norelgestromin (EVRA) taken for contraception, start and stop date were not reported; sertraline taken for depression, start and stop date were not reported. The patient experienced i have ringing in my ears on an unspecified date with outcome of recovering, memory loss on an unspecified date with outcome of recovering, vertigo on 31Jul2021 with outcome of not recovered, nausea on an unspecified date with outcome of not recovered, blurred vision on an unspecified date with outcome of not recovered, ache on an unspecified date with outcome of recovering, ear noises on an unspecified date with outcome of not recovered, cannot stand up for too long on an unspecified date with outcome of unknown, and lightheaded on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date. The events were reported as serious, medically significant by the health authority. Case narrative: I cannot stand up for too long or I get light headed and I experience vertigo, I have ringing in my ears and I have short term memory loss. 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, information about batch number cannot be obtained. No further information is expected.


VAERS ID: 1593119 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF3319 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac discomfort, Cardiac disorder, Cardiac flutter, Chest discomfort, Chest pain, Dyspepsia, Dyspnoea, Dyspnoea exertional, Electrocardiogram, Hypertension, Investigation, Palpitations, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Tachyarrhythmia terms, nonspecific (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure high; Result Unstructured Data: Test Result:166/89; Test Name: ecg; Result Unstructured Data: Test Result:normal; Test Name: Physical observations; Result Unstructured Data: Test Result:Unknown result''s; Test Date: 20210731; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014677

Write-up: chest pressure; sharp pain in heart on exertion; palpitations; blood pressure high; felt like immense pressure/squeezing of heart; Heart fluttering; Heartburn; Chest pain; Heart pressure sensation of; Shortness of breath; Increased blood pressure; Chest pain exertional; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061251091590-MV5PV, Safety Report Unique Identifier GB-MHRA-ADR 25765481. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF3319),via an unspecified route of administration on 31Jul2021 (at the age of 30 year old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included suppressed lactation from an unknown date and unknown if ongoing, Patient has not had symptoms associated with COVID-19 Patient is not pregnant,Patient is not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced heart fluttering on 31Jul2021 with outcome of not recovered , chest pressure on an unspecified date with outcome of recovered , sharp pain in heart on exertion on an unspecified date with outcome of recovered , palpitations on an unspecified date with outcome of recovered , blood pressure high on an unspecified date with outcome of recovered , heartburn on 31Jul2021 with stop date 31Jul2021 and outcome of recovered , chest pain on 31Jul2021 with outcome of recovering , heart pressure sensation of on 31Jul2021 with outcome of not recovered , shortness of breath on 31Jul2021 with outcome of recovering , increased blood pressure on 31Jul2021 with outcome of recovering , chest pain exertional on 31Jul2021 with outcome of not recovered , felt like immense pressure/squeezing of heart on an unspecified date with outcome of unknown. The event were assessed serious as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 166/89 on an unspecified date, electrocardiogram: normal on an unspecified date, investigation: unknown result''s on an unspecified date, sars-cov-2 test: negative on 31Jul2021 No - Negative COVID-19 test. Therapeutic measures were taken as a result of the events including rest and regular Ibuprofen. It was also informed that patient has not tested positive for COVID-19 since having the vaccine and was not enrolled in clinical trial. No follow-up attempts are needed. No further information is expected


VAERS ID: 1593152 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PF3319 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:Fever
CDC Split Type: GBPFIZER INC202101014805

Write-up: Fever chills; Feverish; Ache; Tiredness; This is a spontaneous report from a contactable consumer received from the Medicines Healthcare products Regulatory Agency (MHRA). Regulatory authority report number: GB-MHRA-WEBCOVID-202108061716150950-MKX1I; Safety Report Unique Identifier: GB-MHRA-ADR 25766808. A 30-year-old female patient received BNT16222 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 30Jul2021 (Batch/Lot Number: Pf3319; Expiry date: Not reported) as 2nd single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had not had symptoms associated with COVID-19, and not had a COVID-19 test, and was not enrolled in a clinical trial. On 31Jul2021, the patient experienced fever chills, was feverish, had ache, and tiredness. The events were assessed as medically significant. Paracetamol helped with symptoms. The patient had not tested positive for COVID-19 since having the vaccine. The patient recovered from fever chills on 31Jul2021, from being feverish on 02Aug2021, from ache on 01Aug2021 and from tiredness on 02Aug2021. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1593164 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-31
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Ear pain
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101014271

Write-up: Bell''s palsy; ear ache; This is a spontaneous report from a contactable consumer received from The Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108061852137070-VDFAM, Safety Report Unique Identifier GB-MHRA-ADR 25767416. A 39-years-old non-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 08Jul2021 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 and not had a COVID-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced earache in 2021 and bell''s palsy on 31Jul2021. It was reported that patient had an earache from around 20Jul2021, but onset of full symptoms was around 2 weeks later. It might not have been vaccine-related, but no other recent history of illness or stress as a trigger. Part way through treatment with prednisolone and noticing improvement. The events considered as medically significant. Therapeutic measures were taken as a result of earache and bell''s palsy. The outcome of event bell''s palsy was not resolved and earache was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1593231 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Decreased appetite, Dizziness, Fatigue, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210805; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014316

Write-up: loss of appetite; Stomach cramps; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108062140334800-ZUP4Y. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25768399. A 44-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 31Jul2021 (age at vaccination was 44 years) as dose 1, single for COVID-19 immunization. The patient''s medical history included suppressed lactation from an unknown date. The patient has not had symptoms associated with COVID-19. The patient was not currently breastfeeding. The patient was not enrolled in clinical trial. Concomitant medications were not reported. On 31Jul2021, the patient experienced dizziness. On 01Aug2021, the patient experienced fatigue. On 02Aug2021, the patient experienced stomach cramps. On unspecified date, the patient experienced loss of appetite. Bouts of extreme fatigue, loss of appetite, stomach cramps. The patient underwent lab test which included COVID-19 virus test: negative, no - negative COVID-19 test on 05Aug2021. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event loss of appetite was unknown. The outcome of the other events was not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1593314 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-07-31
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA1027 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Amenorrhoea, Pregnancy test
SMQs:, Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: pregnancy test; Result Unstructured Data: Test Result:not pregnant
CDC Split Type: GBPFIZER INC202101014899

Write-up: Amenorrhoea; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202108071335541980-Z0MC0, safety report unique identifier is GB-MHRA-ADR 25770479. A 32-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 19Jun2021 (Batch/Lot Number: FA1027) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included Lactation decreased from an unknown date and unknown if ongoing. The patient received historic vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot no: unknown), dose 1 on an unspecified date. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. The patients concomitant medications were not reported. The patient experienced amenorrhoea on 31Jul2021. The event was reported as medically significant. The patient stated that her periods have stopped since the vaccine kicked in, with no sign of returning and she was not pregnant, and she said that reaction was not important for her as her family was complete but deserves attention for other women. Patient has not tested positive for COVID-19 since having the vaccine. Investigations or tests conducted was Pregnancy test: not pregnant on an unspecified date. The outcome of event was reported as not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593368 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aggression, Decreased activity, Illness, Lethargy, Nausea, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101014695

Write-up: nausea; physical; activity; Sickness; Lethargy; 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-202108072215070980-GDLSF) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25771018). A 33-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FE3380) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced nausea on an unspecified date with outcome of recovering, physical on an unspecified date with outcome of recovering, activity on an unspecified date with outcome of recovering, lethargy on 31Jul2021 with outcome of recovered on 05Aug2021, sickness on 05Aug2021 with outcome of recovered on 05Aug2021. The patient experienced lethargy from simple short physical activity, getting worse towards the back end of the week. Nausea started at the end and signaled the end of the symptoms. Patient had not tested positive for COVID-19 since having the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: No - Negative COVID-19 test on 04Aug2021. The report was reported as serious with the criteria of medically important condition. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1593488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Migraine, Pruritus, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: Headache; Migraine
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: tiredness; itching; migraine type headache; Itchy skin; Headache; Fatigue extreme; This case was received via United Kingdom MHRA (Reference number: 25783956) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of FATIGUE (tiredness), PRURITUS (itching), MIGRAINE (migraine type headache), PRURITUS (Itchy skin), HEADACHE (Headache) and FATIGUE (Fatigue extreme) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Migraine and Headache. On 31-Jul-2021, the patient received second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion medically significant) and FATIGUE (Fatigue extreme) (seriousness criterion medically significant). On 03-Aug-2021, the patient experienced PRURITUS (Itchy skin) (seriousness criterion medically significant). On an unknown date, the patient experienced FATIGUE (tiredness) (seriousness criterion medically significant), PRURITUS (itching) (seriousness criterion medically significant) and MIGRAINE (migraine type headache) (seriousness criterion medically significant). At the time of the report, FATIGUE (tiredness), PRURITUS (itching) and MIGRAINE (migraine type headache) outcome was unknown, PRURITUS (Itchy skin) was resolving and HEADACHE (Headache) and FATIGUE (Fatigue extreme) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Patient stated anti histamine tablets and cream for the itching. Treatment medication were not reported. Concomitant products were not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 1593506 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8813-L773 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness postural, Fatigue, Headache, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101057743

Write-up: Headache temporal; Dizzy on standing; Tiredness; Painful arm; Shivering; This is a solicited report from the RA Yellow Card Vaccine Monitor program from a contactable consumer. This is the second of 2 reports. The first report is a report downloaded from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-YCVM-202105310745105430-UK8UY. Safety Report Unique Identifier GB-MHRA-ADR 25426392. A 31-year-old female patient received the bnt162b2 via an unspecified route of administration on 31Jul2021 (Lot Number: FD8813-L773) as DOSE 2, SINGLE at age of 31-year-old female for COVID-19 vaccination. Patient last menstrual period date was 14Jul2021. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 05Jun2021 (Lot Number: EW3143) for COVID-19 vaccination and experienced Painful arm and Pain menstrual. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not pregnant, Patient is not currently breastfeeding. The patient experienced tiredness on 31Jul2021 with outcome of not recovered, painful arm on 31Jul2021 with outcome of not recovered, shivering on 31Jul2021 with outcome of recovered, headache temporal on 02Aug2021 with outcome of unknown, dizzy on standing on 01Aug2021 with outcome of unknown. The events were reported as serious for medically significant. Patient has not tested positive for COVID-19 since having the vaccine Patient is not enrolled in clinical trial. 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 temporal association, the reported events are considered related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1593586 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004498 / 1 - / OT

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

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

Write-up: This case was received via Agency (Reference number: 768608) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of HYPERPYREXIA and URTICARIA in a 22-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004498) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 31-Jul-2021, the patient experienced HYPERPYREXIA (seriousness criterion medically significant) and URTICARIA (seriousness criterion medically significant). At the time of the report, HYPERPYREXIA and URTICARIA was resolving. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with Moderna vaccine was not applicable. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The translation of the source document has been requested.


VAERS ID: 1593677 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Feeling hot, Malaise, Pharyngeal swelling, Sensation of foreign body, Throat tightness, Tongue blistering
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade
CDC Split Type: JPPFIZER INC202101023655

Write-up: pharyngolarynx foreign body feeling; posterior tongue blistering; Anaphylaxis; patient complained of body heat/feeling hot in the throat; pharyngeal swelling; pharynx closed sensation of; came home feeling malaise; This is a spontaneous report from a contactable other HCP (nurse) received from the Drug Agency (RA). Regulatory authority report number is v21122761. A 52-year and 1-month-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Intramuscular injection, Lot number EW0207, Expiration date 30Sep2021), via an unspecified route of administration on 31Jul2021 09:30 (the day of vaccination) (at the age of 52-year and 1-month-old) as a 0.3 ml single dose for COVID-19 immunisation. Body temperature before vaccination was 36.7 degrees Centigrade on 31Jul2021. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Medical history included none. The patient''s concomitant medications were not reported. The patient had no family history. On 31Jul2021 at 09:40 (10 minutes after the vaccination), the patient experienced anaphylaxis. On 31Jul2021 at 09:30, patient complained of body heat/feeling hot in the throat, pharyngeal swelling, pharynx closed sensation of. On 31Jul2021 the patient experienced came home feeling malaise, pharyngolarynx foreign body feeling and posterior tongue blistering. The course of the event was as follows: on 31Jul2021, at about 9:30, the patient received COMIRNATY Intramuscular injection (0.3ml) and kept under observation for 15 minutes in the hospital. The patient complained of body heat, so the patient was given temperature measurement. The body temperature was confirmed to be 36.9 degrees Centigrade on 31Jul2021. The patient went home. On 03Aug2021, actually, immediately after receiving the vaccination, the patient felt pharyngeal swelling, pharynx closed sensation of and feeling hot in the throat. The patient came home feeling malaise. On 01Aug2021, the patient experienced pharyngolarynx foreign body feeling and posterior tongue blistering. On 02Aug2021, the patient was diagnosed with anaphylaxis in the internal medicine department of other hospital and call to cancel the second dose. The outcome of the events was reported as unknown. The reporting other HCP classified the event as non-serious and the causality between the event and bnt162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. The reporting other HCP commented as follows: the patient was observed in the hospital for 15 minutes and complained of only the feeling of body heat. On the fourth day from the date of vaccination, a telephone report was received from the patient himself and he was not examined. The reporter consulted the medical policy class and decided to report. No Follow-up attempts are needed. No further information is expected.


VAERS ID: 1593682 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result: 36.6 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202101023723

Write-up: Pyrexia; This is a spontaneous report from a contactable physician received the Regulatory Authority. The Regulatory authority report number is v21122738. The patient was a 65 years old female. Body temperature before vaccination was 36.6 Centigrade. There were no points to be considered on the vaccine screening questionnaire. On 30Jul2021 at 14:17 (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) via an unspecified route of administration as DOSE 2, SINGLE (single dose) for COVID-19 immunization. On 31Jul2021 (reported as 1 day after the vaccination), the patient experienced pyrexia. The outcome of the event was recovering (also reported as unknown; for clarification). The course of the event was had pyrexia the day after vaccination. Urgent medical attention, had drip therapy. The event resulted in emergency room visit. Therapeutic measures were taken as the result of the event which included drip therapy. 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. There was no other possible cause of the event such as any other diseases.


VAERS ID: 1593830 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838585

Write-up: LOSS CONSCIOUSNESS; LIGHT HEADEDNESS; FEVER; This spontaneous report received from a physician via a Regulatory Authority [PHIFDA, PH-PHFDA-300099938] concerned a 41 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2212C21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at 15:00, the patient experienced loss consciousness, light headedness, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from loss consciousness, light headedness, and fever. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210838585-covid-19 vaccine ad26.cov2.s -Loss consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1593835 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 antigen test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210838825

Write-up: COUGH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099223] concerned a 45 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-JUL-2021, at 07:00 hours the patient experienced cough. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. Laboratory data (dates unspecified) included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0- 20210838825 - Covid-19 vaccine ad26.cov2.s-cough. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1593845 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839131

Write-up: DIFFICULTY BREATHING; COLDS; COUGH; FEVER; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098100] concerned a 55 year old female of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 212C21A and expiry: unknown) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021 at 06:00, the patient experienced colds, cough and had fever were reported. On 06-AUG-2021 at 11:00, the patient experienced difficulty in breathing, and was hospitalized (on date unspecified) for unspecified days. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient recovered from colds, cough, and fever, and was recovering from difficulty breathing. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839131- Covid-19 vaccine ad26.cov2.s-difficulty breathing. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1622908 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METILPREDNISOLONA [METHYLPREDNISOLONE]; AMOXICILINA+ACIDO CLAVUL.RATIOPHARM [AMOXICILLIN;CLAVULANIC ACID]; LORATADINA NORMON; SPIRAXIN; CLEMASTINA [CLEMASTINE]; BUDESONIDE;FORMOTEROL FUMARATE
Current Illness: Allergic asthma; Irritable colon
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: Has passed the COVID-19.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210839094

Write-up: TINGLING IN HANDS, FEET, NECK AND FACE; This spontaneous report received from a consumer via a Regulatory Authority [EVHUMAN Vaccines, ES-AEMPS-975500] concerned a 27 year old female. The patient''s weight was 51 kilograms, and height was 165 centimeters. The patient''s past medical history included: covid-19, and concurrent conditions included: allergic asthma, and irritable colon, and other pre-existing medical conditions included: Has passed the COVID-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C18-05, expiry: UNKNOWN) dose was not reported, 1 total administered on 28-JUL-2021 to left arm for covid-19 vaccination. The drug start and last period was 4 days and duration of drug administration was 1 day. The concomitant medications included budesonide/formoterol fumarate for allergic asthma, rifaximin for irritable colon syndrome, loratadine for pollen allergy, amoxicillin/clavulanic acid for sting, clemastine for sting, and methylprednisolone for sting. On 31-JUL-2021, the patient experienced tingling in hands, feet, neck and face. The treatment with covid-19 vaccine ad26.cov2.s was withdrawn on 28-JUL-2021. The patient had not recovered from tingling in hands, feet, neck and face. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210839094-COVID-19 VACCINE AD26.COV2.S-Tingling in hands, feet , neck and face. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1622912 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214011 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Influenza like illness, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (broad)

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

Write-up: Tachycardia; Dyspnoea; Influenza like illness; This case was received via European Medicines Agency (Reference number: BX20217196) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of TACHYCARDIA (Tachycardia) and DYSPNOEA (Dyspnoea) in a 39-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214011) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Obesity. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization) and INFLUENZA LIKE ILLNESS (Influenza like illness). At the time of the report, TACHYCARDIA (Tachycardia), DYSPNOEA (Dyspnoea) and INFLUENZA LIKE ILLNESS (Influenza like illness) had not resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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: 1622972 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003605 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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.MOD20212

Write-up: This case was received via the Regulatory Authority (Reference number: 767377) on 11-Aug-2021 and was forwarded to the company on 11-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of NAUSEA, MYALGIA, PYREXIA, and HEADACHE in a 28-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3003605) for COVID-19 immunisation. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form in total. On 31-Jul-2021, the patient experienced NAUSEA (seriousness criterion medically significant), MYALGIA (seriousness criterion medically significant), PYREXIA (seriousness criterion medically significant), and HEADACHE (seriousness criterion medically significant). At the time of the report, NAUSEA, MYALGIA, PYREXIA, and HEADACHE outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. No concomitant products were reported. No treatment information was reported. 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: 1622984 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-31
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Catheterisation cardiac, Echocardiogram, Electrocardiogram, Inappropriate schedule of product administration, Myocardial necrosis marker, Myocarditis
SMQs:, Cardiomyopathy (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cardiac catheterization; Result Unstructured Data: was performed after admission found no significant stenosis in the coronary artery; Test Date: 20210802; Test Name: Echocardiogram; Result Unstructured Data: decreased cardiac function in echocardiography.; Test Date: 20210802; Test Name: Electrocardiogram; Result Unstructured Data: ST elevation in various leads of electrocardiogram; Test Date: 20210802; Test Name: Cardiac enzymes; Result Unstructured Data: Elevated
CDC Split Type: JPTAKEDA2021TJP076369

Write-up: Acute myocarditis; Second dose early (10-Jul-2021 - 31-JUL-2021, window 21 days); This case was received via Pharmaceuticals Agency (Reference number: 2021TJP076369) on 13-Aug-2021 and was forwarded to Moderna on 19-Aug-2021. This case, reported by a physician, was received by Pharmaceutical Company Limited via Modernas adverse reaction reporting site (TASK0020825). On 10-Jul-2021, at 09:00, the patient received the 1st dose of the vaccine. On 31-Jul-2021, at 14:00, the patient received the 2nd dose of the vaccine. On 01-Aug-2021, at 08:00, the patient experienced pyrexia and chest pain. On 02-Aug-2021, the area of chest pain moved from median to left, and the symptom was worsened. At night, the patient visited the hospital. As there were elevated cardiac enzymes, ST elevation in various leads of electrocardiogram, and decreased cardiac function in echocardiography, the patient was hospitalized suspecting acute myocarditis. Cardiac catheterization that was performed after admission found no significant stenosis in the coronary artery, and the diagnosis of acute myocarditis was made based on various test results. On 12-Aug-2021, acute myocarditis subsided. The outcome of acute myocarditis was reported as resolving. No 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: Not reported.; Sender''s Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273 (lot unknown) with associated adverse event reported as Acute Myocarditis. 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: 1622993 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Malaise, Myalgia, Myocarditis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

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

Write-up: Myopericarditis: pijn op de borst; malaise klachten; Spierpijn; Vermoeidheid; Hoofdpijn; Koorts: 38 tot 40.5 graden Celcius; This case was received via European Medicines Agency (Reference number: 00648480) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDITIS (Myopericarditis: pijn op de borst) in a 31-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Nickel sensitivity (allergy: nikkel). On 29-Jul-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 31-Jul-2021, the patient experienced MYOCARDITIS (Myopericarditis: pijn op de borst) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced MALAISE (malaise klachten), MYALGIA (Spierpijn), FATIGUE (Vermoeidheid), HEADACHE (Hoofdpijn) and PYREXIA (Koorts: 38 tot 40.5 graden Celcius). At the time of the report, MYOCARDITIS (Myopericarditis: pijn op de borst) was resolving, MALAISE (malaise klachten), MYALGIA (Spierpijn) and FATIGUE (Vermoeidheid) outcome was unknown and HEADACHE (Hoofdpijn) and PYREXIA (Koorts: 38 tot 40.5 graden Celcius) had resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment medication were reported by the reporter. Troponin and electrocardiogram tests were performed. Company comment- Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender''s Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.


VAERS ID: 1622997 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough
SMQs:, Anaphylactic reaction (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: PHJNJFOC20210838780

Write-up: COUGH; This spontaneous report received from a pharmacist via a Regulatory Authority [PHIFDA, PH-PHFDA-300099638] concerned a 56 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, with frequency 1 total administered on 26-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-JUL-2021, the patient experienced cough, and was hospitalized (date unspecified). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from cough. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0-20210838780-Covid-19 vaccine ad26.cov2.s- Cough.. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1623007 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210841079

Write-up: FAINTING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA: PH-PHFDA-300098357] concerned a 19 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210841079-covid-19 vaccine ad26.cov2.s-Fainting.This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1623217 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Blood creatine phosphokinase, Pain in extremity, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament 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: 20210805; Test Name: CK; Result Unstructured Data: CK 40''000 7 days after vaccination.
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: In the course then the feeling of weakness; Rhabdomyolysis/ creatinine kinase (CK) 40000 seven days after vaccination; Had a work out and with then only hours later severe pain belt like in the upper arms; This spontaneous case was reported by a physician and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis/ creatinine kinase (CK) 40000 seven days after vaccination) in a 28-year-old patient of an unknown gender who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) at an unspecified dose. On 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (Had a work out and with then only hours later severe pain belt like in the upper arms). On 05-Aug-2021, the patient experienced RHABDOMYOLYSIS (Rhabdomyolysis/ creatinine kinase (CK) 40000 seven days after vaccination) (seriousness criterion medically significant). On an unknown date, the patient experienced ASTHENIA (In the course then the feeling of weakness). At the time of the report, RHABDOMYOLYSIS (Rhabdomyolysis/ creatinine kinase (CK) 40000 seven days after vaccination), PAIN IN EXTREMITY (Had a work out and with then only hours later severe pain belt like in the upper arms) and ASTHENIA (In the course then the feeling of weakness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Aug-2021, Blood creatine phosphokinase: 40000 (High) CK 40''000 7 days after vaccination.. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown), the reporter considered RHABDOMYOLYSIS (Rhabdomyolysis/ creatinine kinase (CK) 40000 seven days after vaccination), PAIN IN EXTREMITY (Had a work out and with then only hours later severe pain belt like in the upper arms) and ASTHENIA (In the course then the feeling of weakness) to be possibly related. Concomitant product use was not provider by the reporter. On 05-Aug-2021, the patient consulted the physician. Under hydration healing without consequences. For only sport as reason for the values are they rather very high, therefore a side effect by the Covid vaccination not to exclude. 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. Regulatory Authority comment: This spontaneous HCP report was received from a physician concerning a 28-year-old patient of unspecified age who received vaccination with Moderna''s COVID-19 Vaccine (mRNA1273) on 29-JUL-2021 (Batch number: not reported; dose chronology not reported; arm not specified) for the prophylaxis of COVID-19 infection. With an onset latency of 7 days after the vaccination the patient experienced rhabdomyolysis (CK 40''000). On 31-JUL-2021 the patient went for a workout and a few hours later experienced severe pain "belt-like" in the upper arms. In the further clinical course, a feeling of weakness occurred prompting specialist consultation on 05-AUG-2021 with a creatine kinase (CK) value of 40''000. Under hydration the patient was healing without consequences at the moment of reporting on 10-AUG-2021. The patient''s medical history was not specified but the HCP reporter mentioned a status of good health. Past or concomitant medications applied at the time of vaccination were not reported. The company assessed the case as serious. Company''s assessment: 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. Regulatory Authority assessment: rhabdomyolysis (onset latency: 7 days after vaccination; reported associated symptoms: muscle pain and weakness, grade not reported; changes in the aspect or characteristics of the urine were not reported; other symptoms were not reported; laboratory tests results including complete blood count (CBC), erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) were not reported; urinalysis results not reported; event resolving under hydration therapy, rate of CK decline was not reported; based on the CK level at presentation, risk of later complications e.g. fluid and electrolyte abnormalities and/or acute kidney injury cannot be completely ruled out; long-term follow up is necessary to confirm recovery without clinical consequences) [unlabeled / no additional risk minimization measures (aRMMs) necessary; missing information about individual risk factors for musculoskeletal complications; at the moment, the CDC recommends "use or exercise the vaccination arm" to minimize post-vaccine soreness but data on specific frequency, duration, or type of exercise are not available. In general, specialists recommend the intensity of workouts be reduced by about 20% after vaccination, but there is no evidence showing that exercising too soon before or after COVID-19 vaccination reduces its effect in any way]. The events reported on 10-AUG-2021 are assessed as possibly related to the vaccine. Further clinical course was not reported; outcome of the acute event is considered resolved, long-term outcome is not known.; 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: 1624684 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2752 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Haematochezia, Stool analysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: Kidney polycystic (Possible polycystic kidney disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood stool; Result Unstructured Data: Test Result:Blood stool
CDC Split Type: ESPFIZER INC202101017225

Write-up: Blood stool; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) WEB ES-AEMPS-963431. A 38-year-old female patient (not pregnant) received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on the left arm on 30Jul2021 (Lot Number: FF2752) as single dose for COVID-19 immunization. Medical history included Kidney polycystic, possible polycystic kidney disease. Recent injection of anti-inflammatory and corticosteroid. The patient didn''t known whether had COVID-19 passed. Concomitant medication was not reported. On 31Jul2021, the patient experienced Blood stool. The outcome of events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1624696 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-31
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC202101017082

Write-up: Pericarditis; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority, WEB ES-AEMPS-964708. A 42-year-old male patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 15Jul2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not provided. The patient previously received the first dose of bnt162b2 (COMIRNATY), on an unspecified date as single dose for COVID-19 immunisation. On 31Jul2021, the patient experienced pericarditis (hospitalized). The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1624703 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-31
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6208 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Auscultation, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood cholesterol, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood iron, Blood lactate dehydrogenase, Blood lactic acid, Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Blood thyroid stimulating hormone, Blood triglycerides, C-reactive protein, Carbon dioxide, Chest X-ray, Computerised tomogram thorax, Fibrin D dimer, Gamma-glutamyltransferase, Glomerular filtration rate, Glycosylated haemoglobin, HIV test, Haemoglobin, Heart rate, Hepatitis B, Hepatitis C, High density lipoprotein, International normalised ratio, Low density lipoprotein, Lymphocyte count, Mean cell haemoglobin, Mean cell volume, Neutrophil count, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Procalcitonin, Prostatic specific antigen, Protein total, Pulmonary embolism, SARS-CoV-2 test, Serum ferritin, Transferrin, Transferrin receptor assay, Transferrin saturation, Ultrasound Doppler, White blood cell count
SMQs:, Liver infections (narrow), Embolic and thrombotic events, venous (narrow), 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? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: APTT; Result Unstructured Data: Test Result:29; Test Date: 20210803; Test Name: APTT; Result Unstructured Data: Test Result:35; Test Date: 20210731; Test Name: ALT; Result Unstructured Data: Test Result:18 IU/l; Test Date: 20210803; Test Name: ALT; Result Unstructured Data: Test Result:19 IU/l; Test Name: Cardiopulmonary auscultation; Result Unstructured Data: Test Result:Rhythmic without murmurs or; Comments: ...extratons. Vesicular murmur with mild hypoventilation at the base with no decrease in the transmission of vocal sounds at this level, without other added noises.; Test Date: 20210731; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:46 IU/l; Test Date: 20210803; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:46 IU/l; Test Date: 20210731; Test Name: Venous blood bicarbonate; Result Unstructured Data: Test Result:27 mmol/L; Test Date: 20210731; Test Name: Venous blood standard bicarbonate; Result Unstructured Data: Test Result:24 mmol/L; Test Date: 20210731; Test Name: Bilirubin; Test Result: 1 mg/dl; Test Date: 20210803; Test Name: Bilirubin; Test Result: 0.7 mg/dl; Test Date: 20210803; Test Name: Cholesterol; Result Unstructured Data: Test Result:166; Test Date: 20210731; Test Name: Creatine phosphhokinase; Result Unstructured Data: Test Result:96 IU/l; Test Date: 20210731; Test Name: Creatinine; Test Result: 0.84 mg/dl; Test Date: 20210803; Test Name: Creatinine; Test Result: 0.99 mg/dl; Test Date: 20210731; Test Name: Fibrinogen; Result Unstructured Data: Test Result:674; Test Date: 20210803; Test Name: Fibrinogen; Result Unstructured Data: Test Result:621; Test Date: 20210731; Test Name: Glucose; Test Result: 100 mg/dl; Test Date: 20210803; Test Name: Glucose; Test Result: 108 mg/dl; Test Date: 20210803; Test Name: iron; Result Unstructured Data: Test Result:41; Test Date: 20210731; Test Name: LDH; Result Unstructured Data: Test Result:149 IU/l; Test Date: 20210731; Test Name: Venous blood lactate; Result Unstructured Data: Test Result:1.2 mmol/L; Test Date: 20210731; Test Name: pH venous blood; Result Unstructured Data: Test Result:7.38; Test Date: 20210731; Test Name: Potassium; Result Unstructured Data: Test Result:4 mmol/L; Test Date: 20210803; Test Name: Potassium; Result Unstructured Data: Test Result:4.1 mmol/L; Test Name: Blood pressure; Result Unstructured Data: Test Result:150/89 mmHg; Test Date: 20210731; Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20210803; Test Name: Sodium; Result Unstructured Data: Test Result:141 mmol/L; Test Date: 20210803; Test Name: TSH; Result Unstructured Data: Test Result:2.51; Test Date: 20210803; Test Name: TG; Result Unstructured Data: Test Result:126; Test Date: 20210731; Test Name: CO2 total venous blood; Result Unstructured Data: Test Result:28 mmol/L; Test Name: Chest X-ray; Result Unstructured Data: Test Result:there is no consolidated objective...; Comments: ... except for a possible slight increase in density in the right base; Test Date: 20210731; Test Name: CT pulmonary arteries; Result Unstructured Data: Test Result:Sudden pleuritic pain in the right lung...; Comments: ... base. dimeroD 350. rule out pulmonary thromboembolism. Thank you. Filling defects in the medial inferior segmental branch of the left lower lobe and anterior basal branch of the right lower lobe, consistent with bilateral acute segmental pulmonary thromboembolism. It presents a subpleural alveolar opacity in the anterior region of the right pulmonary tongue, corresponding to the irrigation territories of the anterior basal branch, compatible with pulmonary infarction. Minimal right pleural effusion of laminar thickness. It does not present data on right heart chamber overload. Rest of the study without significant findings. Conclusion: Acute bilateral segmental pulmonary embolism with right lower lobe pulmonary infarction.; Test Date: 20210731; Test Name: CRP; Test Result: 6.1 mg/dl; Test Date: 20210731; Test Name: DD; Result Unstructured Data: Test Result:357; Test Date: 20210731; Test Name: GGT; Result Unstructured Data: Test Result:16 IU/l; Test Date: 20210803; Test Name: GGT; Result Unstructured Data: Test Result:17 IU/l; Test Date: 20210731; Test Name: Filt. glomerular (CKD-EPI); Result Unstructured Data: Test Result:90 ml/min; Comments: /1.73m2; Test Date: 20210803; Test Name: HbA1c; Test Result: 5.2 %; Test Date: 20210731; Test Name: Hb; Result Unstructured Data: Test Result:15.8; Test Date: 20210803; Test Name: Hb; Result Unstructured Data: Test Result:15.5; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: bpm; Test Date: 20210803; Test Name: HBV; Test Result: Negative ; Test Date: 20210803; Test Name: HCV; Test Result: Negative ; Test Date: 20210803; Test Name: HDL; Result Unstructured Data: Test Result:32; Test Date: 20210803; Test Name: HIV; Test Result: Negative ; Test Date: 20210731; Test Name: INR; Result Unstructured Data: Test Result:1.02; Test Date: 20210803; Test Name: INR; Result Unstructured Data: Test Result:1.12; Test Date: 20210803; Test Name: LDL; Result Unstructured Data: Test Result:109; Test Date: 20210731; Test Name: lymphocytes; Result Unstructured Data: Test Result:1000; Test Date: 20210731; Test Name: MCH; Result Unstructured Data: Test Result:30; Test Date: 20210803; Test Name: MCH; Result Unstructured Data: Test Result:30; Test Date: 20210731; Test Name: MCV; Result Unstructured Data: Test Result:86; Test Date: 20210803; Test Name: MCV; Result Unstructured Data: Test Result:85; Test Date: 20210731; Test Name: Neutrophils; Result Unstructured Data: Test Result:6100; Test Date: 20210731; Test Name: O2 saturation venous blood; Test Result: 64 %; Test Date: 20210731; Test Name: pCO2 (partial pressure CO2) venous blood; Result Unstructured Data: Test Result:45 mmHg; Test Name: Abdomen; Result Unstructured Data: Test Result:Hydro-air noises +....; Comments: ...Generalized painful adbomen with defense on palpation. Table abdomen. Negative renal percussion fist. Lower limbs: No edema or signs of DVT. Distal pulses present and symmetrical; Test Date: 20210731; Test Name: Platelets; Result Unstructured Data: Test Result:147000; Test Date: 20210803; Test Name: Platelets; Result Unstructured Data: Test Result:178000; Test Date: 20210731; Test Name: pO2 (partial pressure O2) venous blood; Result Unstructured Data: Test Result:34 mmHg; Test Date: 20210731; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.04 ug/L; Test Date: 20210803; Test Name: prostate specific antigen; Result Unstructured Data: Test Result:0.22; Test Date: 20210803; Test Name: Proteins; Result Unstructured Data: Test Result:7.3; Test Date: 20210731; Test Name: PCR SARS-CoV2; Test Result: Negative ; Test Date: 20210803; Test Name: Ferritin; Result Unstructured Data: Test Result:243; Test Date: 20210803; Test Name: Transferrin; Result Unstructured Data: Test Result:244; Test Date: 20210803; Test Name: Soluble transferrin receptor; Result Unstructured Data: Test Result:1.77; Test Date: 20210803; Test Name: Transferrin saturation index; Test Result: 20 %; Test Date: 20210802; Test Name: Ecodoppler Lower limbs; Result Unstructured Data: Test Result:the deep venous system of both ...; Comments: ...lower limbs is explored, including common femoral vein, arch of the saphenous, origin of the deep femoral vein, superficial femoral vein in all its length and popliteal vein, as well as distal territory. The entire deep venous system is permeable and collapsible with compression maneuvers.; Test Date: 20210731; Test Name: Leukocytes; Result Unstructured Data: Test Result:7900; Test Date: 20210803; Test Name: Leukocytes; Result Unstructured Data: Test Result:5500; Comments: (FN)
CDC Split Type: ESPFIZER INC202101017230

Write-up: Pulmonary thromboembolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-965060. A 32-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 11Jul2021 (Lot Number: FE6208) as Dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary thromboembolism (hospitalization) on 31Jul2021. The patient was hospitalized for pulmonary thromboembolism from 31Jul2021 to 03Aug2021. Evolution and comments: This patient with no personal history of interest, with a family history of venous thromboembolic disease (grandmother with pulmonary thromboembolism). The patient was admitted on 31Jul21 for an episode of low-risk pulmonary embolism, with no associated provoking factor. Anticoagulation with weight-adjusted LMWH (enoxaparin 90 mg / 12 hours) has been started, with good clinical evolution, with disappearance of pleuritic pain. At discharge eupneic at rest, saturating at 98% baseline and walking on the floor without dyspnea. Principal diagnostic :Low-risk unprovoked pulmonary embolism. Other diagnoses: Pulmonary infarction in secondary LID. Physical exploration:Physical Examination in the Emergency Room.BP 150/89 mmHg HR 100 bpm Regular general condition, Normocoloread and normohydrated. WEIGHT 93-94kg. Size 182 cm. Cardiopulmonary auscultation: Rhythmic without murmurs or extratons. Vesicular murmur with mild hypoventilation at the base with no decrease in the transmission of vocal sounds at this level, without other added noises. Abdomen: Hydro-air noises +. Generalized painful adbomen with defense on palpation. Abdominal splinting. Percussion of the kidneys (fist) negative. Lower limbs: No edema or signs of DVT. Distal pulses present and symmetrical. Summary of complementary tests: Laboratory: N EMERGENCIES 31Jul2021- Hemogram: Hb 15.8. MCV 86. HCM 30. Platelets 147000. Leukocytes 7900 (6100 neutrophils, 1000 lymphocytes).- Coagulation: DD 357. INR 1.02. Fibrinogen 674. APTT 29. - Venous blood gases: Venous blood bicarbonate 27 mmol / L (22 - 30), Venous blood standard bicarbonate 24 mmol / L, Venous blood lactate 1.2 mmol / L (0.6 - 2.2), pCO2 (partial pressure CO2) venous blood 45 mm Hg (40 - 50), pH venous blood 7.38 (7.31 - 7.41), pO2 (partial pressure O2) venous blood * 34 mm Hg (40 - 50), O2 saturation venous blood 64%, CO2 total venous blood 28 mmol / L - Biochemistry: Glucose 100 mg / dL (74 - 110), ALT (GPT) 18 U / L (5 - 41), Bilirubin 1.0 mg / dL (0.1- 1.1), GGT 16 U / L (10 - 60), Alkaline phosphatase 46 U / L (40 - 130), LDH 149 U / L (135 - 225), CK (Creatine phosphhokinase) 96 U / L (39 - 308), Creatinine 0.84 mg / dL (0.7 - 1.2), Sodium 141 mmol / L (135 - 145), Potassium 4.0 mmol / L (3.5 - 5.2), Procalcitonin 0.04 ug / L (0 - 0.5), Filt. glomerular (CKD-EPI) 90 mL / min / 1.73 m2 (60 - 100), CRP * 6.1 mg / dL (0 - 0.5). 03Aug2021, - Biochemistry: glucose 108. ALT 19. Bilirubin 0.7. GGT 17. Alkaline phosphatase 46. Creatinine 0.99. Proteins 7.3. TG 126. Cholesterol 166. HDL 32. LDL 109. Na 141. K 4.1. - Iron 41 ferrokinetic profile. Ferritin 243. Transferrin 244. Transferrin saturation index 20%. Soluble transferrin receptor 1.77.- TSH 2.51.- prostate specific antigen 0.22.- HbA1c 5.2%.- Hemogram: Hb 15.5. MCV 85. MCH 30. Platelets 178000. Leukocytes 5500 (FN).- Coagulation: INR 1.12. APTT 35. Fibrinogen 621. - HIV, HBV, HCV serology: negative. Picture:Chest X-ray: there is no consolidated objective except for a possible slight increase in density in the right base. CT pulmonary arteries (31Jul21): Sudden pleuritic pain in the right lung base. dimeroD 350. rule out pulmonary thromboembolism. Filling defects in the medial inferior segmental branch of the left lower lobe and anterior basal branch of the right lower lobe, consistent with bilateral acute segmental pulmonary thromboembolism. It presents a subpleural alveolar opacity in the anterior region of the right pulmonary tongue, corresponding to the irrigation territories of the anterior basal branch, compatible with pulmonary infarction. Minimal right pleural effusion of laminar thickness. It does not present data on right heart chamber overload. Rest of the study without significant findings. Conclusion: Acute bilateral segmental pulmonary embolism with right lower lobe pulmonary infarction. Ecodoppler Lower limbs (02Aug2021): the deep venous system of both lower limbs is explored, including common femoral vein, arch of the saphenous, origin of the deep femoral vein, superficial femoral vein in all its length and popliteal vein, as well as distal territory. The entire deep venous system is permeable and collapsible with compression maneuvers.- PCR SARS-CoV2 (31Jul21): NEGATIVE.. Treatment: Drugs: Lixiana (edoxaban) 60 mg, 1 tablet daily. The outcome of the event was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1624950 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Back pain, Chest discomfort, Chest pain, Electrocardiogram, Palpitations
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SERTRALINE; SALBUTAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC202101017231

Write-up: Chest pain; Back pain; Heart rapidly beating/racing heartbeat; pressure in chest/tightness in chest; Heart pain and Heart rapidly beating along with pressure in chest; This is a spontaneous report from two contactable consumers downloaded from the Regulatory authority-WEB, regulatory authority number GB-MHRA-EYC 00257659. A 22-year-old male patient received BNT162B2, parenteral on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 vaccination. The patient''s medical history was not reported. Concomitant medications included sertraline taken for an unspecified indication, start and stop date were not reported; salbutamol taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH) on an unknown date for COVID-19 immunisation. The patient experienced heart pain, Heart rapidly beating/racing heartbeat, pressure in chest/tightness in chest and back pain on 31Jul2021; chest pain on an unspecified date. The events were assessed as serious (disability, medically significant). The patient underwent lab tests and procedures which included electrocardiogram: unknown results on an unknown date. The outcome of the events ''chest pain'' and ''back pain'' was unknown and outcome of the other events was not recovered. The clinical course was reported as follows: Pain, racing heartbeat, intolerance to any exercise or standing. Similar to postural orthostatic tachycardia syndrome (POTS). Scared and a lot of discomfort, Heart racing, heart pain, pressure in chest, a feeling of squeezing, chest pain into back, tightness in chest. Went to general practitioner (GP) on an emergency appointment and electrocardiogram (ECG) carried out with medication. No follow-up attempts are possible; information about Batch/Lot Number cannot be obtained.


VAERS ID: 1624985 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3380 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Inappropriate schedule of product administration, SARS-CoV-2 test
SMQs:, Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FERROUS SULFATE; LANSOPRAZOLE
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 INC202101021712

Write-up: Headache; dose 1 BNT162B2 on 29May2021, second dose on 31Jul2021; This is a spontaneous report from a contactable consumer. received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108080822297390-ATWRK. Sender''s (Case) Safety Report Unique Identifier-GB-MHRA-ADR 25771160. A 35-years-old female patient received Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Jul2021 at age of 35-years-old (Batch/Lot Number: FE3380) as single dose for covid-19 immunization. Medical history included lactation decreased. Patient has not had symptoms associated with COVID-19. Patient is not pregnant. Patient is not currently breastfeeding. Concomitant medication included ferrous sulfate; lansoprazole. Historical vaccination included dose 1 BNT162B2 on 29May2021 (Batch/Lot Number: EW3143) for covid-19 immunization. The patient experienced headache every day since 02Aug2021, not always constant, sometimes comes and goes and not always bad enough to need pain relief. Reported to GP who said headaches can last a couple of weeks but go to A&E if it becomes severe. The event was considered as medically significant. The sars-cov-2 test was No - Negative COVID-19 test. The outcome of the event headache was not recovered. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1625590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213-28-001 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Ataxia, Body temperature, Computerised tomogram, Diarrhoea, Dysarthria, Physical examination, Pyrexia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DELTACORTENE
Current Illness: Hyper IgE (a subject with Hyper-immunoglobulin E syndrome)
Preexisting Conditions: Medical History/Concurrent Conditions: Asthmatic; SARS-CoV-2 acute respiratory disease (with previous Severe acute respiratory syndrome-CoV-2 positivity); Tumour necrosis
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Test Result:Unknown results Centigrade; Test Date: 20210731; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 2021; Test Name: computed tomography; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210731; Test Name: Physical examination; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: ITPFIZER INC202101016777

Write-up: Episode of extrinsic asthma with acute exacerbation; Ataxia; Distress respiratory/acute respiratory distress; Fever/38.5 Centigrade; Dysarthria; Diarrhea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority., regulatory authority number IT-MINISAL02-767575. A 53-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left (left shoulder) on 30Jul2021 (Batch/Lot Number: FF4213-28-001) as dose 1, single for covid-19 immunization. Medical history included Hyper IgE from 02Jan2017 to 01Aug2021 (a subject with Hyper-immunoglobulin E syndrome, with previous Severe acute respiratory syndrome-CoV-2 positivity), Tumour Necrosis Factor positive from Feb2021 and asthmatic. Concomitant medication included prednisone (DELTACORTENE) taken for an unspecified indication, start and stop date were not reported. patient previously took cortisone (before vaccination). The patient experienced ataxia on 31Jul2021, distress respiratory on 31Jul2021, fever on 31Jul2021, dysarthria on 31Jul2021, diarrhea on 31Jul2021, episode of extrinsic asthma with acute exacerbation on an unspecified date. Clinical course as follows: At 24 hours after administration of 1st dose of Comirnaty vaccine, fever and diarrhea. After 48 hours (also reported on 31Jul2021) ataxia and dysarthria (on diagnosis of Hyper-immunoglobulin E syndrome). At 96 hours (also reported on 31Jul2021) acute respiratory distress in asthmatic subjects. Ataxia and dysarthria regressed 48 hours after dupilumab intake. Reported taking cortisone before vaccination and for 3 days afterwards. Treatment included S/ Urbason and aerosol. Episode of extrinsic asthma with acute exacerbation. The patient underwent lab tests and procedures which included body temperature: unknown results on 30Jul2021, 38.5 centigrade on 31Jul2021, physical examination: Unknown results on 31Jul2021, computerised tomogram: Unknown results in 2021. Treatment received for the events. Outcome of Episode of extrinsic asthma with acute exacerbation was unknown, outcome of other events was recovering. Seriousness Criteria is Medically Significant. Reporter comment: Autoimmune reaction in a subject with Hyper-immunoglobulin E syndrome, with previous Severe acute respiratory syndrome-CoV-2 positivity. (Tumour Necrosis Factor positive in February 2021). Relative contraindication of the treating immunologist. ; Reporter''s Comments: Autoimmune reaction in a subject with Hyper-immunoglobulin E syndrome, with previous Severe acute respiratory syndrome-CoV-2 positivity. (Tumour Necrosis Factor positive in February 2021). Relative contraindication of the treating immunologist.


VAERS ID: 1625714 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Body temperature increased, Fatigue, Malaise, Myalgia, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaginal haemorrhage
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Eosinophilic pneumonia (broad), Termination of pregnancy and risk of abortion (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: body temperature increased; Result Unstructured Data: Test Result:37.5 up to 38 Centigrade
CDC Split Type: NLPFIZER INC202101016745

Write-up: Possible miscarriage (bleeding with clots); Possible miscarriage (bleeding with clots); Fatigue; Not feeling well; Fever 37.5 up to 38 Celsius degrees; Muscle pain; Inflammatory reaction at the reaction site: pain, swelling, occurring within a week after vaccination; Reaction at or around the injection site: swelling, occurring within a week of vaccination; Reaction at or around the injection site: pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00650253. A 34 years old female patient received second dose of bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration at age of 34 years old on 31Jul2021 (Lot Number: FE8405) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 26Jun2021 for COVID-19 immunisation and experienced Injection site pain. The patient experienced possible miscarriage (bleeding with clots) on 02Aug2021, inflammatory reaction at the reaction site: pain, swelling, occurring within a week after vaccination on 31Jul2021, not feeling well on 01Aug2021, fever 37.5 up to 38 celsius degrees on 01Aug2021, muscle pain on 31Jul2021, reaction at or around the injection site: pain on 31Jul2021, fatigue on 01Aug2021, possible miscarriage (bleeding with clots) on 02Aug2021. The mother reported she became pregnant while taking second dose bnt162b2. The mother was 1 Trimester pregnant at the onset of the event. The pregnancy resulted in spontaneous abortion. Treatment: Body temperature increased was treated with Paracetamol. The patient had not recovered from vaginal bleeding, was recovering from fatigue, inflammatory reaction at the reaction site: pain, swelling, malaise, myalgia, recovered from body temperature increased on 02Aug2021. The assumed miscarriage occurred at a pregnancy duration of about 5 weeks. This was the second Covid vaccination, which took place at a pregnancy duration of about 4,5 weeks. The first Covid vaccination took place before pregnancy. Event Abortion spontaneous was reported as serious other medically important condition. Sender Comment: Since the nature of the reported reaction does imply seriousness according to one of the HA critera, the reaction (Possible miscarriage (bleeding with clots)) was considered as serious by the regulatory authority. Sender''s Diagnosis: Injection site inflammation Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Sore injection site Date: 26Jun2021 Extensive swelling of vaccinated limb: no Possible miscarriage (bleeding with clots) I was about 5 weeks pregnant (didn''t know when I got the injection) and today I started bleeding. confounding factors COVID-19 vaccine exposure during pregnancy week: 0 (second injection at 4/5 weeks) Previous COVID-19 infection: No No follow-up attempts possible. No further information expected.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Sore injection site Date: 26Jun2021 Extensive swelling of vaccinated limb: no Possible miscarriage (bleeding with clots) I was about 5 weeks pregnant (didn''t know when I got the injection) and today I started bleeding. confounding factors COVID-19 vaccine exposure during pregnancy week: 0 (second injection at 4/5 weeks) Previous COVID-19 infection: No


VAERS ID: 1625735 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7053 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC202101016824

Write-up: PERICARDITIS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Ue2q52. A 40-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 29Jul2021 (Batch/Lot Number: FE7053) as single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 31Jul2021, the patient developed pericarditis after two days of hard work out and long walks, and was hospitalized. The patient''s outcome was recovered, at the time of the report. The case was considered to be serious. The center assessed the causal relationship between bnt162b2 and all the reported events as Possible. Reporter Comment: No further information regarding the event is available at the time of report. Additional information has been requested from the reporter. No follow-up attempts possible. No further information expected.; Reporter''s Comments: No further information regarding the event is available at the time of report. Additional information has been requested from the reporter.


VAERS ID: 1625782 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? 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: PTJNJFOC20210838537

Write-up: FATIGUE; ARM PAIN AFTER JANSSEN VACCINE; FEVER; MUSCLE PAIN; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, PT-INFARMED-F202107-5697] concerned a 26-year-old male of unspecified race and ethnic origin. The patient''s weight was 64 kilograms, and height was 167 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were not reported) 0.5 ml, frequency time 1 total, administered on 30-JUL-2021 for Covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fatigue, arm pain after janssen vaccine, fever and muscle pain. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, arm pain after janssen vaccine, fever and muscle pain. This report was serious (Disability Or Permanent Damage).; Sender''s Comments: V0: 20210838537-COVID-19 VACCINE AD26.COV2- fatigue, arm pain after janssen vaccine, fever and muscle pain. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1629440 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, C-reactive protein, Cardiac output, Cardiac stress test, Chest discomfort, Echocardiogram, Ejection fraction, Electrocardiogram, Extrasystoles, Heart rate irregular, Magnetic resonance imaging, Myocarditis, N-terminal prohormone brain natriuretic peptide, N-terminal prohormone brain natriuretic peptide increased, Troponin, Troponin increased, Ventricular extrasystoles
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Tachyarrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (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? 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: 20210801; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:12; Test Date: 20210801; Test Name: cardiac output; Result Unstructured Data: Test Result:3.21; Comments: L/min; Test Date: 20210803; Test Name: stress test; Result Unstructured Data: Test Result:unknown; Test Date: 20210801; Test Name: C-reactive protein; Result Unstructured Data: Test Result:7; Test Date: 20210801; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:Right-side cavities a little dilated; Comments: but right ventricle with good kinetics. Left delay, right axis, infundibular appearance; Test Date: 20210801; Test Name: Left ventricular ejection fraction; Test Result: 65 %; Test Date: 20210801; Test Name: Electrocardiography; Result Unstructured Data: Test Result:negative T waves V1-V4; Comments: sinus, discrete home hospitalization, 80 grades axis.; Test Date: 20210803; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Decline in ventricular extrasystoles; Comments: but still persisting without bursts.; Test Date: 20210801; Test Name: Bigeminy End-Systolic Volume; Result Unstructured Data: Test Result:quintuplets; Comments: monomorphic, 240/min on the scope (well tolerated). Left delay, right axis, infundibular appearance.; Test Date: 20210801; Test Name: Irregular heartbeats; Result Unstructured Data: Test Result:with no perceived murmur; Comments: Femoral pulses perceived.; Test Date: 20210801; Test Name: MRI; Result Unstructured Data: Test Result:unknown; Test Date: 20210801; Test Name: N-terminal pro-brain natriuretic peptide; Result Unstructured Data: Test Result:500; Test Date: 20210803; Test Name: N-terminal pro-brain natriuretic peptide; Result Unstructured Data: Test Result:156; Comments: ng/mL; Test Date: 20210801; Test Name: troponin; Result Unstructured Data: Test Result:Negative; Comments: (2 spaced samples); Test Date: 20210803; Test Name: troponin; Result Unstructured Data: Test Result:<3.0
CDC Split Type: FRPFIZER INC202101016591

Write-up: Extrasystoles ventricular; feeling of chest tightness; Tropo <3.0; N-terminal pro-brain natriuretic peptide 500/156 ng/mL; Irregular pulse; possible myocarditis; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-CF20212270. A 13-year-old female patient received bnt162b2 (COMIRNATY) intramuscular on 31Jul2021 (lot number and expiry date: unknown) at the age of 13-years-old, as dose 2, single, for COVID-19 immunisation. The patient had no relevant medical or family history. The patient was not taking concomitant medications. The patient previously received first dose of bnt162b2 (COMIRNATY) intramuscular on 07Jul2021 for COVID-19 immunisation. On 31Jul2021, the patient experienced extrasystoles ventricular, feeling of chest tightness, and irregular pulse. Outcome of the event extrasystoles ventricular was not recovered, while for the other events was unknown. Reporter''s Comments: Case Summary: MEDICALLY CONFIRMED; Hospitalisation report. MEDICAL HISTORY: NONE either personal or family. Have you had Covid-19? Not specified. OTHER MEDICINES: NONE. MEDICATION CONCERNED: On 07Jul2021: Vaccination with BioNTech-COMIRNATY 1st intramuscular injection - arm not specified - batch number not specified. On 31Jul2021: Vaccination with BioNTech-COMIRNATY 2nd intramuscular injection - arm not specified - batch number not specified. DESCRIPTION OF THE ADVERSE REACTION: On 31Jul2021: Vaccination in the morning. The following night, without any triggering factor: feeling of chest tightness. Feels better lying down. Irregular pulse =$g Emergency Room consultation: From 01Aug2021 to 03Aug2021: Transfer to Paediatric Continuing Care Unit, Paediatric Intensive Care Unit for the monitoring of Extra Ventricular Systoles with doublets. On 03Aug2021 Transfer to the Cardiology ward for stress test. Cardiologist examination planned on 01Aug2021: Clinical: Irregular heartbeats with no perceived murmur. Femoral pulses perceived. Systolic blood pressure 12. Soft abdomen without hysterosalpingogram (HSLG). Electrocardiography: sinus, discrete home hospitalisation, negative T waves V1-V4, 80grades axis. Bigeminy End-Systolic Volume + doublets ==$g quintuplets, monomorphic, 240/min on the scope (well tolerated). Left delay, right axis, infundibular appearance. Trans-thoracic echocardiography: Right-side cavities a little dilated, but right ventricle with good kinetics. Left delay, right axis, infundibular appearance. Left ventricular ejection fraction 65%, Cardiac output at 3.21 L/min. Blood tests: troponin negative (2 spaced samples), C-reactive protein 7, N-terminal pro-brain natriuretic peptide 500, no ionic disorder. Thus, very frequent infundibular End-Systolic Volume: bigeminy, short bursts at 240/mn, responsible for chest tightness, discrete elevation of N-terminal pro-brain natriuretic peptide, on an apparently healthy heart, except for moderate dilatation of the right-side chambers. Scheduled stress test and in case of symptomatic and persistent ventricular extrasystoles: Flecaine then Magnetic Resonance Imaging. Precaution on possible myocarditis. On 03Aug2021: Transfer to cardiology ward for assessment of these ventricular extrasystoles. Normal blood tests excluding N-terminal pro-brain natriuretic peptide: 156 ng/mL, (Tropo <3.0). Electrocardiography: Decline in ventricular extrasystoles but still persisting without bursts. ONGOING MEDICAL CARE: Consultation in the Emergency Room, hospitalisation in progress. OUTCOME: Not Recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.


VAERS ID: 1630365 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7959 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Pruritus, Urticaria
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XANAX; BRINTELLIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nickel sensitivity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101032043

Write-up: Urticaria spread all over the body with large red blisters and severe itching; urticaria spread all over the body with large red blisters and severe itching; urticaria spread all over the body with large red blisters and severe itching; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-768420. A 47-years-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot number: FD7959) via an unspecified route of administration on 30Jul2021 as single dose for covid-19 immunisation. Medical history included allergy to metals from an unknown date and unknown if ongoing. Concomitant medication(s) included alprazolam (XANAX); vortioxetine hydrobromide (BRINTELLIX), all taken for an unspecified indication, start and stop date were not reported. On 31Jul2021 the patient experienced urticaria spread all over the body with large red blisters and severe itching. The patient received treatment for the adverse event. Therapeutic measures were taken as a result of urticaria spread all over the body with large red blisters and severe itching. The clinical outcome of the event was not recovered. Sender Comment: 06Aug asks for n. lot No follow up attempts are possible. No further information is expected.


VAERS ID: 1630843 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210841067

Write-up: FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer via a Regulatory Authority [PT-INFARMED-B202108-67] concerned a 32 year old male of an unspecified race and ethnic origin. The patient''s weight was 64 kilograms, and height was 172 centimeters. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XE393 and expiry: UNKNOWN) 0.5 ml, frequency time 1 total administered on 31-JUL-2021 for covid-19 immunisation. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fever, headache and nausea. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, headache, and nausea on 01-AUG-2021. This report was serious (Disability Or Permanent Damage).; Reporter''s Comments: Did medication error occur? No; Sender''s Comments: V0: 20210841067-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Fever, Headache, Nausea. This event(s) is labeled per RSI and is therefore considered potentially related.


VAERS ID: 1633670 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased embryo viability, Foetal death, Foetal monitoring, Maternal exposure during pregnancy, Off label use, Placental insufficiency, Ultrasound foetal
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Fertility 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERTRALIN ACCORD; INNOVAIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Obsessive-compulsive disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: Cardiotocography; Result Unstructured Data: Test Result:gave suspicion of affected fetus; Test Date: 20210803; Test Name: Ultrasound fetal; Result Unstructured Data: Test Result:shows severely affected blood flow
CDC Split Type: DKPFIZER INC202101045442

Write-up: Dead fetus; Severe impact on the blood supply to the fetus; Feels less life from the fetus; Maternal exposure during pregnancy; off-label; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0082469. This is the first of two reports, only this one is serious. A 31-year-old pregnant female patient received bnt162b2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: FD4555, pregnant at the time of vaccination) via intramuscular route of administration on 31Jul2021 (age at the time of vaccination was not provided) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history included was obsessive-compulsive disorder from 2017 to an unspecified stop date and asthma from an unspecified date to an unspecified date and unknown if ongoing. The concomitant medications included sertraline hydrochloride (SERTRALIN ACCORD, 100mg) 100mg 1x/day, taken for obsessive-compulsive disorder from 2017 to an unspecified stop date, beclomethasone dipropionate, formoterol fumarate (INNOVAIR, beclomethasone dipropionate 200 ug, formoterol fumarate 6 ug) at 2 DF, 1x/day, taken for asthma from 2018 to an unspecified stop date. The historical vaccine included as received bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6134 and Expiration date: 30Apr2021) dose 1, via an unspecified route of administration on 15Jan2021 as DOSE 1, SINGLE for covid-19 immunisation and experienced maternal exposure during pregnancy and off label use on 15Jan2021. On 02Aug2021, the patient experienced dead fetus, severe impact on the blood supply to the fetus, feels less life from the fetus. On 31Jul2021, the patient had maternal exposure during pregnancy, and off-label use. The mother reported she became pregnant while taking bnt162b2. The mother was 30 Weeks pregnant (Gestation Period 30 weeks) at the onset of the event. The patient underwent lab tests and procedures which included foetal monitoring: gave suspicion of affected fetus on 03Aug2021, ultrasound foetal: shows severely affected blood flow on 03Aug2021. The ADRs were by the reporter reported as resulting in hospitalisation. The ADRs were by the reporter reported as resulting in hospitalisation and it was unknown if any treatment due to the ADRs was reported. The outcome of the events dead fetus, Severe impact on the blood supply to the fetus, and feels less life from the fetus was not recovered and event maternal exposure during pregnancy was recovered on 31Jul2021 and while for off-label use it was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : DK-PFIZER INC-202101053823 1st/2nd dose


VAERS ID: 1633739 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Influenza like illness, Monoplegia, Nausea, Pain in extremity, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101037875

Write-up: Arm paralysis; Arm pain; Influenza like illness; Fever; Nausea; Vomiting; Abdominal pain; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number FR-AFSSAPS-LM20212117, Safety Report Unique Identifier FR-AFSSAPS-2021106058. An 18-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, lot number: unknown, expiry date: unknown) via intramuscularly, on 31Jul2021 (age at vaccination: 18-years) as single dose for COVID-19 immunisation. Patient did not complete her second dose yet, no contradiction to dose 2. The patient''s medical history and concomitant medications were not reported. In the evening of the injection on 31Jul2021, the patient experienced paralysis of the left arm and flu syndrome (fever, nausea, vomiting, abdominal pain). arm pain and paralysis caused real disability for 48 hours. The patients mother was giving her paracetamol followed by homeopathy. After 48 hours, the patient could move her arm again, pain still present the fever had subsided completely. The reporter called because of great concern: action to be taken given: stop Fervex, continue paracetamol 1g 3 times a day spaced 6/8 hours apart with a maximum of 3g in 24 hours if pain. There was no contraindication to Dose 2. The time Interval between beginning of drug administration and start of reaction / event was 1 day. The outcome of event for arm paralysis, influenza like illness was recovered on 02Aug2021, pyrexia was recovered on an unspecified date in 2021, arm pain was not recovered, and rest was unknown. The reporter (health authority) considered the events arm pain and paralysis as serious due to disability. No follow-up attempts possible. No further information expected.


VAERS ID: 1634621 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8405 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Maternal exposure during pregnancy
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Respiratory failure (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: NLPFIZER INC202101082710

Write-up: At 11 weeks of pregnancy, the heart stopped beating, exactly around the date of vaccination.; Exposure during pregnancy; This is a spontaneous report from a contactable consumer or other non hcp. This is the second of two reports. The first report is a report downloaded from the Regulatory Authority, WEB NL-LRB-00660593. This is a fetus report. A 36 years old female received bnt162b2 (COMIRNATY), dose 2 transplacental on 31Jul2021 (Batch/Lot Number: FE8405) as Dose 2, single for covid-19 immunisation. The fetus medical history and concomitant medications were not reported. The female first Covid vaccination took place on 20Jun2021at a pregnancy duration of about 5 weeks with no adverse event, the second Covid vaccination took place at a pregnancy duration of about 11 weeks. At 11 weeks of pregnancy, the fetus heart stopped beating, exactly around the date of vaccination. The miscarriage occurred at a pregnancy duration of about 11 weeks. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101038910 mother/child case; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1634634 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210841675

Write-up: FAINTING; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA:PH-PHFDA-300098359] concerned a 27 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A expiry: unknown) dose was not reported, 1 total administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fainting. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210841675- Covid-19 vaccine ad26.cov2.s -Fainting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1638709 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE4728 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Body temperature, Fatigue, Headache, Malaise, Pyrexia, Ultrasound scan
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Termination of pregnancy and risk of abortion (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: 20210627; Test Name: Body temperature; Result Unstructured Data: Test Result:38-40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius; Test Name: Ultrasound examination; Result Unstructured Data: Test Result:unknown results; Comments: unknown results
CDC Split Type: NLPFIZER INC202101038947

Write-up: Miscarriage; Pyrexia; Headache; Malaise; Fatigue; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00660747. This consumer reported information for both mother and fetus. This is first of three reports (maternal report concerning 2nd dose of vaccine). A 29-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 31Jul2021 (Batch/Lot Number: FE4728) (at the age of 29 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took Amoxicillin and had allergy. No previous COVID-19 infection. The patient previously took first dose of BioNTech/Pfizer vaccin (Comirnaty) on 25Jun2021 for COVID-19 immunisation and experienced headache, fever, malaise, fatigue and maternal exposure during pregnancy, first trimester (4 weeks). On 31Jul2021 (as reported), patient experienced fatigue. On 01Aug2021 (1 day after start), patient had headache and malaise. On 05Aug2021 (5 days after start), patient had pyrexia. The patient experienced miscarriage on 05Aug2021. The miscarriage occurred at a pregnancy duration of about 10 weeks. The first COVID-19 vaccination took place at a pregnancy duration of about 4 weeks, and the second COVID-19 vaccination took place at a pregnancy duration of about 9 weeks. The mother reported she became pregnant while taking bnt162b2. The mother was 10 weeks pregnant at the onset of the event. The mother delivered the pregnancy on 05Aug2021. The pregnancy resulted in spontaneous abortion. The fetal outcome is intrauterine death. Fetus has stopped growing after a few weeks of vaccination. The patient underwent lab tests and procedures which included body temperature: 38-40.5 centigrade on 27Jun2021 (Fever: 38 to 40.5 degrees Celsius) and ultrasound examination: unknown results on unspecified date. The outcome of the events fatigue, headache and pyrexia was not recovered; event malaise was recovered on 04Aug2021. Sender''s comments: HA death and birth defect altered in cioms other medically important condition. Reporter''s comments: -BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: Headache, tired, feeling unwell, fever Date: 25Jun2021. -Miscarriage Additional information ADR: fetus has stopped growing after a few weeks of vaccination. - confounding factors allergy: Amoxicillin. COVID-19 vaccine exposure during pregnancy week: 4. - COVID-19 Previous COVID-19 infection: No. - Other diagnostic procedures: Ultrasound examination. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Past drug therapy (Comirnaty) ADRs: Headache, tired, feeling unwell, fever -Miscarriage -fetus has stopped growing after a few weeks of vaccination -exposure during pregnancy week: 4; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101082456 same patient/ drug, different events and dose;NL-PFIZER INC-202101082457 fetus case


VAERS ID: 1640778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210852012

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician by a Regulatory authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-041695) was received on 24-AUG-2021 and concerned a 26 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN) dose was not reported,1 total, administered on 01-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient had vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition)


VAERS ID: 1640779 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210851914

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-041696) on 24-AUG-2021 and concerned a 41 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN) dose was not reported, 1 total administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1640780 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210851421

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory Authority (EMEA EVHUMAN NLP, AT-BASGAGES-2021-041697) on 24-AUG-2021 and concerned a 22 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint.


VAERS ID: 1640849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 6742981-8 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Back pain, Blood test, Headache, Malaise, Myalgia, Neck pain, Peripartum haemorrhage, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Eosinophilic pneumonia (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUPHASTON
Current Illness:
Preexisting Conditions: Comments:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Blood tests; Result Unstructured Data: Test Result:miscarriage
CDC Split Type: BEPFIZER INC202101054455

Write-up: Fever; Malaise/felt unwell; Headache; Neck pain; Back pain; Myalgia; Bleeding peripartum/Blood loss; Miscarriage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-103971. This consumer reported information for mother. This is a maternal report. A 31-year-old pregnant (including at the time of vaccination) female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: 6742981-8) as dose 2, single for COVID-19 immunization. Medical history was not reported. Concomitant medication included dydrogesterone (DUPHASTON 10mg strength) taken for unspecified indication and therapy date. It was reported that the patient had fever, felt unwell/malaise, headache, myalgia, neck and back pain on 31Jul2021 (in the days after the vaccine). The mother was first trimester pregnant at the onset of the event. It was mentioned that pregnancy progressed with no problems before the vaccine. It was also mentioned that the patient had bleeding peripartum/blood loss started the day after the vaccine (31Jul2021) and the pregnancy ended in a miscarriage. Blood tests showed miscarriage in the days after the vaccine. No treatment was received for the events. The events were considered as serious (medically significant). Outcome of miscarriage was unknown and recovered from the remaining events on 04Aug2021 (but also reported as recovering). Reporter comment: Treatment: No No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: Treatment: No


VAERS ID: 1642712 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea
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:
CDC Split Type: PHJNJFOC20210852718

Write-up: SOB; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300100391] concerned a 57 year old male of unspecified 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, route of administration not reported, batch number: unknown) dose was not reported, one total, administered on 31-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 31-JUL-2021, the patient experienced shortness of breath (SOB), and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from SOB. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210852718-Covid-19 vaccine ad26.cov2.s-SOB (Shortness of breath). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1654208 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210850258

Write-up: VACCINATION FAILURE; SARS-COV-2 INFECTION; This spontaneous report received from a physician via Regulatory authority (AT-BASGAGES-2021-041699) on 24-AUG-2021 and concerned a 26 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD974 expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced vaccination failure and sars-cov-2 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccination failure and sars-cov-2 infection was not reported. This report was serious (Other Medically Important Condition). This case is associated with product quality complaint


VAERS ID: 1663461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210855665

Write-up: LUNG EMBOLISM; PNEUMONIA FOLLOWING PULMONARY INFARCTION; This spontaneous report received from a consumer by a Regulatory authority (EVHUMAN Vaccines, DE-PEI-202100171791) was received on 26-AUG-2021 and concerned a 24 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: UNKNOWN) 1 dosage forms,1 total, administered on 06-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced lung embolism, pneumonia following pulmonary infarction and was hospitalized (date unspecified) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lung embolism, and pneumonia following pulmonary infarction. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).


VAERS ID: 1664437 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-07-31
   Days after vaccination:65
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101075633

Write-up: Early miscarriage; This is a non-interventional study/solicited report from a contactable consumer received from the Regulatory Agency (RA), Yellow Card Vaccine Monitor program. The regulatory authority report number is GB-MHRA-YCVM-202108182031190660-HIC9N. Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25820414. This is a maternal report. A 43-years-old pregnant female patient (last menstrual period date: 06May2021, Gestation period: 12 weeks, 12 Weeks pregnant at the onset of the event) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW3143), via an unspecified route of administration on 27May2021 as dose 1, single for covid-19 vaccination (covid-19 immunization). Medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19 and not had a COVID-19 test. The mother was due to deliver on 10Feb2022. It was stated that, on 31Jul2021, the patient experienced early miscarriage. The event was reported as serious with seriousness criteria as hospitalization on an unknown date in 2021. Patient was not enrolled in clinical trial. The outcome for the event was reported as recovered on 07Aug2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664704 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: 20210731; Test Name: BP; Result Unstructured Data: Test Result: 97/57; Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:90/64; Comments: at 14:20; Test Date: 20210731; Test Name: P; Result Unstructured Data: Test Result:78; Comments: at 14:20; Test Date: 20210731; Test Name: consciousness level; Result Unstructured Data: Test Result: JCS 0; Test Date: 20210731; Test Name: SPO2; Result Unstructured Data: Test Result: 98; Comments: at 14:20
CDC Split Type: JPPFIZER INC202101066184

Write-up: Loss of consciousness; fell; This is a spontaneous report from a contactable other healthcare professional received from the Devices Agency (DA). Regulatory authority report number: v21123662. A 15-years-7-month-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 31Jul2021 at 13:48 (Batch/Lot Number: FA5829; Expiration Date: 31Aug2021) as dose 1, single (at the age of 15-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The event onset date was 31Jul2021 at 13:52 (4 minutes after the vaccination). The event course was reported as follows: the patient experienced loss of consciousness in the waiting room and fell from the chair with the face down. When the medical staff arrived, the patient''s consciousness level was at JCS 0, the patient was able to talk, and was transferred to the Emergency Room. BP 97/57, level clear (as reported), no paralysis, no queasy, trance, able to do it by oneself (as reported) and observed the patient 30 minutes. At 14:20, P 78, BP 90/64, SPO2 98, level clear, no subjective symptom. On 31Jul2021, the events resolved. The reporter classified the event as non-serious and the causality between the events and bn162b2 as non-assessable. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1664789 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Coma scale, Fall, Loss of consciousness, Presyncope, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Seizure
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20210731; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:1 for eye opening (E1), 1 for verbal response (V1); Comments: 1 for eye opening (E1), 1 for verbal response (V1), and 1 for motor response (M1)
CDC Split Type: JPPFIZER INC202101076107

Write-up: Loss of consciousness; generalised tonic convulsion; Vasovagal reflex; fell down from the chair; This is a spontaneous report from a contactable physician received from the Devices Agency (DA). Regulatory authority report number is v21123881. A 17-year and 10-month-old patient of an unspecified gender received BNT162B2 (COMIRNATY), dose 1 intramuscular on 31Jul2021 11:30 (Lot Number: FC8736; Expiration Date: 30Sep2021) (at age of 17-year and 10-month-old ) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included seizure. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.2 Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 31Jul2021 (the day of vaccination), the patient experienced loss of consciousness (medically significant), generalised tonic convulsion (medically significant), vasovagal reflex (non-serious), fell down from the chair (non-serious). The event course was reported as follows: After the vaccination, the patient had a rest in 15 minutes after the intramuscular administration. The patient suddenly experienced loss of consciousness, fell down from the chair. The score of the Glasgow Coma Scale (GCS) was 1 for eye opening (E1), 1 for verbal response (V1), and 1 for motor response (M1). few seconds after fall, the patient experienced 10 seconds of generalised tonic convulsion. After that, the patient''s consciousness became clear gradually. Reportedly, the patient had previously experienced a seizure though the clinical course at that time was unknown(did not have the examination of it). The outcome of the events was resolving. The reporter classified the event as non-serious and the causality between the event and bn162b2 as unassessable. Reporter''s comment: It was considered that the loss of consciousness should be regarded as vasovagal reflex (VVR). The causality between the tonic convulsion and bn162b2 was unclear. Since seizure was happened before, a possibility that a recurrent seizure at the time of the 2nd vaccination might lead to convulsive status epilepticus could not be ruled out. Therefore, it would be preferable for the patient to receive the vaccination in a medical facility with adequate manpower. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: It was considered that the loss of consciousness should be regarded as vasovagal reflex (VVR). The causality between the tonic convulsion and bn162b2 was unclear. Since seizure was happened before, a possibility that a recurrent seizure at the time of the 2nd vaccination might lead to convulsive status epilepticus could not be ruled out. Therefore, it would be preferable for the patient to receive the vaccination in a medical facility with adequate manpower.


VAERS ID: 1668001 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoacusis, Maternal exposure during pregnancy
SMQs:, Hearing impairment (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Drug allergy; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101079111

Write-up: Hearing decreased; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable consumer (patient), downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PB20215417. This is a maternal report. A 29-years-old pregnant female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: FE8244), via intramuscular route on 31Jul2021 (at the age of 29-years-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism and drug allergy; both from an unknown start and stop date. Concomitant medications were not reported. The patient was pregnant at the time of vaccination and had maternal exposure during pregnancy, second trimester. The patient was in her second trimester of pregnancy at the time of vaccine exposure and at the onset of the event. On 31Jul2021, (reported as 4 hours or 1 day) after vaccination, the patient experienced hearing decreased. Patient had a hearing loss in the left ear (sensation of a veil as when your ear is blocked after swimming in the pool) which persists 1 week later, appointment taken at the ENT. Lack of healing. It was reported no re-challenge was done, recurrence is not applicable. The outcome of the event hearing decreased was reported as not recovered at the time of report.


VAERS ID: 1676129 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Vulval ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101086947

Write-up: Ulceration of vulva; Fever; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency (MA) EudraVigilance-WEB FR-AFSSAPS-NC20213587. A 15-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 31Jul2021 (Batch/Lot Number: FF0680) (at the age of 15 years old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of Comirnaty on 20Jun2021 (batch FD0168) for COVID-19 immunisation. The patient experienced ulceration of vulva on 02Aug2021. From 31Jul2021 to 04Aug2021, patient had fever. On 02Aug2021, the patient reported ""LIPSCHUTZ (acute vulva ulcer). Summary of ongoing medical care included consultation, went to Emergency Room, not hospitalized. Treatment with Xylocaine in cream for pain (additional information obtained by the Regional Pharmacovigilance Centre). The report is serious (medically significant). The outcome of the event ulceration of vulva was not recovered; and event fever was recovered on 04Aug2021. Possible accountability established according to the usual French method (Ministry of Health No. 84/50, 24Jan1985. Published in Therapies 2011; 66(6): 517- 525) is evidently without prejudice to the elements of investigations that could be carried out as part of legal or amicable compensation. No follow-up attempts possible. No further information expected.


VAERS ID: 1690201 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   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 FD7959 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Alanine aminotransferase, Aspartate aminotransferase, Blood pressure measurement, Chest discomfort, Chest pain, HELLP syndrome, Headache, Hepatic function abnormal, Hypertension, Investigation, Maternal exposure during pregnancy, Platelet count, Proteinuria, SARS-CoV-2 test, Ultrasound scan, Urine analysis, Urine protein/creatinine ratio, Vomiting
SMQs:, Acute renal failure (broad), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Chronic kidney disease (broad), Proteinuria (narrow), Tubulointerstitial diseases (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Embryo transfer (Pregnancy obtained by receiving an embryo on mixed infertility. G1P0); Metrorrhagia; Pregnancy
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: ALAT; Result Unstructured Data: Test Result:59; Test Date: 20210820; Test Name: ASAT; Result Unstructured Data: Test Result:67; Test Date: 20210814; Test Name: blood pressure; Result Unstructured Data: Test Result:180/79; Test Date: 20210820; Test Name: Investigation; Result Unstructured Data: Test Result:Persistence of hypertension, stable platelets, deg; Comments: Persistence of hypertension, stable platelets, degradation of liver function, protein / creatinine ratio = 187; Test Date: 20210820; Test Name: platelet count; Result Unstructured Data: Test Result:150; Test Date: 20210814; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Name: Ultrasound; Result Unstructured Data: Test Result:First trimester ultrasound unremarkable; Test Date: 20210813; Test Name: Ultrasound; Result Unstructured Data: Test Result:Ultrasound showing evidence of intrauterine growth; Comments: Ultrasound showing evidence of intrauterine growth retardation less than 1p with diastole.; Test Date: 20210814; Test Name: urine test; Result Unstructured Data: Test Result:proteinuria; Test Date: 20210820; Test Name: protein/creatinine ratio; Result Unstructured Data: Test Result:187
CDC Split Type: FRPFIZER INC202101155175

Write-up: Hypertension arterial; proteinuria; headache; epigastric pain; degradation of liver function; HELLP syndrome; a sharp pain under the sternum (tightness); a sharp pain under the sternum (tightness); vomiting; Maternal Exposure During Pregnancy, second trimester; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB FR-AFSSAPS-MP20217002. This is the first of two reports for mother report. A 38-year-old pregnant female patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular in the left arm on 31Jul2021 (at the age of 38-year-old; Lot number: FD7959) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included embryo receiving on 25Apr2021 (pregnancy obtained by receiving an embryo on mixed infertility, G1P0). Pregnancy date on 25Apr2021. Early pregnancy marked by metrorrhagia. First trimester ultrasound unremarkable. Date of LMP was 11Apr2021. Pregnancy due date was 16Jan2022. No history of COVID-19. Concomitant medications were not provided. The patient experienced maternal exposure during pregnancy, second trimester on 31Jul2021; hypertension arterial on 14Aug2021; HELLP syndrome (life-threatening) on 20Aug2021. On 01Aug2021, the patient reported the night following the vaccination a sharp pain under the sternum (tightness) and vomiting. Persistence of this oppression. On 13Aug2021, ultrasound showing evidence of intrauterine growth retardation less than 1p with diastole. On 14Aug2021, hospitalization for severe arterial hypertension (180/79) associated with proteinuria. Clinically the patient presented headaches. Introduction of nicardipine (LOXEN). Concept of epigastric pain the following days. On 20Aug2021, blood test disturbance: ASAT was 67, ALAT was 59, platelets were 150, vomiting. Persistence of hypertension, stable platelets, degradation of liver function, protein/creatinine ratio was 187. Decision of a medical termination of pregnancy for maternal rescue with foeticide - mifegyne and laminaria. On 22Aug2021, low delivery breech delivery (vaginal) at the end of 19 weeks of a lifeless child (foetal death, still birth, intrauterine death). All in all, discovery of hypertension associated with proteinuria 15 days after a first dose of vaccine, with progression to HELLP syndrome in a 38-year-old patient with no particular history, requiring medical termination of pregnancy for maternal rescue. Gestation period when reaction/event was observed in the foetus was 19 weeks. Gestation period at time of exposure of bnt162b2 was 16 weeks. Lab data included ultrasound: first trimester ultrasound unremarkable on unspecified date. On 14Aug2021, SARS-CoV-2 test: negative, blood pressure: 180/79, urine test: proteinuria. On 13Aug2021, ultrasound showing evidence of intrauterine growth retardation less than 1p with diastole. On 20Aug2021, ASAT: 67, ALAT: 59, platelet count: 150, Investigation: Persistence of hypertension, stable platelets, degradation of liver function, protein/creatinine ratio was 187. Treatment received for maternal exposure during pregnancy, second trimester; HELLP syndrome; hypertension arterial; proteinuria; a sharp pain under the sternum (tightness); vomiting; headache. Outcome of events maternal exposure during pregnancy, second trimester and HELLP syndrome was recovered with sequel on 22Aug2021, of the event hypertension arterial was recovered on 22Aug2021, while of the other events was unknown.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101168814 maternal /child case.


VAERS ID: 1706157 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8235 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hyperhidrosis, Inappropriate schedule of product administration, Pallor, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101148806

Write-up: Fainting/losing 10 minutes after getting out of bed; sweaty face 10 min after getting out of bed; Headache when waking up; 10 min after getting out of bed white face; 10 min after getting out of bed very hot; Inappropriate schedule of vaccine administered; This is a spontaneous report a contactable consumer downloaded from the [NL-LRB-00659987], Safety Report Unique Identifier [NL-LRB-00676414]. A 12-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot#: FE8235) at single dose on 31Jul2021 at the age of 12-year-old for COVID-19 immunisation. The first dose was on 16Jul2021. Medical history and concomitant medication were not reported. On 31Jul2021 (also reported as 1 days after start), patient experienced fainting/losing 10 minutes after getting out of bed, sweaty face 10 min after getting out of bed, headache when waking up, 10 min after getting out of bed white face, 10 min after getting out of bed very hot, inappropriate schedule of vaccine administered. Patient was with syncope, headache, pallor facial, sweating, fever following administration of covid-19 vaccin pfizer solution for injection. In combination with white face and very warm (sweating face). Previous COVID-19 infection was no. Diagnostic procedures was no. The patient was recovering from the events syncope, sweating, headache, pallor facial and fever. The outcome of rest events was unknown. No follow-up attempts possible. No further information expected.


VAERS ID: 1514241 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 AR / IM

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

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

Write-up: Grand mal seizure took place about 10 minutes after administration. Paramedics arrived on scene after seizure had ended. Upon examining the patient, EMT determined the pt was fit to go home


VAERS ID: 1514832 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

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

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

Write-up: Fever, nausea, vomiting, stomach cramps, headache


VAERS ID: 1515070 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA OSZC21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Dizziness, Dyspnoea, Neck pain
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Arthritis (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: Blood pressure medication 12.5 mg
Current Illness: None
Preexisting Conditions: High blood pressure
Allergies: Peniciin, Latex, Sulfa drugs, Nickel, Levaquin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe pain in shoulders and neck, couldn''t breathe, felt like she was going to pass out. ( 2 episode) 7/30/2021 at 2:30/3am.


VAERS ID: 1515087 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-07-28
Onset:2021-07-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dysmenorrhoea, Hot flush, Menstruation irregular
SMQs:, Fertility disorders (broad)

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

Write-up: menstrual bleeding 2 days after being administered the vaccine (menstrual cycle was not supposed to begin until the next week). bleeding was accompanied by cramping as well as hot flashes.


VAERS ID: 1515120 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / IM

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

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

Write-up: patient waited her 15 minutes and when she got ready to leave, she said she was feeling light headed and faint. She went to front of store to get a coke and came back to pharmacy to ask what to do. RPh said to sit and put head between legs and take deep breaths, but before we could even suggest anything else, patient was swaying and fell into vaccination screen. She immediately came to but had bit her lip when falling and her head on screen and side/back on chair. Ambulance arrived and took her vitals and everything checked out ok, but patient refused to go with them. Her husband came and picked her up and stated she would go see her dr.


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